Gynecological Pelvic Floor Muscle Training

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01811602
• Other study ID #: H12-02473
• Secondary ID: F12-00262
• Status: Recruiting
• Phase: N/A
• First received: March 12, 2013
• Last updated: April 10, 2015
• Start date: December 2013
• Est. completion date: August 2016

Study information

• Verified date: April 2015
• Source: University of British Columbia
• Contact: Kristin Campbell, PhD
• Phone: 604-827-4704
• Email: kristin.campbell[@]ubc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Other:
• Training
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.
• Usual Care
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.

Locations

Country	Name	City	State
Canada	Women's Health Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary incontinence	Urinary incontinence, measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI Short Form) and bladder diary	12 weeks	No