Christopher K. Payne

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.

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.

Effect of amitriptyline on symptoms in treatment naive 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.

Epidemiology, pathophysiology, and evaluation of urinary incontinence and overactive bladder

OBJECTIVES To present an overview of current knowledge regarding the epidemiology, pathophysiology, and evaluation of urinary incontinence (UI) with a focus on the problem of the overactive bladder. METHODS The most recent data on the epidemiology of UI are presented. The literature on the pathophysiology of urinary urge incontinence (UUI) is reviewed, and key concepts related to patient evaluation are summarized. RESULTS The prevalence of UI depends on the population being surveyed. The overactive bladder constitutes a substantial percentage of the overall problem, ranging from > 50% of incontinent men to only 10% to 15% of incontinent younger women. Few data are available on the incidence of the disorder or on racial/ethnic trends. Overactive bladder or urge incontinence is called detrusor hyperreflexia when a neurologic cause is known and detrusor instability when there is no neurologic abnormality. Although the pathophysiology of idiopathic instability is not well understood, some evidence suggests that this condition may result from subclinical neurologic disease or primary smooth muscle disease. Most patients with UUI can be adequately evaluated with a history, physical examination, determination of postvoid residual volume, and urinalysis. When neurologic disease or other complicating factors are present, or if initial treatment fails, sophisticated urodynamic testing is appropriate. CONCLUSIONS Urinary incontinence is prevalent in all strata of the population, although it affects women and the elderly disproportionately. With the exception of cases in which a neurologic lesion can be demonstrated, the etiology of UUI remains elusive. A thorough history, physical examination, determination of postvoid residual, and urinalysis will be adequate to classify and treat the majority of patients.

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.

Mechanisms of Pelvic Floor Muscle Function and the Effect on the Urethra during a Cough

BACKGROUND Current measurement tools have difficulty identifying the automatic physiologic processes maintaining continence, and many questions still remain about pelvic floor muscle (PFM) function during automatic events. OBJECTIVE To perform a feasibility study to characterise the displacement, velocity, and acceleration of the PFM and the urethra during a cough. DESIGN, SETTING, AND PARTICIPANTS A volunteer convenience sample of 23 continent women and 9 women with stress urinary incontinence (SUI) from the general community of San Francisco Bay Area was studied. MEASUREMENTS Methods included perineal ultrasound imaging, motion tracking of the urogenital structures, and digital vaginal examination. Statistical analysis used one-tailed unpaired student t tests, and Welchs correction was applied when variances were unequal. RESULTS AND LIMITATIONS The cough reflex activated the PFM of continent women to compress the urogenital structures towards the pubic symphysis, which was absent in women with SUI. The maximum accelerations that acted on the PFM during a cough were generally more similar than the velocities and displacements. The urethras of women with SUI were exposed to uncontrolled transverse acceleration and were displaced more than twice as far (p=0.0002), with almost twice the velocity (p=0.0015) of the urethras of continent women. Caution regarding the generalisability of this study is warranted due to the small number of women in the SUI group and the significant difference in parity between groups. CONCLUSIONS During a cough, normal PFM function produces timely compression of the pelvic floor and additional external support to the urethra, reducing displacement, velocity, and acceleration. In women with SUI, who have weaker urethral attachments, this shortening contraction does not occur; consequently, the urethras of women with SUI move further and faster for a longer duration.

Pitfalls in the design of clinical trials for interstitial cystitis

I cystitis (IC) is a chronic, debilitating syndrome presenting as urinary urgency, frequency, and/or pelvic pain in the absence of another cause.1–3 Estimates of the prevalence of IC in the United States range from 37 to 67 per 100,000 individuals.4,5 Despite the substantial impact of IC on a patient’s quality of life (QOL),6,7 no consensus has been reached as to the optimal management. This is, in part, because of the poor quality of clinical research in IC. Most studies have been retrospective cohorts or uncontrolled case series.2,3 Moreover, because there are no “hard” endpoints to assess the efficacy of treatment, symptoms are relied on to measure outcome. This presents special challenges in the design of IC clinical trials. We reviewed the major shortcomings that have plagued previous IC research and provide insights into how future trials can be improved.

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.

A new once-daily formulation of tolterodine provides superior efficacy and is well tolerated in women with overactive bladder.

Abstract This study evaluated the efficacy and tolerability of new extended-release (ER) tolterodine for the treatment of overactive bladder in women. In this subpopulation analysis of a double-blind multicenter trial, 1235 female patients were randomized to oral therapy with tolterodine ER 4 mg once daily (n=417), tolterodine IR 2 mg twice daily (n=408) or placebo (n=410) for 12 weeks. Both formulations reduced the mean number of urge incontinence episodes per week (both P=0.001 vs placebo); tolterodine ER was more effective than tolterodine IR (P=0.036). Both formulations significantly improved all other micturition chart variables compared to placebo. Dry mouth was the most common adverse event. There were no safety concerns. Toltrodine ER 4 mg once daily is effective and well tolerated in the treatment of women with overactive bladder, and reduces urge incontinence episodes more than the existing IR twice-daily formulation.

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 (