The Effect of Pre-operatuve Pelvic Floor Muscle Exercise on Surgical Outcomes in Women With Stress Urinary Incontinence (SUIPT)
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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 |
- 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
- 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 |
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| Contact: Linda McLean, PhD | 613-533-6000 ext 36101 | mcleanl@queensu.ca |
| Contact: Lizy Kodiattu | 613-533-6000 ext 79386 | kodiattu@queensu.ca |
| 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 | |
| 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: | May 17, 2012 |
| 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 May 21, 2013