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Voiding Function and Dysfunction, Bladder Physiology and Pharmacology, and Female Urology
Urological Survey
Voiding Function and Dysfunction, Bladder Physiology and Pharmacology, and Female Urology Urinary Incontinence in Women: Direct Costs of Routine Care L. Subak, S. Van Den Eeden, D. Thom, J. M. Creasman, J. S. Brown and Reproductive Risks for Incontinence Study at Kaiser Research Group Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco School of Medicine, San Francisco, California Am J Obstet Gynecol 2007; 197: 596.e1–596.e9.
Objective: The purpose of this study was to estimate the direct costs of routine care for urinary incontinence (UI) in community-dwelling, racially diverse women. Study Design: In the Reproductive Risks for Incontinence Study at Kaiser population-based study, 528 women with UI weekly or more quantified resources that were used for UI. Routine care costs were calculated with the use of national resource costs ($2005). Potential predictors of these outcomes were examined by multivariable linear regression. Results: Mean age was 55 ⫾ 9 (SD) years. Among women with weekly UI, 69% reported incontinence-related costs. Median weekly cost was $1.83 (25%-75% interquartile range [IQR], $0.50, $5.23), increasing from $0.93 (IQR, $0, $3) for moderate to $7.82 (IQR, $5, $37) for very severe incontinence. Costs that increased with incontinence severity (P ⬍ .001) and body mass index (P ⬍ .001) were 2.2-fold higher for African American versus white women (P ⬍ .0001) and 42% higher for women with mixed versus stress incontinence (P ⬍ .05). Conclusion: Women pay a mean of ⬎$250 per year out-of-pocket for UI routine care. Effective incontinence treatment may decrease costs. Editorial Comment: Inclusion was based on the question: “During the past 12 months, on average, how often have you leaked urine, even a small amount?” The choices were daily, weekly, monthly, less than monthly and never. Those who reported weekly or greater frequency of UI completed a questionnaire that was used for inclusion in this study. Community dwelling women with severe and very severe incontinence were determined to pay between $350 and $1,150 per year out of pocket for incontinence routine care, none of which is reimbursed by third-party payers in the United States. Alan J. Wein, M.D., Ph.D. (Hon.)
The Impact of Multichannel Urodynamics Upon Treatment Recommendations for Female Urinary Incontinence R. M. Ward, B. S. Hampton, J. D. Blume, V. W. Sung, C. R. Rardin and D. L. Myers Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Women and Infants’ Hospital, Warren Alpert Medical School of Brown University, Providence, Rhode Island Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 1235–1241.
The aim of this study was to evaluate whether multichannel urodynamic testing changes a physician’s treatment recommendations when managing women with urinary incontinence. In this prospective reader study, four fellowship-trained urogynecologists reviewed 39 abstracted cases of urinary incontinence on two occasions: first without and subsequently with urodynamic data. Treatment recommendations were made for each case after each review. The probability of urodynamic data modifying 0022-5347/10/1831-0253/0 THE JOURNAL OF UROLOGY® Copyright © 2010 by AMERICAN UROLOGICAL ASSOCIATION
Vol. 183, 253-262, January 2010 Printed in U.S.A. DOI:10.1016/j.juro.2009.09.068
www.jurology.com
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treatment recommendations was estimated for each reader and for the population of readers using a random effects logistic regression to account for reader variability. The overall probability that urodynamic data would change treatment was 26.9% (95% confidence interval (CI), 18.6%, 37.2%) for medical treatments and 45.5% (95% CI, 37.8%, 53.4%) for surgical treatments. Reader-to-reader differences accounted for 3% and ⬍1% of the total variance for medical and surgical treatments, respectively. Multichannel urodynamic evaluations are significantly associated with changes in medical and surgical treatment recommendations in a referral population. Editorial Comment: These cases were considered “seemingly straightforward” as opposed to “complex,” regarding which there is little argument about the value of urodynamic testing. The authors conclude that “the study shows that even among straightforward patients with documented stress incontinence, urodynamics change the treatment recommendation in 22% of cases.” In this study urodynamics were estimated to change the diagnosis of stress incontinence (present, absent or indeterminate) in 35.9%, the diagnosis of urgency incontinence was estimated to change in 41.2% and the diagnosis of mixed incontinence was estimated to change in 35.7% of patients. One unanswered question, however, which the authors do mention is, “Did the changes result in improvements in clinical outcomes over the strategy that was originally considered before urodynamics?” With urodynamic studies coming under fire by third-party payers this is the question to which we all should turn our attention. Alan J. Wein, M.D., Ph.D. (Hon.)
Reliability Testing of Urodynamics, Pressure Flow Studies and Cough Leak Point Pressure in Women With Urodynamic Stress Incontinence With and Without Detrusor Overactivity P. Rahmanou, C. Chaliha, E. Kulinskaya and K. Khullar Department of Urogynaecology, Imperial College, St. Mary’s Hospital, London, United Kingdom Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 933–938.
Urodynamic studies which included cough leak point pressure (CLPP) and pressure flow studies were performed at two visits 2 weeks apart. Reproducibility between the two visits and also between the two diagnostic groups, urodynamic stress incontinence (USI) and urodynamic mixed incontinence (UMI) were analysed. Thirty-one women completed both visits, of those 14 had USI in both sets of urodynamic studies, 11 had UMI on both visits, six had USI on one visit and UMI in the other. The urodynamic variables of maximum cystometric capacity and CLPP have the most repeatability. Analysis in women with USI alone compared to USI with detrusor overactivity (DOA) showed that the repeatability for pressure flow parameters and CLPP was better in women without DOA, of which the CLPP was significantly different (p ⫽ 0.036). Urodynamic variables are inconsistent. This may reflect variations in urinary tract behaviour. Editorial Comment: We have always found that, with respect to urodynamic studies and their reproducibility, if you are looking for electrocardiogram reproducibility, you will not find it, or anything close to it. However, our feeling has always been, most of the time, if you are asking a specific question and you can reproduce the clinical symptomatology, you will generally get a qualitative answer and it will generally be the same from time to time, assuming the symptoms are the same and no treatments have been instituted. Alan J. Wein, M.D., Ph.D. (Hon.)
VOIDING FUNCTION, BLADDER PHYSIOLOGY AND PHARMACOLOGY, AND FEMALE UROLOGY
Clarification and Confirmation of the Knack Maneuver: The Effect of Volitional Pelvic Floor Muscle Contraction to Preempt Expected Stress Incontinence J. M. Miller, C. Sampselle, J. Ashton-Miller, G. R. Hong and J. O. DeLancey School of Nursing, University of Michigan, Ann Arbor, Michigan Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 773–782.
The aim of the study was to determine the immediate effect of timing a pelvic muscle contraction with the moment of expected leakage (the Knack maneuver) to preempt cough-related stress incontinence. Women performed a standing stress test using three hard coughs without and then with the Knack maneuver. Volume of urine loss under both conditions was quantified with paper-towel test. Two groups of women were tested: nonpregnant women (n ⫽ 64) and pregnant women (n ⫽ 29). In nonpregnant women, wetted area decreased from a median (range) of 43.2 (0.2–183.7) cm2 without the Knack maneuver to 6.9 (range of 0 to 183.7 cm2) with it (p ⬍ 0.0001); while in pregnant women it decreased from 14.8 (0 –169.7) cm2 to 0 (0 –96.5) cm2, respectively (p ⫽ 0.001). This study confirms the effect from the Knack maneuver as immediate and provides a partial explanation for early response to widely applied pelvic muscle training regimens in women with stress incontinence. Editorial Comment: These folks showed earlier that in selected older women urine loss with effort can be significantly reduced within 1 week by teaching them how to contract the pelvic floor muscles volitionally before and during effort (in this case a cough). They distinguished the intervention of teaching women to tighten their pelvic floor muscles in preparation for a known leakage provoking event from the intervention of setting aside time to contract the pelvic floor muscle as an aid for strength development (assumed to be due to hypertrophy and enhancement of a reflex response, the latter falling under the designation of Kegel exercises). An effective Knack effort recruits the striated muscles associated with the urethra as well as the striated “lifting portion” of the levator ani. It is important to note that approximately 20% of women will show no reduction in leakage volume with the use of this maneuver. The reasons offered are: 1) the muscle may be deficient; 2) they may not be doing the maneuver correctly; 3) they may be doing the maneuver correctly and already have achieved maximal reduction. The Knack maneuver is a sustained contraction. One can also use “quick flicks” of this muscle and in many cases abort the sensation of urgency, whether or not associated with a true involuntary bladder contraction. This maneuver of rapid repeated “quick flicks” does seem to be effective and is hypothesized to be so on the basis of reflex suppression of detrusor activation. Alan J. Wein, M.D., Ph.D. (Hon.)
Radiofrequency Remodelling of the Endopelvic Fascia is Not an Effective Procedure for Urodynamic Stress Incontinence in Women S. I. M. F. Ismail Department of Obstetrics and Gynaecology, Barnsley District General Hospital, Barnsley, South Yorkshire, United Kingdom Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 1205–1209.
The aim of this study was to assess the efficacy and safety of transvaginal radiofrequency remodelling of the endopelvic fascia as a primary procedure for urodynamic stress incontinence due to urethral hypermobility in women. It included 24 patients who had the procedure at two district general hospitals. Outcome measures included the pad test, urodynamic assessment, continence diary, pain scores and operative as well as post-operative complications and assessment was made on recruitment during hospital admission and at 3, 6 and 12 months follow-up. A rising failure rate was noted as early as 3 months, leading to a cumulative cure rate of 45.8% at 12 months follow-up. This low effectiveness could be attributed to inherent weakness of the endopelvic fascia. No major complications were encountered and pain scores were mild.
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Editorial Comment: The author takes a decidedly negative approach to discussing the results of this procedure. It does, in fact, require vaginal incisions with exposure of the endopelvic fascia. It is hard to imagine, given the mechanism of action, how this procedure would produce a truly long lasting result. There is little question that the “effectiveness” is inferior to minimally invasive mid urethral tape surgery but, in view of the seemingly minimal reported risks, what should it be compared to? There was no significant difference in baseline features between those individuals whose result was considered a success and those whose results were considered a failure, except for weight. Interestingly the weight was significantly less in those who failed. There was a numerical difference in the pad test weight, with the median 1-hour pad weight in grams for the failure group being 21.4 and for the success group 10.7. The author concludes, “It is rather difficult to see a role for this technique.” Alan J. Wein, M.D., Ph.D. (Hon.)
Rate of De Novo Stress Urinary Incontinence After Urethal [sic] Diverticulum Repair U. J. Lee, H. Goldman, C. Moore, F. Daneshgari, R. R. Rackley and S. P. Vasavada Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio Urology 2008; 71: 849 – 853.
Objectives: The most recognized complications after urethral diverticulum repair are urethrovaginal fistula, diverticula recurrence, and de novo urinary incontinence. Our objective was to determine the rate of de novo stress urinary incontinence (SUI) after urethral diverticulum repair. Methods: We conducted a retrospective review of female patients who underwent urethral diverticulum repair without a simultaneous anti-incontinence procedure over 4.5 years. To determine the rate of SUI, we looked at responses to domain 3 of the urogenital distress inventory-short form (UDI-6), and the rate of subsequent procedures for the treatment of SUI. Results: A total of 50 female patients underwent urethral diverticulum repair. The median age was 44 years (range, 24 to 73) years. Median follow up was 23 months (range, 3 to 67 months). A total of 34 (68%) were white and 16 (32%) were black; 29 (58%) had simple diverticulum, 19 (38%) had horseshoe diverticulum, and 2 (4%) had circumferential diverticulum. Six (12%) had a history of recurrent diverticulum. Of 50 patients, 5 (10%) underwent a subsequent sling for SUI. Thirty-five patients completed the UDI-6. Eighteen (51%) patients reported no SUI, 10 (29%) reported “a little bit,” 5 (14%) reported “moderate,” and 2 (6%) reported being “greatly” bothered by SUI. Of patients with no preoperative urinary leakage, 5 of 15 (33%) had de novo SUI postoperatively. Of patients with preoperative urinary leakage, 8 of 11 (73%) had postoperative SUI. Conclusions: De novo rate of SUI after diverticulum repair was 49% by UDI-6, although most often the SUI was mild. Twenty percent of patients reported moderate to severe bothersome SUI symptoms after diverticulum repair. Ten percent had a subsequent anti-incontinence procedure. Editorial Comment: Patients who had a simultaneous incontinence procedure (14 of these over the same time period) were not included. Unfortunately the patients who had “preoperative urinary leakage” were not characterized as to the type of leakage that they had preoperatively, although the stress urinary incontinence afterward was apparently characterized. Patients who had bothersome stress urinary incontinence along with the diverticulum constituted the ones who had simultaneous anti-incontinence and diverticulectomy procedures. This would be standard practice. Presumably, then, the patients who had preoperative leakage had leakage from the diverticulum, and it is unclear what specific factors responsible for that sort of leakage would predispose patients after diverticulum repair to SUI. The authors hypothesize that it might be that the ostium of the diverticulum itself is larger, and thus repair would produce a more extensive loss of normal urethral tissue. Even though only 10% of patients required subsequent incontinence surgery, 20% had moderate to severe de novo SUI, and so this must certainly be mentioned as a potential risk in the preoperative patient discussion. It would seem logical
VOIDING FUNCTION, BLADDER PHYSIOLOGY AND PHARMACOLOGY, AND FEMALE UROLOGY
to try to identify those patients prior who had significant SUI so simultaneous corrective surgery could be considered. The authors comment on this, however, as follows: “Ideally, to determine the rate of de novo SUI after diverticulum repair, one would have to demonstrate the lack of SUI preoperatively by urodynamic evaluation or cystoscopic examination, and then study these patients to determine whether they developed de novo SUI after a diverticulum repair. This approach would be costly and clinically unnecessary in every case.” Alan J. Wein, M.D., Ph.D. (Hon.)
Surgical Management of Pelvic Organ Prolapse in Women: A Short Version Cochrane Review C. Maher, K. Baessler, C. M. Glazener, E. J. Adams and S. Hagen Neurourol Urodyn 2008; 27: 3–12.
Background: Pelvic organ prolapse may occur in up to 50% of parous women. A variety of urinary, bowel and sexual symptoms may be associated with prolapse. Objectives: To determine the effects of the many different surgeries in the management of pelvic organ prolapse. Search Strategy: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 3 May 2006) and reference lists of relevant articles. We also contacted researchers in the field. Selection Criteria: Randomised or quasi-randomised controlled trials that included surgical operations for pelvic organ prolapse. Data Collection and Analysis: Trials were assessed and data extracted independently by two reviewers. Six investigators were contacted for additional information with five responding. Main Results: Twenty two randomised controlled trials were identified evaluating 2368 women. Abdominal sacral colpopexy was better than vaginal sacrospinous colpopexy in terms of a lower rate of recurrent vault prolapse (RR 0.23, 95% CI 0.07 to 0.77) and less dyspareunia (RR 0.39, 95% CI 0.18 to 0.86), but the trend towards a lower re-operation rate for prolapse following abdominal sacrocolpopexy was not statistically significant (RR 0.46, 95% CI 0.19 to 1.11). However, the vaginal sacrospinous colpopexy was quicker and cheaper to perform and women had an earlier return to activities of daily living. The data were too few to evaluate other clinical outcomes and adverse events. The three trials contributing to this comparison were clinically heterogeneous. For the anterior vaginal wall prolapse, standard anterior repair was associated with more recurrent cystoceles than when supplemented by polyglactin mesh inlay (RR 1.39, 95% CI 1.02 to 1.90) or porcine dermis mesh inlay (RR 2.72, 95% CI 1.20 to 6.14), but data on morbidity, other clinical outcomes and for other mesh or graft materials were too few for reliable comparisons. For posterior vaginal wall prolapse, the vaginal approach was associated with a lower rate of recurrent rectocele and/or enterocele than the transanal approach (RR 0.24, 95% CI 0.09 to 0.64), although there was a higher blood loss and postoperative narcotic use. However, data on the effect of surgery on bowel symptoms and the use of polyglactin mesh inlay or porcine small intestine graft inlay on the risk of recurrent rectocele were insufficient for metaanalysis. Meta-analysis on the impact of pelvic organ prolapse surgery on continence issues was limited and inconclusive, although about 10% of women developed new urinary symptoms after surgery. Although the addition of tension-free vaginal tape to endopelvic fascia plication (RR 5.5, 95% CI 1.36 to 22.32) and Burch colposuspension to abdominal sacrocolpopexy (RR 2.13, 95% CI 1.39 to 3.24) were followed by a lower risk of women developing new postoperative stress incontinence, but other outcomes, particularly economic, remain to be evaluated. Authors’ Conclusions: Abdominal sacrocolpopexy is associated with a lower rate of recurrent vault prolapse and dyspareunia than the vaginal sacrospinous colpopexy. These benefits must be balanced against a longer operating time, longer time to return to activities of daily living and increased cost of the abdominal approach. The use of mesh or graft inlays at the time of anterior vaginal wall repair may reduce the risk of recurrent cystocele. Posterior vaginal wall repair may be better than transanal repair in the management of rectoceles in terms of recurrence of prolapse. The addition of a continence procedure to a prolapse repair operation may reduce the incidence of postoperative urinary incontinence but this benefit needs to be balanced against possible differences in costs and adverse effects. Adequately powered randomised controlled clinical trials are urgently needed.
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Editorial Comment: These authors have done their best to put a maximum amount of information into a minimal amount of space. They come out with a generally negative view of the ability to draw meaningful conclusions from the body of literature that has been amassed on this subject. They make some very good points: 1) “Generally, the impact of surgery on associated pelvic floor symptoms including bladder, bowel and sexual function, quality of life, cost and patient satisfaction were poorly reported. . . . Until recently, neither standardised history, validated pelvic organ prolapse or specific quality of life questionnaires or other outcome assessment tools were available”; 2) “It was disappointing that few trials were found which evaluated conservative, physical, lifestyle or mechanical means of prolapse treatment and none which compared these interventions with surgery”; 3) “The data from randomized trials are currently insufficient to guide practice.” They recommend that long-term outcomes be reported at least at 2 and 5 years after surgery— go find one! There is an excellent editorial comment, first authored by Grant with the coauthors being 2 of the coauthors of the article— unusual. The comment bemoans the limited evidence base for prolapse surgery and states further, “This is a particular concern at a time when new procedures, particularly involving mesh or grafts, with or without introducer kits, and laparoscopic approaches, are being promoted without any rigorous evidence about their effectiveness or safety. This raises questions about how well the interests of women are being safeguarded. In particular, the plethora of mesh or graft material, ranging from absorbable (synthetic and biological) to non-absorbable materials, indicates how uncertain we are about the best management. If these were new drugs they would require much more stringent evaluation before widespread use. What should we do? One attitude is to just say that there is nothing that can be done, as any research started now will be outdated by the time it is completed. The alternative is to get together as a community, identify the fundamental differences in approaches and to mount collaborative randomized trials to find out which are the most effective, cost-effective and safe. We could also lobby the regulatory authorities to consider introducing safeguards over the introduction of new devices at least until basic safety and efficacy is established. Current impediments at the moment are: lack of standardised, validated outcomes; lack of collaborative clinical networks; a perception that it is not possible to evaluate new surgical procedures (for cost reasons, the long time scale until evidence is available, learning and skill issues, and the introduction of newer procedures before the older ones have been evaluated); and as a result of all these factors, no international track record in mounting such trials.” Alan J. Wein, M.D., Ph.D. (Hon.)
Geriatrics Health and Happiness Among Older Adults: A Community-Based Study E. Angner, M. N. Ray, K. G. Saag and J. J. Allison Department of Philosophy, University of Alabama at Birmingham, Birmingham, Alabama J Health Psychol 2009; 14: 503–512.
The relationship between health and happiness was explored using a cross-sectional survey of 383 community-dwelling older adults. As a function of self-reported health, median happiness was increasing at a decreasing rate; happiness variability was decreasing at a decreasing rate. In multivariable logistic regression, lowest-quartile happiness was associated with poverty, unfavorable subjective health, debilitating pain and urinary incontinence, but not with the comorbidity count or other comorbidities. The results, robust to common method bias, suggest that subjective health measures are better predictors of happiness than objective measures are, except for conditions that disrupt daily functioning or are associated with social stigma.
Voiding Function and Dysfunction, Bladder Physiology and Pharmacology, and Female Urology Urinary Incontinence in Women: Direct Costs of Routine Care L. Subak, S. Van Den Eeden, D. Thom, J. M. Creasman, J. S. Brown and Reproductive Risks for Incontinence Study at Kaiser Research Group Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco School of Medicine, San Francisco, California Am J Obstet Gynecol 2007; 197: 596.e1–596.e9.
Objective: The purpose of this study was to estimate the direct costs of routine care for urinary incontinence (UI) in community-dwelling, racially diverse women. Study Design: In the Reproductive Risks for Incontinence Study at Kaiser population-based study, 528 women with UI weekly or more quantified resources that were used for UI. Routine care costs were calculated with the use of national resource costs ($2005). Potential predictors of these outcomes were examined by multivariable linear regression. Results: Mean age was 55 ⫾ 9 (SD) years. Among women with weekly UI, 69% reported incontinence-related costs. Median weekly cost was $1.83 (25%-75% interquartile range [IQR], $0.50, $5.23), increasing from $0.93 (IQR, $0, $3) for moderate to $7.82 (IQR, $5, $37) for very severe incontinence. Costs that increased with incontinence severity (P ⬍ .001) and body mass index (P ⬍ .001) were 2.2-fold higher for African American versus white women (P ⬍ .0001) and 42% higher for women with mixed versus stress incontinence (P ⬍ .05). Conclusion: Women pay a mean of ⬎$250 per year out-of-pocket for UI routine care. Effective incontinence treatment may decrease costs. Editorial Comment: Inclusion was based on the question: “During the past 12 months, on average, how often have you leaked urine, even a small amount?” The choices were daily, weekly, monthly, less than monthly and never. Those who reported weekly or greater frequency of UI completed a questionnaire that was used for inclusion in this study. Community dwelling women with severe and very severe incontinence were determined to pay between $350 and $1,150 per year out of pocket for incontinence routine care, none of which is reimbursed by third-party payers in the United States. Alan J. Wein, M.D., Ph.D. (Hon.)
The Impact of Multichannel Urodynamics Upon Treatment Recommendations for Female Urinary Incontinence R. M. Ward, B. S. Hampton, J. D. Blume, V. W. Sung, C. R. Rardin and D. L. Myers Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Women and Infants’ Hospital, Warren Alpert Medical School of Brown University, Providence, Rhode Island Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 1235–1241.
The aim of this study was to evaluate whether multichannel urodynamic testing changes a physician’s treatment recommendations when managing women with urinary incontinence. In this prospective reader study, four fellowship-trained urogynecologists reviewed 39 abstracted cases of urinary incontinence on two occasions: first without and subsequently with urodynamic data. Treatment recommendations were made for each case after each review. The probability of urodynamic data modifying 0022-5347/10/1831-0253/0 THE JOURNAL OF UROLOGY® Copyright © 2010 by AMERICAN UROLOGICAL ASSOCIATION
Vol. 183, 253-262, January 2010 Printed in U.S.A. DOI:10.1016/j.juro.2009.09.068
www.jurology.com
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treatment recommendations was estimated for each reader and for the population of readers using a random effects logistic regression to account for reader variability. The overall probability that urodynamic data would change treatment was 26.9% (95% confidence interval (CI), 18.6%, 37.2%) for medical treatments and 45.5% (95% CI, 37.8%, 53.4%) for surgical treatments. Reader-to-reader differences accounted for 3% and ⬍1% of the total variance for medical and surgical treatments, respectively. Multichannel urodynamic evaluations are significantly associated with changes in medical and surgical treatment recommendations in a referral population. Editorial Comment: These cases were considered “seemingly straightforward” as opposed to “complex,” regarding which there is little argument about the value of urodynamic testing. The authors conclude that “the study shows that even among straightforward patients with documented stress incontinence, urodynamics change the treatment recommendation in 22% of cases.” In this study urodynamics were estimated to change the diagnosis of stress incontinence (present, absent or indeterminate) in 35.9%, the diagnosis of urgency incontinence was estimated to change in 41.2% and the diagnosis of mixed incontinence was estimated to change in 35.7% of patients. One unanswered question, however, which the authors do mention is, “Did the changes result in improvements in clinical outcomes over the strategy that was originally considered before urodynamics?” With urodynamic studies coming under fire by third-party payers this is the question to which we all should turn our attention. Alan J. Wein, M.D., Ph.D. (Hon.)
Reliability Testing of Urodynamics, Pressure Flow Studies and Cough Leak Point Pressure in Women With Urodynamic Stress Incontinence With and Without Detrusor Overactivity P. Rahmanou, C. Chaliha, E. Kulinskaya and K. Khullar Department of Urogynaecology, Imperial College, St. Mary’s Hospital, London, United Kingdom Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 933–938.
Urodynamic studies which included cough leak point pressure (CLPP) and pressure flow studies were performed at two visits 2 weeks apart. Reproducibility between the two visits and also between the two diagnostic groups, urodynamic stress incontinence (USI) and urodynamic mixed incontinence (UMI) were analysed. Thirty-one women completed both visits, of those 14 had USI in both sets of urodynamic studies, 11 had UMI on both visits, six had USI on one visit and UMI in the other. The urodynamic variables of maximum cystometric capacity and CLPP have the most repeatability. Analysis in women with USI alone compared to USI with detrusor overactivity (DOA) showed that the repeatability for pressure flow parameters and CLPP was better in women without DOA, of which the CLPP was significantly different (p ⫽ 0.036). Urodynamic variables are inconsistent. This may reflect variations in urinary tract behaviour. Editorial Comment: We have always found that, with respect to urodynamic studies and their reproducibility, if you are looking for electrocardiogram reproducibility, you will not find it, or anything close to it. However, our feeling has always been, most of the time, if you are asking a specific question and you can reproduce the clinical symptomatology, you will generally get a qualitative answer and it will generally be the same from time to time, assuming the symptoms are the same and no treatments have been instituted. Alan J. Wein, M.D., Ph.D. (Hon.)
VOIDING FUNCTION, BLADDER PHYSIOLOGY AND PHARMACOLOGY, AND FEMALE UROLOGY
Clarification and Confirmation of the Knack Maneuver: The Effect of Volitional Pelvic Floor Muscle Contraction to Preempt Expected Stress Incontinence J. M. Miller, C. Sampselle, J. Ashton-Miller, G. R. Hong and J. O. DeLancey School of Nursing, University of Michigan, Ann Arbor, Michigan Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 773–782.
The aim of the study was to determine the immediate effect of timing a pelvic muscle contraction with the moment of expected leakage (the Knack maneuver) to preempt cough-related stress incontinence. Women performed a standing stress test using three hard coughs without and then with the Knack maneuver. Volume of urine loss under both conditions was quantified with paper-towel test. Two groups of women were tested: nonpregnant women (n ⫽ 64) and pregnant women (n ⫽ 29). In nonpregnant women, wetted area decreased from a median (range) of 43.2 (0.2–183.7) cm2 without the Knack maneuver to 6.9 (range of 0 to 183.7 cm2) with it (p ⬍ 0.0001); while in pregnant women it decreased from 14.8 (0 –169.7) cm2 to 0 (0 –96.5) cm2, respectively (p ⫽ 0.001). This study confirms the effect from the Knack maneuver as immediate and provides a partial explanation for early response to widely applied pelvic muscle training regimens in women with stress incontinence. Editorial Comment: These folks showed earlier that in selected older women urine loss with effort can be significantly reduced within 1 week by teaching them how to contract the pelvic floor muscles volitionally before and during effort (in this case a cough). They distinguished the intervention of teaching women to tighten their pelvic floor muscles in preparation for a known leakage provoking event from the intervention of setting aside time to contract the pelvic floor muscle as an aid for strength development (assumed to be due to hypertrophy and enhancement of a reflex response, the latter falling under the designation of Kegel exercises). An effective Knack effort recruits the striated muscles associated with the urethra as well as the striated “lifting portion” of the levator ani. It is important to note that approximately 20% of women will show no reduction in leakage volume with the use of this maneuver. The reasons offered are: 1) the muscle may be deficient; 2) they may not be doing the maneuver correctly; 3) they may be doing the maneuver correctly and already have achieved maximal reduction. The Knack maneuver is a sustained contraction. One can also use “quick flicks” of this muscle and in many cases abort the sensation of urgency, whether or not associated with a true involuntary bladder contraction. This maneuver of rapid repeated “quick flicks” does seem to be effective and is hypothesized to be so on the basis of reflex suppression of detrusor activation. Alan J. Wein, M.D., Ph.D. (Hon.)
Radiofrequency Remodelling of the Endopelvic Fascia is Not an Effective Procedure for Urodynamic Stress Incontinence in Women S. I. M. F. Ismail Department of Obstetrics and Gynaecology, Barnsley District General Hospital, Barnsley, South Yorkshire, United Kingdom Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 1205–1209.
The aim of this study was to assess the efficacy and safety of transvaginal radiofrequency remodelling of the endopelvic fascia as a primary procedure for urodynamic stress incontinence due to urethral hypermobility in women. It included 24 patients who had the procedure at two district general hospitals. Outcome measures included the pad test, urodynamic assessment, continence diary, pain scores and operative as well as post-operative complications and assessment was made on recruitment during hospital admission and at 3, 6 and 12 months follow-up. A rising failure rate was noted as early as 3 months, leading to a cumulative cure rate of 45.8% at 12 months follow-up. This low effectiveness could be attributed to inherent weakness of the endopelvic fascia. No major complications were encountered and pain scores were mild.
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Editorial Comment: The author takes a decidedly negative approach to discussing the results of this procedure. It does, in fact, require vaginal incisions with exposure of the endopelvic fascia. It is hard to imagine, given the mechanism of action, how this procedure would produce a truly long lasting result. There is little question that the “effectiveness” is inferior to minimally invasive mid urethral tape surgery but, in view of the seemingly minimal reported risks, what should it be compared to? There was no significant difference in baseline features between those individuals whose result was considered a success and those whose results were considered a failure, except for weight. Interestingly the weight was significantly less in those who failed. There was a numerical difference in the pad test weight, with the median 1-hour pad weight in grams for the failure group being 21.4 and for the success group 10.7. The author concludes, “It is rather difficult to see a role for this technique.” Alan J. Wein, M.D., Ph.D. (Hon.)
Rate of De Novo Stress Urinary Incontinence After Urethal [sic] Diverticulum Repair U. J. Lee, H. Goldman, C. Moore, F. Daneshgari, R. R. Rackley and S. P. Vasavada Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio Urology 2008; 71: 849 – 853.
Objectives: The most recognized complications after urethral diverticulum repair are urethrovaginal fistula, diverticula recurrence, and de novo urinary incontinence. Our objective was to determine the rate of de novo stress urinary incontinence (SUI) after urethral diverticulum repair. Methods: We conducted a retrospective review of female patients who underwent urethral diverticulum repair without a simultaneous anti-incontinence procedure over 4.5 years. To determine the rate of SUI, we looked at responses to domain 3 of the urogenital distress inventory-short form (UDI-6), and the rate of subsequent procedures for the treatment of SUI. Results: A total of 50 female patients underwent urethral diverticulum repair. The median age was 44 years (range, 24 to 73) years. Median follow up was 23 months (range, 3 to 67 months). A total of 34 (68%) were white and 16 (32%) were black; 29 (58%) had simple diverticulum, 19 (38%) had horseshoe diverticulum, and 2 (4%) had circumferential diverticulum. Six (12%) had a history of recurrent diverticulum. Of 50 patients, 5 (10%) underwent a subsequent sling for SUI. Thirty-five patients completed the UDI-6. Eighteen (51%) patients reported no SUI, 10 (29%) reported “a little bit,” 5 (14%) reported “moderate,” and 2 (6%) reported being “greatly” bothered by SUI. Of patients with no preoperative urinary leakage, 5 of 15 (33%) had de novo SUI postoperatively. Of patients with preoperative urinary leakage, 8 of 11 (73%) had postoperative SUI. Conclusions: De novo rate of SUI after diverticulum repair was 49% by UDI-6, although most often the SUI was mild. Twenty percent of patients reported moderate to severe bothersome SUI symptoms after diverticulum repair. Ten percent had a subsequent anti-incontinence procedure. Editorial Comment: Patients who had a simultaneous incontinence procedure (14 of these over the same time period) were not included. Unfortunately the patients who had “preoperative urinary leakage” were not characterized as to the type of leakage that they had preoperatively, although the stress urinary incontinence afterward was apparently characterized. Patients who had bothersome stress urinary incontinence along with the diverticulum constituted the ones who had simultaneous anti-incontinence and diverticulectomy procedures. This would be standard practice. Presumably, then, the patients who had preoperative leakage had leakage from the diverticulum, and it is unclear what specific factors responsible for that sort of leakage would predispose patients after diverticulum repair to SUI. The authors hypothesize that it might be that the ostium of the diverticulum itself is larger, and thus repair would produce a more extensive loss of normal urethral tissue. Even though only 10% of patients required subsequent incontinence surgery, 20% had moderate to severe de novo SUI, and so this must certainly be mentioned as a potential risk in the preoperative patient discussion. It would seem logical
VOIDING FUNCTION, BLADDER PHYSIOLOGY AND PHARMACOLOGY, AND FEMALE UROLOGY
to try to identify those patients prior who had significant SUI so simultaneous corrective surgery could be considered. The authors comment on this, however, as follows: “Ideally, to determine the rate of de novo SUI after diverticulum repair, one would have to demonstrate the lack of SUI preoperatively by urodynamic evaluation or cystoscopic examination, and then study these patients to determine whether they developed de novo SUI after a diverticulum repair. This approach would be costly and clinically unnecessary in every case.” Alan J. Wein, M.D., Ph.D. (Hon.)
Surgical Management of Pelvic Organ Prolapse in Women: A Short Version Cochrane Review C. Maher, K. Baessler, C. M. Glazener, E. J. Adams and S. Hagen Neurourol Urodyn 2008; 27: 3–12.
Background: Pelvic organ prolapse may occur in up to 50% of parous women. A variety of urinary, bowel and sexual symptoms may be associated with prolapse. Objectives: To determine the effects of the many different surgeries in the management of pelvic organ prolapse. Search Strategy: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 3 May 2006) and reference lists of relevant articles. We also contacted researchers in the field. Selection Criteria: Randomised or quasi-randomised controlled trials that included surgical operations for pelvic organ prolapse. Data Collection and Analysis: Trials were assessed and data extracted independently by two reviewers. Six investigators were contacted for additional information with five responding. Main Results: Twenty two randomised controlled trials were identified evaluating 2368 women. Abdominal sacral colpopexy was better than vaginal sacrospinous colpopexy in terms of a lower rate of recurrent vault prolapse (RR 0.23, 95% CI 0.07 to 0.77) and less dyspareunia (RR 0.39, 95% CI 0.18 to 0.86), but the trend towards a lower re-operation rate for prolapse following abdominal sacrocolpopexy was not statistically significant (RR 0.46, 95% CI 0.19 to 1.11). However, the vaginal sacrospinous colpopexy was quicker and cheaper to perform and women had an earlier return to activities of daily living. The data were too few to evaluate other clinical outcomes and adverse events. The three trials contributing to this comparison were clinically heterogeneous. For the anterior vaginal wall prolapse, standard anterior repair was associated with more recurrent cystoceles than when supplemented by polyglactin mesh inlay (RR 1.39, 95% CI 1.02 to 1.90) or porcine dermis mesh inlay (RR 2.72, 95% CI 1.20 to 6.14), but data on morbidity, other clinical outcomes and for other mesh or graft materials were too few for reliable comparisons. For posterior vaginal wall prolapse, the vaginal approach was associated with a lower rate of recurrent rectocele and/or enterocele than the transanal approach (RR 0.24, 95% CI 0.09 to 0.64), although there was a higher blood loss and postoperative narcotic use. However, data on the effect of surgery on bowel symptoms and the use of polyglactin mesh inlay or porcine small intestine graft inlay on the risk of recurrent rectocele were insufficient for metaanalysis. Meta-analysis on the impact of pelvic organ prolapse surgery on continence issues was limited and inconclusive, although about 10% of women developed new urinary symptoms after surgery. Although the addition of tension-free vaginal tape to endopelvic fascia plication (RR 5.5, 95% CI 1.36 to 22.32) and Burch colposuspension to abdominal sacrocolpopexy (RR 2.13, 95% CI 1.39 to 3.24) were followed by a lower risk of women developing new postoperative stress incontinence, but other outcomes, particularly economic, remain to be evaluated. Authors’ Conclusions: Abdominal sacrocolpopexy is associated with a lower rate of recurrent vault prolapse and dyspareunia than the vaginal sacrospinous colpopexy. These benefits must be balanced against a longer operating time, longer time to return to activities of daily living and increased cost of the abdominal approach. The use of mesh or graft inlays at the time of anterior vaginal wall repair may reduce the risk of recurrent cystocele. Posterior vaginal wall repair may be better than transanal repair in the management of rectoceles in terms of recurrence of prolapse. The addition of a continence procedure to a prolapse repair operation may reduce the incidence of postoperative urinary incontinence but this benefit needs to be balanced against possible differences in costs and adverse effects. Adequately powered randomised controlled clinical trials are urgently needed.
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Editorial Comment: These authors have done their best to put a maximum amount of information into a minimal amount of space. They come out with a generally negative view of the ability to draw meaningful conclusions from the body of literature that has been amassed on this subject. They make some very good points: 1) “Generally, the impact of surgery on associated pelvic floor symptoms including bladder, bowel and sexual function, quality of life, cost and patient satisfaction were poorly reported. . . . Until recently, neither standardised history, validated pelvic organ prolapse or specific quality of life questionnaires or other outcome assessment tools were available”; 2) “It was disappointing that few trials were found which evaluated conservative, physical, lifestyle or mechanical means of prolapse treatment and none which compared these interventions with surgery”; 3) “The data from randomized trials are currently insufficient to guide practice.” They recommend that long-term outcomes be reported at least at 2 and 5 years after surgery— go find one! There is an excellent editorial comment, first authored by Grant with the coauthors being 2 of the coauthors of the article— unusual. The comment bemoans the limited evidence base for prolapse surgery and states further, “This is a particular concern at a time when new procedures, particularly involving mesh or grafts, with or without introducer kits, and laparoscopic approaches, are being promoted without any rigorous evidence about their effectiveness or safety. This raises questions about how well the interests of women are being safeguarded. In particular, the plethora of mesh or graft material, ranging from absorbable (synthetic and biological) to non-absorbable materials, indicates how uncertain we are about the best management. If these were new drugs they would require much more stringent evaluation before widespread use. What should we do? One attitude is to just say that there is nothing that can be done, as any research started now will be outdated by the time it is completed. The alternative is to get together as a community, identify the fundamental differences in approaches and to mount collaborative randomized trials to find out which are the most effective, cost-effective and safe. We could also lobby the regulatory authorities to consider introducing safeguards over the introduction of new devices at least until basic safety and efficacy is established. Current impediments at the moment are: lack of standardised, validated outcomes; lack of collaborative clinical networks; a perception that it is not possible to evaluate new surgical procedures (for cost reasons, the long time scale until evidence is available, learning and skill issues, and the introduction of newer procedures before the older ones have been evaluated); and as a result of all these factors, no international track record in mounting such trials.” Alan J. Wein, M.D., Ph.D. (Hon.)
Geriatrics Health and Happiness Among Older Adults: A Community-Based Study E. Angner, M. N. Ray, K. G. Saag and J. J. Allison Department of Philosophy, University of Alabama at Birmingham, Birmingham, Alabama J Health Psychol 2009; 14: 503–512.
The relationship between health and happiness was explored using a cross-sectional survey of 383 community-dwelling older adults. As a function of self-reported health, median happiness was increasing at a decreasing rate; happiness variability was decreasing at a decreasing rate. In multivariable logistic regression, lowest-quartile happiness was associated with poverty, unfavorable subjective health, debilitating pain and urinary incontinence, but not with the comorbidity count or other comorbidities. The results, robust to common method bias, suggest that subjective health measures are better predictors of happiness than objective measures are, except for conditions that disrupt daily functioning or are associated with social stigma.