Recruiting

Pelvic Floor Training

Sponsor:

University of British Columbia

Code:

NCT01811602

Conditions

Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 19 - 65

Healthy Volunteers: Not accepted

Interventions

Training

Usual Care

Study Details

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).

Conditions

Urinary Incontinence

Study ID

NCT01811602

Start date

Dec, 2013

Status verified date

Apr, 2015

Completion date

Aug, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 65

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Training

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

other: 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.

Interventions

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.

Primary outcome measure

  • Urinary incontinence [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Kristin Campbell, PhD

604-827-4704kristin.campbell@ubc.ca

Sarah Finlayson

604-877-6000Sarah.Finlayson@vch.ca

Locations

Women's Health Centre

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Pat Lieblich, PT

plieblich@cw.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Apr 13, 2015

Last verified

Apr, 2015

Keywords

  • Training
  • Physiotherapy
  • Pelvic floor muscles

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2015-04-13.