Systematized Quality Exercise Alternatives for Stress Incontinence
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Urinary Incontinence
- Sponsor
- University of New Mexico
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Change in Quality of Life
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This randomized controlled study evaluates the effect of home biofeedback compared to pelvic floor physical therapy for the treatment of stress urinary incontinence. Half of the participants will use a home biofeedback device for 3 months and the other half will attend pelvic floor physical therapy appointments for 3 months.
Detailed Description
Biofeedback has been shown to be highly effective the treatment of stress urinary incontinence when used in conjunction with pelvic floor physical therapy under the instruction of a healthcare provider. Home biofeedback has not been well studied, even though several FDA cleared devices are on the market and available for patients to purchase. It is unclear if the biofeedback improves women's urinary incontinence, or if the increased contact with a healthcare provider causes the improvement. Using a home biofeedback device, a woman places the device in her vagina and contracts the muscles of her pelvic floor to improve the strength, which can improve or cure incontinence when performed over time. Typically it takes 3 months for benefit to be seen.
Investigators
Gena Dunivan
Associate Professor
University of New Mexico
Eligibility Criteria
Inclusion Criteria
- •Female Subjects \>18 years of age
- •SUI or Mixed UI with stress predominant symptoms and more bother by the SUI
- •English speaking/reading
- •Own a smartphone that can support phone application and Bluetooth for the biofeedback device
- •Willing to come for 4 PFPT visits over 3 months if randomized
Exclusion Criteria
- •Prior anti-incontinence surgery
- •Had prior pelvic floor physical therapy for SUI
- •Prolapse of any compartment noted below the hymen
- •Inability to speak/understand English
- •Decline or unable to return for frequent PT visits during study period
- •Unable to be contacted for follow up by telephone
- •Neurologic disorders known to cause neurogenic bladder
Outcomes
Primary Outcomes
Change in Quality of Life
Time Frame: 3 months
Scale is International Consultation Incontinence Questionnaire short form (ICIQ-SF). Minimum is 0 and Maximum is 21. A higher score indicates greater impairment from incontinence.
Secondary Outcomes
- Sexual Function(3 Months)