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Enhancing behavioral treatment for women with pelvic floor disorders: Study protocol for a pilot randomized controlled trial.

ABSTRACT: Approximately one in four American women report bothersome urinary symptoms (e.g., urgency, frequency), which greatly impact quality of life, including mental health. Bidirectional relationships have been found between urinary symptoms and anxiety, such that urinary symptoms worsen emotional distress (i.e., anxiety and depression), and in turn anxiety can exacerbate these symptoms. Current methods to treat urinary symptoms, such as physical therapy and medications, do not address their emotional impact. As such, our multidisciplinary team is conducting a randomized control trial (RCT) of cognitive-behavior therapy (CBT) using the Unified Protocol (UP) versus supportive therapy in the context of integrated behavioral treatment in the urogynecology context. Women with bothersome urinary symptoms and anxiety are recruited from the Northwestern Medicine Integrated Pelvic Health Program (IPHP) -a transdisciplinary clinic including urogynecologists, urologists, colorectal surgeons, nurses, and physical therapists- and Northwestern Medicine Urology. Participants are randomized to one of two interventions: UP or supportive therapy. All participants attend therapy once per week for 12 weeks. Assessments of urinary symptoms, anxiety, and other indicators of psychological and physical functioning are completed at baseline, mid-treatment, post-treatment, and at 3- and 6-month follow-ups using patient-reported outcomes. The study has been preregistered on clinicaltrails.gov (ID: NCT03623880) and is currently ongoing.

SUBMITTER: Taple BJ

PROVIDER: S-EPMC6962649 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Enhancing behavioral treatment for women with pelvic floor disorders: Study protocol for a pilot randomized controlled trial.

Taple Bayley J BJ Griffith James W JW Weaver Claire C Kenton Kimberly S KS

Contemporary clinical trials communications 20200103

Approximately one in four American women report bothersome urinary symptoms (e.g., urgency, frequency), which greatly impact quality of life, including mental health. Bidirectional relationships have been found between urinary symptoms and anxiety, such that urinary symptoms worsen emotional distress (i.e., anxiety and depression), and in turn anxiety can exacerbate these symptoms. Current methods to treat urinary symptoms, such as physical therapy and medications, do not address their emotional ...[more]

PMID: 31956723

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Project description:BackgroundThere is a risk of pelvic floor dysfunction (PFD) from baby delivery. Many clinical guidelines recommend pelvic floor muscle training (PFMT) as the conservative treatment for PFD because pelvic floor muscles (PFMs) play a crucial role in development of PFD. However, there is disagreement about the method and intensity of PFM training and the relevant measurements. To pilot the study in PFM training, we designed a Pelvic Floor Workout (PEFLOW) for women to train their pelvic through entire body exercises, and we planned a trial to evaluate its effectiveness through comparing the outcomes from a group of postpartum women who perform PELFLOW at home under professional guidance online with the control group.Methods/designThe randomized controlled trial was projected to be conducted from November 2021 to March 2023. A total of 260 postpartum women would be recruited from the obstetrics departments of the study hospital and women would be eligible for participation randomized into experimental or control groups (EG/CG) if their PFM strength are scaled by less than Modified Oxford grading Scale (MOS) to be less than grade 3. Women in EG would perform a 12-week PEFLOW online under the supervision and guidance of a physiotherapist, while women in CG would have no interventions. Assessments would be conducted at enrollment, post intervention (for EG) or 18th to 24th week postpartum (for CG), and 1 year postpartum. Assessment would be performed in terms of pelvic floor symptoms, including MOS, cough stress test, urinary leakage symptoms, pelvic organ prolapse quantitation (POP-Q), and vaginal relaxation, clinic examinations including Pelvic floor electrophysiological test, Pelvic floor ultrasound and Spine X-ray, overall body test including trunk endurance test, handgrip test, body composition test, and questionnaires including International Physical Activity Questionnaire Score-Short Form(IPAQ-SF), Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20), Pelvic Floor Impact Questionnaire-7 (PFIQ-7), the 6-item Female Sexual Function Index (FSFI-6), and the Pittsburgh Sleep Quality Index (PSQI). Primary analysis will be performed to test our main hypothesis that PEFLOW is effective with respect to strengthen PFM strength.DiscussionThis trial will demonstrate that pelvic floor-care is accessible to most women and clinical practice on PFD may change relevantly should this study find that Online PEFLOW approach is effective to improve PFMs.Trial registrationClinicalTrials.gov, NCT05218239.

Project description:Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with urinary incontinence and has a significant negative impact on quality of life. Pelvic floor exercises are the most common non-invasive management strategy for urinary incontinence following radical prostatectomy; however, studies provide inconsistent findings regarding their efficacy. One potential reason for sub-optimal efficacy of these interventions is the under-utilization of regional muscles that normally co-activate with the pelvic floor, such as the transverse abdominis, rectus abdominis, and the diaphragm. Two novel approaches to improve urinary continence recovery are 'Pfilates' and 'Hypopressives' that combine traditional pelvic floor exercises with the activation of additional supportive muscles. Our study will compare an advanced pelvic floor exercise training program that includes Pfilates and Hypopressives, to a conventional pelvic floor exercises regimen for the treatment of post-radical prostatectomy urinary incontinence.This is a pilot, randomized controlled trial of advanced pelvic floor muscle training versus conventional pelvic floor exercises for men with localized prostate cancer undergoing radical prostatectomy. Eighty-eight men who will be undergoing radical prostatectomy at hospitals in Toronto, Canada will be recruited. Eligible participants must not have undergone androgen deprivation therapy and/or radiation therapy. Participants will be randomized 1:1 to receive 26 weeks of the advanced or conventional pelvic floor exercise programs. Each program will be progressive and have comparable exercise volume. The primary outcomes are related to feasibility for a large, adequately powered randomized controlled trial to determine efficacy for the treatment of urinary incontinence. Feasibility will be assessed via recruitment success, participant retention, outcome capture, intervention adherence, and prevalence of adverse events. Secondary outcomes of intervention efficacy include measures of pelvic floor strength, urinary incontinence, erectile function, and quality of life. Secondary outcome measures will be collected prior to surgery (baseline), and at 2, 6, 12, 26-weeks post-operatively.Pfilates and Hypopressives are novel approaches to optimizing urinary function after radical prostatectomy. This trial will provide the foundation of data for future, large-scale trials to definitively describe the effect of these advanced pelvic floor exercise modalities compared to conventional pelvic floor exercise regimes for men with prostate cancer undergoing radical prostatectomyClinicalstrials.gov Identifier: NCT02233608.

Project description:Although behavioral therapy has been shown to improve postoperative recovery of continence, there have been no controlled trials of behavioral therapy for postprostatectomy incontinence persisting more than 1 year.To evaluate the effectiveness of behavioral therapy for reducing persistent postprostatectomy incontinence and to determine whether the technologies of biofeedback and pelvic floor electrical stimulation enhance the effectiveness of behavioral therapy.A prospective randomized controlled trial involving 208 community-dwelling men aged 51 through 84 years with incontinence persisting 1 to 17 years after radical prostatectomy was conducted at a university and 2 Veterans Affairs continence clinics (2003-2008) and included a 1-year follow-up after active treatment. Twenty-four percent of the men were African American; 75%, white.After stratification by type and frequency of incontinence, participants were randomized to 1 of 3 groups: 8 weeks of behavioral therapy (pelvic floor muscle training and bladder control strategies); behavioral therapy plus in-office, dual-channel electromyograph biofeedback and daily home pelvic floor electrical stimulation at 20 Hz, current up to 100 mA (behavior plus); or delayed treatment, which served as the control group.Percentage reduction in mean number of incontinence episodes after 8 weeks of treatment as documented in 7-day bladder diaries.Mean incontinence episodes decreased from 28 to 13 per week (55% reduction; 95% confidence interval [CI], 44%-66%) after behavioral therapy and from 26 to 12 (51% reduction; 95% CI, 37%-65%) after behavior plus therapy. Both reductions were significantly greater than the reduction from 25 to 21 (24% reduction; 95% CI, 10%-39%) observed among controls (P = .001 for both treatment groups). However, there was no significant difference in incontinence reduction between the treatment groups (P = .69). Improvements were durable to 12 months in the active treatment groups: 50% reduction (95% CI, 39.8%-61.1%; 13.5 episodes per week) in the behavioral group and 59% reduction (95% CI, 45.0%-73.1%; 9.1 episodes per week) in the behavior plus group (P = .32).Among patients with postprostatectomy incontinence for at least 1 year, 8 weeks of behavioral therapy, compared with a delayed-treatment control, resulted in fewer incontinence episodes. The addition of biofeedback and pelvic floor electrical stimulation did not result in greater effectiveness.clinicaltrials.gov Identifier: NCT00212264.

Dataset Information

Enhancing behavioral treatment for women with pelvic floor disorders: Study protocol for a pilot randomized controlled trial.

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Enhancing behavioral treatment for women with pelvic floor disorders: Study protocol for a pilot randomized controlled trial.

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