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Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT03957434
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
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

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.

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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

Resource links provided by the National Library of Medicine


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.



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957434


Locations
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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)

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

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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:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders