Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence

NCT ID: NCT03957434

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2025-10-16

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.

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.

Conditions

Gynecologic Cancer; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physiotherapy

12-weekly physiotherapy treatment sessions.

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

Education, pelvic floor muscle exercises with biofeedback and home exercises.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physiotherapy

Education, pelvic floor muscle exercises with biofeedback and home exercises.

Intervention Type: OTHER

Other Intervention Names

Pelvic floor rehabilitation

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role: collaborator

Institut Universitaire de Gériatrie de Montréal

OTHER

Sponsor Role: collaborator

Jewish General Hospital

OTHER

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Mélanie Morin

Researcher and Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

MP-31-2017-1683

Identifier Type: -

Identifier Source: org_study_id