Adherence to Perioperative Behavioral Therapy With Pelvic Floor Muscle Training in Women Receiving Vaginal Reconstructive Surgery for Pelvic Organ Prolapse.

OBJECTIVE: The objective of this study was to describe adherence to behavioral and pelvic floor muscle training in women undergoing vaginal reconstructive surgery for organ prolapse and to examine whether adherence was associated with 24-month outcomes. METHODS: Participants were women ≥18 years of age, with vaginal bulge and stress urinary incontinence symptoms, planning to undergo vaginal reconstructive surgery for stages 2 to 4 vaginal or uterine prolapse. They were randomized to either sacrospinous ligament fixation or uterosacral ligament suspension and to perioperative behavioral and pelvic floor muscle training or usual care. Measurements included anatomic failure, pelvic floor muscle strength, participant-reported symptoms, and perceived improvement. Analyses compared women with lower versus higher adherence. RESULTS: Forty-eight percent of women performed pelvic floor muscle exercises (PFMEs) daily at the 4- to 6-week visit. Only 33% performed the prescribed number of muscle contractions. At 8 weeks, 37% performed PFMEs daily, and 28% performed the prescribed number of contractions. No significant relationships were found between adherence and 24-month outcomes. CONCLUSION: Adherence to a behavioral intervention was low following vaginal reconstructive surgery for pelvic organ prolapse. The degree of adherence to perioperative training did not appear to influence 24-month outcomes in women undergoing vaginal prolapse surgery. IMPACT: This study contributes to the understanding of participant adherence to PFMEs and the impact that participant adherence has on outcomes at 2, 4 to 6, 8, and 12 weeks and 24 months postoperatively. It is important to educate women to follow up with their therapist or physician to report new or unresolved pelvic symptoms.

Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.

OBJECTIVE: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence. METHODS: Four-hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) compared with midurethral sling alone for mixed incontinence with 1-year follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective or objective failure or both. Subjective failure was defined as not meeting the minimal clinical important difference for improvement on the UDI (Urogenital Distress Inventory) total score (26.1 points). Objective failure was defined as not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for persistent urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated. RESULTS: One hundred twelve of 379 (29.6%) women had overall treatment failure, with 56 of 379 (14.7%) undergoing additional treatment but only two needing intervention for stress incontinence. Previous overactive bladder (OAB) medication (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.96, 95% CI 1.17-3.31); detrusor overactivity on cystometrogram (OR 2.25, aOR 2.82, 95% CI 1.60-4.97); and higher volume at first urge (OR 1.03, aOR 1.04, 95% CI 1.01-1.07) were associated with overall failure. Worse UDI-urgency scores were associated with failure, with an added interaction effect in the midurethral sling-alone group. CONCLUSIONS: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling in women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. Overall, the need for additional urinary treatment was low and primarily for OAB. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01959347.

Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.

OBJECTIVE: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence. METHODS: Four hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone for mixed incontinence with 1 year of follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective failure, objective failure, or both. Subjective failure was defined as not meeting the minimal clinically important difference for improvement on the UDI (Urogenital Distress Inventory)-total score (26.1 points). Objective failure was not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated. RESULTS: Previous overactive bladder medication use (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.89, 95% CI 1.10-3.25), detrusor overactivity on cystometrogram (OR 2.25, aOR 2.72, 95% CI 1.53-4.84), body mass index (OR 1.29, aOR 1.27, 95% CI 1.03-1.57), and Valsalva leak point pressure less than 60 cm H2O (OR 1.96, aOR 3.13, 95% CI 1.65-5.94) were associated with overall failure. Worse UDI urgency scores were associated with failure in the midurethral sling-alone group. Sling type (retropubic vs transobturator) was not associated with failure. CONCLUSION: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. This information is helpful for counseling women with mixed incontinence who are considering surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01959347.

Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial.

Importance: Mixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman's quality of life. Studies evaluating treatments to simultaneously improve both components are lacking. Objective: To determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms. Design, Setting, and Participants: Randomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017. Interventions: Behavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207). Main Outcomes and Measures: The primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms. Results: Among 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change -128.1 points (95% CI, -146.5 to -109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2). The model-estimated between-group difference (-13.4 points; 95% CI, -25.9 to -1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only). Conclusions and Relevance: Among women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance. Trial Registration: ClinicalTrials.gov Identifier: NCT01959347.

Structured behavioral treatment research protocol for women with mixed urinary incontinence and overactive bladder symptoms.

AIMS: The primary aim is to provide detailed rationale and methodology for the development and implementation of a perioperative behavioral/pelvic floor exercise research protocol for women who self-chose surgical intervention and who may or may not have been offered behavioral treatments initially. This protocol is part of the ESTEEM trial (Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence Trial) which was designed to determine the effect of a combined surgical and perioperative behavioral/pelvic floor exercise intervention versus surgery alone on improving mixed urinary incontinence (MUI) and overactive bladder (OAB) symptoms. METHODS: As part of a multi-site, prospective, randomized trial of women with MUI electing midurethral sling (MUS) surgical treatment, participants were randomized to a standardized perioperative behavioral/pelvic floor exercise intervention + MUS versus MUS alone. The specific behavioral intervention included: education on voiding habits, pelvic floor muscle training (PFMT), bladder training (BT), strategies to control urgency and reduce/prevent urinary symptoms, and monitoring/promoting adherence to behavioral recommendations. To ensure consistency across all eight research sites in the pelvic floor disorders network (PFDN), selective behavioral treatments sessions were audiotaped and audited for protocol adherence. RESULTS: The behavioral intervention protocol includes individualization of interventions using an algorithm based on pelvic floor muscle (PFM) assessment, participant symptoms, and findings from the study visits. We present, here, the specific perioperative behavioral/pelvic floor exercise interventions administered by study interventionists. CONCLUSIONS: This paper details a perioperative behavioral/pelvic floor exercise intervention research study protocol developed for women undergoing surgery for MUI.

Perspective on Physical Therapist Management of Functional Constipation.

Functional constipation is a common bowel disorder leading to activity restrictions and reduced health-related quality of life. Typically, this condition is initially managed with prescription of laxatives or fiber supplementation, or both. However, these interventions are often ineffective and fail to address the underlying pathophysiology and impairments contributing to this condition. Physical therapists possess the knowledge and skills to diagnose and manage a wide range of musculoskeletal and motor coordination impairments that may contribute to functional constipation. Relevant anatomic, physiologic, and behavioral contributors to functional constipation are discussed with regard to specific constipation diagnoses. A framework for physical therapist examination of impairments that can affect gastrointestinal function, including postural, respiratory, musculoskeletal, neuromuscular, and behavioral impairments, is offered. Within the context of diagnosis-specific patient cases, multifaceted interventions are described as they relate to impairments underlying functional constipation type. The current state of evidence to support these interventions and patient recommendations is summarized. This perspective article aims not only to heighten physical therapists' awareness and management of this condition, but also to stimulate clinical questioning that will open avenues for future research to improve patient care.

Movement System Impairment-Guided Approach to the Physical Therapist Treatment of a Patient With Postpartum Pelvic Organ Prolapse and Mixed Urinary Incontinence: Case Report.

Background and Purpose: Women with postpartum pelvic organ prolapse (POP) and urinary incontinence are often treated by physical therapists specializing in women's health. Movement system impairments often coexist in this patient population. The purpose of this case report is to describe the physical therapist treatment of a woman with postpartum POP complicated by additional pelvic symptoms. Case Description: A 31-year-old woman presented with postpartum POP, diastasis recti, urinary incontinence, and constipation. Movement system impairments were consistent with a physical therapist diagnosis of femoral adduction-medial rotation syndrome exacerbated by levator ani muscle weakness and incoordination and impaired intra-abdominal pressure regulation. Interventions, based on a movement system guided approach, included postural correction; pelvic-floor, abdominal, and hip muscle strengthening; functional training to correct identified movement faults; and patient education. Outcomes: Movement system impairment outcomes included: correction of femoral adduction-medial rotation and knee hyperextension during standing at rest, ambulation, and exercise; increased hip muscle strength; and effective regulation of intra-abdominal pressure (resolution of breath holding with the Valsalva maneuver) during all transitional movements and therapeutic exercise. The patient also demonstrated reductions in POP, urinary, and colorectal symptom severity that exceeded the minimal clinically important difference. Additionally, she demonstrated a reduction in diastasis rectus distance. Discussion: A movement system impairment-guided approach led the physical therapist to consider impairments outside the pelvic floor that could have contributed to the patient's pelvic symptoms. Using this approach, the patient achieved resolution of musculoskeletal and movement impairments and reductions in POP, urinary and colorectal symptoms, and symptom-related distress.

Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial.

INTRODUCTION AND HYPOTHESIS: Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. METHODS: ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment. RESULTS: The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized. CONCLUSIONS: We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.

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.

Adherence to behavioral interventions for stress incontinence: rates, barriers, and predictors.

BACKGROUND: First-line conservative treatment for stress urinary incontinence (SUI) in women is behavioral intervention, including pelvic-floor muscle (PFM) exercise and bladder control strategies. OBJECTIVE: The purposes of this study were: (1) to describe adherence and barriers to exercise and bladder control strategy adherence and (2) to identify predictors of exercise adherence. DESIGN: This study was a planned secondary analysis of data from a multisite, randomized trial comparing intravaginal continence pessary, multicomponent behavioral therapy, and combined therapy in women with stress-predominant urinary incontinence (UI). METHODS: Data were analyzed from the groups who received behavioral intervention alone (n=146) or combined with continence pessary therapy (n=150). Adherence was measured during supervised treatment and at 3, 6, and 12 months post-randomization. Barriers to adherence were surveyed during treatment and at the 3-month time point. Regression analyses were performed to identify predictors of exercise adherence during supervised treatment and at the 3- and 12-month time points. RESULTS: During supervised treatment, ≥86% of the women exercised ≥5 days a week, and ≥80% performed at least 30 contractions on days they exercised. At 3, 6, and 12 months post-randomization, 95%, 88%, and 80% of women, respectively, indicated they were still performing PFM exercises. During supervised treatment and at 3 months post-randomization, ≥87% of the women reported using learned bladder control strategies to prevent SUI. In addition, the majority endorsed at least one barrier to PFM exercise, most commonly "trouble remembering to do exercises." Predictors of exercise adherence changed over time. During supervised intervention, less frequent baseline UI and higher baseline 36-Item Short-Form Health Survey (SF-36) mental scores predicted exercise adherence. At 3 months post-randomization, women who dropped out of the study had weaker PFMs at baseline. At 12 months post-randomization, only "trouble remembering" was associated with exercise adherence. LIMITATIONS: Adherence and barrier questionnaires were not validated. CONCLUSIONS: Adherence to PFM exercises and bladder control strategies for SUI can be high and sustained over time. However, behavioral interventions to help women link exercise to environmental and behavioral cues may only be beneficial over the short term.

Physical therapy management of female chronic pelvic pain: Anatomic considerations.

The multisystem nature of female chronic pelvic pain (CPP) makes this condition a challenge for physical therapists and other health care providers to manage. This article uses a case scenario to illustrate commonly reported somatic, visceral, and neurologic symptoms and their associated health and participation impact in a female with CPP. Differential diagnosis of pain generators requires an in-depth understanding of possible anatomic and physiologic contributors to this disorder. This article provides a detailed discussion of the relevant clinical anatomy with specific attention to complex interrelationships between anatomic structures potentially leading to the patient's pain. In addition, it describes the physical therapy management specific to this case, including examination, differential diagnosis, and progression of interventions.

Predictors of success and satisfaction of nonsurgical therapy for stress urinary incontinence.

OBJECTIVE: To identify factors that may predict success and satisfaction in women undergoing nonsurgical therapy for stress urinary incontinence. METHODS: Baseline demographic and clinical characteristics of women participating in a multicenter randomized trial of pessary, behavioral, or combined therapy for stress urinary incontinence were evaluated for potential predictors of success and satisfaction. Success and satisfaction outcomes were assessed at 3 months and included the Patient Global Impression of Improvement, stress incontinence subscale of the Pelvic Floor Distress Inventory, and Patient Satisfaction Questionnaire. Logistic regression was performed to identify predictors, adjusting for treatment and other important clinical covariates. Adjusted odds ratios (ORs), 95% confidence intervals (CIs), and associated P values are presented. RESULTS: Four hundred forty-six women were randomized. College education or more and no previous urinary incontinence surgery predicted success based on the stress subscale of the Pelvic Floor Distress Inventory (adjusted OR 1.61, 95% CI 1.01-2.55, P=.04 and adjusted OR 3.15, 95% CI 1.04- 9.53, P=.04, respectively). Menopausal status predicted success using the Patient Global Impression of Improvement (adjusted OR 2.52 postmenopausal compared with premenopausal, 95% CI 1.29-4.95; adjusted OR 1.32 unsure menopausal status compared with premenopausal, 95% CI 0.65-2.66; P=.03 across all three groups). Fewer than 14 incontinence episodes per week predicted satisfaction with the Patient Satisfaction Questionnaire (adjusted OR 1.97, 95% CI 1.21-3.19; P=.01). These predictors did not differ across the three treatment groups. CONCLUSION: Menopause, higher education, no previous urinary incontinence surgery, and lower incontinence frequency were found to be predictors of success and satisfaction with nonsurgical therapy for stress urinary incontinence. This information may help better-align provider and patient expectations with nonsurgical treatment outcomes.

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.

The effects of drug and behavior therapy on urgency and voiding frequency.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to examine the effects of drug therapy alone and combined with behavioral therapy on urgency and 24-voiding frequency in women with urge-predominant incontinence and to identify predictors of change. METHODS: A planned analysis of data from a multi-site, randomized, controlled trial (N = 307). Bladder diaries were used to document voids, incontinence, and urgency severity. RESULTS: Urgency scores decreased significantly within both treatment groups, but changes did not differ between groups (p = 0.30). Improvement in urgency was associated with greater baseline urgency (p < 0.0001) and black ethnicity (p = 0.03). Voiding frequency increased with drug alone and decreased slightly with combined therapy (p = 0.009), and improvement was associated with combined treatment (p < 0.0001), higher baseline frequency (p < 0.0001), and lower baseline incontinence episode frequency (p = 0.001). CONCLUSIONS: Although combined drug and behavioral therapy does not appear to improve urgency more than drug alone, it resulted in better outcomes on voiding frequency.

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.

Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: design and methods.

The primary aims of this trial are: 1) to compare surgical outcomes following sacrospinous ligament fixation to uterosacral vaginal vault suspension in women undergoing vaginal surgery for apical or uterine pelvic organ prolapse and stress urinary incontinence and 2) to examine the effects of a structured perioperative program consisting of behavioral techniques and pelvic floor muscle training compared to usual care. This trial is performed through the Pelvic Floor Disorders Network (PFDN), which is funded by National Institute of Child Health and Human Development. Subjects will be enrolled from hospitals associated with seven PFDN clinical centers across the United States. A centralized biostatistical coordinating center will oversee data collection and analysis. Two approaches will be investigated simultaneously using a 2x2 randomized factorial design: a surgical intervention (sacrospinous ligament fixation versus uterosacral vaginal vault suspension) and a perioperative behavioral intervention (behavioral and pelvic floor muscle training versus usual care). Surgeons have standardized essential components of each surgical procedure and have met specific standards of expertise. Providers of the behavioral intervention have undergone standardized training. Anatomic, functional, and health-related quality of life outcomes will be assessed using validated measures by researchers blinded to all randomization assignments. Cost-effectiveness analysis will be performed using prospectively collected data on health care costs and resource utilization. The primary surgical endpoint is a composite outcome defined by anatomic recurrence, recurrence of bothersome vaginal prolapse symptoms and/or retreatment and will be assessed 2 years after the index surgery. Endpoints for the behavioral intervention include both short-term (6-month) improvement in urinary symptoms and long-term (2-year) improvement in anatomic outcomes and prolapse symptoms. This article describes the rationale and design of this randomized trial, focusing on several key design features of potential interest to researchers in the field of female pelvic floor disorders and others conducting randomized surgical trials.

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 CONCLUSION: 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

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.

Changes in physical activity after abdominal sacrocolpopexy for advanced pelvic organ prolapse.

OBJECTIVE: The objective of the study was to describe changes in physical activity 1 year after sacrocolpopexy for pelvic organ prolapse. STUDY DESIGN: This was a prospective cohort of 301 randomized trial participants. RESULTS: Compared with baseline, 1 year after surgery, 36% increased, 18% decreased, and 47% did not change preoperative exercise intensity level. In contrast, women were more likely to reduce (24%) than increase (11%) the frequency of major effort activities, like heavy lifting. Of 99 women who reported preoperatively that prolapse interfered substantially with doing exercise or recreation, house/yard work, or work outside the home, 83 (84%) reported no substantial interference 1 year later. After surgery, women reporting substantial interference from prolapse or treatment had similar rates of interval treatment for stress incontinence or prolapse as women not reporting substantial interference. CONCLUSION: After sacrocolpopexy, one third of women increased exercise intensity, few increased major effort activities, and most reported that prolapse no longer interfered with activities.