Non-surgical management of urinary stress incontinence

Non-surgical management of urinary stress incontinence

Reviews in Gynaecological Practice 5 (2005) 237–242 www.elsevier.com/locate/rigp Non-surgical management of urinary stress incontinence Zeenat Eva Kh...

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Reviews in Gynaecological Practice 5 (2005) 237–242 www.elsevier.com/locate/rigp

Non-surgical management of urinary stress incontinence Zeenat Eva Khan *, Javed Rizvi Department of Obstetrics & Gynaecology, The Aga Khan University Hospital, Stadium Road, P.O. Box 3500, Karachi 74800, Pakistan Received 3 May 2005; accepted 20 July 2005 Available online 26 September 2005

Abstract This article reviews the non-surgical approach to urinary stress incontinence. As the cost of medical care increases and the waiting lists for surgical operations grow bigger, non-surgical management of incontinence takes on importance. The cure rates or improvement of quality of life with conservative management of urinary stress incontinence are not as good as with the surgical approach but it is an option which may be used in selected patients. Whenever a patient or the health care provider embarks upon the non-surgical options, consideration should be given to the success rates of the modality, either used alone or in combination. The motivation and compliance of patient is important, individuals who have realistic expectations from non-surgical management of urinary stress incontinence usually have the best result. Recent literature was reviewed and an attempt has been made to present an objective assessment for all the modalities currently available for the incontinent woman. It is necessary to stress the need for the use of a combination of modalities for better results when non-surgical approach is used as the first line option. It is also important to be empathetic and supportive of such women as they usually have an extremely poor self esteem, are depressed and reclusive. # 2005 Elsevier B.V. All rights reserved. Keywords: Urinary stress incontinence; Non-surgical management; Multi modality approach; Positive re-enforcement

Urinary stress incontinence affects up to 50% of women over the age of 50 years and with better health care facilities in affluent societies, the life expectancy is increasing which is now making the conservative approach to stress incontinence an economic necessity. The annual direct cost of managing urinary incontinence in the United States is estimated at US$ 16 billion in 1995 [1]. As better health care facilities increase coupled with the awareness of the problems that geriatric patients face, so should the management options be outlined in this sub group of women. It is expected that the population of women ranging from 80 to 99 years will double by the year 2008 and it is this very group that will need the most help with urinary incontinence problems and its associated irksome sequelea, e.g. vulval irritation and urinary tract infections, etc. It is also expected that these geriatric women will be unfit for

surgical management hence conservative management of urinary stress incontinence should be the first line treatment option, for them, infact it may be the only option for these women. Although conservative management ‘‘cures’’ fewer women than surgery it has a role in patients who opt for non-surgical management, who are at the extremes of age (i.e. child bearing or the elderly frail), poor surgical risk patients or with multiple co-morbid conditions, in women who have limited incontinence, such as at sport, those who are awaiting surgery, or in third world countries where there is a dearth of trained urogynaecologists, the economic aspect of surgical management makes conservative therapy an attractive first line management option. The non-surgical approach to urinary stress incontinence is multifaceted but in general the options are summarized as:

* Corresponding author. Fax: +92214934294. E-mail addresses: [email protected] (Z.E. Khan), [email protected] (J. Rizvi).

   

1471-7697/$ – see front matter # 2005 Elsevier B.V. All rights reserved. doi:10.1016/j.rigp.2005.07.002

Life style interventions. Behavioral modification. Bladder training. Pelvic floor muscle training.

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 Mechanical devices.  Pharmacologic therapy.

1. Life style interventions Simple alterations in life style can reduce the episodes of urinary incontinence. Weight loss in moderately obese women alleviates stress incontinence. Women with a BMI of 25–40 kg/m2 were randomly allocated in one trial into an immediate weight reduction program or a delayed weight reduction, i.e. after 3 months. The women in the weight loss group had a 53% decrease in weekly incontinent episodes compared to 4% in the control group [2,3]. A reduction in caffeine intake and bladder irritants, such as oxalates improves symptoms in many women with a reduction in daytime incontinence episodes [4,5]. Asthma and smoking are associated with coughing which raises intra abdominal pressure and worsens urinary stress incontinence. Hence adequate treatment of asthma and cessation of smoking should be encouraged [6]. Chronic constipation and straining at stool may damage the pudendal nerve function. Effective treatment of constipation may reduce the episodes of urinary incontinence [7–8]. Childhood straining at stool has also been implicated in urinary stress incontinence in adulthood. Certain drugs, such as diuretics and the alpha— adrenergic blocking agent prazosin can worsen or precipitate stress incontinence [9].

3. Bladder training Many different schedules for bladder retraining have been recommended. Timed voiding or habit training means voiding on a fix schedule while prompted voiding implies that the patient is asked at regular intervals about the need to pass urine. These regimens are used widely in nursing homes where a care provider helps a cognitively intact patient with a bladder drill [12]. The main characteristics of bladder training are patient education, schedule voiding and positive reinforcement. A urinary diary is helpful to plan and motivate during the treatment. Women are instructed in relaxation and distraction techniques. Patient compliance and positive affirmation are essential for success. Positive results are seen after a week and unsuccessful bladder training should not be continued beyond 2–3 weeks [13–15]. In a randomized control trial of a 6 weeks course of formal bladder training, Fantl et al. [15] reported a reduction of 57% in incontinent episodes (controls 14%) and 54% reduction in the amount of urine lost on the pad. These effects were seen in women with both an overactive bladder as well as those who had urinary stress incontinence with the effects being maintained at 6 months follow ups. Bladder training does not impose any fluid modifications. A recent Cochrane Database analysis for prompted voiding and habit retraining for the management of urinary incontinence looked at three and five trials, respectively. The reviewers found insufficient evidence to reach a firm conclusion though there was evidence of short-term benefit [16,17].

2. Behavior modification The severity of incontinence as well as ‘‘trigger’’ factors can be determined by a simple voiding diary. By reviewing a 3–7 day record of the woman’s intake and output chart and voiding schedule appropriate changes can be made. The voiding diary identifies an individual’s natural voiding pattern and can help develop a toilet schedule. Reduction in fluid intake is not usually recommended unless abnormally large volumes are ingested, though reduction of fluid intake after 6:00 p.m. results in fewer nocturnal voids [10]. Certain professions are associated with infrequent voiding and stress incontinence may have a connection with a full bladder, hence such women should be asked to find time to void once at least once in the middle of her working day. Exercise modification, such as high impact exercises like jogging and aerobics should be changed to non-impact types of exercises like swimming, walking or cycling. Behavioral modification tends to be of use primarily in patients with an overactive bladder although there have been some reports of benefit in patients with urinary stress incontinence as well. Subjectively many women reported fewer incontinence episodes though the significant finding was that many women needed to increase their fluid intake [11].

4. Pelvic floor muscle training 4.1. Kegel’s exercises Pelvic floor exercises are one of the traditional methods of non-operative treatments used for the management of urinary stress incontinence in women. These exercises were first described by Arnold Kegel in 1948 and were designed to strength the support of the bladder, urethra and the pelvic floor musculature. Kegel recommended the concomitant use of a pneumatic device, a perineometer to measure the strength of the pelvic muscle contractions during the exercise which is essentially a biofeedback therapy. Elia and Bergman examined the ability of pre-treatment urodynamic parameters to predict continence outcome measures. They found that the urethral closure pressures improved after pelvic floor exercises in women who reported symptomatic improvement. Eighty six percent of women with mild incontinence had significant subjective improvement compared to only 13% of women with severe incontinence [18]. It is crucial that the correct muscles are recruited during the exercise which needs to be taught to the patient by her

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physician, nurse or physiotherapist during a pelvic examination, there is a correlation between success and the intensity of the training. A recent Cochrane database analysis of 43 clinical trials concluded that pelvic floor exercises were better than no therapy or placebo for women with stress or mixed incontinence. Success as far as subjective improvement ranged from 41% to 85% at 4 months follow-up [19]. Ancillary devices to be used in conjunction with pelvic floor exercises include the following: (a) Vaginal cones: The use of vaginal cones was introduced by Plevnik in 1985. The cones are inserted in the vaginal and held in place by the contraction of the pelvic floor muscles while performing daily chores. The cones are held for 15 min twice a day with gradual increase in the weight of the cones over a 12 weeks treatment program. The weighted cones act by providing a constant stimulus for proprioceptive feed back to improve the pelvic floor muscle exercise efficacy. A recent Cochrane review examined the use of vaginal cones. Fifteen studies included a total of 1126 patients of which 466 used vaginal cones. The analysis revealed that cones were better than no active treatment (failure to cure incontinence RR: 0.74; 95% C1; 0.59– 0.93) but not significantly better than pelvic floor muscles exercises alone (RR: 1.09; 95% CI: 86–1.38) or electric stimulation (RR 1.0; 95% CI: 0.89–1.13) [20]. (b) Bio feedback therapy: This uses a monitoring device which provides visual or auditory cues to help the patient gain awareness that indicate that the patient is contracting the correct pelvic muscles and can measure the strength of the contractions. Biofeedback therapy entail sessions that last 4–8 weeks with 1–3 visits per week. Portable hand-held home devices for bio feedback are also available. Studies comparing pelvic floor muscle exercises with or without the biofeedback component yield mixed results. Burgio et al. have demonstrated a treatment efficacy in elderly patients with urinary stress incontinence and overactive bladders of 82% to 94% after a mean 3.5 treatment sessions [21]. In a randomized control trial, 222 women between the ages of 55–92 years were assigned to received 8 weeks of biofeedback assisted behavioral training, 8 weeks of behavioral training with only verbal feedback based on vaginal palpation and 8 weeks of self administered behavioral treatment using a self help booklet. There were similar reductions in the incontinence episodes in all groups and similar improvement in quality of life in all groups, however the patients perceptions of treatment were best in the two active interventions groups [22]. (c) Electrical stimulation: Electrical stimulation is delivered through a vaginal probe or conduction pads attached to the anus via a small portable battery operated units. The electrical charge is delivered to the nerves innervating the pelvic floor musculature for a

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duration of 15–30 min twice a day for 3–6 months, though a variety of regimens have been described. Theoretically electrical stimulation helps to restore the normal reflexes in the muscle of the pelvic floor. It is also thought to convert the fast twitch fibres to slow twitch fibres which improves the resting tone of the pelvic floor musculature. In a randomized, controlled, double blind study of 121 incontinent women, Brubaker et al. [23] found that electrical stimulation improved outcomes over a sham probe. The improvement was seen more so in women who had an overactive bladder and improvement was not marked with urinary stress incontinence. In contrast Sand et al. should significant improvement with electrical stimulation for urinary stress incontinence compared to sham controls [24]. Yamanshi et al. reported 60% of patients in the electrical stimulation group had a favorable outcome compared to only 8% of sham control patients [25]. A recent prospective study of home based electrical stimulation may be effective for the treatment of stress urinary incontinence. Three thousand and one hundred and ninety eight women in Norway used home managed electrical stimulation devices in conjunction with pelvic floor exercise. The overall reported improvement was 61% with 29% of women reporting cure or great improvement [26]. Only 12% of patients discontinued treatment and 79% of women would recommend this form of treatment to others [27]. Electrical stimulation is contraindicated in patients who have cardiac arrthymias or wear a pace makers. (d) Extracorporeal magnetic innervation therapy (EXMI): This modality of treatment works on the pelvic floor musculature to strength it by pulse magnetic technology. Patients are seated fully clothed in a chair with a magnetic field therapy head in the seat. Treatment sessions last 20 min are repeated twice a week for 6 weeks. In a multi central trial study of extracorporeal magnetic innervation therapy III women were recruited with demonstrable urinary stress incontinence of which 97 women completed the study for analysis. The outcomes measured were bladder diaries, dynamic pad weight test, urodynamics and quality of life survey at 8 weeks and 6 months after completing the therapy. At 6 months 43 patients had completed the study of which 28% were completely dry. Fifty three percent used less than one pad per day and the use of pads was reduced in 70% of the women [28].

5. Mechanical devices 5.1. Pessaries The armamentanum of mechanical devices which have been used to treat urinary stress incontinence range from the

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simple pessaries to the very cumbersome occlusive devices. The use of the devices may be limited to be worn only when certain activities, such as jogging or sport causes on incontinent episodes. The wearing of simple tampon during the exercise keeps about 58% of women dry while 86% of women noticed a reduction in urine loss [29]. Broadly two types of devices are used which are pessaries to elevate the bladder neck which are placed in the vagina. Pessaries of varies sizes and shapes have been described by each company which produced them as the panacea of cures related to pelvic organ prolapse and urinary stress incontinence. The pessary which has been advocated most is the Hodge pessary and its various modifications. Proper insertion and follow up care is required to avoid complications, such as vaginal ulcerations discharge and erosions. Before the pessary is inserted pretreatment with topical application if estrogen creams in post menopausal women is recommended. The patient comes with a comfortably full bladder to allow the testing of the efficacy of the pessary and once the fitting is complete the patient is asked walk around strain and pass urine before leaving the clinic. The adverse effects of prolonged use of a pessary, such as malodorous discharge can be avoided if the patient is advised to remove the pessary over night at least once a week and reinserted it herself. Review of literature has shown that prolapse is helped by wearing a tampon and with newer variants of the Hodges pessaries, i.e. with incontinence knobs and support about 25–75% of women who have stress incontinence may find partial or overall improvement. Urodynamic studies reveal a greater urethral closure pressure and increase in functional urethral length after pessary placement [30]. One recent study followed 100 women retrospectively who wore pessaries to control their urinary incontinence. Mean follow up was at 11 months and 59 women, i.e. over half chose to continue wearing the continence pessary for control of symptoms.

6. Occlusive devices Newer devices for urinary stress incontinence include devices which are inserted into the urethra to occlude the urethral meatus, urethra patches or external suction cups to fit over the urethral meatus. The occlusive devices have a role in women who have relatively pure stress incontinence with no history of recurrent urinary tract infections, dermatitis of the vulva or any contra-indication, such as artificial heart valves which may increase the risk of sub acute bacterial endocarditis. The occlusive devices which have been approved by the FDA of USA are the Reliance urinary control insert and the Femsoft insert. A sterile insert is placed into the urethra and removed before each void after which a new sterile urethral insert is replaced. The urethral patch called Impress soft patch is applied over the urethral meatus and acts as an absorbent continence

pad. It appears to be safe and does not require a physician’s guidance. A new patch needs to be re applied after each void but its main draw back seems to be that the patch is difficult to keep in place and may get dislodged. Reusable external suction caps that fit over the urethra meatus and can be reapplied after voids up to a week are being used by limited centres. Two caps the FemAssist and Capsure have received FDA approval. In a study which is ongoing and multicentral recruited 150 women. Three devices the FemSoft, Reliance urethral insert and the Capsure shield were studied. Results were a negative pad weight test of 93% with FemSoft, 79–82% with the Reliance urethral insert and 82% with the Capsure shield. Adverse effects included symptomatic urinary infection in 31% of the inserts and 1.5% with the external suction cups. Haematuria was seen in 3.3% of women measuring Femsoft, 6.7% of mild trauma at insertion and 1.3% of women had migration of the occlusive device into the urethra and bladder [31,32].

7. Pharmacological therapy 7.1. Hormones Oestrogens theoretical seem an attractive therapeutic agent whether used orally or topically in vaginal due to presence of oestrogen receptors in the vagina, urethra and bladder neck. Theoretically the advantages are increased vascularity, improved urethra coaptation and improvement in collagen synthesis in the area. Short-term use of oestrogens has shown subjective improvement which has not been replicated or been consistent with long term use [33,34]. In a recent randomized trial of 1525 women with incontinence at the time of recruitment into the study were given hormone replacement therapy and placebo. Twenty one percent of those using hormone therapy improved and 26% of those using a placebo, however more women had worsening of urinary stress incontinence in the hormone group than those using a placebo (39% versus 27%, respectively) [35]. There is evidence that selective oestrogen receptor modulators (SERMS) may have a role in urinary incontinence. In 6926 women who were randomly assigned to either the raloxifene or placebo, the women receiving the SERM were less likely to undergo surgery for prolapse in the 3 year study period (7% versus 1.5%) [36]. In contrast another study with a different type of SERM levormeloxifene used in 2924 women was halted at 10 months due to a marked increase in urinary incontinence (17% in the study group versus 4% in the placebo group) [37]. 7.2. Alpha adrenergic agonists The bladder neck and proximal urethra in women predominantly have alpha-adrenergic receptors and stimulating them should generate smooth muscle contractions. These drugs have found to improve urinary stress incontinence in

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women with mild stress [38,39] but not with severe disease [40]. Side effects of alpha adrenergic agonists are rare but serious, such as cardiac arrhythmia and hypertension. 7.3. Tricyclic antidepressants Imipramine hydrochloride is an anti-depressant with alpha-adrenergic agonist and anti cholinergic effects which appears to help improve symptoms in some women with urinary stress incontinence. A non-randomized trial in which 30 women received imipramine 75 mg daily for 4 weeks stated that 71% had improvement after treatment, but 9% had no improvement [41]. A greater benefit is also observed when tricyclic anti depressants are used in conjunction with topical oestrogen c reams. 7.4. Serotonin reuptake inhibitors As the role for non-surgical management of stress incontinence is gaining momentum, so is the search for a drug which can help cure or control stress incontinence, none of the drugs at present which are being used for control of stress incontinence are FDA approved hence research is continuing on a new drug Duloxetine. This drug is a serotonin and nor epinephrine uptake inhibitor which has its effect at the spinal cord which result in increasing signals through the pudendal nerve to the urethral sphincter. Currently Duloxetine is in the Phase III trial arm and data has recruited close to 700 women (exact 683). The demographic data is that these women’s ages range from 22 to 84 years. They have predominantly stress urinary incontinence episodes, normal frequency and bladder capacity, a positive cough stress test and positive pad test and urodynamically proven stress incontinence [42]. In this study 344 women were recruited to the Duloxetine 80 mg/daily group of which 69%, complete the study and 339 women in the placebo group of which 89% completed the study. Both groups were studied for the following variables at the end of a 12 weeks period which were the number of incontinent episodes per week, the second primary variable was the incontinence, quality of life (1-QOL) score and the patients’ global impression of improvement index (PG1). In summary 64% of patients in the Duloxetine group had a decrease in incontinence episodes versus 41% in the placebo group. Over 30% of patients had an improvement in PG1 score. Another finding was that women were going 20 min longer in between urine voids [43]. Adverse effects with the new drug Duloxetine were nausea, fatigue, insomnia, dry mouth, constipation, dizziness and headache of which nausea and fatigue were the commonest [44]. 8. Absorbent products Absorbent products are pads or garments which are designed to trap urine and odour, to protect the skin and

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clothes of incontinent people, so that they can function comfortably and maintain their dignity during their daily activity. These absorbent products range from pant liners, under pants either washable or disposable, to adult diapers. The cost of these products varies with the number of incontinent episodes and the amount of urine lost per episode though the cost is higher in women who have an over active bladder than in women with urinary stress incontinence (US$ 76 versus US$ 63 in 1999).

9. Conclusion The success of non-surgical treatment for urinary stress incontinence seems to lie in a multimodality treatment regimen, such as a combination of pelvic floor exercise with biofeedback or pharmacological therapy. Committed physicians or therapist are require to reinforce the success of conservative therapy for incontinence with patients understanding the rationale behind the therapy, its non-invasiveness and that they have a realistic approach to the improvement rates. Compliance is best if the patient understands these factors and positive reinforcement is usually constantly required [45].

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