Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence
Primary Purpose
Gynecologic Cancer, Urinary Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Gynecologic Cancer focused on measuring Pilot study, Gynecological cancer survivors, Urinary Incontinence, Physiotherapy
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
Sites / Locations
- Centre de Recherche du Centre Hospitalier Universitaire de SherbrookeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physiotherapy
Standard usual care
Arm Description
12-weekly physiotherapy treatment sessions.
Participants will be asked to continue the usual care established during the regular follow-up with their medical doctor for 12 weeks.
Outcomes
Primary Outcome Measures
Adherence rates
To determine acceptability by assessing adherence to exercises.
Retention rate
To determine feasibility by evaluating attrition.
Secondary Outcome Measures
Change from baseline in number of urinary leaks
7-day voiding schedule will be used to evaluate the reduction of urinary leakage.
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.
Change from baseline in pelvic floor muscle function
To explore changes in pelvic floor muscle function at rest and during contraction (dynamometry).
Change from baseline in pelvic floor muscle morphometry
To explore changes in pelvic floor muscle function at rest and during contraction (ultrasound).
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.
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.
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.
Rate of adverse events
To document any adverse events.
Full Information
NCT ID
NCT03957434
First Posted
April 10, 2019
Last Updated
May 9, 2023
Sponsor
Université de Sherbrooke
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)
1. Study Identification
Unique Protocol Identification Number
NCT03957434
Brief Title
Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence
Official Title
Pilot Study Examining Feasibility and Effects of Physiotherapy Treatment Compared to Standard Usual Care in Gynecological Cancer Survivors With Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
October 16, 2023 (Anticipated)
Study Completion Date
October 16, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
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)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Urinary Incontinence
Keywords
Pilot study, Gynecological cancer survivors, Urinary Incontinence, Physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Baseline evaluation - Randomization to physiotherapy or standard usual care (12 weeks) - Post-treatment evaluation
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy
Arm Type
Experimental
Arm Description
12-weekly physiotherapy treatment sessions.
Arm Title
Standard usual care
Arm Type
No Intervention
Arm Description
Participants will be asked to continue the usual care established during the regular follow-up with their medical doctor for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Pelvic floor rehabilitation
Intervention Description
Education, pelvic floor muscle exercises with biofeedback and home exercises.
Primary Outcome Measure Information:
Title
Adherence rates
Description
To determine acceptability by assessing adherence to exercises.
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Retention rate
Description
To determine feasibility by evaluating attrition.
Time Frame
Baseline to 2-week post-treatment evaluation
Secondary Outcome Measure Information:
Title
Change from baseline in number of urinary leaks
Description
7-day voiding schedule will be used to evaluate the reduction of urinary leakage.
Time Frame
Baseline to 2-week post-treatment
Title
Change from baseline in symptoms of pelvic floor dysfunction
Description
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.
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Change from baseline in pelvic floor muscle function
Description
To explore changes in pelvic floor muscle function at rest and during contraction (dynamometry).
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Change from baseline in pelvic floor muscle morphometry
Description
To explore changes in pelvic floor muscle function at rest and during contraction (ultrasound).
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Change from baseline in sexual function
Description
To explore changes in sexual function (Female Sexual Function Index ranging from 2 to 36), a low score represents a low sexual function.
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Change from baseline in quality of life
Description
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.
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Patient's global impression of change
Description
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.
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Rate of adverse events
Description
To document any adverse events.
Time Frame
Baseline to 2-week post-treatment evaluation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Guixiang Nadeau, PT
Phone
819-346-1110
Ext
18439
Email
labomorin@usherbrooke.ca
First Name & Middle Initial & Last Name & Degree
Mélanie Morin, PT, PhD
First Name & Middle Initial & Last Name & Degree
Marie-Pierre Cyr, PT, MSc
12. IPD Sharing Statement
Learn more about this trial
Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence
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