Gynecological Pelvic Floor Muscle Training

NCT01811602 | Unknown

• 2 other identifiers: H12-02473F12-00262
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Training; Physiotherapy; Pelvic floor muscles

Outcome Measures

Primary Outcomes (1)

• Urinary incontinence

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

  12 weeks

Study Arms (2)

Training

OTHER

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

Other: Training

Usual Care Control

OTHER

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

Interventions

Training OTHER

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.

Also known as: Pelvic Floor Muscle Training

Training

Usual Care OTHER

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.

Also known as: Educational pamphlet

Usual Care Control

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- treated with surgery and adjuvant treatment, including radiation, for gynecological cancer within the last 3 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• British Columbia Cancer Agency: collaborator

Study Sites (1)

Women's Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristin Campbell, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Campbell, PhD

CONTACT

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

Sarah Finlayson

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 14, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

CA (1)