Systematized Quality Exercise Alternatives for Stress Incontinence

Not Applicable

Completed

• Conditions: Pelvic Floor; Weak; Quality of Life; Incontinence, Urinary; Stress Urinary Incontinence

• Registration Number: NCT03443687
• Lead Sponsor: University of New Mexico

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.

Study Timeline

• Study First Submitted: 2018-02-17
• Study First Submitted QC: 2018-02-17
• Study First Posted: 2018-02-23
• Study Start: 2018-06-01
• Primary Completion: 2020-03-03
• Study Completion: 2020-03-03
• Results First Submitted: 2021-09-28
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-01
• Last Update Submitted: 2023-12-01
• Results First Posted: 2023-12-21
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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
• Pregnant
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life	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 Outcome Measures

Name	Time	Method
Sexual Function	3 Months	Female sexual index will be used to assess change in sexual function over study. Female sexual function index (FSFI) questionnaire and Pelvic organ prolapse incontinence sexual questionnaire were PI developed questionnaires. The minimum is 0 and the maximum is 36. A higher score indicates greater sexual impairment.

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States