Diane Borello-France

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

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.

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.

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.

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

OBJECTIVE: To compare the effectiveness of a continence pessary to evidence-based behavioral therapy for stress incontinence and to assess whether combined pessary and behavioral therapy is superior to single-modality therapy. METHODS: This was a multisite, randomized clinical trial (Ambulatory Treatments for Leakage Associated with Stress Incontinence [ATLAS]) that randomly assigned 446 women with stress incontinence to pessary, behavioral therapy, or combined treatment. Primary outcome measures, at 3 months, were Patient Global Impression of Improvement and the stress incontinence subscale of the Pelvic Floor Distress Inventory. A priori, to be considered clinically superior, combination therapy had to be better than both single-modality therapies. Outcome measures were repeated at 6 and 12 months. Primary analyses used an intention-to-treat approach. RESULTS: At 3 months, scores from 40% of the pessary group and 49% of the behavioral group were “much better” or “very much better” on the Patient Global Impression of Improvement (P=.10). Compared with the pessary group, more women in the behavioral group reported having no bothersome incontinence symptoms (49% compared with 33%, P=.006) and treatment satisfaction (75% compared with 63%, P=.02). Combination therapy was significantly better than pessary as shown on the Patient Global Impression of Improvement (53%, P=.02) and Pelvic Floor Distress Inventory (44%, P=.05) but not better than behavioral therapy; it was therefore not superior to single-modality therapy. Group differences were not sustained to 12 months on any measure, and patient satisfaction remained above 50% for all treatment groups. CONCLUSION: Behavioral therapy resulted in greater patient satisfaction and fewer bothersome incontinence symptoms than pessary at 3 months, but differences did not persist to 12 months. Combination therapy was not superior to single-modality therapy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00270998. LEVEL OF EVIDENCE: I

Risk Factors for Fecal and Urinary Incontinence After Childbirth: The Childbirth and Pelvic Symptoms Study

OBJECTIVE: To identify risk factors for postpartum FI and UI.METHODS: Secondary analysis of data from the CAPS study, which estimated the prevalence of postpartum FI and UI in primiparous women with clinically recognized anal sphincter tears after vaginal delivery, compared with women who delivered vaginally without recognized tears or by cesarean before labor. A total of 921 women were enrolled while in the hospital and 759 (82%) were interviewed by telephone 6 months postpartum. FI was assessed using the FISI and UI using the Medical, Epidemiological, and Social Aspects of Aging Questionnaire. FI risk factor analyses were conducted within each group, because of higher prevalence in the tear group. UI analyses were conducted with the groups combined.RESULTS: In women with sphincter tears, FI at 6 months was associated with white race (OR 6.1, 95% CI 1.3–29.4), antenatal UI (OR 2.2, CI 1.1–4.3), 4th versus 3rd degree tear (OR 2.0, CI 1.0–4.0), older age at delivery (OR 1.6 per 5 yr, CI 1.2–2.1), and higher body mass index (BMI) (OR 1.3 per 5 kg/m2, CI 1.0–1.7). No factors were associated with FI in the vaginal or cesarean control groups. Across all groups, risk factors for postpartum UI were antenatal UI (OR 3.5, CI 2.4–5.2), less education (OR 2.0, CI 1.4–2.8), and higher BMI (OR 1.2 per 5 kg/m2, CI 1.1–1.4); cesarean delivery was protective (OR 0.5, CI 0.3–0.9).CONCLUSIONS: Postpartum FI and UI are associated with few modifiable risk factors. However, the presence of antenatal UI and high BMI may help clinicians target at-risk women for early intervention.

Quality of life in women with stress urinary incontinence

The objective of this study was to identify clinical and demographic factors associated with incontinence-related quality of life (QoL) in 655 women with stress urinary incontinence who elected surgical treatment. The following factors were examined for their association with QoL as measured with the Incontinence Impact Questionnaire (IIQ): number of incontinence (UI) episodes/day; self-reported type of UI symptoms (stress and urge); sexual function as measured by the Prolapse/Urinary Incontinence Sexual Questionnaire; symptom bother as measured by the Urogenital Distress Inventory; as well as other clinical and sociodemographic factors. A stepwise least-squares regression analysis was used to identify factors significantly associated with QoL. Lower QoL was related to the greater frequency of stress UI symptoms, increasing severity, greater symptom bother, prior UI surgery or treatment, and sexual dysfunction (if sexually active). Health and sociodemographic factors associated with lower incontinence-related QoL included current tobacco use, younger age, lower socioeconomic status, and Hispanic ethnicity.

Adherence to Behavioral Interventions for Urge Incontinence When Combined With Drug Therapy: Adherence Rates, Barriers, and Predictors

Background Behavioral intervention outcomes for urinary incontinence (UI) depend on active patient participation. Objective The purpose of this study was to describe adherence to behavioral interventions (pelvic-floor muscle [PFM] exercises, UI prevention strategies, and delayed voiding), patient-perceived exercise barriers, and predictors of exercise adherence in women with urge-predominant UI. Design This was a prospectively planned secondary data analysis from a 2-stage, multicenter, randomized clinical trial. Patients and Intervention Three hundred seven women with urge-predominant UI were randomly assigned to receive either 10 weeks of drug therapy only or 10 weeks of drug therapy combined with a behavioral intervention for UI. One hundred fifty-four participants who received the combined intervention were included in this analysis. Measurements Pelvic-floor muscle exercise adherence and exercise barriers were assessed during the intervention phase and 1 year afterward. Adherence to UI prevention strategies and delayed voiding were assessed during the intervention only. Results During intervention, 81% of women exercised at least 5 to 6 days per week, and 87% performed at least 30 PFM contractions per day. Ninety-two percent of the women used the urge suppression strategy successfully. At the 12-month follow-up, only 32% of the women exercised at least 5 to 6 days per week, and 56% performed 15 or more PFM contractions on the days they exercised. The most persistent PFM exercise barriers were difficulty remembering to exercise and finding time to exercise. Similarly, difficulty finding time to exercise persisted as a predictor of PFM exercise adherence over time. Limitations Co-administration of medication for UI may have influenced adherence. Conclusions Most women adhered to exercise during supervised intervention; however, adherence declined over the long term. Interventions to help women remember to exercise and to integrate PFM exercises and UI prevention strategies into daily life may be useful to promote long-term adherence.

Continence and Quality-of-Life Outcomes 6 Months Following an Intensive Pelvic-Floor Muscle Exercise Program for Female Stress Urinary Incontinence: A Randomized Trial Comparing Low- and High-Frequency Maintenance Exercise

Background and Objectives: Few studies have examined the effectiveness of pelvic-floor muscle (PFM) exercises to reduce female stress urinary incontinence (SUI) over the long term. This study: (1) evaluated continence and quality-of-life outcomes of women 6 months following formalized therapy and (2) determined whether low- and high-frequency maintenance exercise programs were equivalent in sustaining outcomes. Subjects and Methods: Thirty-six women with SUI who completed an intensive PFM exercise intervention trial were randomly assigned to perform a maintenance exercise program either 1 or 4 times per week. Urine leaks per week, volume of urine loss, quality of life (Incontinence Impact Questionnaire [IIQ] score), PFM strength (Brink score), and prevalence of urodynamic stress incontinence (USI) were measured at a 6-month follow-up for comparison with postintervention status. Parametric and nonparametric statistics were used to determine differences in outcome status over time and between exercise frequency groups. Results: Twenty-eight women provided follow-up data. Postintervention status was sustained at 6 months for all outcomes (mean [SD] urine leaks per week=1.2±2.1 versus 1.4±3.1; mean [SD] urine loss=0.2±0.5 g versus 0.2±0.8 g; mean [SD] IIQ score=17±20 versus 22±30; mean [SD] Brink score=11±1 versus 11±1; and prevalence of USI=48% versus 35%). Women assigned to perform exercises once or 4 times per week similarly sustained their postintervention status. Discussion and Conclusions: Benefits of an initial intensive intervention program for SUI were sustained over 6 months. However, only 15 of the 28 women provided documentation of their exercise adherence, limiting conclusions regarding the need for continued PFM exercise during follow-up intervals of ≤6 months.

Functional reach and single leg stance in patients with peripheral vestibular disorders.

The purpose of this study was to compare functional reach distance and right single leg stance time in patients who had peripheral vestibular disease. Twenty-eight patients (15 female, 13 male) between the ages of 35 and 84 were asked to perform 3 trials each of functional reach (FR) and right single leg stance (SLS). SLS times were measured by a Kistler static force platform on line with a Caspar personal computer. FR distance was measured by using a free-standing 147-cm rule. In addition, each subject filled out the Dizziness Handicap Inventory (DHI). Trials were randomized to prevent fatigue or practice effects. A Pearson product-moment correlation was performed between FR and SLS (r = 0.59, P = 0.001). Post hoc analyses of the first, the best, and the average scores highlighted the importance of using means for comparison in a population as variable as the vestibularly impaired. Post hoc analyses showed no correlation between the DHI score and either functional reach distance or single leg stance time. However, when the subjects were divided into groups based on DHI score (group 1 with DHI or = 50/100) and a pooled two-sample t-test was performed, a significant difference (P = 0.05) was found in functional reach distance; the subjects who reported less perception of handicap reached farther than those who reported more perception of handicap. No difference was found between the two DHI groups in single leg stance time. Post hoc correlations of functional reach and single leg stance time. Post hoc correlations of functional reach and single leg stance within the two DHI groups showed a higher correlation in group 1 (DHI or = 50/100), with r equals 0.38 (P = 0.20). The study found a highly significant, moderate correlation between functional reach distance and single leg stance times in patients with peripheral vestibular disease. These results support the use of FR as an additional assessment tool with patients who have peripheral vestibular disease.