Development and assessment of a self-management intervention for urinary incontinence among patients with prostate cancer: protocol for a randomized feasibility study.

BACKGROUND: Urinary incontinence is a common complication among patients with prostate cancer who have undergone radical prostatectomy. Guided by social cognitive theory and a framework for the recovery of health and well-being, we propose to develop and test a self-management intervention for patients with prostate cancer who experience urinary incontinence after undergoing radical prostatectomy. METHODS: In this study, a self-management intervention for urinary incontinence (SMI-UI) is developed, comprising a mobile self-management application, a self-management handbook, and professional support. The feasibility, acceptability, and effectiveness of this intervention will be assessed. Patient data from the urology departments of two hospitals will be collected through convenience sampling by adopting an experimental, parallel, and random assignment research design. Patients experiencing urinary incontinence after undergoing radical prostatectomy will be invited to participate. After completing the pretest questionnaire, patients will be randomly divided into the experimental and attention control groups. The experimental group will undergo a 12-week SMI-UI, whereas the attention control group will receive an intervention consisting of a single dietetic education information package. The two groups will be tested 12 and 16 weeks after the pretest. In this study, we recorded the sociodemographic and clinical variables; recruitment rate; retention rate; satisfaction with the intervention; cancer-related self-efficacy; urination symptoms and disturbance; social participation and satisfaction; resilience; and demoralization. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT05335967 [date of registration 04-04-2022].

Single-incision sling operations for urinary incontinence in women.

BACKGROUND: Stress urinary incontinence imposes a significant health and economic burden on individuals and society. Single-incision slings are a minimally-invasive treatment option for stress urinary incontinence. They involve passing a short synthetic device through the anterior vaginal wall to support the mid-urethra. The use of polypropylene mesh in urogynaecology, including mid-urethral slings, is restricted in many countries. This is a review update (previous search date 2012). OBJECTIVES: To assess the effects of single-incision sling operations for treating urinary incontinence in women, and to summarise the principal findings of relevant economic evaluations. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from: CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, and two trials registers. We handsearched journals, conference proceedings, and reference lists of relevant articles to 20 September 2022. SELECTION CRITERIA: We included randomised or quasi-randomised controlled trials in women with stress (or stress-predominant mixed) urinary incontinence in which at least one, but not all, trial arms included a single-incision sling. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. The primary outcome was subjective cure or improvement of urinary incontinence. MAIN RESULTS: We included 62 studies with a total of 8051 women in this review. We did not identify any studies comparing single-incision slings to no treatment, conservative treatment, colposuspension, or laparoscopic procedures. We assessed most studies as being at low or unclear risk of bias, with five studies at high risk of bias for outcome assessment. Sixteen trials used TVT-Secur, a single-incision sling withdrawn from the market in 2013. The primary analysis in this review excludes trials using TVT-Secur. We report separate analyses for these trials, which did not substantially alter the effect estimates. We identified two cost-effectiveness analyses and one cost-minimisation analysis. Single-incision sling versus autologous fascial sling One study (70 women) compared single-incision slings to autologous fascial slings. It is uncertain if single-incision slings have any effect on risk of dyspareunia (painful sex) or mesh exposure, extrusion or erosion compared with autologous fascial slings. Subjective cure or improvement of urinary incontinence at 12 months, patient-reported pain at 24 months or longer, number of women with urinary retention, quality of life at 12 months and the number of women requiring repeat continence surgery or sling revision were not reported for this comparison. Single-incision sling versus retropubic sling Ten studies compared single-incision slings to retropubic slings. There may be little to no difference between single-incision slings and retropubic slings in subjective cure or improvement of incontinence at 12 months (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.91 to 1.07; 2 trials, 297 women; low-certainty evidence). It is uncertain whether single-incision slings increase the risk of mesh exposure, extrusion or erosion compared with retropubic minimally-invasive slings; the wide confidence interval is consistent with both benefit and harm (RR 1.55, 95% CI 0.24 to 9.82; 3 trials, 267 women; low-certainty evidence). It is uncertain whether single-incision slings lead to fewer women having postoperative urinary retention compared with retropubic slings; the wide confidence interval is consistent with possible benefit and harm (RR 0.47, 95% CI 0.12 to 1.84; 2 trials, 209 women; low-certainty evidence). The effect of single-incision slings on the risk of repeat continence surgery or mesh revision compared with retropubic slings is uncertain (RR 4.19, 95% CI 0.31 to 57.28; 2 trials, 182 women; very low-certainty evidence). One study reported quality of life, but not in a suitable format for analysis. Patient-reported pain at more than 24 months and the number of women with dyspareunia were not reported for this comparison. We downgraded the evidence due to concerns about risks of bias, imprecision and inconsistency. Single-incision sling versus transobturator sling Fifty-one studies compared single-incision slings to transobturator slings. The evidence ranged from high to low certainty. There is no evidence of a difference in subjective cure or improvement of incontinence at 12 months when comparing single-incision slings with transobturator slings (RR 1.00, 95% CI 0.97 to 1.03; 17 trials, 2359 women; high-certainty evidence). Single-incision slings probably have a reduced risk of patient-reported pain at 24 months post-surgery compared with transobturator slings (RR 0.12, 95% CI 0.02 to 0.68; 2 trials, 250 women; moderate-certainty evidence). The effect of single-incision slings on the risk of dyspareunia is uncertain compared with transobturator slings, as the wide confidence interval is consistent with possible benefit and possible harm (RR 0.78, 95% CI 0.41 to 1.48; 8 trials, 810 women; moderate-certainty evidence). There are a similar number of mesh exposures, extrusions or erosions with single-incision slings compared with transobturator slings (RR 0.61, 95% CI 0.39 to 0.96; 16 trials, 2378 women; high-certainty evidence). Single-incision slings probably result in similar or reduced cases of postoperative urinary retention compared with transobturator slings (RR 0.68, 95% CI 0.47 to 0.97; 23 trials, 2891 women; moderate-certainty evidence). Women with single-incision slings may have lower quality of life at 12 months compared to transobturator slings (standardised mean difference (SMD) 0.24, 95% CI 0.09 to 0.39; 8 trials, 698 women; low-certainty evidence). It is unclear whether single-incision slings lead to slightly more women requiring repeat continence surgery or mesh revision compared with transobturator slings (95% CI consistent with possible benefit and harm; RR 1.42, 95% CI 0.94 to 2.16; 13 trials, 1460 women; low-certainty evidence). We downgraded the evidence due to indirectness, imprecision and risks of bias. AUTHORS' CONCLUSIONS: Single-incision sling operations have been extensively researched in randomised controlled trials. They may be as effective as retropubic slings and are as effective as transobturator slings for subjective cure or improvement of stress urinary incontinence at 12 months. It is uncertain if single-incision slings lead to better or worse rates of subjective cure or improvement compared with autologous fascial slings. There are still uncertainties regarding adverse events and longer-term outcomes. Therefore, longer-term data are needed to clarify the safety and long-term effectiveness of single-incision slings compared to other mid-urethral slings.

Medium-Term Outcomes of Conservative and Surgical Treatments for Stress Urinary Incontinence: A Medicare Claims Analysis: Developed by the AUGS Payment Reform Committee.

OBJECTIVE: This study aimed to evaluate the 3- to 5-year retreatment outcomes for conservatively and surgically treated urinary incontinence (UI) in a population of women 66 years and older. METHODS: This retrospective cohort study used 5% Medicare data to evaluate UI retreatment outcomes of women undergoing physical therapy (PT), pessary treatment, or sling surgery. The data set used inpatient, outpatient, and carrier claims from 2008 to 2016 in women 66 years and older with fee-for-service coverage. Treatment failure was defined as receiving another UI treatment (pessary, PT, sling, Burch urethropexy, or urethral bulking) or repeat sling. A secondary analysis was performed where additional treatment courses of PT or pessary were also considered a treatment failure. Survival analysis was used to evaluate the time from treatment initiation to retreatment. RESULTS: Between 2008 and 2013, 13,417 women were included with an index UI treatment, and follow-up continued through 2016. In this cohort, 41.4% received pessary treatment, 31.8% received PT, and 26.8% underwent sling surgery. In the primary analysis, pessaries had the lowest treatment failure rate compared with PT (P<0.001) and sling surgery (P<0.001; survival probability, 0.94 [pessary], 0.90 [PT], 0.88 [sling]). In the analysis where retreatment with PT or a pessary was considered a failure, sling surgery had the lowest retreatment rate (survival probability, 0.58 [pessary], 0.81 [PT], 0.88 [sling]; P<0.001 for all comparisons). CONCLUSIONS: In this administrative database analysis, there was a small but statistically significant difference in treatment failure among women undergoing sling surgery, PT, or pessary treatment, but pessary use was commonly associated with the need for repeat pessary fittings.

Concurrent Surgery for Locoregional Gynecologic Cancers and Pelvic Floor Disorders in a Population of Patients With Medicare Insurance.

OBJECTIVE: To estimate the rate of concurrent surgery for locoregional gynecologic cancer and pelvic organ prolapse-urinary incontinence (POP-UI) and to assess the rate of surgery for POP-UI within 5 years for those who did not undergo concurrent surgery. METHODS: This is a retrospective cohort study. The SEER-Medicare data set was used to identify cases of local or regional endometrial, cervical, and ovarian cancer diagnosed from 2000 to 2017. Patients were followed up for 5 years from diagnosis. We used χ 2 tests to identify categorical variables associated with having a concurrent POP-UI procedure with hysterectomy or within 5 years of hysterectomy. Logistic regression was used to calculate odds ratios and 95% CIs adjusted for variables statistically significant (α=.05) in the univariate analyses. RESULTS: Of 30,862 patients with locoregional gynecologic cancer, only 5.5% underwent concurrent POP-UI surgery. Of those with a preexisting diagnosis related to POP-UI, however, 21.1% had concurrent surgery. Of the patients who had a diagnosis of POP-UI at the time of initial surgery for cancer and who did not undergo concurrent surgery, an additional 5.5% had a second surgery for POP-UI within 5 years. The rate of concurrent surgery remained constant over the time period (5.7% in 2000 and 2017) despite an increase in the frequency of POP-UI diagnosis in the same time frame. CONCLUSION: The rate of concurrent surgery for patients with an early-stage gynecologic cancer and POP-UI-associated diagnosis in women older than age 65 years was 21.1%. Of women who did not undergo concurrent surgery but had a diagnosis of POP-UI, 1 in 18 underwent surgery for POP-UI within 5 years of their index cancer surgery. Dedicated efforts must be made to identify patients who would most benefit from concurrent cancer and POP-UI surgery in those with locoregional gynecologic cancers and pelvic floor disorders.

Cost-effectiveness Analysis: Autologous Rectus Fascial Sling Versus Retropubic Midurethral Sling for Female Stress Urinary Incontinence.

IMPORTANCE: There are limited data on the economic comparison between retropubic midurethral sling and autologous fascial sling. OBJECTIVE: This study aims to evaluate the cost-effectiveness of autologous rectus fascial sling compared with retropubic midurethral sling from both hospital and health care perspectives. STUDY DESIGN: A decision tree model was developed with 1 year of follow-up. We included variables such as objective success rate, complications and subsequent treatments, and retreatment for incontinence. The model included the index procedure and 1 retreatment for stress urinary incontinence. Cost estimates were calculated from both hospital and health care perspectives. The outcomes were expressed in incremental cost-effectiveness ratio (ICER) or cost per quality-adjusted life-year (QALY). An ICER <$50,000/QALY was considered cost-effective. RESULTS: From a hospital perspective, the overall cost of retropubic midurethral sling was higher than autologous rectus fascial sling ($2,348.94 vs $2,114.06), but was more effective (0.82 vs 0.80 QALYs). The ICER was $17,452/QALY. From a health care perspective, the overall cost of autologous rectus fascial sling was higher than retropubic midurethral sling ($4,656.63 vs $4,630.47) and was less effective. Retropubic midurethral sling was the dominant strategy, with ICER of -$1,943.32/QALY. If the success rate of autologous rectus fascial sling was ≥84.39%, or the cost of retropubic midurethral sling surgery was > $2,654.36, then autologous rectus fascial sling would become cost-effective. CONCLUSIONS: Retropubic midurethral sling is the cost-effective treatment from the hospital perspective and the dominant treatment from the health care perspective. However, changes in the costs and success rates of surgical procedures can alter the cost-effectiveness results.

Cost Effectiveness of Concurrent Midurethral Sling at the Time of Prolapse Repair: Results From a Randomized Controlled Trial.

IMPORTANCE: The relative cost per improvement in quality of life can help guide decisions about adding a midurethral sling at the time of prolapse surgery. OBJECTIVE: This study aimed to assess the cost-effectiveness of prophylactic midurethral slings placed at the time of prolapse surgery to reduce de novo urinary incontinence based on a randomized controlled trial. STUDY DESIGN: Costs and effectiveness were collected as part of a planned secondary analysis from the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial, where 337 women without symptomatic stress urinary incontinence were randomly assigned to a midurethral sling or sham incisions during vaginal prolapse surgery. Within-trial cost-effectiveness analysis was performed from the societal perspective. Effectiveness was measured in quality-adjusted life-years (QALYs) and de novo urinary incontinence. We calculated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. RESULTS: Within-trial societal costs were higher for the sling group than for the control group ($18,170 [95% confidence interval (CI), $16,420-$19,920] vs $15,700 [95% CI, $14,110-$17300], P = 0.041). The changes in QALY were 0.04 (95% CI, 0.02-0.06) versus 0.03 (95% CI, 0.02-0.05; P = 0.54). The incremental cost-effectiveness ratio for prophylactic sling was $309,620/QALY. This is above the generally accepted range of willingness-to-pay thresholds of $50,000 to $150,000/QALY. At 1 year, urinary incontinence was more common in the control group, and the cost to prevent 1 case was $91. The probability that prophylactic sling is cost-effective is 24%. CONCLUSIONS: Prophylactic sling placed during vaginal prolapse surgery reduced the rate of de novo urinary incontinence, but was not cost-effective.

CT-based preoperative risk assessment of prolonged urine leak in patients undergoing partial nephrectomy.

OBJECTIVES: This study aims to evaluate risk factors of prolonged urine leak following partial nephrectomy (PN) to identify objective imaging characteristics on preoperative CT. METHODS: A total of 865 patients who underwent PN and had preoperative CT and postoperative imaging were included. We set a twofold size-matched control group without urine leak, with all tumors located ≤ 4 mm to the collecting system to identify imaging parameters that increase the risk of urine leak other than tumor size and location. Four CT parameters that show the relationship of the tumor and collecting system, namely, curvilinear border length, protruding distance, margin at the interface, and pelvicalyceal contact, were analyzed. Multivariate logistic regression analyses were performed to identify significant predictors of urine leak. The diagnostic performance of the significant parameters was evaluated using the area under the receiver operating characteristic curve (AUC). RESULTS: Fifty-three of 865 patients (6.1%) demonstrated urine leak. Compared with the control group, urine leak group showed longer curvilinear border length, longer protruding distance, frequent non-smooth contact interface, and frequent direct pelvicalyceal contact (p < 0.05 for all). In the multivariate analysis, pelvicalyceal contact was the independent predictor of urine leak (OR = 2.62; 95% C.I 1.02-6.63). Combining four CT parameters, an AUC of 0.70 with a sensitivity of 58.5% and a specificity of 79.2% for identifying urine leak after PN could be obtained. CONCLUSIONS: The four CT features that describe the relationship between the tumor and collecting system might be useful for evaluating the risk of urine leak before PN. KEY POINTS: • Four CT parameters (curvilinear border length, protruding distance, margin at the interface, and pelvicalyceal contact) were significantly associated with postoperative urine leak after partial nephrectomy. • A comprehensive preoperative imaging evaluation of the relationship between the tumor and renal sinus may help in selecting the optimal surgical options and afford better patient counseling of complication risk.

Avaliação da qualidade de vida de mulheres submetidas a Sling para incontinência urinária / Assessment of the quality of life of women undergoing Sling for urinary incontinence

Introdução: A incontinência urinária é caracterizada como a perda involuntária de urina, atingindo uma proporção de 2 mulheres para 1 homem. Aspectos psicológicos, sociais e sexuais são afetados pela incontinência urinária. Mulheres com essa condição apresentam-se deprimidas, angustiadas ou irritadas. O afastamento das atividades sociais pelo receio do estigma contribui para a procura tardia por auxílio. A avaliação do impacto na qualidade de vida em mulheres com incontinência urinária pode ser feita através de questionários validados. Objetivo: O objetivo deste estudo é avaliar o impacto do tratamento cirúrgico suburetral para incontinência urinária na qualidade de vida de pacientes atendidas no Ambulatório de Urologia do HSPM. Metodologia: Trata-se de um estudo observacional, prospectivo e retrospectivo envolvendo pacientes com mais de 18 anos e incontinência urinária de esforço submetida a tratamento cirúrgico por técnica suburetral. Foi aplicado o questionário Quality of Life in Persons with Urinary Incontinence (I-QoL), validado em língua portuguesa, no pré-operatório e 6 (seis) meses após a cirurgia. Resultados e Discussão: O aumento na qualidade de vida observado foi estatisticamente significante pelo Teste T pareado (p<0,001). A avaliação da percepção da qualidade de vida das pacientes através do questionário I-QoL demonstrou resultados semelhantes aos verificados na literatura. Conclusão: Nesse estudo foi observada melhora na percepção da qualidade de vida das mulheres submetidas ao tratamento cirúrgico suburetral para incontinência urinária de esforço. Palavras-chave: Incontinência urinária. Qualidade de Vida. Slings Suburetrais.

Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT.

BACKGROUND: Stress urinary incontinence is the most common type of urinary incontinence in premenopausal women. Until recently, synthetic mid-urethral slings (mesh/tape) were the standard surgical treatment, if conservative management failed. Adjustable anchored single-incision mini-slings are newer, use less mesh and may reduce perioperative morbidity, but it is unclear how their success rates and safety compare with those of standard tension-free mid-urethral slings. OBJECTIVE: The objective was to compare tension-free standard mid-urethral slings with adjustable anchored single-incision mini-slings among women with stress urinary incontinence requiring surgical intervention, in terms of patient-reported effectiveness, health-related quality of life, safety and cost-effectiveness. DESIGN: This was a pragmatic non-inferiority randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio). SETTING: The trial was set in 21 UK hospitals. PARTICIPANTS: Participants were women aged ≥ 18 years with predominant stress urinary incontinence, undergoing a mid-urethral sling procedure. INTERVENTIONS: Single-incision mini-slings, compared with standard mid-urethral slings. MAIN OUTCOME MEASURES: The primary outcome was patient-reported success rates on the Patient Global Impression of Improvement scale at 15 months post randomisation (≈ 1 year post surgery), with success defined as outcomes of 'very much improved' or 'much improved'. The primary economic outcome was incremental cost per quality-adjusted life-year gained. Secondary outcomes were adverse events, impact on other urinary symptoms, quality of life and sexual function. RESULTS: A total of 600 participants were randomised. At 15 months post randomisation, adjustable anchored single-incision mini-slings were non-inferior to tension-free standard mid-urethral slings at the 10% margin for the primary outcome [single-incision mini-sling 79% (212/268) vs. standard mid-urethral sling 76% (189/250), risk difference 4.6, 95% confidence interval -2.7 to 11.8; p non-inferiority < 0.001]. Similarly, at 3 years' follow-up, patient-reported success rates in the single-incision mini-sling group were non-inferior to those of the standard mid-urethral sling group at the 10% margin [single-incision mini-sling 72% (177/246) vs. standard mid-urethral sling 67% (157/235), risk difference 5.7, 95% confidence interval -1.3 to 12.8; p non-inferiority < 0.001]. Tape/mesh exposure rates were higher for single-incision mini-sling participants, with 3.3% (9/276) [compared with 1.9% (5/261) in the standard mid-urethral sling group] reporting tape exposure over the 3 years of follow-up. The rate of groin/thigh pain was slightly higher in the single-incision mini-sling group at 15 months [single-incision mini-sling 15% (41/276) vs. standard mid-urethral sling 12% (31/261), risk difference 3.0%, 95% confidence interval -1.1% to 7.1%]; however, by 3 years, the rate of pain was slightly higher among the standard mid-urethral sling participants [single-incision mini-sling 14% (39/276) vs. standard mid-urethral sling 15% (39/261), risk difference -0.8, 95% confidence interval -4.1 to 2.5]. At the 3-year follow-up, quality of life and sexual function outcomes were similar in both groups: for the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life, the mean difference in scores was -1.1 (95% confidence interval -3.1 to 0.8; p = 0.24), and for the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecological Association-Revised, it was 0 (95% confidence interval -0.1, 0.1; p = 0.92). However, more women in the single-incision mini-sling group reported dyspareunia [12% (17/145), compared with 4.8% (7/145) in the standard mid-urethral sling group, risk difference 7.0%, 95% confidence interval 1.9% to 12.1%]. The base-case economics results showed no difference in costs (-£6, 95% confidence interval -£228 to £208) or quality-adjusted life-years (0.005, 95% confidence interval -0.068 to 0.073) between the groups. There is a 56% probability that single-incision mini-slings will be considered cost-effective at the £20,000 willingness-to-pay threshold value for a quality-adjusted life-year. LIMITATIONS: Follow-up data beyond 3 years post randomisation are not available to inform longer-term safety and cost-effectiveness. CONCLUSIONS: Single-incision mini-slings were non-inferior to standard mid-urethral slings in patient-reported success rates at up to 3 years' follow-up. FUTURE WORK: Success rates, adverse events, retreatment rates, symptoms, and quality-of-life scores at 10 years' follow-up will help inform long-term effectiveness. TRIAL REGISTRATION: This trial was registered as ISRCTN93264234. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 47. See the NIHR Journals Library website for further project information.

Stress urinary incontinence, the involuntary leakage of urine, is a common and distressing condition, particularly for women aged > 40 years. In the UK, it is estimated that 6 million (40%) of this age group have symptoms bothersome enough for doctors to investigate. It causes embarrassment, low self-esteem and even social isolation. Standard surgical treatment used to be a mid-urethral sling made of mesh, inserted, in most cases, under general anaesthetic. Recently, a single-incision mini-sling, using less mesh, has been available under local anaesthetic. A number of small studies have shown that mini-slings have similar success rates to those of standard slings, necessitate shorter hospital stays and are less painful immediately after surgery. However, these results were uncertain and the potential longer-term benefits and disadvantages of both types of sling treatments were unknown. We compared the two types of sling treatments in a randomised trial of 600 women to see if they were equally effective. Success was measured by asking women to report on their symptoms and experiences. We also collected information on safety, quality of life, sexual function, and costs to women and the NHS. Every participant had an equal chance of starting treatment with the standard sling or the mini-sling. Participants were followed up for 3 years. Women allocated to each treatment reported similar success rates, quality of life and sexual function at 3 years. Women who received the new mini-sling had more mesh exposure (3% for the mini-sling vs. 2% for the standard sling) and were more likely to report pain during intercourse (12% vs. 5%) than women who received the standard sling. Both treatments had similar costs. Follow-up to 10 years is under way to establish the long-term benefits and disadvantages.

Synthetic sling or artificial urinary sphincter for men with urodynamic stress incontinence after prostate surgery: the MASTER non-inferiority RCT.

BACKGROUND: Stress urinary incontinence is common in men after prostate surgery and can be difficult to improve. Implantation of an artificial urinary sphincter is the most common surgical procedure for persistent stress urinary incontinence, but it requires specialist surgical skills, and revisions may be necessary. In addition, the sphincter is relatively expensive and its operation requires adequate patient dexterity. New surgical approaches include the male synthetic sling, which is emerging as a possible alternative. However, robust comparable data, derived from randomised controlled trials, on the relative safety and efficacy of the male synthetic sling and the artificial urinary sphincter are lacking. OBJECTIVE: We aimed to compare the clinical effectiveness and cost-effectiveness of the male synthetic sling with those of the artificial urinary sphincter surgery in men with persistent stress urinary incontinence after prostate surgery. DESIGN: This was a multicentre, non-inferiority randomised controlled trial, with a parallel non-randomised cohort and embedded qualitative component. Randomised controlled trial allocation was carried out by remote web-based randomisation (1 : 1), minimised on previous prostate surgery (radical prostatectomy or transurethral resection of the prostate), radiotherapy (or not, in relation to prostate surgery) and centre. Surgeons and participants were not blind to the treatment received. Non-randomised cohort allocation was participant and/or surgeon preference. SETTING: The trial was set in 28 UK urological centres in the NHS. PARTICIPANTS: Participants were men with urodynamic stress incontinence after prostate surgery for whom surgery was deemed appropriate. Exclusion criteria included previous sling or artificial urinary sphincter surgery, unresolved bladder neck contracture or urethral stricture after prostate surgery, and an inability to give informed consent or complete trial documentation. INTERVENTIONS: We compared male synthetic sling with artificial urinary sphincter. MAIN OUTCOME MEASURES: The clinical primary outcome measure was men's reports of continence (assessed from questions 3 and 4 of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) at 12 months post randomisation (with a non-inferiority margin of 15%). The primary economic outcome was cost-effectiveness (assessed as the incremental cost per quality-adjusted life-year at 24 months post randomisation). RESULTS: In total, 380 men were included in the randomised controlled trial (n = 190 in each group), and 99 out of 100 men were included in the non-randomised cohort. In terms of continence, the male sling was non-inferior to the artificial urinary sphincter (intention-to-treat estimated absolute risk difference -0.034, 95% confidence interval -0.117 to 0.048; non-inferiority p = 0.003), indicating a lower success rate in those randomised to receive a sling, but with a confidence interval excluding the non-inferiority margin of -15%. In both groups, treatment resulted in a reduction in incontinence symptoms (as measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form). Between baseline and 12 months' follow-up, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score fell from 16.1 to 8.7 in the male sling group and from 16.4 to 7.5 in the artificial urinary sphincter group (mean difference for the time point at 12 months 1.30, 95% confidence interval 0.11 to 2.49; p = 0.032). The number of serious adverse events was small (male sling group, n = 8; artificial urinary sphincter group, n = 15; one man in the artificial urinary sphincter group experienced three serious adverse events). Quality-of-life scores improved and satisfaction was high in both groups. Secondary outcomes that showed statistically significant differences favoured the artificial urinary sphincter over the male sling. Outcomes of the non-randomised cohort were similar. The male sling cost less than the artificial sphincter but was associated with a smaller quality-adjusted life-year gain. The incremental cost-effectiveness ratio for male slings compared with an artificial urinary sphincter suggests that there is a cost saving of £425,870 for each quality-adjusted life-year lost. The probability that slings would be cost-effective at a £30,000 willingness-to-pay threshold for a quality-adjusted life-year was 99%. LIMITATIONS: Follow-up beyond 24 months is not available. More specific surgical/device-related pain outcomes were not included. CONCLUSIONS: Continence rates improved from baseline, with the male sling non-inferior to the artificial urinary sphincter. Symptoms and quality of life significantly improved in both groups. Men were generally satisfied with both procedures. Overall, secondary and post hoc analyses favoured the artificial urinary sphincter over the male sling. FUTURE WORK: Participant reports of any further surgery, satisfaction and quality of life at 5-year follow-up will inform longer-term outcomes. Administration of an additional pain questionnaire would provide further information on pain levels after both surgeries. TRIAL REGISTRATION: This trial is registered as ISRCTN49212975. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 36. See the NIHR Journals Library website for further project information.

Leakage of urine associated with physical exertion (e.g. sporting activities, sneezing or coughing) is common in men who have undergone prostate surgery, but it is difficult to improve. Many men still leak urine 12 months after their prostate surgery and may continue to wear protective pads or sheaths. The most common operation to improve incontinence is implantation of an artificial urinary sphincter. An artificial urinary sphincter is an inflatable cuff that is placed around the urethra, the tube that drains urine from the bladder. The cuff is inflated and compresses the urethra to prevent leaking. When the man needs to pass urine, he must deflate the cuff by squeezing a pump placed in his scrotum, which releases the compression on the urethra and allows the bladder to empty. Recently, a new device, the male sling (made from non-absorbable plastic mesh), has been developed. The sling, which is surgically inserted under the urethra, supports the bladder, but, in contrast to the artificial sphincter, it does not need to be deactivated by a pump and, therefore, the patient does not need to do anything to operate it. A sling is also easier for the surgeon to insert than a sphincter. However, in some men, the sling does not provide enough improvement in incontinence symptoms and another operation, to place an artificial urinary sphincter, is needed. The aim of this study was to determine if the male sling was as effective as the artificial urinary sphincter in treating men with bothersome incontinence after prostate surgery. The study took the form of a randomised controlled trial (the gold standard and most reliable way to compare treatments) in which men were randomised (allocated at random to one of two groups using a computer) to either a male sling or an artificial urinary sphincter operation. We asked men how they got on in the first 2 years after their operation. Regardless of which operation they had, incontinence and quality of life significantly improved and complications were rare. A small number of men did require another operation to improve their incontinence, and it was more likely that an artificial urinary sphincter was needed, rather than another sling operation, if a male sling was not successful. Satisfaction was high in both groups, but it was significantly higher in the artificial urinary sphincter group than in the male sling group. Those who received a male sling were less likely than those who received an artificial urinary sphincter to say that they would recommend their surgery to a friend.

Urodynamic assessment and quality of life outcomes of robot-assisted totally intracorporeal radical cystectomy and orthotopic neobladder for bladder cancer: a preliminary study.

PURPOSE: Few data exist regarding the functional outcomes of robot-assisted radical cystectomy (RARC) with intracorporeal orthotopic neobladder. The aim of this study was to evaluate the urodynamic and functional outcomes in patients undergoing RARC and totally intracorporeal orthotopic neobladder for bladder cancer. METHODS: In this monocentric, observational study carried out between 2016 and 2020, consecutive patients undergoing RARC and intracorporeal orthotopic neobladder in the Department of Urology, Pitié-Salpêtrière Hospital, were included. Reconstruction was totally intracorporeal Y-shaped neobladder. Main outcomes were urodynamic findings 6 months post-surgery, continence and quality of life (QoL). Continence was defined by no pad or one safety pad. International Consultation on Incontinence Questionnaire (ICIQ), International Index of Erectile Function questionnaire (IIEF-5) and Bladder Cancer Index (BCI) scores were recorded. RESULTS: Fourteen male patients were included (median age: 64 years [IQR 54-67]. Median maximal neobladder cystometric capacity was 495 ml [IQR 410-606] and median compliance was 35.5 ml/cm H2O [IQR 28-62]. All patients had post-void residual volume < 30 ml, except for three (22%) who required clean intermittent-self catheterisation. Daytime continence was achieved in 10 patients (71%) and night-time continence in two (14.3%). Median ICIQ score was 7 [IQR 5-11]. Postoperative erectile function was present in 7% of patients (mean IIEF-5 = 5 [IQR 2-7]). Thirteen patients (93%) were satisfied with their choice of neobladder. CONCLUSION: RARC with totally intracorporeal orthotopic neobladder for bladder cancer provides satisfactory urodynamic results and good QoL. These findings should be confirmed long-term.

Objective and Subjective Assessment of Bladder Function after Robot-assisted Laparoscopic Radical Hysterectomy for Early-stage Cervical Cancer.

STUDY OBJECTIVE: To examine whether objective bladder function after robot-assisted radical hysterectomy (RRH) for early-stage cervical cancer is correlated with subjective patient-reported outcomes and quality of life during the first year after RRH. DESIGN: Prospective observational study. SETTING: Karolinska University Hospital, Sweden. PATIENTS: Women with early-stage cervical cancer (International Federation of Gynecology and Obstetrics stage IA2-IB1) between July 2017 and May 2019 were assessed for eligibility. INTERVENTIONS: RRH. MEASUREMENTS AND MAIN RESULTS: Subjective bladder function was evaluated with the Female Lower Urinary Tract Symptoms and Urinary Incontinence Quality of Life modules of the International Consultation on Incontinence Questionnaire. Objective urinary function was characterized with urodynamic tests, and the nerves ablated at RRH were quantified by using immunohistochemical staining of biopsies from the resected paracervix, vesicouterine, and sacrouterine ligaments. Twenty-seven women were included for analysis at baseline, 2 weeks, 3 months, and 12 months after surgery. RRH caused hypotonia of the urinary bladder (p <.05). Patient-reported outcomes of voiding and filling dysfunction were most significant 2 weeks after surgery (p <.05) but for most of the women, bladder function recovered within 3 months. No correlations were found with either subjective or objective urinary function and the number of ablated nerves. CONCLUSION: For most women, objective and subjective urinary bladder dysfunction recovered within 3 months after RRH. The absence of correlation between functional outcomes and ablated autonomous nerves suggests that other underlying causes play a significant role. Early detection of bladder overextension after RRH is paramount, and the role of postoperative bladder catheterization needs further investigation.

Male sling placement for post-prostatectomy incontinence can involve a lengthy learning curve: A multi-outcome assessment via cumulative sum failure analysis.

PURPOSES: Little research exists on potential learning curve for male sling procedures. We aimed to perform a learning curve analysis of a single surgeon's experience of sling placement evaluating multiple outcomes and using the cumulative sum failure methodology. METHODS: The study included 65 consecutive patients that underwent implantation of a fixed transobturator sling (TiLOOP Male) for post-radical prostatectomy stress incontinence at our institution from January 2013 to December 2018. Dichotomous outcomes evaluated with cumulative sum failure analysis included 12-months continence defined based on Patient Global Impression of Improvement (PGI-I) questionnaire (primary outcome), 24 h pad test and, 24 h pad use, operative time (⩽/>60 min), and complications (yes/no). Univariate and multivariate logistic regression analyses were performed to evaluate the association of the procedures' chronological sequence number with the outcomes. RESULTS: Cumulative sum failure curves revealed a clear and lengthy learning curve effect for most of subjective and quantitative continence outcomes and for operative time. For the primary outcome (at least much improved at PGI-I), 62 procedures were required to overcome the learning curve. Accordingly, multivariate analyses showed that the sequence number was statistically significant for predicting failures based on PGI-I (adjusted OR 0.95; 95% CI: 0.91-0.99; p = 0.02), objective outcomes, and operative time. CONCLUSIONS: An evident and lengthy learning curve was observed in our series of male sling placement to achieve the end level of proficiency, independently from case-mix. Individualized structured training on male sling surgery will benefit patients treated in the initial surgeon's experience. Surgical experience should be considered when reporting studies on male slings.

Evaluation of the 24-h pad weight test as continence rate assessment tool after artificial urinary sphincter implantation for postprostatectomy urinary incontinence: A Swedish retrospective cohort study.

AIM: Patient-reported pad-count as continence rate assessment tool after artificial urinary sphincter (AUS) implantation is common. However, lack of standardized continence definition using this method results in heterogeneous published efficacy outcomes. Data on 24-h pad weight tests (PWT) after primary AUS implantation for postprostatectomy urinary incontinence (PPUI) is scarce. Our aim was to evaluate the 24-h PWT as an efficacy assessment tool and correlate it to qualitative outcomes using validated questionnaires. METHODS: This retrospective, single center, follow-up cohort study, evaluated 180 patients who underwent primary AUS implantation for PPUI from 2005 to 2018. Voiding diaries, 24-h PWT, validated patient satisfaction and quality of life (QoL) questionnaires were collected pre-operatively and at 3-6 months postactivation, using the institution's Electronic Medical Records. RESULTS: The median preoperative and postoperative 24-h PWT values were 494 (interquartile range [IQR]: 304-780) and 7 (IQR: 0-25) g respectively with a significant improvement in urinary leakage of 489.5 g 99.1% (p < 0.001). Median preoperative and postoperative I-QoL results increased from 33.5 (IQR: 19.3-63.6) to 86.4 (IQR: 73.9-94.3) points, with a significant 52.9 points improvement in QoL (p < 0.001). Similarly, the median preoperative and postoperative ICIQ-SF values decreased from 20 (IQR: 17-21) to 5 (IQR: 3-9) points, showing a significant improvement of 15 points (p < 0.001). We also found a significant correlation between PWT and patient satisfaction. CONCLUSION: The 24-h PWT provides a reliable and objective assessment of continence rates, with a strong correlation to qualitative outcomes, after primary AUS implantation for PPUI. Its use could help reduce reported outcome heterogeneity across studies.

Access to Academic Female Pelvic Medicine and Reconstructive Surgery Providers for New Patient Visits: How Long Are Wait Times?

OBJECTIVES: To determine the wait times to see an academic Female Pelvic Medicine and Reconstructive Surgery (FPMRS) urologist or gynecologist and to identify factors that may impact these wait times. METHODS: We reviewed all Accreditation Council for Graduate Medical Education accredited urology and gynecology residency programs. Offices of FPMRS providers were called to ascertain the earliest available new patient visit for a fictional female patient with "urine leakage." Programs without FPMRS faculty (18.7%) were excluded. FPMRS providers that did not accept Medicaid (15.6%) were also excluded. Negative binomial regression was performed using SPSS v24. RESULTS: Final analysis included 362 FPMRS providers. Median wait time for a patient with Medicaid was 30 days (interquartile range [IQR] 15-51) and 26 days (IQR 14-42) for Medicare. The median wait time to see an FPMRS-trained gynecologist was 28 days (IQR 15-50) while FPMRS-trained urologists had a median wait time of 25 days (IQR 13.8-43.3). Female providers had longer median wait times when compared to male providers (30 vs 25 days). On regression analysis, only female gender of the provider was significant (P < .01). CONCLUSION: Our study found that nearly 1 in 5 academic departments did not have an FPMRS-trained provider. We found that new patients with urinary incontinence encountered substantial wait times to see FPMRS providers at academic institutions. As we project increased demand for the FPMRS workforce, our findings reflect a challenging landscape where training additional FPMRS providers may be needed to meet demand.

Multicentered Assessment of Clinical Outcomes and Factors Associated With Failure of the Adjustable TransObturator Male System (ATOMS).

OBJECTIVE: To assess postoperative outcomes from the Adjustable TransObturator Male System (ATOMS) and identify factors influencing failure to achieve continence. PATIENTS AND METHODS: A multicentered analysis was performed on all patients treated for postprostatectomy incontinence using the third-generation ATOMS at 9 Canadian tertiary referral centers. The primary outcome was continence (defined as requiring ≤1 pad postoperatively for patients requiring ≥2 pads preoperatively and 0 pads for those requiring 1 pad preoperatively). Secondary outcomes included improvement (>50% change in pad use), patient satisfaction, explantation, and postoperative complications. RESULTS: Two hundred and eighty nine patients with a mean age of 68.9 years were analyzed. Pre-operatively mean pad per day use was 4.2 (1-12), 31.5% of patients reported severe incontinence (≥5 pads/day), 33.9% had concurrent radiotherapy and 19.4% had failed previous incontinence surgery. Overall continence rate was 73.3% (n = 212) at a mean follow-up of 19.6 months. More than eighty nine percent (89.3%) (n = 258) of patients experienced >50% improvement, 84.4% (n = 244) of patients were satisfied with the results of surgery. More than seven percent (7.9%) (n = 23) required device explantation. On multivariate Cox regression analysis, concurrent radiotherapy (hazard ratio [H.R.] 2.3, P < .001), diabetes (H.R. 2.2, P = .007) and increased pre-operative pad usage (H.R. 1.1, P = .02) were each associated with failure to achieve continence, while patient age (P = .60), obesity (P = .08), prior urethral stenosis (P = .56), and prior incontinence surgery (P = .13) were not. Radiation therapy was also associated with device explantation (H.R. 2.7, P = .02). CONCLUSION: ATOMS is a safe and efficacious for treatment of postprostatectomy incontinence. However, patients with prior radiation, increased pre-operative pad use, or diabetes are less likely to achieve continence.

Traditional suburethral sling operations for urinary incontinence in women.

BACKGROUND: Stress urinary incontinence constitutes a significant health and economic burden to society. Traditional suburethral slings are surgical operations used to treat women with symptoms of stress urinary incontinence. OBJECTIVES: To assess the effectiveness of traditional suburethral sling procedures for treating stress urinary incontinence in women; and summarise the principal findings of relevant economic evaluations. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), as well as MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); we handsearched journals and conference proceedings (searched 27 February 2017) and the reference lists of relevant articles. On 23 January 2019, we updated this search; as a result, several additional reports of studies are awaiting classification. SELECTION CRITERIA: Randomised or quasi-randomised trials that assessed traditional suburethral slings for treating stress or mixed urinary incontinence. DATA COLLECTION AND ANALYSIS: At least two review authors independently extracted data from included trials and assessed risk of bias. When appropriate, a summary statistic was calculated: risk ratio (RR) for dichotomous data, odds ratio (OR) for continence and cure rates that were expected to be high, and mean difference (MD) for continuous data. We adopted the GRADE approach to assess the quality of evidence. MAIN RESULTS: A total of 34 trials involving 3244 women were included. Traditional slings were compared with 10 other treatments and with each other. We did not identify any trials comparing suburethral slings with no treatment or sham treatment, conservative management, anterior repair, or laparoscopic retropubic colposuspension. Most trials did not distinguish between women having surgery for primary or recurrent incontinence. One trial compared traditional slings with bladder neck needle suspension, and another trial compared traditional slings with single-incision slings. Both trials were too small to be informative. Traditional suburethral sling operation versus drugs One small trial compared traditional suburethral sling operations with oxybutynin to treat women with mixed urinary incontinence. This trial did not report any of our GRADE-specific outcomes. It is uncertain whether surgery compared with oxybutynin leads to more women being dry (83% vs 0%; OR 195.89, 95% confidence interval (CI) 9.91 to 3871.03) or having less urgency urinary incontinence (13% vs 43%; RR 0.29, 95% CI 0.09 to 0.94) because the quality of this evidence is very low. Traditional suburethral sling versus injectables One small trial compared traditional slings with suburethral injectable treatment. The impact of surgery versus injectables is uncertain in terms of the number of continent women (100% were dry with a traditional sling versus 71% with the injectable after the first year; OR 11.57, 95% CI 0.56 to 239.74), the need for repeat surgery for urinary incontinence (RR 0.52, 95% CI 0.05 to 5.36) or the occurrence of perioperative complications (RR 1.57, 95% CI 0.29 to 8.49), as the quality of evidence is very low. Traditional suburethral sling versus open abdominal retropubic colposuspension Eight trials compared slings with open abdominal retropubic colposuspension. Moderate-quality evidence shows that the traditional suburethral sling probably leads to more continent women in the medium term (one to five years) (69% vs 59% after colposuspension: OR 1.70, 95% CI 1.22 to 2.37). High-quality evidence shows that women were less likely to need repeat continence surgery after a traditional sling operation than after colposuspension (RR 0.15, 95% CI 0.05 to 0.42). We found no evidence of a difference in perioperative complications between the two groups, but the CI was very wide and the quality of evidence was very low (RR 1.24, 95% CI 0.83 to 1.86). Traditional suburethral sling operation versus mid-urethral slings Fourteen trials compared traditional sling operations and mid-urethral sling operations. Depending on judgements about what constitutes a clinically important difference between interventions with regard to continence, traditional suburethral slings are probably no better, and may be less effective, than mid-urethral slings in terms of number of women continent in the medium term (one to five years) (67% vs 74%; OR 0.67, 95% CI 0.44 to 1.02; n = 458; moderate-quality evidence). One trial reported more continent women with the traditional sling after 10 years (51% vs 32%: OR 2.22, 95% CI 1.07 to 4.61). Mid-urethral slings may be associated with fewer perioperative complications (RR 1.74, 95% CI 1.16 to 2.60; low-quality evidence). One type of traditional sling operation versus another type of traditional sling operation Nine trials compared one type of traditional sling operation with another. The different types of traditional slings, along with the number of different materials used, mean that trial results could not be pooled due to clinical heterogeneity. Complications were reported by two trials - one comparing non-absorbable Goretex with a rectus fascia sling, and the second comparing Pelvicol with a rectus fascial sling. The impact was uncertain due to the very low quality of evidence. AUTHORS' CONCLUSIONS: Low-quality evidence suggests that women may be more likely to be continent in the medium term (one to five years) after a traditional suburethral sling operation than after colposuspension. It is very uncertain whether there is a difference in urinary incontinence after a traditional suburethral sling compared with a mid-urethral sling in the medium term. However, these findings should be interpreted with caution, as long-term follow-up data were not available from most trials. Long-term follow-up of randomised controlled trials (RCTs) comparing traditional slings with colposuspension and mid-urethral slings is essential. Evidence is insufficient to suggest whether traditional suburethral slings may be better or worse than other management techniques. This review is confined to RCTs and therefore may not identify all of the adverse effects that may be associated with these procedures. A brief economic commentary (BEC) identified three eligible economic evaluations, which are not directly comparable due to differences in methods, time horizons, and settings. End users of this review will need to assess the extent to which methods and results of identified economic evaluations may be applicable (or transferable) to their own setting.

National Trends in the Surgical Management of Urinary Incontinence among Insured Women, 2004 to 2013: The Urologic Diseases in America Project.

PURPOSE: The objective of this study was to examine national trends in the surgical management of urinary incontinence in women in the United States from 2004 to 2013. MATERIALS AND METHODS: We analyzed the CDM (Optum® de-identified Clinformatics® Data Mart) for women 18 to 64 years old and the CMS (Centers for Medicare and Medicaid Services) Medicare 5% Sample for women 65 years old or older. We created annual cross-sectional cohorts and assessed trends in the annual prevalence of urinary incontinence related surgical procedures overall and by age, race/ethnicity and geographic region. RESULTS: We observed a decline in the percent of women with urinary incontinence who underwent surgical treatment according to the CMS (from 4.7% in 2004 to 2.7% in 2013) and the CDM (from 12.5% in 2004 to 9.1% in 2013). This trend persisted independently of age, race/ethnicity and geographic region. Slings were the most common procedure but started to decline in 2011, ultimately decreasing by about 50% during the study period. Compared to other groups the prevalence of urinary incontinence related surgical procedures, including slings, was highest among women 35 to 54 years old and White women, and lowest among women residing in the Northeast. These sociodemographic patterns persisted with time. During the study period injection procedures remained stable, sacral neuromodulation increased slightly but remained uncommon and suspension decreased to nearly 0% of all anti-incontinence procedures. CONCLUSIONS: Surgical management of female urinary incontinence experienced several shifts from 2004 to 2013, including a decline in sling procedures. Age, racial/ethnic and regional differences in treatment persisted with time. Improved understanding of the drivers of these trends may help direct future development of treatments of pelvic floor disorders.

Magnetic resonance imaging as an assessment tool following intervention with an AdVance XP suburethral sling for postprostatectomy urinary incontinence.

AIMS: The aim of this study was to compare magnetic resonance imaging (MRI) parameters in patients with mild incontinence after radical prostatectomy, who had undergone treatment with a suburethral sling. The objective was to compare patients who had been successfully treated with unsuccessful patients. METHODS: This observational cohort study at a single institution evaluated consecutive patients treated with an AdVance XP sling. MRI was performed using a 1.5 Tesla system. Preoperative urodynamic assessment and flexible cystoscopy were performed. The qualitative analysis was based on sling indentation (complete vs incomplete). The quantitative analysis comprised the following three parameters: the sling-pubis distance, the thickness of the proximal urethral bulb, and the sling backward distance (SBD), defined as the distance between the prolongation of a line through the major axis of the pubis (the line-segment joining the vertices of the pubis) and the sling indentation. The primary outcome was pad count at 3 months; cure as zero pads. A logistic univariate regression model was employed to assess the potential predictors of successful outcomes. An adjusted multivariate logistic regression model using the significant univariate factors was developed. RESULTS: Of the 83 patients enrolled, the univariate analysis revealed a relationship between failure and adverse urodynamics and between success and sling indentation, thickness of the proximal bulb and SBD. Only the association with SBD persisted in the multivariate analysis. CONCLUSIONS: MRI revealed a strong relationship between proper positioning of the sling (small SBD) and continence outcome. These data have important implications for a second surgery following initial sling failure.

Achieving urinary continence in cloacal exstrophy: The surgical cost.

INTRODUCTION: Cloacal exstrophy (CE) is a severe midline congenital abnormality that requires numerous surgical corrections to achieve an acceptable quality of life. Candidates for urinary continence undergo multiple procedures, most often continent bladder diversions, to become socially dry. Here, the authors investigate the number of genitourinary interventions that patients with CE undergo to attain urinary continence. MATERIALS AND METHODS: A retrospective review of a prospectively maintained database of 1311 exstrophy epispadias complex patients was performed. Patients with CE who have had at least one continence procedure were included. A continence procedure was defined as bladder neck reconstruction with or without augmentation, bladder neck transection with continent urinary diversion, augmentation cystoplasty, or use of injectable bulking agents. Continence was defined as a dry interval greater than 3 hours without leakage at night. RESULTS: In total, 140 CE and CE variant patients have been managed at the authors' institution. Of the 116 CE patients, 59 received at least one continence procedure, 14 were excluded for incontinent diversion or cystectomy, and the remaining 43 patients are awaiting a continence procedure. At the time of analysis, 42 (71%) patients who underwent a continence procedure were dry. The median number of total urologic procedures to reach urinary continence was 4 (range 2-10). This included 1 bladder closure (range 1-3), 2 urinary continence procedures (range 1-4), and 1 (range 0-4) "other" genitourinary procedures. The median time to urinary continence was 11.0 years (95% CI [9.2-14.2]). CONCLUSIONS: A majority of CE patients who undergo a diversion procedure can achieve urinary continence. However multiple continence procedures are likely necessary. Of patients who are candidates for a continence procedure, half will be continent by the age of 11. LEVEL OF EVIDENCE: Level IV, Case series with no comparison group.