Alison C. Weidner

Fecal Incontinence in US Adults: Epidemiology and Risk Factors

BACKGROUND & AIMS The study aims were to estimate the prevalence of different types and frequencies of fecal incontinence (FI), describe demographic factors, and identify risk factors. METHODS The National Health and Nutrition Examination Survey (NHANES) assesses health status in the civilian noninstitutionalized US population. The validated Fecal Incontinence Severity Index was added to NHANES in 2005-2006. Participants were 2229 women and 2079 men aged 20 years or older. FI was defined as accidental leakage of solid, liquid, or mucus at least once in the preceding month. Sampling weights were used to obtain prevalence estimates for the national population. Multivariate logistic regression identified independent risk factors. RESULTS The estimated prevalence of FI in noninstitutionalized US adults is 8.3% (95% confidence interval, 7.1-9.5) and consists of liquid stool in 6.2%, solid stool in 1.6%, and mucus in 3.1%. It occurs at least weekly in 2.7%. Prevalence is similar in women (8.9%) and men (7.7%) and increases with age from 2.6% in 20 to 29 year olds up to 15.3% in participants aged 70 years and older. FI is not significantly associated with race/ethnicity, education, income, or marital status after adjusting for age. Independent risk factors in women are advancing age, loose or watery stools, more than 21 stools per week, multiple chronic illnesses, and urinary incontinence. Independent risk factors in men are age, loose or watery stools, poor self-rated health, and urinary incontinence. CONCLUSIONS FI is a prevalent age-related disorder. Chronic diarrhea is a strong modifiable risk factor that may form the basis for prevention and treatment.

The Standardization of Terminology for Researchers in Female Pelvic Floor Disorders

Abstract: The lack of standardized terminology in pelvic floor disorders (pelvic organ prolapse, urinary incontinence, and fecal incontinence) is a major obstacle to performing and interpreting research. The National Institutes of Health convened the Terminology Workshop for Researchers in Female Pelvic Floor Disorders to: (1) agree on standard terms for defining conditions and outcomes; (2) make recommendations for minimum data collection for research; and (3) identify high priority issues for future research. Pelvic organ prolapse was defined by physical examination staging using the International Continence Society system. Stress urinary incontinence was defined by symptoms and testing; ‘cure’ was defined as no stress incontinence symptoms, negative testing, and no new problems due to intervention. Overactive bladder was defined as urinary frequency and urgency, with and without urge incontinence. Detrusor instability was defined by cystometry. For all urinary symptoms, defining ‘improvement’ after intervention was identified as a high priority. For fecal incontinence, more research is needed before recommendations can be made. A standard terminology for research on pelvic floor disorders is presented and areas of high priority for future research are identified.

A Survey of Pessary Use by Members of the American Urogynecologic Society

Objective To describe trends in pessary use for pelvic organ prolapse. Methods An anonymous survey administered to the membership of the American Urogynecologic Society covered indications, management, and choice of pessary for specific support defects. Results The response rate was 48% (359 of 748). Two hundred fifty surveys were received at the scientific meeting and 109 were returned by mail. Seventy-seven percent used pessaries as first-line therapy for prolapse, while 12% reserved pessaries for women who were not surgical candidates. With respect to specific support defects, 89% used a pessary for anterior defects, 60% for posterior defects, 74% for apical defects, and 76% for complete procidentia. Twenty-two percent used the same pessary, usually a ring pessary, for all support defects. In the 78% who tailored the pessary to the defect, support pessaries were more common for anterior (ring) and apical defects (ring), while space-filling pessaries were more common for posterior defects (donut) and complete procidentia (Gellhorn). Less than half considered a prior hysterectomy or sexual activity contraindications for a pessary, while 64% considered hypoestrogenism a contraindication. Forty-four percent used a different pessary for women with a prior hysterectomy and 59% for women with a weak pelvic diaphragm. Ninety-two percent of physicians believed that pessaries relieve symptoms associated with pelvic organ prolapse, while 48% felt that pessaries also had therapeutic benefit in addition to relieving symptoms. Conclusion While there are identifiable trends in pessary use, there is no clear consensus regarding the indications for support pessaries compared with space-filling pessaries, or the use of a single pessary for all support defects compared with tailoring the pessary to the specific defect. Randomized clinical trials are needed to define optimal pessary use.

Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse: The OPTIMAL Randomized Trial

IMPORTANCE More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery. OBJECTIVE To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. DESIGN, SETTING, AND PARTICIPANTS Multicenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%. INTERVENTIONS The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188). MAIN OUTCOMES AND MEASURES The primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success. RESULTS At 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months. CONCLUSIONS AND RELEVANCE Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00597935.

Diagnosing intrinsic sphincteric deficiency: Comparing urethral closure pressure, urethral axis, and Valsalva leak point pressures

Abstract OBJECTIVES: Our purpose was to compare three measures proposed to diagnose intrinsic sphincteric deficiency: maximum urethral closure pressure, Valsalva leak point pressure, and straining urethral axis. STUDY DESIGN: A total of 159 women with pure genuine stress incontinence had the three measures determined in a standardized fashion. Critical cutoff values for the Valsalva leak point pressure (52 cm) and urethral axis (22 degrees) were established by examining relative frequency distribution curves, using closure pressure of 20 as the arbitrary benchmark value for the prevalence of intrinsic sphincteric deficiency. The distribution of cutoff values is described and differences among the measures with respect to risk factors for intrinsic sphincteric deficiency and incontinence severity were determined. RESULTS: Half the subjects fell below at least one cutoff value, but only 10% fell below all three. Sixty-four percent of subjects with either low closure pressure or leak point pressure had low values for the other, whereas 21% had discordance between them. Only 53% of subjects with low closure pressure and 40% with low leak point pressure had an axis ≤22 degrees. Conversely, a substantial portion (36%) of subjects with pure genuine stress incontinence without urethral hypermobility had neither low urethral or leak point pressures. All three cutoff values were associated with risk factors for intrinsic sphincteric deficiency, but only low closure and leak point pressures had significant associations with the severity of incontinence. CONCLUSIONS: Intrinsic sphincteric deficiency should be diagnosed by a composite of historic, urodynamic, anatomic, and clinical severity criteria. We would include a maximum urethral closure pressure ≤20, a Valsalva leak point pressure ≤50, and a stress urethral axis ≤20 in this composite. (Am J Obstet Gynecol 1997;177:10.)

Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: The OPTIMAL randomized trial

IMPORTANCE More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery. OBJECTIVE To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. DESIGN, SETTING, AND PARTICIPANTS Multicenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%. INTERVENTIONS The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188). MAIN OUTCOMES AND MEASURES The primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success. RESULTS At 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months. CONCLUSIONS AND RELEVANCE Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00597935.

Cost-effectiveness of universal cystoscopy to identify ureteral injury at hysterectomy

Objective To evaluate the cost-effectiveness of routine cystoscopy at the time of abdominal, vaginal, and laparoscopically assisted vaginal hysterectomy in terms of cost per ureteral injury identified and treated. Methods Using a hospital-based perspective, a decision-analysis model was constructed to estimate the outcomes and costs of cystoscopy or no cystoscopy at the time of abdominal hysterectomy. A similar model was constructed for vaginal and laparoscopically assisted vaginal hysterectomy to account for the cost of conversion to laparotomy. Cost estimates were based on estimated costs of Duke University Medical Center and from average Medicare reimbursements for similar Diagnostic Related Groups from the Health Care Financing Administration. The incidence of ureteral injury was obtained from a review of the literature. Sensitivity analyses were performed for the following variables: ureteral injury rate, silent ureteral injury rate, cost of cystoscopy, and cost of therapeutic interventions. We assumed a silent renal death rate of 0%. Results Routine cystoscopy at abdominal hysterectomy was cost-saving above a threshold ureteral injury rate of 1.5%. At a ureteral injury rate of 0.2%, the marginal increase in the cost of routine intraoperative cystoscopy was

Correlation between levator ani muscle injuries on magnetic resonance imaging and fecal incontinence, pelvic organ prolapse, and urinary incontinence in primiparous women

108 per abdominal hysterectomy, with an associated cost of

Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: A randomized controlled trial

54,000 per ureteral injury identified. In comparison, at a ureteral injury rate of 2%, routine cystoscopy gave a marginal cost savings of

Single-Incision Mini-Sling Compared With Tension-Free Vaginal Tape for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial.

44 per hysterectomy, with a cost savings of