Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence

November 1, 2023 updated by: Mélanie Morin, Université de Sherbrooke

Pilot Study Examining Feasibility and Effects of Physiotherapy Treatment Compared to Standard Usual Care in Gynecological Cancer Survivors With Urinary Incontinence

The aims of this pilot study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence in preparation of a large randomized controlled study.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Epidemiological studies demonstrated a growing number of gynecological cancer survivors, and this population is at great risk of developing pelvic floor dysfunction after cancer and its treatment. Representing the most prevalent pelvic floor dysfunction, urinary incontinence affects up to 70% of gynecological cancer survivors. International practice guidelines, in line with available meta-analysis, recommend physiotherapy as a first-line treatment to reduce urinary incontinence. However, there is limited evidence on its effectiveness in gynecological cancer survivors. Considering the current knowledge and the negative impacts of urinary incontinence, there is an urgent need to examine whether this population can benefit from this intervention in a pilot study, to conduct eventually a larger randomized controlled trial. The objectives of the present study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence. A total of 44 participants will be randomized to receive either physiotherapy or standard usual care (wait-list for physiotherapy). Baseline and post-treatment evaluations will be realized by a physiotherapist.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
        • Contact:
        • Principal Investigator:
          • Mélanie Morin, PT, PhD
        • Sub-Investigator:
          • Marie-Pierre Cyr, PT, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of gynecological cancer (endometrial, cervical, vaginal or other parts of the uterus)
  • Scheduled oncological treatments completed
  • Stress or mixed urinary incontinence with a frequency of at least three urinary leakage per

Exclusion Criteria:

  • Pelvic floor rehabilitation in the last year
  • Other conditions interfering with assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physiotherapy
12-weekly physiotherapy treatment sessions.
Education, pelvic floor muscle exercises with biofeedback and home exercises.
Other Names:
  • Pelvic floor rehabilitation
No Intervention: Standard usual care
Participants will be asked to continue the usual care established during the regular follow-up with their medical doctor for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence rates
Time Frame: Baseline to 2-week post-treatment evaluation
To determine acceptability by assessing adherence to exercises.
Baseline to 2-week post-treatment evaluation
Retention rate
Time Frame: Baseline to 2-week post-treatment evaluation
To determine feasibility by evaluating attrition.
Baseline to 2-week post-treatment evaluation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in number of urinary leaks
Time Frame: Baseline to 2-week post-treatment
7-day voiding schedule will be used to evaluate the reduction of urinary leakage.
Baseline to 2-week post-treatment
Change from baseline in symptoms of pelvic floor dysfunction
Time Frame: Baseline to 2-week post-treatment evaluation
To explore changes in pelvic floor symptoms (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form ranging from 0 to 21), a high score represents high pelvic floor symptoms.
Baseline to 2-week post-treatment evaluation
Change from baseline in pelvic floor muscle function
Time Frame: Baseline to 2-week post-treatment evaluation
To explore changes in pelvic floor muscle function at rest and during contraction (dynamometry).
Baseline to 2-week post-treatment evaluation
Change from baseline in pelvic floor muscle morphometry
Time Frame: Baseline to 2-week post-treatment evaluation
To explore changes in pelvic floor muscle function at rest and during contraction (ultrasound).
Baseline to 2-week post-treatment evaluation
Change from baseline in sexual function
Time Frame: Baseline to 2-week post-treatment evaluation
To explore changes in sexual function (Female Sexual Function Index ranging from 2 to 36), a low score represents a low sexual function.
Baseline to 2-week post-treatment evaluation
Change from baseline in quality of life
Time Frame: Baseline to 2-week post-treatment evaluation
To explore changes in quality of life (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ranging from 0 to 100), a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life represents a high quality of life and a high score for a symptom scale / item represents a high level of symptomatology / problems.
Baseline to 2-week post-treatment evaluation
Patient's global impression of change
Time Frame: Baseline to 2-week post-treatment evaluation
To determine patient self-reported improvement (Patient's Global Impression of Change ranging from "very much worse" to "very much improved" on a 7-point scale.
Baseline to 2-week post-treatment evaluation
Rate of adverse events
Time Frame: Baseline to 2-week post-treatment evaluation
To document any adverse events.
Baseline to 2-week post-treatment evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Estimated)

October 16, 2025

Study Completion (Estimated)

October 16, 2025

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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