Holly E. Richter

Retropubic versus Transobturator Midurethral Slings for Stress Incontinence

BACKGROUND Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. RESULTS A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)

Refractory Idiopathic Urge Urinary Incontinence and Botulinum A Injection

PURPOSE We compared 200 U intradetrusor botulinum toxin A vs placebo in women with refractory idiopathic urge incontinence. MATERIALS AND METHODS This institutional review board approved, multicenter registered trial randomized women with refractory urge incontinence, detrusor overactivity incontinence and 6 or greater urge incontinence episodes in 3 days to botulinum toxin A or placebo at a 2:1 ratio. Refractory was defined as inadequate symptom control after 2 or more attempts at pharmacotherapy and 1 or more other first line therapies for detrusor overactivity incontinence. The primary outcome measure was time to failure, as evidenced by a Patient Global Impression of Improvement score of 4 or greater at least 2 months after injection, or changes in treatment (initiation or increase) at any time after injection. Safety data, including increased post-void residual volume, defined as more than 200 ml irrespective of symptoms, was obtained at specified time points. RESULTS Approximately 60% of the women who received botulinum toxin A had a clinical response based on the Patient Global Impression of Improvement. The median duration of their responses was 373 days, significantly longer than the 62 days or less for placebo (p <0.0001). In the botulinum toxin A group increased post-void residual urine (12 of 28 women or 43%) and urinary tract infection in those with increased post-void residual urine (9 of 12 or 75%) exceeded expected ranges. Further injections were stopped after 43 patients were randomized, including 28 to botulinum toxin A and 15 to placebo. CONCLUSIONS Local injection of 200 U botulinum toxin A was an effective and durable treatment for refractory overactive bladder. However, a transient post-void residual urine increase was experienced in 43% of patients. Botulinum toxin A for idiopathic overactive bladder is still under investigation.

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.

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

Douching in relation to bacterial vaginosis, lactobacilli, and facultative bacteria in the vagina

OBJECTIVE To study how frequency, recentness, and reason for douching impact bacterial vaginosis‐related vaginal microflora and the occurrence of cervical pathogens. Douching has been linked to bacterial vaginosis as well as to chlamydial cervicitis in some, but not all, studies. METHODS A total of 1200 women at high risk for sexually transmitted infections were enrolled from five clinical sites around the United States. Cross‐sectional, structured interviews were conducted and vaginal swabs were self‐obtained for Gram stain, culture, and DNA amplification tests for Neisseria gonorrhoeae and Chlamydia trachomatis. RESULTS Douching at least once per month was associated with an increased frequency of bacterial vaginosis. Those who douched recently (within 7 days) were at highest risk [odds ratio (OR) 2.1, 95% confidence interval (CI) 1.3, 3.1]. Douching for symptoms (OR 1.7, 95% CI 1.1, 2.6) and for hygiene (OR 1.3, 95% CI 1.0, 1.9) both related to bacterial vaginosis risk. The associations between douching and Gardnerella vaginalis, Mycoplasma hominis, and lack of hydrogen peroxide‐producing lactobacilli were similar to those between douching and bacterial vaginosis. Gonococcal or chlamydial cervicitis was not associated with douching. CONCLUSION Douching for symptoms or hygiene, particularly frequent or recent douching, was associated with bacterial vaginosis and bacterial vaginosis‐associated vaginal microflora, but not with gonococcal or chlamydial cervicitis.

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 Midurethral Sling to Reduce Incontinence after Vaginal Prolapse Repair

BACKGROUND Women without stress urinary incontinence undergoing vaginal surgery for pelvic-organ prolapse are at risk for postoperative urinary incontinence. A midurethral sling may be placed at the time of prolapse repair to reduce this risk. METHODS We performed a multicenter trial involving women without symptoms of stress incontinence and with anterior prolapse (of stage 2 or higher on a Pelvic Organ Prolapse Quantification system examination) who were planning to undergo vaginal prolapse surgery. Women were randomly assigned to receive either a midurethral sling or sham incisions during surgery. One primary end point was urinary incontinence or treatment for this condition at 3 months. The second primary end point was the presence of incontinence at 12 months, allowing for subsequent treatment for incontinence. RESULTS Of the 337 women who underwent randomization, 327 (97%) completed follow-up at 1 year. At 3 months, the rate of urinary incontinence (or treatment) was 23.6% in the sling group and 49.4% in the sham group (P<0.001). At 12 months, urinary incontinence (allowing for subsequent treatment of incontinence) was present in 27.3% and 43.0% of patients in the sling and sham groups, respectively (P=0.002). The number needed to treat with a sling to prevent one case of urinary incontinence at 12 months was 6.3. The rate of bladder perforation was higher in the sling group than in the sham group (6.7% vs. 0%), as were rates of urinary tract infection (31.0% vs. 18.3%), major bleeding complications (3.1% vs. 0%), and incomplete bladder emptying 6 weeks after surgery (3.7% vs. 0%) (P≤0.05 for all comparisons). CONCLUSIONS A prophylactic midurethral sling inserted during vaginal prolapse surgery resulted in a lower rate of urinary incontinence at 3 and 12 months but higher rates of adverse events. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Womens Health; OPUS ClinicalTrials.gov number, NCT00460434.).

A randomized comparison of total or supracervical hysterectomy: surgical complications and clinical outcomes

Abstract Objective To compare surgical complications and clinical outcomes after total versus supracervical abdominal hysterectomy for control of abnormal uterine bleeding, symptomatic uterine leiomyomata, or both. Methods We conducted a randomized intervention trial in four US clinical centers among 135 patients who had abdominal hysterectomy for symptomatic uterine leiomyomata, abnormal uterine bleeding refractory to hormonal treatment, or both. Patients were randomly assigned to receive a total or supracervical hysterectomy performed using the surgeons customary technique. Using an intention-to-treat approach, we compared surgical complications and clinical outcomes for 2 years after randomization. Results Sixty-eight participants were assigned to supracervical hysterectomy (SCH) and 67 to total abdominal hysterectomy (TAH). Hysterectomy by either technique led to statistically significant reductions in most symptoms, including pelvic pain or pressure, back pain, urinary incontinence, and voiding dysfunction. Patients randomly assigned to (SCH) tended to have more hospital readmissions than those randomized to TAH, but this difference was not statistically significant. There were no statistically significant differences in the rate of complications, degree of symptom improvement, or activity limitation. Participants weighing more than 100 kg at study entry were twice as likely to be readmitted to the hospital during the 2-year follow-up period (relative risk [RR] 2.18, 95% confidence interval [CI] 1.06, 4.48, P = .034). Conclusion We found no statistically significant differences between (SCH) and TAH in surgical complications and clinical outcomes during 2 years of follow-up.

Changes in urinary and fecal incontinence symptoms with weight loss surgery in morbidly obese women.

OBJECTIVE: To examine changes in the prevalence and severity of urinary incontinence (UI) and fecal incontinence in morbidly obese women undergoing laparoscopic weight loss surgery. METHODS: In a prospective cohort study, 101 women (aged 20–55 years) with body mass index (BMI) of 40 or more underwent laparoscopic Roux-en-Y gastric bypass and were followed to 6 and 12 months. Presence, severity, and effect of UI were assessed using the Medical, Epidemiological, and Social Aspects of Aging Questionnaire, Urogenital Distress Inventory, and Incontinence Impact Questionnaire. Fecal incontinence was assessed by self-report of anal leakage. RESULTS: Mean BMI decreased from 48.9±7.2 presurgery to 35.3±6.5 at 6 months and 30.2±5.7 at 12 months postsurgery. Prevalence of UI decreased from 66.7% presurgery to 41.0% at 6 months and 37.0% at 12 months (P<.001; 95% confidence interval [CI] for change 18.6–40.0%). Reduction in prevalence of UI was significantly associated with decreases in BMI (P=.01). Among incontinent women who lost 18 or more BMI points, 71% regained urinary continence at 12 months. Medical, Epidemiological, and Social Aspects of Aging Questionnaire urge and stress scores decreased (both P<.001; 95% CI 0.5–1.85 and 2.71–5.34, respectively), as did scores on the Urogenital Distress Inventory (P<.001; 95% CI 8.31–16.21) and Incontinence Impact Questionnaire (P<.001; 95% CI 4.71–14.60), indicating reduction in severity. Prevalence of fecal incontinence (solid or liquid stool) decreased from 19.4% to 9.1% at 6 months and 8.6% at 12 months (P=.018; 95% CI 2.1–19.4%). CONCLUSION: Prevalence of UI and fecal incontinence decreased after bariatric surgery. Magnitude of weight loss was associated with reduction in UI prevalence, strengthening the inference that improvements are attributable to weight loss. LEVEL OF EVIDENCE: II

Prevalence and Correlates of Fecal Incontinence in Community‐Dwelling Older Adults

Objectives: To determine prevalence and correlates of fecal incontinence in older community‐dwelling adults.