Gynecological Pelvic Floor Muscle Training

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of British Columbia
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01811602
First received: March 12, 2013
Last updated: February 4, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Urinary Incontinence
Other: Training
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Efficacy of Pelvic Floor Muscle Training in Gynecological Cancer Survivors: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Urinary incontinence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Urinary incontinence, measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI Short Form) and bladder diary


Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Training
Pelvic floor muscle training delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction
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.
Other Name: Pelvic Floor Muscle Training
Usual Care Control
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.
Other: 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.
Other Name: Educational pamphlet

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811602

Contacts
Contact: Kristin Campbell, PhD 604-827-4704 kristin.campbell@ubc.ca
Contact: Sarah Finlayson 604-877-6000 ext 2367 Sarah.Finlayson@vch.ca

Locations
Canada, British Columbia
Women's Health Centre Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: Pat Lieblich, PT       plieblich@cw.bc.ca   
Sponsors and Collaborators
University of British Columbia
British Columbia Cancer Agency
Investigators
Principal Investigator: Kristin Campbell, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01811602     History of Changes
Other Study ID Numbers: H12-02473, F12-00262
Study First Received: March 12, 2013
Last Updated: February 4, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Training
Physiotherapy
Pelvic floor muscles

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014