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Maintaining standards for surgery for female urinary incontinence
Maturitas 65 (2010) 5–10
Contents lists available at ScienceDirect
Maturitas journal homepage: www.elsevier.com/locate/maturitas
Review
Maintaining standards for surgery for female urinary incontinence P. Riss ∗ , S. Hinterholzer Department of Gynecology & Obstetrics, Landesklinikum Thermenregion Moedling, Sr. Maria Restituta Gasse 12, A-2340 Moedling, Austria
a r t i c l e
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Article history: Received 20 October 2009 Accepted 22 October 2009
Keywords: Stress urinary incontinence Surgery Tension free tapes Fascial slings
a b s t r a c t Maintaining standards in surgery for female urinary incontinence: Operations for female stress urinary incontinence (SUI) are among the most common operations performed. In particular, recent advances in surgical technique and materials available for this type of surgery have made these operations more accessible, but even if an operation is characterized as “minimally invasive” surgeons must aim to maintain the highest possible standards in the interest of their patients. Standards in patient selection: Great care has to be taken to do a thorough workup of a patient about to undergo surgery. A detailed history and a good clinical evaluation including a clinical stress test is a prerequisite. It is highly recommended to do an urodynamic investigation prior to any surgery which affects bladder storage and micturition in order to confirm the presumptive diagnosis and to exclude patients who should not undergo surgery (e.g. with voiding disorders). Standards in surgery: Before taking a patient to theatre the surgeon must be clear in him or her mind about which operation to do. In other words preoperative selection of the appropriate type of operation is of the greatest importance. For this reason every surgeon has to be familiar with a certain range of incontinence procedures from which she can choose in a particular instance. There is no doubt that tension-free mid-urethral slings have become the procedures of choice in most cases of stress urinary incontinence. However, there will be cases where other procedures are called for such as traditional colposuspension or fascial slings. It is the responsibility of every surgeon not to use procedures which are outdated or not recommended. To maintain standards in incontinence surgery every surgeon has to familiarize him or herself with the procedure, to learn the procedure, to practice the procedure with the help of experienced peers, and finally to achieve the highest level of competence him or herself. So-called Industry sponsored “training centres” can be helpful but there are no shortcut to use all possible resources to learn and practice new surgery. Guidelines have become very important in evaluating new procedures and in categorizing the available evidence. They focus on specific recommendations which we can and should use in our daily practice. Again we still have the responsibility to follow the medical literature closely and to adapt our practice as new evidence becomes available—even before it is incorporated into guidelines. Standards in follow-up: Last but not least we have to follow standards when following up on our patients. As far as possible in the context of the health care system where we practice we should aim to see the patient we have operated on at least once 6–12 weeks after surgery. We must also make sure that the patient has access to care in case a problem develops later. And we ourselves must be familiar with the complications and consequences of surgery for stress urinary incontinence and must be able to manage a patient who is not completely satisfied after surgery. © 2009 Elsevier Ireland Ltd. All rights reserved.
Contents 1. 2.
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Standards in patient selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1. Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2. Clinical stress test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3. Urodynamic testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
∗ Corresponding author. Tel.: +43 2236 204 231; fax: +43 2236 204 245. E-mail addresses: [email protected] (P. Riss), [email protected] (S. Hinterholzer). 0378-5122/$ – see front matter © 2009 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.maturitas.2009.10.005
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Standards in surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1. Tension-free mid-urethral sling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2. Burch colposuspension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3. Abdomino-vaginal sling operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4. Criteria for selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Standards in follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1. Clinical follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2. Registries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3. Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4. Comparative effectiveness research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Competing interests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1. Introduction Urinary incontinence is a common disorder which affects many women and often severely impacts on quality of life [1]. Surgery is often seen as a quick fix for urinary incontinence, and indeed can be very successful if the incontinence is due to defective bladder closure mechanism. However, incontinence can also be due to other factors such as an overactive bladder. In these cases surgery is bound to fail because the problem is not the closure mechanism of the bladder. Another reason why surgery must never be undertaken lightly is that every operation also is potentially harmful and can cause transient or long-lasting complications [2–5]. Therefore the decision to proceed with surgery must be made carefully and responsibly. This is particularly true for elective operations which aim to improve a function. This review therefore addresses the issues relevant to incontinence surgery regarding patient selection, standards in surgery and follow-up. Every health care provider must aim for the highest standards in elective surgery so that the expected benefits outweigh any possible complications and that the patient goes home and remains satisfied with the procedure. 2. Standards in patient selection The question always is: is the patient a candidate for this kind of surgery? And if yes, which preoperative diagnostic procedure must be undertaken in order to maintain a high standard in patient selection. 2.1. Indication Strictly speaking the only indication for surgery for female urinary incontinence is stress incontinence. The effect of all operations for incontinence is to increase the pressure in the urethra at the time of an increase in bladder pressure—such as during coughing, sneezing, and heavy lifting. Many believe that these operations cause a certain degree of obstruction. It would be unreasonable to assume that such an operation also would improve symptoms of urgency or even cure incontinence due ton uncontrollable urgency and detrusor contractions. It goes without saying that the same is true of course for incontinence due to other causes such as fistulas or neurologic disease. Not only must the patient suffer from stress urinary incontinence, she must also be sufficiently affected in her daily activities and quality of life in order to be a candidate for surgery [6,7]. Many women experience isolated incidents of stress incontinence from time to time and know perfectly well how to avoid these situations. In order to become a candidate for surgery stress incontinence must be bothersome and severe enough to warrant surgery.
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When treating a patient with incontinence and considering surgery every doctor must ask him or herself 2 questions: 1. is the diagnosis stress urinary incontinence? and 2. is the incontinence bothersome enough to warrant surgical intervention? While this seems reasonable enough in actual clinical practice things often are not as straightforward. First of all many women, especially older women, show symptoms of both stress and urge incontinence so that the diagnosis of mixed incontinence is made. In these cases the effect of surgery is very difficult to predict: while the stress component might be improved, urgency can be better, unchanged or even worse after the operation [8–10]. Also the degree of bother by incontinence can be assessed by a good history or with the use of a questionnaire. One must remember that the severity of symptoms can change and that the same symptom can be experienced differently by different women. It is therefore highly recommended never to force an operation for stress urinary incontinence on a patient but offer the operation to the patient and have her ask for it specifically—often after a trial of pelvic floor exercises or other conservative measures. Symptoms may also improve with lifestyle changes such as retirement, and it is reassuring for many patients to be told that these operations can be done irrespective of age and that there is no harm in waiting. 2.2. Clinical stress test The clinical stress test (or bladder stress test) is a very simple but extremely useful test which must be undertaken in every patient planning to undergo surgery for stress incontinence [11]. Urinary tract infection must be ruled out. The bladder is filled to 300 ml and the patient is asked to cough in the supine and standing position (Table 1). The physician can directly observe the loss of urine on coughing (Fig. 1). By placing 2 fingers into the vagina next to the bladder neck and elevating them one can see the potential effect of incontinence surgery on the closure mechanism of the urethra. This simple to perform and inexpensive test helps to answer 2 questions: can urgency as the cause of incontinence be ruled out? And how severe is the loss of urine on straining? With some experience it is easy to assess the intensity of the cough and to grade the concomitant loss of urine. Also a patient who experiences the first desire to void at around 100 ml and tolerates the filling of the bladder to 300 ml most probably does not suffer from severe urgency incontinence. 2.3. Urodynamic testing There is no consensus whether a full urodynamic workup is required before every operation for stress urinary incontinence [12,13]. If we look for guidelines for guidance we note that very
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Table 1 The clinical stress test. Performance Empty bladder/residual urine with catheter Bladder filling to 300 ml First sensation to void Bladder capacity Coughing supine/standing Information gained Residual urine (ml) First sensation to void (ml) Involuntary detrusor contractions (±) Maximum bladder capacity (ml)a Loss of urine on coughing supine/standing (±) Effect of the elevation of the bladder neck on loss of urine (±) a Bladder filling is usually stopped at 300 ml to have a standardized bladder volume when asking the patient o cough. Although strictly speaking the maximum bladder capacity is not determined. It is possible to determine whether the patient tolerates filling up to 300 ml or has a reduced bladder capacity.
often the wording is vague and leaves ample room for individualized decision making. It is also not always entirely clear why urodynamics are done: to make the proper positive diagnosis, to exclude other diagnoses, to help in decision making, to improve outcome after surgery, or to increase patient satisfaction? There is no doubt that urodynamic investigations are very helpful to establish the diagnosis of stress urinary incontinence and to exclude urge incontinence. It is less clear whether the use of urodynamics improves overall outcome as has been shown in a Cochrane review and subsequent papers [14,15]. Several authors have tried to define subgroups of patients in whom urodynamic investigation can be safely omitted before surgery [16,17] but at the present time no definite conclusions can be drawn. The NICE (National Institute of Clinical Excellence) Guidelines on Urinary Incontinence [18] state that “Urodynamics are of value if the clinical diagnosis is unclear prior to surgery or if initial surgical treatment has failed”. However, more recently, the International Consultation on Incontinence in Paris in 2008 recommended that “urodynamic studies are carried out in all women prior to surgical intervention for stress urinary incontinence” [19,20], this in spite of the vague wording by the same committee “that the result of urodynamic investigation is applied to ‘optimise’ treatment strategy without attributing perfect specificity to the result of treatment, in an individual patient” and “that the cost effectivity of urodynamic testing is taken into account when discussing the necessity of urodynamic investigation.” To summarize these seemingly contradictive recommendations it is safe to say that
Fig. 1. Clinical stress test. Loss of (dyed) urine is observed with the patient coughing in the supine position.
Fig. 2. Pelvic model. The arrows indicate the location of the retropubic sling, the transobturator sling and the short-arm sling.
(1) urodynamics are useful in assessing and evaluating a patient with incontinence, (2) it is possible to exclude urge incontinence, (3) urodynamics should always be done when repeat surgery is considered after failed primary surgery for incontinence, and (4) urodynamics probably are not necessary in a routine preoperative workup when the diagnosis of stress urinary incontinence can be made on clinical grounds. 3. Standards in surgery Over the years many operations to cure or at least improve stress urinary incontinence have been developed [21–24]. All of them aim to increase the pressure in the urethra when there is an increase in pressure in the bladder. They usually achieve this by providing support under the urethra, by elevating the proximal urethra or by causing obstruction. It is impossible to be familiar with and an expert in many different procedures. Every surgeon should aim to become experienced with a few proven procedures which she or he can use depending on the circumstances—e.g. primary or secondary procedure, low urethral pressure, or mixed incontinence. 3.1. Tension-free mid-urethral sling Tension-free mid-urethral slings were introduced by Ulmsten et al. in 1996 [21] and have since become the de-facto gold standard in incontinence surgery. These operations are based on a valid theory, namely that continence is based on the fact that the highest pressure in the urethra on stress is achieved in the mid-urethra, and that is where the tapes are placed. Since they must be placed without tension there is very little obstruction, making recovery of normal micturition after surgery much easier than with other, older procedures. The placement of tension-free mid-urethral slings is technically relatively easy, operation time is short, and the frequency of possible complications is low. Most important cure rates after mid-urethral slings are between 70 and 90% depending on the definition of cure, and they remain stable over time. Currently there are 3 possible approaches in use (Fig. 2): the retropubic approach as originally described by Ulmsten et al. [21], the transobturator approach [24,25], and the so-called short slings. The transobturator approach was developed in order to avoid bladder perforations, and short slings are an industry driven development with insufficient data to support their widespread adoption.
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Table 2 Comparison between retropubic and transobturator tension-free mid-urethral slings.
Success rate Technical difficulty Bladder perforation Pain Hematoma Abscess
Retropubic
Transobturator
+ + + 0 + 0
+ + 0 + +/0 +
The success rates of retropubic and transobturator slings are similar [3,26–29]. It seems that retropubic slings are slightly superior in patients with a low-pressure urethra, while transobturator sling seem to cause fewer de novo postoperative urgency problems [30–33]. Table 2 summarizes the differences between the retropubic and the transobturator approach. 3.2. Burch colposuspension Before the advent of tension-free mid-urethral slings the Burch colposuspension was the preferred operation for stress incontinence. The space of Retzius is entered from above, the vaginal fascia is exposed and elevated in the direction of the pelvic brim, and 2–4 sutures are placed between the vaginal fascia and the periostium of the anterior ramus of the pubic bone (i.e. Cooper’s ligament) [34]. The operation is standardized and gives excellent short and long term results. However, laparotomy – or sometimes laparoscopy – is required making the procedure much more invasive than the mid-urethral slings. Today Burch colposuspension is used mainly in cases of recurrence or in conjunction with laparotomy for other indications. 3.3. Abdomino-vaginal sling operation Abdomino-vaginal sling operations are more complex procedures where fascia is harvested from the abdominal wall or from the fascia lata and placed under the urethra and passed behind the symphysis to the abdominal fascia [34]. These operations are performed when other operations have failed, maximum pressure in the urethra is low or the vagina is of insufficient length or mobility. Although abdomino-vaginal sling operations have a high success rate a common postoperative problem is obstruction resulting in the need for self-catheterization. 3.4. Criteria for selection The selection of a specific operation for stress urinary incontinence will depend on several factors. Most important the operation must have a high success rate, implying that there is sufficient data to warrant such a claim. The frequency and type and severity of complications also play an important role. For example bladder perforations occur almost exclusively with retropubic mid-urethral Table 3 Austrian TVT registry. Patients entered Median Op time Anesthesia
Bladder perforation Reoperation Tamussino et al. [36].
Minutes Local Regional General Previous surgery w/o previous surg Total Hematoma
2795 30 (10–120) 44% 43% 12% 4.4% 2.0% 2.4% 0.7%
slings (ca 5%) but are of little consequence when diagnosed during surgery. Thigh pain, tape exposure and infection are more often seen with the transobturator approach [35,36]. Often the decision to choose a certain procedure is also based on the personal experience and preference of the surgeon. Increasingly attention is paid to the expectations of the patient. It is obvious that patients worry about improved bladder function after surgery, but recent studies have shown that patients also are concerned about the time to resume work and the effect of surgery on sexual function [37]. 4. Standards in follow-up 4.1. Clinical follow-up The most important follow-up is the one by the physician or the institution where the operation was performed. It is customary to see the patient 6–12 weeks after the operation when healing is completed, and a second time after one year when it is possible to evaluate function. The learning effect of such a program of quality assurance for the individual physician must not be underestimated. 4.2. Registries Because data from many centres are collected and entered in the registry it is an excellent means to give a cross-section of surgical practice and to discover even rare complications [36,38,39] (Table 3). However, to calculate the frequency of rare events one must be sure that the denominator is known, which means that all operations at participating centres must be reported. In order for a registry to work it must be easy to administer, entry criteria must be very clear, report forms must not be too long, and problems must be quickly addressed. Registries are particularly useful as an instrument to monitor a surgical procedure after its introduction [36]. It is preferable for registries to be set up and administered by a recognized academic institution or a professional society. Industry-sponsored registries usually do not include products from competing firms, data is entirely in the hands of industry, and there is always the danger that the company loses interest and closes a registry prematurely. 4.3. Trials Case series and registries produce important information but it is highly desirable to have prospective trials which compare different procedures to established operations. Fortunately for the retropubic mid-urethral sling Ward and Hilton [40] did just such a prospective, randomized comparison between a retropubic sling (TVTTM ) and the Burch colposuspension. However, registries and trials take years to be completed. Fig. 3 shows the timeline from the presentation of the new procedure by Ulmsten et al. and the publication of the results of the Austrian TVT registry (Tamussino et al. [36]) and of the Ward & Hilton trial [40]. What is disturbing but not unexpected is the observation that from 1998 to 2002 more than 10,000 kits for TVT were sold in Austria alone by one company (Gynecare personal communication). 4.4. Comparative effectiveness research Recently the field of comparative effectiveness research (CER) has attracted attention. Clinical trials usually look only at a set of parameters (primary and secondary outcomes) but do deal with the question how a treatment might benefit a particular patient. The latter obviously depends on many additional factors which usually are not addressed in trials: socioeconomic status, access to health
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References
Fig. 3. TVT Publications. Total number of publications called up with the keyword “TVT” on PubMed on May 13,2009.
care, insurance, compliance, work and lifestyle factors CER also tries to address the question how health care money can be used for maximum effect in a particular disease and in a specific setting. It is interesting to note that the United States is giving generous funding to CER of drugs, medical devices, surgical procedures, etc. in the hope of allocating resources more effectively [41,42]. Urinary incontinence and operations for incontinence are ideal subjects for CER. New procedures are described and new technology is introduced all the time making it difficult for a physician to sort through the data and to determine what will work best and with maximum effect for the resources available in typical patient.
5. Conclusion The diagnosis and surgical treatment of female urinary incontinence have become standardized, and several excellent operations are available with tension-free mid-urethral slings the de-facto gold standard. The individual surgeon can turn with confidence to guidelines and reviews to determine how a woman with urinary incontinence should be evaluated and which surgical treatment would be appropriate. Ongoing research is focusing more on the patient’s perspective, her expectations and her goals. This is a trend away from purely clinical trials with a short list of endpoints which may not be aligned with what the patient has in mind. It is to be expected that comparative effectiveness research (CER) will focus on the larger context in which surgery for female urinary incontinence is performed, on what will work best in a typical patient and how health care monies are allocated with maximum effect to help women with urinary incontinence.
Provenance Commissioned and externally peer reviewed.
Contributors Paul Riss, PhD., M.D. and Susanne Hinterholzer M.D. contributed equally to this manuscript.
Competing interests Paul Riss: speaker’s fees from Astellas, travel support from Gynecare. Susanne Hinterholzer: none.
[1] Abrams P, Cardozo L, Fall M, et al. The standardization of terminology of the lower urinary tract function. Report from the standardization subcommittee of the International Continence Society. Neurourol Urodyn 2002;21:167–78. [2] Karram MM, Sehal JL, Vassallo BJ, Kleeman SD. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol 2003;101:929–32. [3] Latthe PM, Foon R, Tooz-Hobson P. Transobturator and retropubic tape procedure in stress urinary incontinence: a systematic review and meta-analysis of effectiveness and complications. BJOG 2007;114:522–31. [4] Sung VW, Schleinitz MD, Radin CR, Ward RM, Meyers DL. Comparison of retropubic vs transobturator approach to midurethral slings: a systematic review and meta-analysis. Am J Obstet Gynecol 2007;197:3–11. [5] Vervest HA, Bisseling TM, Heintz AP, Schraffortdt Koops SE. The prevalence of voiding difficulty after TVT, its impact on quality of life, and related risk factors. Int Urogyn J Pelvic Floor Dysfunct 2007;18(2):173–82. [6] Langford CF, Elmissiry MM, Ghoniem GM. Do women have realistic expectations of treatment for stress urinary incontinence? Neurourol Urodyn 2009;27:480–4. [7] Kelleher CJ, Cardozo LD, Khullar V, et al. A new questionnaire to assess the quality of life of urinary incontinent women. BJOG 1997;104:1374–9. [8] Campeau L, Tu LM, Lermieux MC, et al. A multicenter, prospective, randomized clinical trial comparing tension-free vaginal tape surgery and no treatment for the management of stress urinary incontinence in elderly women. Neurourol Urodyn 2007;26(7):990–4. [9] Holmgren C, Nilsson S, Lanner L, Hellberg D. Frequency of de novo urgency in 463 women who had undergone the tension-free vaginal tape procedure for genuine stress urinary incontinence—a long term follow up. Eur J Obstet Gynecol Reprod Biol 2007;132(May (1)):121–5. [10] Holmgren C, Nilsson S, Lanner L, Hellberg D. Long-term results with tensionfree vaginal tape on mixed and stress urinary incontinence. Obstet Gynecol 2005;106(1):38–43. [11] Holroyd-Leduc JM, Tannenbaum C, Thorpe KE, Straus SE. What type of urinary incontinence does this woman have? JAMA 2008;299(March (12)):1446–56. [12] Ghoniem G, Stanford E, Kenton K, et al. Evaluation and outcome measures in the treatment of female urinary stress incontinence: International Urogynecological Association (IUGA) guidelines for research and clinical practice. Int Urogynecol J Pelvic Floor Dysfunct 2008;19:5–33. [13] Farrell SA, Epp A, Flood C, et al. The evaluation of stress incontinence prior to primary surgery. J Obstet Gynaecol Can 2003;25:313–24. [14] Glazener CM, Lapitan MC. Urodynamic investigations for management of urinary incontinence in adults (review). Cochrane Database Syst Rev 2002;3:CD003195. [15] Houwert RM, Venema PL, Aquarius AE, Bruinse HW, Kil PJ, Vervest HA. Predictive value of urodynamics on outcome after mid-urethral sling surgery for female stress urinary incontinence. Am J Obstet Gynecol 2009;200(6):649, e1e1. [16] Houwert RM, Roovers JP, Venema PL, Bruinse HW, Dijkgraaf MG, Vervest HA. When to perform urodynamics before mid-urethral sling surgery for feml stress urinary incontinence? Int Urogynecol J; 2009 Nov. 17 (Epub ahead of print). [17] Roovers JPWR, Oelke M. Clinical relevance of urodynamic investigation tests prior to surgical correction of genital prolapse: a literature review. Int Urogynecol J Pelvic Floor Dysfunct 2007;4:455–60. [18] NICE guidelines urodynamics. Urinary incontinence: the management of urinary incontinence in women; Issue date: October 2006. [19] Abrams P, Cardozo L, Khoury S, Wein A. 4th International Consultation on Incontinence. Recommendations of the international scientific committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse and faecal incontinence. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence. 4th Edition Paris: Editions 21; 2009. p. 1767–820. [20] Hosker G, Committee 6. Dynamic testing. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence. 4th Edition Paris: Editions 21; 2009. p. 413–522. [21] Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anaesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996;7:81–6. [22] Ward KL, Hilton P. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol 2004;190:324–31. [23] Delancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesisi. Am J Obstet Gynecol 1994;170:1713–20. [24] de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 2003;44:724–30. [25] Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001;11:1306–13. [26] Meschia M, Bertozzi R, Pifarotti P, et al. Peri-operative morbidity and early results of a randomized trial comparing TVT and TVT-O. Int Urogynecol J Pelvic Floor Dysfunct 2007;18(11):1257–61. [27] Zullo MA, Plotti F, Calcagno M, et al. One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVTO) for surgical treatment of female stress urinary incontinence: a prospective randomized trial. Eur Urol 2007;51(5):1376–82.
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[28] Dietz HP, Barry C, Lim Y, Rane A. TVT vs Monarc: a comparative study. Int Urogynecol J 2006;17:566–9. [29] Lee KS, Han DH, Choi YS, et al. A prospective trial comparing tensionfree vaginal tape and transobturator vaginal tape inside-out for the surgical treatment of female stress urinary incontinence: 1-year follow up. J Urol 2007;177(1):214–830. [30] Houwert RM, Roovers JP, Venema PL, Bruinse HW, Dijkgraaf MG, Vervest HA. Outcome and complications of retropubic and mid-urethral slings translated into Surgical Therapeutic Indices. Am J Obstet Gynecol; 2009 Oct. 19 (Epub ahead of print). [31] Porena M, Constantine E, Frea B, et al. Tension-free vaginal tape versus transobturator tape as surgery for stress urinary incontinence: results of a multicenter randomized trial. Eur Urol 2007;52:1481–91. [32] Botros SM, Miller JJ, Goldberg RP, et al. Detrusor overactivity and urge urinary incontinence following transobturator versus midurethral slings. Neurourol Urodyn 2007;26(1):42–5. [33] Miller JJ, Botros SM, Akl MN, et al. Is transobturator tape as effective as tension-free vaginal tape in patients with borderline maximum urethral closure pressure? Am J Obstet Gynecol 2006;195(6):1799–804. [34] Albo EM, Richter HE, Brubaker L, et al. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med 2007;356:2143–55. [35] Hinterholzer S. Management of vaginal tape erosion and thigh abscess after vaginal tape obturator. Geburtsh Frauenheilk 2007;67:66–9.
[36] Tamussino KF, Hanzal E, Koelle D, Ralph G, Riss PA, Austrian Urogynecology Working Group. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol 2001;98(November (5) Pt 1):732–7. [37] Houwert RM, van Munster DN, Roovers JP, et al. Perspectives by patients and physicians on outcomes of mid-urethral sling surgery. Int Urogynecol J; 2009 Nov. 19 (Epub ahead of print). [38] Bjelic-Radisic V, Hartmann G, Abendstein B, Tamussino K, Riss PA, Austrian Urogynecology Working Group. The posterior intravaginal slingplasty operation: results of the Austrian registry. Eur J Obstet Gynecol Reprod Biol 2009;144(May (1)):88–9139. [39] Schraffordt Koops SE, Bisseling TM, Heintz AP, Vervest HA. Quality of life before and after TVT, a prospective multicentre cohort study, results from the Netherlands TVT database. BJOG 2006;113:26–9. [40] Ward K, Hilton P, United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002;325(July (7355)):67. [41] Avorn J. Debate about funding comparative-effectiveness research. N Engl J Med 2009;360:1927–9. [42] Naik AD, Petersen AL. The neglected purpose of comparative-effectiveness research. N Engl J Med 2009;360(May (19)):1929–31.
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Maturitas journal homepage: www.elsevier.com/locate/maturitas
Review
Maintaining standards for surgery for female urinary incontinence P. Riss ∗ , S. Hinterholzer Department of Gynecology & Obstetrics, Landesklinikum Thermenregion Moedling, Sr. Maria Restituta Gasse 12, A-2340 Moedling, Austria
a r t i c l e
i n f o
Article history: Received 20 October 2009 Accepted 22 October 2009
Keywords: Stress urinary incontinence Surgery Tension free tapes Fascial slings
a b s t r a c t Maintaining standards in surgery for female urinary incontinence: Operations for female stress urinary incontinence (SUI) are among the most common operations performed. In particular, recent advances in surgical technique and materials available for this type of surgery have made these operations more accessible, but even if an operation is characterized as “minimally invasive” surgeons must aim to maintain the highest possible standards in the interest of their patients. Standards in patient selection: Great care has to be taken to do a thorough workup of a patient about to undergo surgery. A detailed history and a good clinical evaluation including a clinical stress test is a prerequisite. It is highly recommended to do an urodynamic investigation prior to any surgery which affects bladder storage and micturition in order to confirm the presumptive diagnosis and to exclude patients who should not undergo surgery (e.g. with voiding disorders). Standards in surgery: Before taking a patient to theatre the surgeon must be clear in him or her mind about which operation to do. In other words preoperative selection of the appropriate type of operation is of the greatest importance. For this reason every surgeon has to be familiar with a certain range of incontinence procedures from which she can choose in a particular instance. There is no doubt that tension-free mid-urethral slings have become the procedures of choice in most cases of stress urinary incontinence. However, there will be cases where other procedures are called for such as traditional colposuspension or fascial slings. It is the responsibility of every surgeon not to use procedures which are outdated or not recommended. To maintain standards in incontinence surgery every surgeon has to familiarize him or herself with the procedure, to learn the procedure, to practice the procedure with the help of experienced peers, and finally to achieve the highest level of competence him or herself. So-called Industry sponsored “training centres” can be helpful but there are no shortcut to use all possible resources to learn and practice new surgery. Guidelines have become very important in evaluating new procedures and in categorizing the available evidence. They focus on specific recommendations which we can and should use in our daily practice. Again we still have the responsibility to follow the medical literature closely and to adapt our practice as new evidence becomes available—even before it is incorporated into guidelines. Standards in follow-up: Last but not least we have to follow standards when following up on our patients. As far as possible in the context of the health care system where we practice we should aim to see the patient we have operated on at least once 6–12 weeks after surgery. We must also make sure that the patient has access to care in case a problem develops later. And we ourselves must be familiar with the complications and consequences of surgery for stress urinary incontinence and must be able to manage a patient who is not completely satisfied after surgery. © 2009 Elsevier Ireland Ltd. All rights reserved.
Contents 1. 2.
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Standards in patient selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1. Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2. Clinical stress test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3. Urodynamic testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
∗ Corresponding author. Tel.: +43 2236 204 231; fax: +43 2236 204 245. E-mail addresses: [email protected] (P. Riss), [email protected] (S. Hinterholzer). 0378-5122/$ – see front matter © 2009 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.maturitas.2009.10.005
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3.
4.
5.
Standards in surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1. Tension-free mid-urethral sling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2. Burch colposuspension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3. Abdomino-vaginal sling operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4. Criteria for selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Standards in follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1. Clinical follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2. Registries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3. Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4. Comparative effectiveness research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Competing interests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1. Introduction Urinary incontinence is a common disorder which affects many women and often severely impacts on quality of life [1]. Surgery is often seen as a quick fix for urinary incontinence, and indeed can be very successful if the incontinence is due to defective bladder closure mechanism. However, incontinence can also be due to other factors such as an overactive bladder. In these cases surgery is bound to fail because the problem is not the closure mechanism of the bladder. Another reason why surgery must never be undertaken lightly is that every operation also is potentially harmful and can cause transient or long-lasting complications [2–5]. Therefore the decision to proceed with surgery must be made carefully and responsibly. This is particularly true for elective operations which aim to improve a function. This review therefore addresses the issues relevant to incontinence surgery regarding patient selection, standards in surgery and follow-up. Every health care provider must aim for the highest standards in elective surgery so that the expected benefits outweigh any possible complications and that the patient goes home and remains satisfied with the procedure. 2. Standards in patient selection The question always is: is the patient a candidate for this kind of surgery? And if yes, which preoperative diagnostic procedure must be undertaken in order to maintain a high standard in patient selection. 2.1. Indication Strictly speaking the only indication for surgery for female urinary incontinence is stress incontinence. The effect of all operations for incontinence is to increase the pressure in the urethra at the time of an increase in bladder pressure—such as during coughing, sneezing, and heavy lifting. Many believe that these operations cause a certain degree of obstruction. It would be unreasonable to assume that such an operation also would improve symptoms of urgency or even cure incontinence due ton uncontrollable urgency and detrusor contractions. It goes without saying that the same is true of course for incontinence due to other causes such as fistulas or neurologic disease. Not only must the patient suffer from stress urinary incontinence, she must also be sufficiently affected in her daily activities and quality of life in order to be a candidate for surgery [6,7]. Many women experience isolated incidents of stress incontinence from time to time and know perfectly well how to avoid these situations. In order to become a candidate for surgery stress incontinence must be bothersome and severe enough to warrant surgery.
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When treating a patient with incontinence and considering surgery every doctor must ask him or herself 2 questions: 1. is the diagnosis stress urinary incontinence? and 2. is the incontinence bothersome enough to warrant surgical intervention? While this seems reasonable enough in actual clinical practice things often are not as straightforward. First of all many women, especially older women, show symptoms of both stress and urge incontinence so that the diagnosis of mixed incontinence is made. In these cases the effect of surgery is very difficult to predict: while the stress component might be improved, urgency can be better, unchanged or even worse after the operation [8–10]. Also the degree of bother by incontinence can be assessed by a good history or with the use of a questionnaire. One must remember that the severity of symptoms can change and that the same symptom can be experienced differently by different women. It is therefore highly recommended never to force an operation for stress urinary incontinence on a patient but offer the operation to the patient and have her ask for it specifically—often after a trial of pelvic floor exercises or other conservative measures. Symptoms may also improve with lifestyle changes such as retirement, and it is reassuring for many patients to be told that these operations can be done irrespective of age and that there is no harm in waiting. 2.2. Clinical stress test The clinical stress test (or bladder stress test) is a very simple but extremely useful test which must be undertaken in every patient planning to undergo surgery for stress incontinence [11]. Urinary tract infection must be ruled out. The bladder is filled to 300 ml and the patient is asked to cough in the supine and standing position (Table 1). The physician can directly observe the loss of urine on coughing (Fig. 1). By placing 2 fingers into the vagina next to the bladder neck and elevating them one can see the potential effect of incontinence surgery on the closure mechanism of the urethra. This simple to perform and inexpensive test helps to answer 2 questions: can urgency as the cause of incontinence be ruled out? And how severe is the loss of urine on straining? With some experience it is easy to assess the intensity of the cough and to grade the concomitant loss of urine. Also a patient who experiences the first desire to void at around 100 ml and tolerates the filling of the bladder to 300 ml most probably does not suffer from severe urgency incontinence. 2.3. Urodynamic testing There is no consensus whether a full urodynamic workup is required before every operation for stress urinary incontinence [12,13]. If we look for guidelines for guidance we note that very
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Table 1 The clinical stress test. Performance Empty bladder/residual urine with catheter Bladder filling to 300 ml First sensation to void Bladder capacity Coughing supine/standing Information gained Residual urine (ml) First sensation to void (ml) Involuntary detrusor contractions (±) Maximum bladder capacity (ml)a Loss of urine on coughing supine/standing (±) Effect of the elevation of the bladder neck on loss of urine (±) a Bladder filling is usually stopped at 300 ml to have a standardized bladder volume when asking the patient o cough. Although strictly speaking the maximum bladder capacity is not determined. It is possible to determine whether the patient tolerates filling up to 300 ml or has a reduced bladder capacity.
often the wording is vague and leaves ample room for individualized decision making. It is also not always entirely clear why urodynamics are done: to make the proper positive diagnosis, to exclude other diagnoses, to help in decision making, to improve outcome after surgery, or to increase patient satisfaction? There is no doubt that urodynamic investigations are very helpful to establish the diagnosis of stress urinary incontinence and to exclude urge incontinence. It is less clear whether the use of urodynamics improves overall outcome as has been shown in a Cochrane review and subsequent papers [14,15]. Several authors have tried to define subgroups of patients in whom urodynamic investigation can be safely omitted before surgery [16,17] but at the present time no definite conclusions can be drawn. The NICE (National Institute of Clinical Excellence) Guidelines on Urinary Incontinence [18] state that “Urodynamics are of value if the clinical diagnosis is unclear prior to surgery or if initial surgical treatment has failed”. However, more recently, the International Consultation on Incontinence in Paris in 2008 recommended that “urodynamic studies are carried out in all women prior to surgical intervention for stress urinary incontinence” [19,20], this in spite of the vague wording by the same committee “that the result of urodynamic investigation is applied to ‘optimise’ treatment strategy without attributing perfect specificity to the result of treatment, in an individual patient” and “that the cost effectivity of urodynamic testing is taken into account when discussing the necessity of urodynamic investigation.” To summarize these seemingly contradictive recommendations it is safe to say that
Fig. 1. Clinical stress test. Loss of (dyed) urine is observed with the patient coughing in the supine position.
Fig. 2. Pelvic model. The arrows indicate the location of the retropubic sling, the transobturator sling and the short-arm sling.
(1) urodynamics are useful in assessing and evaluating a patient with incontinence, (2) it is possible to exclude urge incontinence, (3) urodynamics should always be done when repeat surgery is considered after failed primary surgery for incontinence, and (4) urodynamics probably are not necessary in a routine preoperative workup when the diagnosis of stress urinary incontinence can be made on clinical grounds. 3. Standards in surgery Over the years many operations to cure or at least improve stress urinary incontinence have been developed [21–24]. All of them aim to increase the pressure in the urethra when there is an increase in pressure in the bladder. They usually achieve this by providing support under the urethra, by elevating the proximal urethra or by causing obstruction. It is impossible to be familiar with and an expert in many different procedures. Every surgeon should aim to become experienced with a few proven procedures which she or he can use depending on the circumstances—e.g. primary or secondary procedure, low urethral pressure, or mixed incontinence. 3.1. Tension-free mid-urethral sling Tension-free mid-urethral slings were introduced by Ulmsten et al. in 1996 [21] and have since become the de-facto gold standard in incontinence surgery. These operations are based on a valid theory, namely that continence is based on the fact that the highest pressure in the urethra on stress is achieved in the mid-urethra, and that is where the tapes are placed. Since they must be placed without tension there is very little obstruction, making recovery of normal micturition after surgery much easier than with other, older procedures. The placement of tension-free mid-urethral slings is technically relatively easy, operation time is short, and the frequency of possible complications is low. Most important cure rates after mid-urethral slings are between 70 and 90% depending on the definition of cure, and they remain stable over time. Currently there are 3 possible approaches in use (Fig. 2): the retropubic approach as originally described by Ulmsten et al. [21], the transobturator approach [24,25], and the so-called short slings. The transobturator approach was developed in order to avoid bladder perforations, and short slings are an industry driven development with insufficient data to support their widespread adoption.
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Table 2 Comparison between retropubic and transobturator tension-free mid-urethral slings.
Success rate Technical difficulty Bladder perforation Pain Hematoma Abscess
Retropubic
Transobturator
+ + + 0 + 0
+ + 0 + +/0 +
The success rates of retropubic and transobturator slings are similar [3,26–29]. It seems that retropubic slings are slightly superior in patients with a low-pressure urethra, while transobturator sling seem to cause fewer de novo postoperative urgency problems [30–33]. Table 2 summarizes the differences between the retropubic and the transobturator approach. 3.2. Burch colposuspension Before the advent of tension-free mid-urethral slings the Burch colposuspension was the preferred operation for stress incontinence. The space of Retzius is entered from above, the vaginal fascia is exposed and elevated in the direction of the pelvic brim, and 2–4 sutures are placed between the vaginal fascia and the periostium of the anterior ramus of the pubic bone (i.e. Cooper’s ligament) [34]. The operation is standardized and gives excellent short and long term results. However, laparotomy – or sometimes laparoscopy – is required making the procedure much more invasive than the mid-urethral slings. Today Burch colposuspension is used mainly in cases of recurrence or in conjunction with laparotomy for other indications. 3.3. Abdomino-vaginal sling operation Abdomino-vaginal sling operations are more complex procedures where fascia is harvested from the abdominal wall or from the fascia lata and placed under the urethra and passed behind the symphysis to the abdominal fascia [34]. These operations are performed when other operations have failed, maximum pressure in the urethra is low or the vagina is of insufficient length or mobility. Although abdomino-vaginal sling operations have a high success rate a common postoperative problem is obstruction resulting in the need for self-catheterization. 3.4. Criteria for selection The selection of a specific operation for stress urinary incontinence will depend on several factors. Most important the operation must have a high success rate, implying that there is sufficient data to warrant such a claim. The frequency and type and severity of complications also play an important role. For example bladder perforations occur almost exclusively with retropubic mid-urethral Table 3 Austrian TVT registry. Patients entered Median Op time Anesthesia
Bladder perforation Reoperation Tamussino et al. [36].
Minutes Local Regional General Previous surgery w/o previous surg Total Hematoma
2795 30 (10–120) 44% 43% 12% 4.4% 2.0% 2.4% 0.7%
slings (ca 5%) but are of little consequence when diagnosed during surgery. Thigh pain, tape exposure and infection are more often seen with the transobturator approach [35,36]. Often the decision to choose a certain procedure is also based on the personal experience and preference of the surgeon. Increasingly attention is paid to the expectations of the patient. It is obvious that patients worry about improved bladder function after surgery, but recent studies have shown that patients also are concerned about the time to resume work and the effect of surgery on sexual function [37]. 4. Standards in follow-up 4.1. Clinical follow-up The most important follow-up is the one by the physician or the institution where the operation was performed. It is customary to see the patient 6–12 weeks after the operation when healing is completed, and a second time after one year when it is possible to evaluate function. The learning effect of such a program of quality assurance for the individual physician must not be underestimated. 4.2. Registries Because data from many centres are collected and entered in the registry it is an excellent means to give a cross-section of surgical practice and to discover even rare complications [36,38,39] (Table 3). However, to calculate the frequency of rare events one must be sure that the denominator is known, which means that all operations at participating centres must be reported. In order for a registry to work it must be easy to administer, entry criteria must be very clear, report forms must not be too long, and problems must be quickly addressed. Registries are particularly useful as an instrument to monitor a surgical procedure after its introduction [36]. It is preferable for registries to be set up and administered by a recognized academic institution or a professional society. Industry-sponsored registries usually do not include products from competing firms, data is entirely in the hands of industry, and there is always the danger that the company loses interest and closes a registry prematurely. 4.3. Trials Case series and registries produce important information but it is highly desirable to have prospective trials which compare different procedures to established operations. Fortunately for the retropubic mid-urethral sling Ward and Hilton [40] did just such a prospective, randomized comparison between a retropubic sling (TVTTM ) and the Burch colposuspension. However, registries and trials take years to be completed. Fig. 3 shows the timeline from the presentation of the new procedure by Ulmsten et al. and the publication of the results of the Austrian TVT registry (Tamussino et al. [36]) and of the Ward & Hilton trial [40]. What is disturbing but not unexpected is the observation that from 1998 to 2002 more than 10,000 kits for TVT were sold in Austria alone by one company (Gynecare personal communication). 4.4. Comparative effectiveness research Recently the field of comparative effectiveness research (CER) has attracted attention. Clinical trials usually look only at a set of parameters (primary and secondary outcomes) but do deal with the question how a treatment might benefit a particular patient. The latter obviously depends on many additional factors which usually are not addressed in trials: socioeconomic status, access to health
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References
Fig. 3. TVT Publications. Total number of publications called up with the keyword “TVT” on PubMed on May 13,2009.
care, insurance, compliance, work and lifestyle factors CER also tries to address the question how health care money can be used for maximum effect in a particular disease and in a specific setting. It is interesting to note that the United States is giving generous funding to CER of drugs, medical devices, surgical procedures, etc. in the hope of allocating resources more effectively [41,42]. Urinary incontinence and operations for incontinence are ideal subjects for CER. New procedures are described and new technology is introduced all the time making it difficult for a physician to sort through the data and to determine what will work best and with maximum effect for the resources available in typical patient.
5. Conclusion The diagnosis and surgical treatment of female urinary incontinence have become standardized, and several excellent operations are available with tension-free mid-urethral slings the de-facto gold standard. The individual surgeon can turn with confidence to guidelines and reviews to determine how a woman with urinary incontinence should be evaluated and which surgical treatment would be appropriate. Ongoing research is focusing more on the patient’s perspective, her expectations and her goals. This is a trend away from purely clinical trials with a short list of endpoints which may not be aligned with what the patient has in mind. It is to be expected that comparative effectiveness research (CER) will focus on the larger context in which surgery for female urinary incontinence is performed, on what will work best in a typical patient and how health care monies are allocated with maximum effect to help women with urinary incontinence.
Provenance Commissioned and externally peer reviewed.
Contributors Paul Riss, PhD., M.D. and Susanne Hinterholzer M.D. contributed equally to this manuscript.
Competing interests Paul Riss: speaker’s fees from Astellas, travel support from Gynecare. Susanne Hinterholzer: none.
[1] Abrams P, Cardozo L, Fall M, et al. The standardization of terminology of the lower urinary tract function. Report from the standardization subcommittee of the International Continence Society. Neurourol Urodyn 2002;21:167–78. [2] Karram MM, Sehal JL, Vassallo BJ, Kleeman SD. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol 2003;101:929–32. [3] Latthe PM, Foon R, Tooz-Hobson P. Transobturator and retropubic tape procedure in stress urinary incontinence: a systematic review and meta-analysis of effectiveness and complications. BJOG 2007;114:522–31. [4] Sung VW, Schleinitz MD, Radin CR, Ward RM, Meyers DL. Comparison of retropubic vs transobturator approach to midurethral slings: a systematic review and meta-analysis. Am J Obstet Gynecol 2007;197:3–11. [5] Vervest HA, Bisseling TM, Heintz AP, Schraffortdt Koops SE. The prevalence of voiding difficulty after TVT, its impact on quality of life, and related risk factors. Int Urogyn J Pelvic Floor Dysfunct 2007;18(2):173–82. [6] Langford CF, Elmissiry MM, Ghoniem GM. Do women have realistic expectations of treatment for stress urinary incontinence? Neurourol Urodyn 2009;27:480–4. [7] Kelleher CJ, Cardozo LD, Khullar V, et al. A new questionnaire to assess the quality of life of urinary incontinent women. BJOG 1997;104:1374–9. [8] Campeau L, Tu LM, Lermieux MC, et al. A multicenter, prospective, randomized clinical trial comparing tension-free vaginal tape surgery and no treatment for the management of stress urinary incontinence in elderly women. Neurourol Urodyn 2007;26(7):990–4. [9] Holmgren C, Nilsson S, Lanner L, Hellberg D. Frequency of de novo urgency in 463 women who had undergone the tension-free vaginal tape procedure for genuine stress urinary incontinence—a long term follow up. Eur J Obstet Gynecol Reprod Biol 2007;132(May (1)):121–5. [10] Holmgren C, Nilsson S, Lanner L, Hellberg D. Long-term results with tensionfree vaginal tape on mixed and stress urinary incontinence. Obstet Gynecol 2005;106(1):38–43. [11] Holroyd-Leduc JM, Tannenbaum C, Thorpe KE, Straus SE. What type of urinary incontinence does this woman have? JAMA 2008;299(March (12)):1446–56. [12] Ghoniem G, Stanford E, Kenton K, et al. Evaluation and outcome measures in the treatment of female urinary stress incontinence: International Urogynecological Association (IUGA) guidelines for research and clinical practice. Int Urogynecol J Pelvic Floor Dysfunct 2008;19:5–33. [13] Farrell SA, Epp A, Flood C, et al. The evaluation of stress incontinence prior to primary surgery. J Obstet Gynaecol Can 2003;25:313–24. [14] Glazener CM, Lapitan MC. Urodynamic investigations for management of urinary incontinence in adults (review). Cochrane Database Syst Rev 2002;3:CD003195. [15] Houwert RM, Venema PL, Aquarius AE, Bruinse HW, Kil PJ, Vervest HA. Predictive value of urodynamics on outcome after mid-urethral sling surgery for female stress urinary incontinence. Am J Obstet Gynecol 2009;200(6):649, e1e1. [16] Houwert RM, Roovers JP, Venema PL, Bruinse HW, Dijkgraaf MG, Vervest HA. When to perform urodynamics before mid-urethral sling surgery for feml stress urinary incontinence? Int Urogynecol J; 2009 Nov. 17 (Epub ahead of print). [17] Roovers JPWR, Oelke M. Clinical relevance of urodynamic investigation tests prior to surgical correction of genital prolapse: a literature review. Int Urogynecol J Pelvic Floor Dysfunct 2007;4:455–60. [18] NICE guidelines urodynamics. Urinary incontinence: the management of urinary incontinence in women; Issue date: October 2006. [19] Abrams P, Cardozo L, Khoury S, Wein A. 4th International Consultation on Incontinence. Recommendations of the international scientific committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse and faecal incontinence. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence. 4th Edition Paris: Editions 21; 2009. p. 1767–820. [20] Hosker G, Committee 6. Dynamic testing. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence. 4th Edition Paris: Editions 21; 2009. p. 413–522. [21] Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anaesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996;7:81–6. [22] Ward KL, Hilton P. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol 2004;190:324–31. [23] Delancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesisi. Am J Obstet Gynecol 1994;170:1713–20. [24] de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 2003;44:724–30. [25] Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001;11:1306–13. [26] Meschia M, Bertozzi R, Pifarotti P, et al. Peri-operative morbidity and early results of a randomized trial comparing TVT and TVT-O. Int Urogynecol J Pelvic Floor Dysfunct 2007;18(11):1257–61. [27] Zullo MA, Plotti F, Calcagno M, et al. One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVTO) for surgical treatment of female stress urinary incontinence: a prospective randomized trial. Eur Urol 2007;51(5):1376–82.
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P. Riss, S. Hinterholzer / Maturitas 65 (2010) 5–10
[28] Dietz HP, Barry C, Lim Y, Rane A. TVT vs Monarc: a comparative study. Int Urogynecol J 2006;17:566–9. [29] Lee KS, Han DH, Choi YS, et al. A prospective trial comparing tensionfree vaginal tape and transobturator vaginal tape inside-out for the surgical treatment of female stress urinary incontinence: 1-year follow up. J Urol 2007;177(1):214–830. [30] Houwert RM, Roovers JP, Venema PL, Bruinse HW, Dijkgraaf MG, Vervest HA. Outcome and complications of retropubic and mid-urethral slings translated into Surgical Therapeutic Indices. Am J Obstet Gynecol; 2009 Oct. 19 (Epub ahead of print). [31] Porena M, Constantine E, Frea B, et al. Tension-free vaginal tape versus transobturator tape as surgery for stress urinary incontinence: results of a multicenter randomized trial. Eur Urol 2007;52:1481–91. [32] Botros SM, Miller JJ, Goldberg RP, et al. Detrusor overactivity and urge urinary incontinence following transobturator versus midurethral slings. Neurourol Urodyn 2007;26(1):42–5. [33] Miller JJ, Botros SM, Akl MN, et al. Is transobturator tape as effective as tension-free vaginal tape in patients with borderline maximum urethral closure pressure? Am J Obstet Gynecol 2006;195(6):1799–804. [34] Albo EM, Richter HE, Brubaker L, et al. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med 2007;356:2143–55. [35] Hinterholzer S. Management of vaginal tape erosion and thigh abscess after vaginal tape obturator. Geburtsh Frauenheilk 2007;67:66–9.
[36] Tamussino KF, Hanzal E, Koelle D, Ralph G, Riss PA, Austrian Urogynecology Working Group. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol 2001;98(November (5) Pt 1):732–7. [37] Houwert RM, van Munster DN, Roovers JP, et al. Perspectives by patients and physicians on outcomes of mid-urethral sling surgery. Int Urogynecol J; 2009 Nov. 19 (Epub ahead of print). [38] Bjelic-Radisic V, Hartmann G, Abendstein B, Tamussino K, Riss PA, Austrian Urogynecology Working Group. The posterior intravaginal slingplasty operation: results of the Austrian registry. Eur J Obstet Gynecol Reprod Biol 2009;144(May (1)):88–9139. [39] Schraffordt Koops SE, Bisseling TM, Heintz AP, Vervest HA. Quality of life before and after TVT, a prospective multicentre cohort study, results from the Netherlands TVT database. BJOG 2006;113:26–9. [40] Ward K, Hilton P, United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002;325(July (7355)):67. [41] Avorn J. Debate about funding comparative-effectiveness research. N Engl J Med 2009;360:1927–9. [42] Naik AD, Petersen AL. The neglected purpose of comparative-effectiveness research. N Engl J Med 2009;360(May (19)):1929–31.