Gynecological Pelvic Floor Muscle Training

Study Overview
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Brief Summary
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A randomized controlled trial pilot study to test the efficacy of a pelvic muscular training intervention led by a physiotherapist on urinary incontinence, quality of life and sexual health in women who report urinary urgency and incontinence following surgery and radiation treatment for gynecological cancer vs. usual care (a 1-page sheet on Kegel exercises).

Official Title
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The Efficacy of Pelvic Floor Muscle Training in Gynecological Cancer Survivors: A Pilot Study

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Other: Training
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - treated with surgery and adjuvant treatment, including radiation, for gynecological cancer within the last 3 years Exclusion Criteria: stage IV cancer or stage III and IV cervical cancer radiation not part of treatment known spinal or long bone metastases diagnosis with a neuromuscular disorder that may impact pelvic floor muscle function urinary incontinence issues prior to cancer diagnosis scheduled or previous surgical treatment of incontinence fecal incontinence body mass index (BMI) > 35 use of medications to improve bladder function unable to complete questionnaires in English or unable to actively participate in physiotherapy treatment provided in English.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Training<br>Pelvic floor muscle training delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction | Other: Training<br>* The participants randomized to the pelvic floor muscle training intervention will receive pelvic floor muscle training (0-12 weeks) delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction. The intervention is 9 individual, one-on-one, 45-minute sessions; weekly for weeks 0-6 and bi-weekly for weeks 7-12 (first session will be 60 minutes). The sessions will provide pelvic floor muscle training based on the latest evidence, including biofeedback, to teach the correct technique for pelvic floor contractions, and participants will be asked to complete daily pelvic floor exercises at home.<br>* Other names: Pelvic Floor Muscle Training;|
| Other: Usual Care Control<br>Participants randomized to this arm will receive a 1-page educational pamphlet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures. | Other: Usual Care<br>* The participants randomized to the educational pamphlet intervention (usual care control) will receive a 1-page sheet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures.<br>* Other names: Educational pamphlet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary incontinence | Urinary incontinence, measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI Short Form) and bladder diary | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Training, Physiotherapy, Pelvic floor muscles