Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence

• ClinicalTrials.gov Identifier: NCT03957434
• Recruitment Status: Recruiting
• First Posted: May 21, 2019
• Last Update Posted: May 21, 2019
• Sponsor: Université de Sherbrooke
• Collaborators: Centre de recherche du Centre hospitalier universitaire de Sherbrooke; Institut Universitaire de Gériatrie de Montréal; Jewish General Hospital; Centre hospitalier de l'Université de Montréal (CHUM)
• Information provided by (Responsible Party): Mélanie Morin, Université de Sherbrooke

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Gynecologic Cancer; Urinary Incontinence	Other: Physiotherapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Baseline evaluation - Randomization to physiotherapy or standard usual care (12 weeks) - Post-treatment evaluation
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pilot Study Examining Feasibility and Effects of Physiotherapy Treatment Compared to Standard Usual Care in Gynecological Cancer Survivors With Urinary Incontinence
• Actual Study Start Date: October 16, 2018
• Estimated Primary Completion Date: October 16, 2021
• Estimated Study Completion Date: October 16, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Physiotherapy; 12-weekly physiotherapy treatment sessions.	Other: Physiotherapy; Education, pelvic floor muscle exercises with biofeedback and home exercises.; Other Name: 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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).
4. 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).
5. 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.
6. 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.
7. 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.
8. Rate of adverse events [ Time Frame: Baseline to 2-week post-treatment evaluation ]
   To document any adverse events.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, Quebec

Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke; Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contact: Ma Guixiang Nadeau, PT 819-346-1110 ext 18439 labomorin@usherbrooke.ca

Principal Investigator: Mélanie Morin, PT, PhD

Sub-Investigator: Marie-Pierre Cyr, PT, MSc

Sponsors and Collaborators

Université de Sherbrooke

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Institut Universitaire de Gériatrie de Montréal

Jewish General Hospital

Centre hospitalier de l'Université de Montréal (CHUM)

More Information

• Responsible Party: Mélanie Morin, Researcher and Associate Professor, Université de Sherbrooke
• ClinicalTrials.gov Identifier: NCT03957434
• Other Study ID Numbers: MP-31-2017-1683
• First Posted: May 21, 2019
• Last Update Posted: May 21, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mélanie Morin, Université de Sherbrooke:

Pilot study; Gynecological cancer survivors; Urinary Incontinence; Physiotherapy

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders