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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01602107
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : November 7, 2017
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Dr. Linda McLean, Queen's University

Brief Summary:

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 or disease Intervention/treatment Phase
Stress Urinary Incontinence Other: Pelvic Floor muscle strengthening exercises Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2011
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    Changes in ICIQ FLUTS scores will be compared between treatment and control groups

  2. 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 ]
    Changes in questionnaire scores will be compared between treatment and control groups

  3. Change in pad weight on a standardized 30 minute pad test [ Time Frame: 12 weeks before surgery (TVT, TVT-O) to 12 weeks after surgery ]
    Change in pad weight (in g) on a standardized pad test will be compared between the treatment and control groups

Secondary Outcome Measures :
  1. 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 ]
    Changes in ICIQ-FLUTS QoL scores will be compared between the treatment and control groups.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01602107

Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
School of Rehabilitation Therapy, Queen's University
Kingston, Ontario, Canada, K7L3N6
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Montfort Hospital
Ottawa, Ontario, Canada
Sponsors and Collaborators
Queen's University
Ottawa Hospital Research Institute
Principal Investigator: Linda McLean, PhD School Of Rehabilittion Therapy, Queen's University

Responsible Party: Dr. Linda McLean, Associate Professor, Queen's University Identifier: NCT01602107     History of Changes
Other Study ID Numbers: REH-503-11
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

Keywords provided by Dr. Linda McLean, Queen's University:

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders