Mary P. FitzGerald

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.

Fecal and urinary incontinence in primiparous women

OBJECTIVE: To prospectively investigate the relationship between anal sphincter tears and postpartum fecal and urinary incontinence. METHODS: The Childbirth and Pelvic Symptoms study was a prospective cohort study performed by the Pelvic Floor Disorders Network to estimate the prevalence of postpartum fecal and urinary incontinence in primiparous women: 407 with clinically recognized anal sphincter tears during vaginal delivery, 390 without recognized sphincter tears (vaginal controls), and 124 delivered by cesarean before labor. Women were recruited postpartum while hospitalized and interviewed by telephone 6 weeks and 6 months postpartum. We assessed fecal and urinary incontinence symptoms using the Fecal Incontinence Severity Index and the Medical, Epidemiological, and Social Aspects of Aging Questionnaire, respectively. Odds ratios were adjusted for age, race, and clinical site. RESULTS: Compared with the vaginal control group, women in the sphincter tear cohort reported more fecal incontinence (6 weeks, 26.6% versus 11.2%; adjusted odds ratio [AOR] 2.8, 95% confidence interval [CI] 1.8–4.3; 6 months, 17.0% versus 8.2%; AOR 1.9, 95% CI 1.2–3.2), more fecal urgency and flatal incontinence, and greater fecal incontinence severity at both times. Urinary incontinence prevalence did not differ between the sphincter tear and vaginal control groups. Six months postpartum, 22.9% of women delivered by cesarean reported urinary incontinence, whereas 7.6% reported fecal incontinence. CONCLUSION: Women with clinically recognized anal sphincter tears are more than twice as likely to report postpartum fecal incontinence than women without sphincter tears. Cesarean delivery before labor is not entirely protective against pelvic floor disorders. LEVEL OF EVIDENCE: II-3

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.

Association of Nocturia and Mortality: Results From the Third National Health and Nutrition Examination Survey

PURPOSE Nocturia, a common problem in men and women, has been associated with chronic illnesses such as heart disease and hypertension. Using data from the Third National Health and Nutrition Examination Survey we investigated the association of nocturia with subsequent mortality risk. MATERIALS AND METHODS NHANES III is a national probability survey of the United States between 1988 and 1994. Mortality data were obtained by linkage of NHANES III to the National Death Index. Cox proportional hazards regression models were used to assess the association between nocturia and all cause mortality, controlling for potential confounders in a sample of 15,988 men and women 20 years old or older. RESULTS The prevalence of nocturia, defined as 2 or more voiding episodes nightly, was 15.5% in men and 20.9% in women. Multivariate analyses showed a statistically significant trend of increased mortality risk with increased number of voiding episodes in men and women. The magnitude of the nocturia and mortality association was greater in those younger than 65 years with attenuated associations in the 65 years old or older age group. CONCLUSIONS Nocturia is a strong predictor of mortality, more so in younger men and women than in the elderly, with a dose-response pattern in increased mortality risk with increasing number of voiding episodes nightly. Potential underlying mechanisms of the observed association of nocturia and increased mortality risk include sleep disruption and subsequent development of related comorbid conditions.

Functional failure of fascia lata allografts.

OBJECTIVES Fascia lata allografts are commonly used in urogynecologic procedures. Functional failure of several grafts has occurred, and such failure has been recognized as a materials problem in 12 patients. STUDY DESIGN Twelve patients with failure of an initial urogynecologic procedure performed with irradiated and freeze-dried donor fascia lata grafts underwent reoperation. Portions of the implanted fascia lata grafts could be retrieved in 7 cases. Graft specimens underwent histologic processing followed by hematoxylin and eosin staining. RESULTS Histopathologic analyses of the retrieved material demonstrated several ongoing processes in the failed grafts. A few grafts showed areas of ideal remodeling. Most grafts, however, showed areas of disorganized remodeling and areas of graft degeneration. Evidence of immune reaction to the graft was observed in some cases. CONCLUSION The high materials failure rate associated with the use of irradiated and freeze-dried donor fascia lata grafts suggests that such tissue should not be used for urogynecologic procedures.

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.

Colpocleisis: a review

Objective: To summarize published data about colpocleisis and to highlight areas about which data are lacking. Data sources: We conducted a literature search on Medline using Ovid and PubMed, from 1966 to January 2004, using search terms “colpocleisis”, “colpectomy”, “vaginectomy”, “pelvic organ prolapse (POP) and surgery”, and “vaginal vault prolapse and surgery” and included articles with English-language abstracts. We examined reference lists of published articles to identify other articles not found on the electronic search. Methods of study selection: We examined all studies identified in our search that provided any outcome data on colpocleisis. Because of the heterogeneity of outcome measures and follow-up intervals in case series, we did not apply meta-analytic techniques to the data. Results: Colpocleisis for POP is apparently successful in nearly 100% of patients in recent series. The rate of reoperation for stress incontinence or POP after colpocleisis is unknown. Concomitant elective hysterectomy is associated with increased blood loss and length of hospital stay, without known improvement in outcomes. Few studies systematically assess pelvic symptoms. The role of preoperative urodynamic testing to direct optimal management of urinary incontinence and retention remains to be established in this setting. Conclusions: Colpocleisis is an effective procedure for treatment of advanced POP in patients who no longer desire preservation of coital function. Complications are relatively common in this group of elderly patients. Prospective trials are needed to understand the impact of colpocleisis on functional outcomes and patient satisfaction.

Childhood Urinary Symptoms Predict Adult Overactive Bladder Symptoms

PURPOSE A relationship between childhood urinary symptoms and adult lower urinary tract symptoms in women is often clinically suspected. In this analysis we investigated the relationship between childhood and adult urinary symptoms in middle-aged women. MATERIALS AND METHODS A population based cohort of 2,109 women 40 to 69 years old who were members of a large health maintenance organization was randomly selected from age and race strata. Through self-reported questionnaires, women recalled a childhood history of and current urinary lower urinary tract symptoms, including frequent daytime urination, nocturia, urinary incontinence, nocturnal enuresis and UTIs. Current incontinence was also classified as urge or stress incontinence. Multivariate analysis was used to evaluate the association between childhood and current lower urinary tract symptoms controlling for age, race, hysterectomy status, parity, oral estrogen use, body mass index and diabetes. RESULTS Women who reported childhood daytime frequency were more likely to report adult urgency (OR 1.9, 95% CI 1.3-2.6, p < 0.001). Frequent nocturia in childhood was strongly associated with adult nocturia (OR 2.3, 95% CI 1.5-3.5, p < 0.001). Childhood daytime incontinence was associated with adult urge incontinence (OR 2.6, 95% CI 1.1-5.9, p < 0.05), as was childhood nocturnal enuresis (OR 2.7, CI 1.3-5.5, p < 0.01). A history of more than 1 childhood UTI was associated with adult UTIs (OR 2.6, 95% CI 1.5-4.5, p < 0.001). CONCLUSIONS Childhood urinary symptoms and UTIs were significantly associated with adult overactive bladder symptoms. There is a need to investigate the significance of childhood symptoms as predictors of eventual adult disorders to determine whether treatment of childhood symptoms will alter the prevalence of eventual adult disorders, and if such a history should alter clinical care of the older adult with OAB symptoms.

Behavioral Therapy to Enable Women with Urge Incontinence to Discontinue Drug Treatment: A Randomized Trial

BACKGROUND Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy. OBJECTIVE To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy. DESIGN 2-stage, multicenter, randomized clinical trial conducted from July 2004 to January 2006. SETTING 9 university-affiliated outpatient clinics. PATIENTS 307 women with urge-predominant incontinence. INTERVENTION 10 weeks of open-label, extended-release tolterodine alone (n = 153) or combined with behavioral training (n = 154), followed by discontinuation of therapy and follow-up at 8 months. MEASUREMENTS The primary outcome, measured at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment. RESULTS 237 participants completed the trial. According to life-table estimates, the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups (41% in both groups; difference, 0 percentage points [95% CI, -12 to 12 percentage points]). A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks (69% vs. 58%; difference, 11 percentage points [CI, -0.3 to 22.1 percentage points]). Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Questionnaire (both P <0.001) at both time points for patient satisfaction and perceived improvement but not health-related quality of life. Adverse events were uncommon (12 events in 6 participants [3 in each group]). LIMITATIONS Behavioral therapy components (daily bladder diary and recommendations for fluid management) in the group receiving drug therapy alone may have attenuated between-group differences. Assigned treatment was completed by 68% of participants, whereas 8-month outcome status was assessed on 77%. CONCLUSION The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy has a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms.

Risk factors for anal sphincter tear during vaginal delivery.

OBJECTIVE: To identify risk factors associated with anal sphincter tear during vaginal delivery and to identify opportunities for preventing this cause of fecal incontinence in young women. METHODS: We used baseline data from two groups of women who participated in the Childbirth and Pelvic Symptoms (CAPS) study: those women who delivered vaginally, either those with or those without a recognized anal sphincter tear. Univariable analyses of demographic and obstetric information identified factors associated with anal sphincter tear. We calculated odds ratios (ORs) for these factors alone and in combination, adjusted for maternal age, race, and gestational age. RESULTS: We included data from 797 primaparous women: 407 with a recognized anal sphincter tear and 390 without. Based on univariable analysis, a woman with a sphincter tear was more likely to be older, to be white, to have longer gestation or prolonged second stage of labor, to have a larger infant (birth weight/head circumference), or an infant who was in occiput posterior position, or to have an episiotomy or operative delivery. Logistic regression found forceps delivery (OR 13.6, 95% confidence interval [CI] 7.9–23.2) and episiotomy (OR 5.3, 95% CI 3.8–7.6) were strongly associated with a sphincter tear. The combination of forceps and episiotomy was markedly associated with sphincter tear (OR 25.3, 95% CI 10.2–62.6). The addition of epidural anesthesia to forceps and episiotomy increased the OR to 41.0 (95% CI 13.5–124.4). CONCLUSION: Our results highlight the existence of modifiable obstetric interventions that increase the risk of anal sphincter tear during vaginal delivery. Our results may be used by clinicians and women to help inform their decisions regarding obstetric interventions. LEVEL OF EVIDENCE: II