Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence

• ClinicalTrials.gov Identifier: NCT03957434
• Recruitment Status: Recruiting
• First Posted: May 21, 2019
• Last Update Posted: May 21, 2019
• 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)
• Information provided by (Responsible Party): Mélanie Morin, Université de Sherbrooke

Tracking Information

• First Submitted Date: April 10, 2019
• First Posted Date: May 21, 2019
• Last Update Posted Date: May 21, 2019
• Actual Study Start Date: October 16, 2018
• Estimated Primary Completion Date: October 16, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 17, 2019)

• Adherence rates [ Time Frame: Baseline to 2-week post-treatment evaluation ]
  To determine acceptability by assessing adherence to exercises.
• Retention rate [ Time Frame: Baseline to 2-week post-treatment evaluation ]
  To determine feasibility by evaluating attrition.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 17, 2019)

• 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.
• 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.
• 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).
• 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).
• 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.
• 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.
• 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.
• Rate of adverse events [ Time Frame: Baseline to 2-week post-treatment evaluation ]
  To document any adverse events.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Gynecologic Cancer
• Urinary Incontinence

Intervention

Other: Physiotherapy

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

Other Name: Pelvic floor rehabilitation

Study Arms

• Experimental: Physiotherapy
  12-weekly physiotherapy treatment sessions.
  Intervention: Other: Physiotherapy
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 17, 2019): 44
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 16, 2021
• Estimated Primary Completion Date: October 16, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03957434
• Other Study ID Numbers: MP-31-2017-1683
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Mélanie Morin, Université de Sherbrooke
• Study 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)

• Investigators: Not Provided
• PRS Account: Université de Sherbrooke
• Verification Date: May 2019