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

NCT01602107 | Completed DMC

• 1 other identifier: REH-503-11
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 4

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.

Conditions

Stress Urinary Incontinence

Keywords

Stress; Urinary; Incontinence; Pelvic; Physiotherapy

Outcome Measures

Primary Outcomes (3)

• Change in International Consultation on Incontinence Questionnaire: Female Lower Urinary Tract Symptoms (FLUTS)

  Changes in ICIQ FLUTS scores will be compared between treatment and control groups

  12 weeks before surgrey (TVT or TVT-O) to 12 weeks after surgery

• Change in International Consultation on Incontinence Questionnaire - Short form score

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

  12 weeks before surgery (TVT or TVT-O) to 12 weeks after surgery

• Change in pad weight on a standardized 30 minute pad test

  Change in pad weight (in g) on a standardized pad test will be compared between the treatment and control groups

  12 weeks before surgery (TVT, TVT-O) to 12 weeks after surgery

Secondary Outcomes (1)

• Change in International Consultation on Incontinence Questionnaire Quality of Life module score

  12 weeks before surgery (TVT, TVT-O) to 12 weeks after surgery

Study Arms (2)

Control

NO INTERVENTION

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.

Pelvic Floor Therapy

EXPERIMENTAL

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

Interventions

Pelvic Floor muscle strengthening exercises OTHER

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.

Also known as: Physical Therapy

Pelvic Floor Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead
• Ottawa Hospital Research Institute: collaborator

Study Sites (4)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

School of Rehabilitation Therapy, Queen's University

Kingston, Ontario, K7L3N6, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Montfort Hospital

Ottawa, Ontario, Canada

Location

Related Publications (3)

• Antonio FI, Yamamoto G, Varette K, McLean L. One in four women with stress urinary incontinence who are taught "the knack" maneuver adopt this motor pattern while coughing: A prospective interventional cohort study. Neurourol Urodyn. 2023 Aug;42(6):1290-1298. doi: 10.1002/nau.25196. Epub 2023 May 2.

  PMID: 37130076 DERIVED

• McLean L, Charette M, Varette K, Brooks K, Harvey MA, Robert M, Baker K, Day A, Della Zazzera V, Sauerbrei E, Brison R. Pelvic floor muscle training as an adjunct to a midurethral sling: a single-blind randomised controlled trial. Int Urogynecol J. 2022 Apr;33(4):809-819. doi: 10.1007/s00192-020-04668-9. Epub 2021 Mar 3.

  PMID: 33660001 DERIVED

• Brooks KCL, Varette K, Harvey MA, Robert M, Brison RJ, Day A, Baker K, Della Zazzera V, Sauerbrei E, McLean L. A model identifying characteristics predictive of successful pelvic floor muscle training outcomes among women with stress urinary incontinence. Int Urogynecol J. 2021 Mar;32(3):719-728. doi: 10.1007/s00192-020-04583-z. Epub 2020 Nov 25.

  PMID: 33237355 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Linda McLean, PhD

  School Of Rehabilittion Therapy, Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 18, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

CA (4)