Geoffrey W. Cundiff

Prevalence and burden of overactive bladder in the United States

Abstract.Context: the National Overactive BLadder Evaluation (NOBLE) Program was initiated to better understand the prevalence and burden of overactive bladder in a broad spectrum of the United States population. Objective: to estimate the prevalence of overactive bladder with and without urge incontinence in the US, assess variation in prevalence by sex and other factors, and measure individual burden. Design: US national telephone survey using a clinically validated interview and a follow-up nested study comparing overactive bladder cases to sex- and age-matched controls. Setting: noninstitutionalized US adult population. Participants: a sample of 5,204 adults ≥18 years of age and representative of the US population by sex, age, and geographical region. Main outcome measures: prevalence of overactive bladder with and without urge incontinence and risk factors for overactive bladder in the US. In the nested case-control study, SF-36, CES-D, and MOS sleep scores were used to assess impact. Results: the overall prevalence of overactive bladder was similar between men (16.0%) and women (16.9%), but sex-specific prevalence differed substantially by severity of symptoms. In women, prevalence of urge incontinence increased with age from 2.0% to 19% with a marked increase after 44 years of age, and in men, increased with age from 0.3% to 8.9% with a marked increase after 64 years of age. Across all age groups, overactive bladder without urge incontinence was more common in men than in women. Overactive bladder with and without urge incontinence was associated with clinically and significantly lower SF-36 quality-of-life scores, higher CES-D depression scores, and poorer quality of sleep than matched controls. Conclusions: the NOBLE studies do not support the commonly held notion that women are considerably more likely than men to have urgency-related bladder control problems. The overall prevalence of overactive bladder does not differ by sex; however, the severity and nature of symptom expression does differ. Sex-specific anatomic differences may increase the probability that overactive bladder is expressed as urge incontinence among women compared with men. Nonetheless, overactive bladder, with and without incontinence, has a clinically significant impact on quality-of-life, quality-of-sleep, and mental health, in both men and women.

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.

Interobserver and intraobserver reliability of the proposed International Continence Society, Society of Gynecologic Surgeons, and American Urogynecologic Society pelvic organ prolapse classification system ☆ ☆☆ ★

OBJECTIVE Our purpose was to determine the intraobserver and interobserver reliability of site-specific measurements and stages with the proposed international Continence Society, Society of Gynecologic Surgeons, and American Urogynecologic Society 1994 draft prolapse terminology document. STUDY DESIGN Women who completed informed consent procedures underwent pelvic examinations by two investigators, each blinded to the results of the others examination. The reproducibility of the nine site-specific measurements and the summary stage and substage were analyzed with Spearmans correlation coefficient (rs) and Kendel tau B Correlation Coefficient (tau b), respectively. Similar analyses were performed on supine and upright examinations performed at two different times by one examiner. RESULTS Experienced examiners averaged 2.05 minutes per examination and new examiners averaged 3.73 minutes. In the study of interobserver reliability, 48, subjects, mean age 61 +/- 14 years, parity 3 +/- 2, weight 74 +/- 31 kg, comprised the study population. Correlations for each of the nine measurements were substantial and highly significant (rs 0.817, 0.895, 0.522, 0.767, 0.746, 0.747, 0.913, 0.514, and 0.488, p = 0.0008 to < 0.0001). Staging and substaging were highly reproducible (tau b 0.702 and 0.652). In no subject did the stage vary by more than one; in 69% stages were identical. In the study of intraobserver reliability, for 25 subjects correlations for each of the nine measurements were equally strong (rs 0.780, 0.934, 0.765, 0.759, 0.859, 0.826, 0.812, 0.659, 0.431). Measurements from the upright examinations reflected greater prolapse. Staging and substaging were highly reproducible (tau b 0.712 and 0.712). In no subject did the stage vary by more than one; in 64% stages were identical. All stage discrepancies represented an increase in the upright position. CONCLUSIONS There is good reproducibility of measures with the proposed system. The data suggest that the reliability is independent of examiner experience. Patient position is likely important in maximizing the severity of the prolapse.

Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse

IMPORTANCE More than 225 000 surgeries are performed annually in the United States for pelvic organ prolapse (POP). Abdominal sacrocolpopexy is considered the most durable POP surgery, but little is known about safety and long-term effectiveness. OBJECTIVES To describe anatomic and symptomatic outcomes up to 7 years after abdominal sacrocolpopexy, and to determine whether these are affected by concomitant anti-incontinence surgery (Burch urethropexy). DESIGN, SETTING, AND PARTICIPANTS Long-term follow-up of the randomized, masked 2-year Colpopexy and Urinary Reduction Efforts (CARE) trial of women with stress continence who underwent abdominal sacrocolpopexy between 2002 and 2005 for symptomatic POP and also received either concomitant Burch urethropexy or no urethropexy. Ninety-two percent (215/233) of eligible 2-year CARE trial completers were enrolled in the extended CARE study; and 181 (84%) and 126 (59%) completed 5 and 7 years of follow-up, respectively. The median follow-up was 7 years. MAIN OUTCOMES AND MEASURES Symptomatic POP failure requiring retreatment or self-reported bulge; or anatomic POP failure requiring retreatment or Pelvic Organ Prolapse Quantification evaluation demonstrating descent of the vaginal apex below the upper third of the vagina, or anterior or posterior vaginal wall prolapse beyond the hymen. Stress urinary incontinence (SUI) with more than 1 symptom or interval treatment; or overall UI score of 3 or greater on the Incontinence Severity Index. RESULTS By year 7, the estimated probabilities of treatment failure (POP, SUI, UI) from parametric survival modeling for the urethropexy group and the no urethropexy group, respectively, were 0.27 and 0.22 for anatomic POP (treatment difference of 0.050; 95% CI, -0.161 to 0.271), 0.29 and 0.24 for symptomatic POP (treatment difference of 0.049; 95% CI, -0.060 to 0.162), 0.48 and 0.34 for composite POP (treatment difference of 0.134; 95% CI, -0.096 to 0.322), 0.62 and 0.77 for SUI (treatment difference of -0.153; 95% CI, -0.268 to 0.030), and 0.75 and 0.81 for overall UI (treatment difference of -0.064; 95% CI, -0.161 to 0.032). Mesh erosion probability at 7 years (estimated by the Kaplan-Meier method) was 10.5% (95% CI, 6.8% to 16.1%). CONCLUSIONS AND RELEVANCE During 7 years of follow-up, abdominal sacrocolpopexy failure rates increased in both groups. Urethropexy prevented SUI longer than no urethropexy. Abdominal sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00099372.

Abdominal sacral colpoperineopexy: A new approach for correction of posterior compartment defects and perineal descent associated with vaginal vault prolapse☆☆☆★

OBJECTIVE Our purpose was to assess a modification of abdominal sacral colpopexy in 19 patients. STUDY DESIGN The rectovaginal space was dissected to the superior aspect of the posterior vaginal fascia still contiguous with the perineal body. Mersilene (Ethicon, Somerville, N.J.) mesh was sutured to this fascia and along the entire posterior vaginal wall. Patients with vault prolapse, perineal descent, and associated rectoceles or enteroceles are reported. Outcome measures included bowel symptoms and pelvic organ prolapse staging. Defecography was performed in three patients. Wilcoxon signed rank analysis was used for comparison of prolapse measures. RESULTS Mean follow-up was 11 weeks. Bowel symptoms improved in 8 of 11 women. No subjects had greater than stage II prolapse postoperatively and median improvement in stage was 3 (range 2 to 4). The mean decrease in the genital hiatus measurement was 3.13 +/- 1.25 (range 2 to 6) cm. Postoperative defecography documented correction of rectoceles and enteroceles and improvement in perineal descent with straining. CONCLUSIONS Abdominal sacral colpoperineopexy is effective surgery for vaginal vault prolapse associated with perineal descent and posterior vaginal defects.

Two-Year Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence

OBJECTIVES: To report anatomic and functional outcomes 2 years after sacrocolpopexy in stress-continent women with or without prophylactic Burch colposuspension. METHODS: In the Colpopexy and Urinary Reduction Efforts (CARE) trial, stress-continent women undergoing sacrocolpopexy were randomized to receive or not receive a Burch colposuspension. Outcomes included urinary symptoms, other pelvic symptoms, and pelvic support. Standardized pelvic organ prolapse quantification examinations and validated outcome measures including the Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire were completed before surgery and at several postoperative intervals, including at 2 years. RESULTS: This analysis is based on 302 of 322 randomized participants. Most were Caucasian (94%), with a mean age of 62±10 years (mean±standard deviation). Two years after surgery, 32.0% and 45.2% of women in the Burch and control groups, respectively, met the stress incontinence endpoint (presence of symptoms or positive cough stress test or interval treatment for stress incontinence, P=.026). The apex was well supported (point C within 2 cm of total vaginal length) in 95% of women, and this was not affected by concomitant Burch (P=.18). There was a trend toward fewer urgency symptoms in the Burch group (32.0% versus 44.5% no Burch, P=.085). Twenty participants experienced mesh or suture erosions. CONCLUSION: The early advantage of prophylactic Burch colposuspension for stress incontinence that was seen at 3 months remains at 2 years. Apical anatomic success rates are high and not affected by concomitant Burch. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, ClinicalTrials.gov, NCT00065845 LEVEL OF EVIDENCE: I

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.

The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Reduction Efforts (CARE) randomized surgical trial

The aim of this study is to describe results of reduction testing in stress-continent women undergoing sacrocolpopexy and to estimate whether stress leakage during urodynamic testing with prolapse reduction predicts postoperative stress incontinence. Three hundred twenty-two stress-continent women with stages II–IV prolapse underwent standardized urodynamics. Five prolapse reduction methods were tested: two at each site and both performed for each subject. Clinicians were masked to urodynamic results. At sacrocolpopexy, participants were randomized to Burch colposuspension or no Burch (control). P-values were computed by two-tailed Fisher’s exact test or t-test. Preoperatively, only 12 of 313 (3.7%) subjects demonstrated urodynamic stress incontinence (USI) without prolapse reduction. More women leaked after the second method than after the first (22% vs. 16%; p = 0.012). Preoperative detection of USI with prolapse reduction at 300ml was pessary, 6% (5 of 88); manual, 16% (19 of 122); forceps, 21% (21 of 98); swab, 20% (32 of 158); and speculum, 30% (35 of 118). Women who demonstrated preoperative USI during prolapse reduction were more likely to report postoperative stress incontinence, regardless of concomitant colposuspension (controls 58% vs. 38% (p = 0.04) and Burch 32% vs. 21% (p = 0.19)). In stress-continent women undergoing sacrocolpopexy, few women demonstrated USI without prolapse reduction. Detection rates of USI with prolapse reduction varied significantly by reduction method. Preoperative USI leakage during reduction testing is associated with a higher risk for postoperative stress incontinence at 3 months. Future research is warranted in this patient population to evaluate other treatment options to refine predictions and further reduce the risk of postoperative stress incontinence.

Risk factors for mesh/suture erosion following sacral colpopexy

OBJECTIVE The purpose of this study was to identify risks for mesh/suture erosions following abdominal sacral colpopexy (ASC). STUDY DESIGN We analyzed demographic, perioperative variables, and erosion status in 322 participants in the Colpopexy and Urinary Reduction Efforts study 2 years after sacral colpopexy. RESULTS The predominant graft used was synthetic mesh: woven polyester (Mersilene; Ethicon, Inc, Somerville, NJ) (42%) or polypropylene (48%). Twenty subjects (6%) experienced mesh/suture erosion. Unadjusted risk factors for mesh/suture erosion were expanded polytrafluroethylene (ePTFE) mesh (ePTFE 4/21 [19%] vs non-ePTFE 16/301 [5%]; odds ratio [OR], 4.2), concurrent hysterectomy (OR, 4.9), and current smoking (OR, 5.2). Of those with mesh erosion, most affected women (13/17) underwent at least 1 surgery for partial or total mesh removal. Two were completely resolved, 6 had persistent problems, and 5 were lost to follow-up. No resolution was documented in the 4 women who elected observation. CONCLUSION Expanded PTFE mesh should not be used for sacral colpopexy. Concurrent hysterectomy and smoking are modifiable risks for mesh/suture erosion.

Uterosacral ligament: description of anatomic relationships to optimize surgical safety☆

Objective To determine the optimal site in the uterosacral ligament for suspension of the vaginal vault with regard to adjacent anatomy and suspension strength. Methods Fifteen female cadavers were evaluated between December 1998 and September 1999. Eleven hemisected pelves were dissected to better define the uterosacral ligament and identify adjacent anatomy. Ureteral pressure profiles with and without relaxing incisions were done on four fresh specimens. Suture pullout strengths also were assessed in the uterosacral ligament. Results The uterosacral ligament was attached broadly to the first, second, and third sacral vertebrae, and variably to the fourth sacral vertebrae. The intermediate portion of the uterosacral ligament had fewer vital, subjacent structures. The mean ± standard deviation distance from ureter to uterosacral ligament was 0.9 ± 0.4, 2.3 ± 0.9, and 4.1 ± 0.6 cm in the cervical, intermediate, and sacral portions of the uterosacral ligament, respectively. The distance from the ischial spine to the ureter was 4.9 ± 2.0 cm. The ischial spine was consistently beneath the intermediate portion but variable in location beneath the breadth of the ligament. Uterosacral ligament tension was transmitted to the ureter, most notably near the cervix. The cervical and intermediate portions of the uterosacral ligament supported more than 17 kg of weight before failure. Conclusion Our findings suggest that the optimal site for fixation is the intermediate portion of the uterosacral ligament, 1 cm posterior to its most anterior palpable margin, with the ligament on tension.