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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

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