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Gynecological Pelvic Floor Muscle Training

Primary Purpose

Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Training
Usual Care
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence focused on measuring Training, Physiotherapy, Pelvic floor muscles

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Women's Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Training

Usual Care Control

Arm Description

Pelvic floor muscle training delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 12, 2013
Last Updated
April 10, 2015
Sponsor
University of British Columbia
Collaborators
British Columbia Cancer Agency
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1. Study Identification

Unique Protocol Identification Number
NCT01811602
Brief Title
Gynecological Pelvic Floor Muscle Training
Official Title
The Efficacy of Pelvic Floor Muscle Training in Gynecological Cancer Survivors: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
British Columbia Cancer Agency

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Training, Physiotherapy, Pelvic floor muscles

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training
Arm Type
Other
Arm Description
Pelvic floor muscle training delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction
Arm Title
Usual Care Control
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Training
Other Intervention Name(s)
Pelvic Floor Muscle Training
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Educational pamphlet
Intervention 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.
Primary Outcome Measure Information:
Title
Urinary incontinence
Description
Urinary incontinence, measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI Short Form) and bladder diary
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Campbell, PhD
Phone
604-827-4704
Email
kristin.campbell@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Finlayson
Phone
604-877-6000
Ext
2367
Email
Sarah.Finlayson@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Campbell, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Health Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pat Lieblich, PT
Email
plieblich@cw.bc.ca

12. IPD Sharing Statement

Learn more about this trial

Gynecological Pelvic Floor Muscle Training

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