Gynecological Pelvic Floor Muscle Training

Not Applicable

• Conditions: Urinary Incontinence
• Interventions: Other: Usual Care; Other: Training

• Registration Number: NCT01811602
• Lead Sponsor: University of British Columbia

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-14
• Study Start: 2013-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-10
• Last Update Posted: 2015-04-13
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• treated with surgery and adjuvant treatment, including radiation, for gynecological cancer within the last 3 years

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Control	Usual Care	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.
Training	Training	Pelvic floor muscle training delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction

Primary Outcome Measures

Name	Time	Method
Urinary incontinence	12 weeks	Urinary incontinence, measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI Short Form) and bladder diary

Trial Locations

Locations (1)

Women's Health Centre; 🇨🇦 Vancouver, British Columbia, Canada