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Active, Not Recruiting

NCT Number: NCT03957434

Physiotherapy Treatment for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gynecologic Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy

Other

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

Other names: Pelvic floor rehabilitation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
May 21, 2019
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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