Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03957434
• Other study ID #: MP-31-2017-1683
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: October 16, 2025

Study information

• Verified date: November 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: October 16, 2025
• Est. primary completion date: October 16, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Gynecologic Cancer
• Urinary Incontinence

Intervention

Other:
• Physiotherapy
Education, pelvic floor muscle exercises with biofeedback and home exercises.

Locations

Country	Name	City	State
Canada	Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (5)

Lead Sponsor	Collaborator
Université de Sherbrooke	Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Centre hospitalier de l'Université de Montréal (CHUM), Institut Universitaire de Gériatrie de Montréal, Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence rates	To determine acceptability by assessing adherence to exercises.	Baseline to 2-week post-treatment evaluation
Primary	Retention rate	To determine feasibility by evaluating attrition.	Baseline to 2-week post-treatment evaluation
Secondary	Change from baseline in number of urinary leaks	7-day voiding schedule will be used to evaluate the reduction of urinary leakage.	Baseline to 2-week post-treatment
Secondary	Change from baseline in symptoms of pelvic floor dysfunction	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
Secondary	Change from baseline in pelvic floor muscle function	To explore changes in pelvic floor muscle function at rest and during contraction (dynamometry).	Baseline to 2-week post-treatment evaluation
Secondary	Change from baseline in pelvic floor muscle morphometry	To explore changes in pelvic floor muscle function at rest and during contraction (ultrasound).	Baseline to 2-week post-treatment evaluation
Secondary	Change from baseline in sexual function	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
Secondary	Change from baseline in quality of life	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
Secondary	Patient's global impression of change	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
Secondary	Rate of adverse events	To document any adverse events.	Baseline to 2-week post-treatment evaluation