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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

Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE October 16, 2018
Estimated Primary Completion Date October 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Gynecologic Cancer
  • Urinary Incontinence
Intervention  ICMJE Other: Physiotherapy
Education, pelvic floor muscle exercises with biofeedback and home exercises.
Other Name: Pelvic floor rehabilitation
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2019)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 16, 2021
Estimated Primary Completion Date October 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957434
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Mélanie Morin, Université de Sherbrooke
Study Sponsor  ICMJE Université de Sherbrooke
Collaborators  ICMJE
  • 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  ICMJE Not Provided
PRS Account Université de Sherbrooke
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP