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Trial Title:
Gynecological Pelvic Floor Muscle Training
NCT ID:
NCT01811602
Condition:
Urinary Incontinence
Conditions: Official terms:
Urinary Incontinence
Conditions: Keywords:
Training
Physiotherapy
Pelvic floor muscles
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Training
Description:
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.
Arm group label:
Training
Other name:
Pelvic Floor Muscle Training
Intervention type:
Other
Intervention name:
Usual Care
Description:
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.
Arm group label:
Usual Care Control
Other name:
Educational pamphlet
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).
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
19 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Women's Health Centre
Address:
City:
Vancouver
Zip:
V6H 3N1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Pat Lieblich, PT
Email:
plieblich@cw.bc.ca
Start date:
December 2013
Completion date:
August 2016
Lead sponsor:
Agency:
University of British Columbia
Agency class:
Other
Collaborator:
Agency:
British Columbia Cancer Agency
Agency class:
Other
Source:
University of British Columbia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01811602
