Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence

NCT03957434 | Active Not Recruiting

• 1 other identifier: MP-31-2017-1683
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer; Urinary Incontinence

Keywords

Pilot study; Gynecological cancer survivors; Urinary Incontinence; Physiotherapy

Outcome Measures

Primary Outcomes (2)

• Adherence rates

  To determine acceptability by assessing adherence to exercises.

  Baseline to 2-week post-treatment evaluation

• Retention rate

  To determine feasibility by evaluating attrition.

  Baseline to 2-week post-treatment evaluation

Secondary Outcomes (8)

• Change from baseline in number of urinary leaks

  Baseline to 2-week post-treatment

• Change from baseline in symptoms of pelvic floor dysfunction

  Baseline to 2-week post-treatment evaluation

• Change from baseline in pelvic floor muscle function

  Baseline to 2-week post-treatment evaluation

• Change from baseline in pelvic floor muscle morphometry

  Baseline to 2-week post-treatment evaluation

• Change from baseline in sexual function

  Baseline to 2-week post-treatment evaluation

Study Arms (2)

Physiotherapy

EXPERIMENTAL

12-weekly physiotherapy treatment sessions.

Other: Physiotherapy

Standard usual care

NO INTERVENTION

Participants will be asked to continue the usual care established during the regular follow-up with their medical doctor for 12 weeks.

Interventions

Physiotherapy OTHER

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

Also known as: Pelvic floor rehabilitation

Physiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator
• Institut Universitaire de Gériatrie de Montréal: collaborator
• Jewish General Hospital: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

Study Sites (1)

Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Physical Therapy Modalities

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher and Associate Professor

Model Details: Baseline evaluation - Randomization to physiotherapy or standard usual care (12 weeks) - Post-treatment evaluation

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: May 21, 2019
• Study Start: October 16, 2018
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

CA (1)