Characteristics of persistent urinary incontinence after successful fistula closure in Ethiopian women.

INTRODUCTION AND HYPOTHESIS: Obstetric fistulas have devastating consequences for women. Although surgical repair is largely successful in closing the defect, many women with successful fistula closure report persistent urinary incontinence. Our study is aimed at characterizing incontinence after successful fistula repair and its impact on quality of life. METHODS: This cross-sectional study enrolled women with a history of successful obstetric fistula closure with (n = 51; cases) or without (n = 50; controls) persistent urinary incontinence. Data were collected in Mekelle, Ethiopia, between 2016 and 2018. All cases underwent clinical evaluation and completed questionnaires characterizing the type, severity, and impact of incontinence. RESULTS: Cases were significantly more likely to have acquired their fistula at an earlier age and with their first vaginal delivery compared with controls. Almost all cases reported both stress (98%) and urgency (94%) incontinence, and half reported constant urinary leakage (49%) despite successful fistula closure. Of cases who completed urodynamic evaluation (n = 22), all had genuine stress incontinence and none had detrusor overactivity. All cases reported moderate to severe (80.4%) or very severe (19.6%) incontinence (measured by ICIQ-SF) and this had a moderate to severe negative impact on their quality of life (as measured by ICIQ-QoL). Although history of suicidal ideation was not significantly different between the groups, among those with suicidal ideation, cases were more likely to report having made a plan and/or attempted to commit suicide. CONCLUSIONS: When urinary incontinence persists after successful fistula closure, it tends to be severe and of mixed etiology and has a significant negative impact on quality of life and mental health.

Capacity building in female pelvic medicine and reconstructive surgery: Global Health Partnership beyond fistula care in Ethiopia.

OBJECTIVE: Obstetric fistula is a devastating childbirth injury that leaves women incontinent, stigmatized and often isolated from their families and communities. In Ethiopia, although much attention has focused on treating and preventing obstetric fistula, other more prevalent childbirth-related pelvic floor disorders, such as pelvic organ prolapse, non-fistula-related incontinence and post-fistula residual incontinence, remain largely unattended. The lack of international and local attention to addressing devastating pelvic floor disorders is concerning for women in low- and middle-income countries. The objective of this article is to highlight the need for a more comprehsive approach to pelvic floor care and to share our experience in addressing it. METHODS: Here, we share our experience launching one of the first formal training programs in Female Pelvic Medicine and Reconstructive Surgery (FPMRS) in Ethiopia. RESULTS: This fellowship program provides quality care while strengthening the health system in its local context. This program has positioned Ethiopia to be a regional leader by providing comprehensive training of surgeons and allied health professionals, building appropriate health system and research infrastructure, and developing a formal FPMRS training curriculum. CONCLUSION: We hope that sharing this experience will serve as a template for others championing comprehensive pelvic floor care for women in low- and middle-income countries.

International continence society white paper regarding female genital mutilation/cutting.

Female genital mutilation/cutting (FGM/C)-also known as Female Genital Cutting or Mutilation-is defined as the partial or total removal of the female external genitalia for non-therapeutic reasons. This White Paper, prepared under the auspices of the International Continence Society (ICS), is intended by the ICS as a statement promoting the abandonment of this practice. The ICS also supports the respectful and evidence-based care or treatment of women and girls already affected by FGM/C, in keeping with the World Health Organization (WHO) Guidelines on the Management of Health Complications from Female Genital Mutilation. Our members specialize in pelvic floor disorders from perspectives within a range of specialties; we encounter and treat women living with FGM/C and its consequences-particularly incontinence, infections, voiding dysfunction, sexual dysfunction, chronic pelvic pain, and obstetric trauma. Understanding the ethical, sociocultural, medical and surgical factors surrounding FGM/C is central to caring for women and girls with a history of FGM/C. The ICS voices herein state strong opposition to FGM/C. We encourage members to apply their skills to improve prevention strategies and the management of those affected.

Urinary Urgency in the Elderly.

The last 2 decades have brought an explosion of research, new products, and general attention to the problem of urinary urgency, and yet patients continue to be plagued by this symptom - especially the elderly. What is it? What does it mean? How can we guide patients successfully through this challenge? This paper presents a review of current thinking about urgency relevant to the practicing clinician, including the epidemiology, pathophysiology, evaluation, and treatment of these patients.

An International Continence Society (ICS) report on the terminology for adult neurogenic lower urinary tract dysfunction (ANLUTD).

INTRODUCTION: The terminology for adult neurogenic lower urinary tract dysfunction (ANLUTD) should be defined and organized in a clinically based consensus Report. METHODS: This Report has been created by a Working Group under the auspices and guidelines of the International Continence Society (ICS) Standardization Steering Committee (SSC) assisted at intervals by external referees. All relevant definitions for ANLUTD were updated on the basis of research over the last 14 years. An extensive process of 18 rounds of internal and external review was involved to exhaustively examine each definition, with decision-making by collective opinion (consensus). RESULTS: A Terminology Report for ANLUTD, encompassing 97 definitions (42 NEW and 8 CHANGED, has been developed. It is clinically based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different groups involved not only in lower urinary tract dysfunction but additionally in many other medical specialties. CONCLUSION: A consensus-based Terminology Report for ANLUTD has been produced to aid clinical practice and research.

A review of the current status of laparoscopic and robot-assisted sacrocolpopexy for pelvic organ prolapse.

CONTEXT: Abdominal sacrocolpopexy (ASC) represents the superior treatment for apical pelvic organ prolapse (POP) but is associated with increased length of stay, analgesic requirement, and cost compared with transvaginal procedures. Laparoscopic sacrocolpopexy (LSC) and robot-assisted sacrocolpopexy (RSC) may offer shorter postoperative recovery while maintaining equivalent rates of cure. OBJECTIVE: This review evaluates the literature on LSC and RSC for clinical outcomes and complications. EVIDENCE ACQUISITION: A PubMed search of the available literature from 1966 to 2013 on LSC and RSC with a follow-up of at least 12 mo was performed. A total of 256 articles were screened, 69 articles selected, and outcomes from 26 presented. A review, not meta-analysis, was conducted due to the quality of the articles. EVIDENCE SYNTHESIS: LSC has become a mature technique with results from 11 patient series encompassing 1221 patients with a mean follow-up of 26 mo. Mean operative time was 124 min (range: 55-185) with a 3% (range: 0-11%) conversion rate. Objective cure was achieved in 91% of patients, with similar satisfaction rates (92%). Six patient series encompassing 363 patients treated with RSC with a mean follow-up of 28 mo have been reported. Mean operative time was 202 min (range: 161-288) with a 1% (range: 0-4%) conversion rate. Objective cure rate was 94%, with a 95% subjective success rate. Overall, early outcomes and complication rates for both LSC and RSC appeared comparable with open ASC. CONCLUSIONS: LSC and RSC provide excellent short- to medium-term reconstructive outcomes for patients with POP. RSC is more expensive than LSC. Further studies are required to better understand the clinical performance of RSC versus LSC and confirm long-term efficacy. PATIENT SUMMARY: Laparoscopic and robot-assisted sacrocolpopexy represent attractive minimally invasive alternatives to abdominal sacrocolpopexy. They may offer reduced patient morbidity but are associated with higher costs.

Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes.

PURPOSE: We determined the feasibility of conducting a randomized clinical trial designed to compare 2 methods of manual therapy (myofascial physical therapy and global therapeutic massage) in patients with urological chronic pelvic pain syndromes. MATERIALS AND METHODS: We recruited 48 subjects with chronic prostatitis/chronic pelvic pain syndrome or interstitial cystitis/painful bladder syndrome at 6 clinical centers. Eligible patients were randomized to myofascial physical therapy or global therapeutic massage and were scheduled to receive up to 10 weekly treatments of 1 hour each. Criteria to assess feasibility included adherence of therapists to prescribed therapeutic protocol as determined by records of treatment, adverse events during study treatment and rate of response to therapy as assessed by the patient global response assessment. Primary outcome analysis compared response rates between treatment arms using Mantel-Haenszel methods. RESULTS: There were 23 (49%) men and 24 (51%) women randomized during a 6-month period. Of the patients 24 (51%) were randomized to global therapeutic massage, 23 (49%) to myofascial physical therapy and 44 (94%) completed the study. Therapist adherence to the treatment protocols was excellent. The global response assessment response rate of 57% in the myofascial physical therapy group was significantly higher than the rate of 21% in the global therapeutic massage treatment group (p = 0.03). CONCLUSIONS: We judged the feasibility of conducting a full-scale trial of physical therapy methods and the preliminary findings of a beneficial effect of myofascial physical therapy warrants further study.

Interstitial cystitis and the overlap with overactive bladder.

The overlap between interstitial cystitis-painful bladder syndrome and overactive bladder can present a diagnostic challenge to the treating practitioner. Both can present with similar patient symptoms. Further compounding this dilemma is the fact that no gold standard test exists to differentiate one from the other. This review will serve to highlight their similarities and distinguishing features.

Cyclosporine A for refractory interstitial cystitis/bladder pain syndrome: experience of 3 tertiary centers.

PURPOSE: Cyclosporine A is a fifth-tier treatment option in the American Urological Association guidelines for interstitial cystitis/bladder pain syndrome. It was more effective than pentosanpolysulfate in a Finnish trial, but experience elsewhere is limited. Some centers use cyclosporine A off label for carefully selected patients but the number of patients in each center is small. We performed a retrospective review combining data from 3 tertiary centers that focus on interstitial cystitis/bladder pain syndrome. MATERIALS AND METHODS: Charts were reviewed for patients with interstitial cystitis/bladder pain syndrome who received cyclosporine A. Response was defined as markedly improved on the 7-point global response assessment (2 centers) or as at least a 50% decrease in Interstitial Cystitis Symptom Index score (1 center). RESULTS: The study included 14 men and 30 women. Mean patient age was 55.5 years (range 27 to 75) and mean followup was 20.8 months (range 3 to 81). A total of 34 patients had Hunner lesions. Of these patients 29 (85%) responded but 6 eventually stopped cyclosporine A for adverse events, resulting in a success rate of 68% (23 of 34) for patients with Hunner lesions. In contrast, only 3 of 10 patients without Hunner lesions responded (30%). For all responders, the response occurred within 4 months. CONCLUSIONS: Cyclosporine A had a high success rate for patients with Hunner lesions in whom more conservative options, including endoscopic treatment, had failed. The success rate was low for patients without Hunner lesions. A 3 to 4-month trial is sufficient time to assess response. Adverse events were common and led to discontinuation of cyclosporine A for some patients. Close monitoring is needed, especially for blood pressure and renal function.

Robot-assisted versus open sacrocolpopexy: a cost-minimization analysis.

PURPOSE: Abdominal sacrocolpopexy is considered a standard of care operation for apical vaginal vault prolapse repair. Using outcomes at our center we evaluated whether the robotic approach to sacrocolpopexy is as cost-effective as the open approach. MATERIALS AND METHODS: After obtaining institutional review board approval we performed cost-minimization analysis in a retrospective cohort of patients who underwent sacrocolpopexy at our institution between 2006 and 2010. Threshold values, that is model variable values at which the most cost effective approach crosses over to an alternative approach, were determined by testing model variables over realistic ranges using sensitivity analysis. Hospital billing data were also evaluated to confirm our findings. RESULTS: Operative time was similar for robotic and open surgery (226 vs 221 minutes) but postoperative length of stay differed significantly (1.0 vs 3.3 days, p <0.001). Base case analysis revealed an overall 10% cost savings for robot-assisted vs open sacrocolpopexy ($10,178 vs $11,307). Tornado analysis suggested that the number of institutional robotic cases done annually, length of stay and cost per hospitalization day in the postoperative period were the largest drivers of cost. Analysis of our hospital billing data showed a similar trend with robotic surgery costing 4.2% less than open surgery. CONCLUSIONS: A robot-assisted approach to sacrocolpopexy can be equally or less costly than an open approach. This depends on a sufficient institutional robotic case volume and a shorter postoperative stay for patients who undergo the robot-assisted procedure.

AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome.

PURPOSE: To provide a clinical framework for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. MATERIALS AND METHODS: A systematic review of the literature using the MEDLINE® database (search dates 1/1/83-7/22/09) was conducted to identify peer reviewed publications relevant to the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. Insufficient evidence-based data were retrieved regarding diagnosis and, therefore, this portion of the Guideline is based on Clinical Principles and Expert Opinion statements. The review yielded an evidence base of 86 treatment articles after application of inclusion/exclusion criteria. These publications were used to create the majority of the treatment portion of the Guideline. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate) or C (low). Additional treatment information is provided as Clinical Principles and Expert Opinion when insufficient evidence existed. See text and algorithm for definitions, and detailed diagnostic management, and treatment frameworks. RESULTS: The evidence-based guideline statements are provided for diagnosis and overall management of interstitial cystitis/bladder pain syndrome as well as for various treatments. The panel identified first through sixth line treatments as well as developed guideline statements on treatments that should not be offered. CONCLUSIONS: Interstitial cystitis/bladder pain syndrome is best identified and managed through use of a logical algorithm such as is presented in this Guideline. In the algorithm the panel identifies an overall management strategy for the interstitial cystitis/bladder pain syndrome patient. Diagnosis and treatment methodologies can be expected to change as the evidence base grows in the future.

Early termination of a trial of mycophenolate mofetil for treatment of interstitial cystitis/painful bladder syndrome: lessons learned.

PURPOSE: We evaluated the efficacy and tolerability of mycophenolate mofetil in patients with treatment refractory interstitial cystitis/painful bladder syndrome. MATERIALS AND METHODS: A total of 210 patients with interstitial cystitis/painful bladder syndrome were to be randomized into a multicenter, placebo controlled trial using a 2:1 randomization. Participants in whom at least 3 interstitial cystitis/painful bladder syndrome specific treatments had failed and who had at least moderately severe symptoms were enrolled in a 12-week treatment study. The primary study end point was the global response assessment. Secondary end points were general and disease specific symptom questionnaires, and voiding diaries. RESULTS: Only 58 subjects were randomized before a black box warning regarding mycophenolate mofetil safety was issued by the manufacturer in October 2007. The trial was halted, and interim analysis was performed and presented to an independent data and safety monitoring board. Six of the 39 subjects (15%) randomized at study cessation were considered responders for mycophenolate mofetil compared to 3 of 19 controls (16%, p=0.67). Secondary outcome measures reflected more improvement in controls. CONCLUSIONS: In a randomized, placebo controlled trial that was prematurely halted mycophenolate mofetil showed efficacy similar to that of placebo to treat symptoms of refractory interstitial cystitis/painful bladder syndrome. The results of this limited study cannot be used to confirm or refute the hypothesis that immunosuppressive therapy may be beneficial to at least a subgroup of patients with interstitial cystitis/painful bladder syndrome. Despite study termination lessons can be gleaned to inform future investigations.

Treatment choice, duration, and cost in patients with interstitial cystitis and painful bladder syndrome.

INTRODUCTION AND HYPOTHESIS: In order to better understand provider treatment patterns for interstitial cystitis (IC)/painful bladder syndrome, we sought to document the therapies utilized and their associated expenditures using a national dataset. METHODS: A cohort was created by applying the ICD-9 diagnosis of IC (595.1) to INGENIX claims for the year 1999. Subjects were followed for 5 years, and patterns of care and related expenditures were evaluated. RESULTS: Of 553,910 adults insured in 1999, 89 subjects had a diagnosis of IC with 5-year follow-up data. All subjects were treated with oral medication(s), 26% received intravesical treatments, and 22% underwent hydrodistension. Total expenditures per subject were $2,808. CONCLUSIONS: The majority of IC expenditures were attributable to oral medical therapy. Hydrodistension and intravesical instillations were utilized in less than 25% of patients. Hydrodistension was used more frequently among subjects with a new diagnosis; this may reflect its utilization as part of a diagnostic algorithm.

Effect of amitriptyline on symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome.

PURPOSE: Amitriptyline is frequently used to treat patients with interstitial cystitis/painful bladder syndrome. The evidence to support this practice is derived mainly from a small, single site clinical trial and case reports. MATERIALS AND METHODS: We conducted a multicenter, randomized, double-blind, placebo controlled clinical trial of amitriptyline in subjects with interstitial cystitis/painful bladder syndrome who were naïve to therapy. Study participants in both treatment arms received a standardized education and behavioral modification program. The drug dose was increased during a 6-week period from 10 up to 75 mg once daily. The primary outcome was a patient reported global response assessment of symptom improvement evaluated after 12 weeks of treatment. RESULTS: A total of 271 subjects were randomized and 231 (85%) provided a global response assessment at 12 weeks of followup. Study participants were primarily women (83%) and white (74%), with a median age of 38 years. In an intent to treat analysis (271) the rate of response of subjects reporting moderate or marked improvement from baseline in the amitriptyline and placebo groups was 55% and 45%, respectively (p = 0.12). Of the subgroup of subjects (207) who achieved a drug dose of at least 50 mg, a significantly higher response rate was observed in the amitriptyline group (66%) compared to placebo (47%) (p = 0.01). CONCLUSIONS: When all randomized subjects were considered, amitriptyline plus an education and behavioral modification program did not significantly improve symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome. However, amitriptyline may be beneficial in persons who can achieve a daily dose of 50 mg or greater, although this subgroup comparison was not specified in advance.

Laparoscopic management of ureteral endometriosis: the Stanford University hospital experience with 96 consecutive cases.

PURPOSE: We report the clinical characteristics and the principles of laparoscopic management of ureteral endometriosis at our institution. MATERIALS AND METHODS: We retrospectively reviewed the charts of patients with ureteral endometriosis. RESULTS: Preoperatively 97% of patients complained of pain but only a third had urinary symptoms. The left ureter was affected in 64% of cases and disease was bilateral in 10%. Four patients had hydroureter and 2 had hydronephrosis. CONCLUSIONS: To our knowledge this report represents the largest series of laparoscopically treated, pathologically confirmed ureteral endometriotic cases to date. It confirms that laparoscopic diagnosis and management of ureteral endometriosis are safe and efficient. All patients who undergo laparoscopy for endometriosis should be evaluated for possible ureteral involvement regardless of the presence or absence of urinary symptoms, or prior radiological evaluation since undiagnosed ureteral disease may result in loss of renal function.

Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes.

PURPOSE: We determined the feasibility of conducting a randomized clinical trial designed to compare 2 methods of manual therapy (myofascial physical therapy and global therapeutic massage) in patients with urological chronic pelvic pain syndromes. MATERIALS AND METHODS: We recruited 48 subjects with chronic prostatitis/chronic pelvic pain syndrome or interstitial cystitis/painful bladder syndrome at 6 clinical centers. Eligible patients were randomized to myofascial physical therapy or global therapeutic massage and were scheduled to receive up to 10 weekly treatments of 1 hour each. Criteria to assess feasibility included adherence of therapists to prescribed therapeutic protocol as determined by records of treatment, adverse events during study treatment and rate of response to therapy as assessed by the patient global response assessment. Primary outcome analysis compared response rates between treatment arms using Mantel-Haenszel methods. RESULTS: There were 23 (49%) men and 24 (51%) women randomized during a 6-month period. Of the patients 24 (51%) were randomized to global therapeutic massage, 23 (49%) to myofascial physical therapy and 44 (94%) completed the study. Therapist adherence to the treatment protocols was excellent. The global response assessment response rate of 57% in the myofascial physical therapy group was significantly higher than the rate of 21% in the global therapeutic massage treatment group (p = 0.03). CONCLUSIONS: We judged the feasibility of conducting a full-scale trial of physical therapy methods and the preliminary findings of a beneficial effect of myofascial physical therapy warrants further study.

The relationship among symptoms, sleep disturbances and quality of life in patients with interstitial cystitis.

PURPOSE: We conducted a retrospective analysis to determine associations among symptoms, sleep disturbances and quality of life in responder and nonresponder groups of patients with interstitial cystitis. MATERIALS AND METHODS: Patients in a multidose pentosan polysulfate sodium clinical trial with a diagnosis of interstitial cystitis who were randomized to 300 mg pentosan polysulfate sodium per day (128) completed the Interstitial Cystitis Symptom Index, an adapted Medical Outcomes Study Sleep scale and the Medical Outcomes Study Short Form-12 Health Survey at baseline, and at weeks 8, 16, 24 and 32. Responders were defined as those achieving a 30% or greater reduction in Interstitial Cystitis Symptom Index score from baseline to study end point (week 32 or last observation carried forward). RESULTS: A positive correlation at baseline was observed between sleep scores and Short Form-12 physical and mental components (r = 0.43 and 0.37, respectively, p <0.0001). Patients showed statistically significant improvement in Interstitial Cystitis Symptom Index and sleep scores by week 32. Responders (48, 43%) had a mean change in sleep score of 11.8 +/- 22.4 while nonresponders (64, 57%) had a mean change of 1.6 +/- 15.7 (p = 0.0055 between groups). The reduction in Interstitial Cystitis Symptom Index score correlated with improvement in sleep score from baseline to study end point (r = -0.33, p = 0.0003). At the study end point responders demonstrated a significant improvement in the Short Form-12 physical component compared with baseline (p <0.0001). CONCLUSIONS: Reduction in interstitial cystitis symptoms may be associated with patient reported improvement in sleep and quality of life.

Office dilation of the female urethra: a quality of care problem in the field of urology.

PURPOSE: Historically dilation of the female urethra was thought to be of value in the treatment of a variety of lower urinary tract symptoms. Subsequent work has more accurately classified these complaints as parts of various diseases or syndromes in which scant data exist to support the use of dilation. Yet Medicare reimbursement for urethral dilation remains generous and we describe practice patterns regarding female urethral dilation to characterize a potential quality of care issue. MATERIALS AND METHODS: Health care use by females treated with urethral dilation was compiled using a complementary set of databases. Data sets were examined for relevant inpatient, outpatient and emergency room services for women of all ages. RESULTS: Female urethral dilation is common (929 per 100,000 patients) and is performed almost as much as treatment for male urethral stricture disease. Approximately 12% of these patients are subjected to costly studies such as retrograde urethrography. The overall national costs for treatment exceed $61 million per year and have increased 10% to 17% a year since 1994. A diagnosis of female urethral stricture increases health care expenditures by more than $1,800 per individual per year in insured populations. CONCLUSIONS: Urethral dilation is still common despite the fact that true female urethral stricture is an uncommon entity. This scenario is likely secondary to the persistence of the mostly discarded practice of dilating the unstrictured female urethra for a wide variety of complaints despite the lack of data suggesting that it improves lower urinary tract symptoms.

Followup of patients with interstitial cystitis responsive to treatment with intravesical bacillus Calmette-Guerin or placebo.

PURPOSE: We evaluated the longer term response in patients with interstitial cystitis who initially responded to intravesical bacillus Calmette-Guerin or placebo in a randomized clinical trial. MATERIALS AND METHODS: Patients with interstitial cystitis who responded positively to treatment with bacillus Calmette-Guerin or placebo after 34 weeks of followup in a double-blind clinical trial were followed for an additional 34 weeks in an observational study to assess response durability. Outcomes at 68 weeks included a patient reported global response assessment, 24-hour voiding diary, and pain, urgency and validated interstitial cystitis symptom indexes. RESULTS: Of responders to bacillus Calmette-Guerin or placebo in the clinical trial 38 continued extended followup in the observational study. A total of 12 (75%) responders who received placebo and 19 (86%) who received bacillus Calmette-Guerin considered themselves to remain moderately or markedly improved at week 68. Improved symptom outcomes were also generally maintained during followup in the 2 groups. CONCLUSIONS: Most patients who respond to therapy with intravesical bacillus Calmette-Guerin or placebo maintain improved symptoms for up to 68 weeks after the initiation of therapy. However, initial response rates are low and placebo responders demonstrated essentially the same durability of response as bacillus Calmette-Guerin responders. These results argue against the routine use of bacillus Calmette-Guerin in this patient group.