The Effect of Pre-operative Pelvic Floor Muscle Exercise on Surgical Outcomes in Women With Stress Urinary Incontinence (SUIPT)

This study is currently recruiting participants.
Verified November 2013 by Queen's University
Sponsor:
Collaborator:
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Linda McLean, Queen's University
ClinicalTrials.gov Identifier:
NCT01602107
First received: May 16, 2012
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

Urinary incontinence (UI) affects up to 50% of adult populations and stress urinary incontinence (SUI) is the most common form of UI, accounting for approximately 60% of patients. Women are affected by SUI much more often than men. Urine leakage in women with SUI occurs on exertion or during tasks that increase pressure on the bladder such as sneezing or coughing. SUI has been shown to be a barrier to physical activity in women, and as such can contribute to the development of diseases and disorders associated with inactivity.

SUI appears to have many contributing factors such as structural damage (eg. tears in the pelvic organ supporting tissues), muscle weakness related to nerve injury or aging, or thinning of the urethral wall and/or its surrounding muscular sphincters. Currently the most common treatments for SUI are conservative therapy, which normally takes the form of exercise therapy provided by specialized nurses or physical therapists, and surgery, which is aimed at enhancing urethral support. Exercise therapy is effective, resulting in complete cure in 50% of cases, and surgery is effective for approximately 80% of patients but carries risks such as the development of urinary retention. It is currently not clear which treatment approach is better for which women.

Through the proposed research, the investigators aim to determine how to predict which patients will improve or be cured with exercise therapy such that surgery can be avoided. Specifically the investigators will determine what is different between patients in whom exercise therapy succeeds and in whom exercise therapy fails. The investigators will also determine whether physiotherapist-supervised training of the pelvic floor muscles before surgery improves surgical outcomes. The proposed research will enable us to better understand the female continence system and how it responds to physiotherapeutic intervention. It will help us to develop improved assessment procedures that can streamline patient management.


Condition Intervention Phase
Stress Urinary Incontinence
Other: Pelvic Floor muscle strengthening exercises
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Treatment Outcomes for Women With Stress Urinary Incontinence Through the Identification of Factors Contributing to Successful Interventions

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Change in International Consultation on Incontinence Questionnaire: Female Lower Urinary Tract Symptoms (FLUTS) [ Time Frame: 12 weeks before surgrey (TVT or TVT-O) to 12 weeks after surgery ] [ Designated as safety issue: No ]
    Changes in ICIQ FLUTS scores will be compared between treatment and control groups

  • Change in International Consultation on Incontinence Questionnaire - Short form score [ Time Frame: 12 weeks before surgery (TVT or TVT-O) to 12 weeks after surgery ] [ Designated as safety issue: No ]
    Changes in questionnaire scores will be compared between treatment and control groups

  • Change in pad weight on a standardized 20 minute pad test [ Time Frame: 12 weeks before surgery (TVT, TVT-O) to 12 weeks after surgery ] [ Designated as safety issue: No ]
    Change in pad weight (in g) on a standardized pad test will be compared between the treatment and control groups


Secondary Outcome Measures:
  • Change in International Consultation on Incontinence Questionnaire Quality of Life module score [ Time Frame: 12 weeks before surgery (TVT, TVT-O) to 12 weeks after surgery ] [ Designated as safety issue: No ]
    Changes in ICIQ-FLUTS QoL scores will be compared between the treatment and control groups.


Estimated Enrollment: 400
Study Start Date: November 2011
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Participants in the control group will not receive therapist-supervised intervention. An exercise sheet briefly describing pelvic floor muscle exercises will be provided, as would be the standard practice from most physicians.
Experimental: Pelvic Floor Therapy
Participants in the experimental group undergo and assessment and treatment by a registered physiotherapist. Treatments will include two sessions of biofeedback training, therapist-assisted strengthening exercises, and will a prescribed home exercise program to strengthen their pelvic floor muscles.
Other: Pelvic Floor muscle strengthening exercises
Participants will attend regular physical therapy visits (weekly X 2 weeks, bi-weekly X 4 weeks, and continuing monthly) until the time of their surgery. they will then see the physical therapist for assessment, exercise and advice at 2 and 4 weeks after their surgery. During physical therapy visits, patients will receive two sessions of biofeedback training, and at each visit will work on strength and motor control exercises for their pelvic floor muscles.
Other Name: Physical Therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female
  • minimum age of 18
  • primary diagnosis of stress urinary incontinence by urogynaecologist
  • on the surgical wait list for surgery to address stress urinary incontinence

Exclusion Criteria:

  • currently pregnant or <6 months post-partum
  • pelvic mass (es)
  • pad test weight gain less than 1g at baseline testing
  • no episode of SUI as demonstrated by a 3-day bladder diary
  • having received more than 4 sessions of physical therapy in the past 5 years specifically for treating their symptoms of SUI
  • detrusor instability as identified by routine urodynamics studies performed as part of the patient evaluation by the urogynaecologist
  • prolapse (> POP-Q stage 2)
  • are taking medications known to increase or alleviate incontinence
  • not willing to cease other treatment for SUI treatment during the course of study
  • fecal incontinence (e.g., pessary)
  • prior urogynecological surgery to address urinary incontinence
  • neurological impairments involving the central nervous system or the sacral nerves or known connective tissue disorders
  • major psychiatric conditions which impact significantly with daily functioning and would prevent full participation in the study
  • physical impairment that would prevent the participant from completing the 20-minute pad test (a major study outcome measure)
  • in situ devices that would not be suitable for ultrasound testing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602107

Contacts
Contact: Linda McLean, PhD 613-533-6000 ext 36101 mcleanl@queensu.ca
Contact: Lizy Kodiattu 613-533-6000 ext 79386 kodiattu@queensu.ca

Locations
Canada, Ontario
School of Rehabilitation Therapy, Queen's University Recruiting
Kingston, Ontario, Canada, K7L3N6
Contact: Linda McLean, PhD    613-533-6000 ext 36101    mcleanl@queensu.ca   
Contact: Lizy Kodiattu    613-533-6000 ext 79382    kodiattu@queensu.ca   
Principal Investigator: Linda McLean, PhD         
The Ottawa Hospital Active, not recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Queen's University
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Linda McLean, PhD School Of Rehabilittion Therapy, Queen's University
  More Information

No publications provided

Responsible Party: Linda McLean, Associate Professor, Queen's University
ClinicalTrials.gov Identifier: NCT01602107     History of Changes
Other Study ID Numbers: REH-503-11
Study First Received: May 16, 2012
Last Updated: November 5, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Queen's University:
Stress
Urinary
Incontinence
Pelvic
Physiotherapy

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014