Systematized Quality Exercise Alternatives for Stress Incontinence

Not Applicable

Completed

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

Interventions: Device: Home Biofeedback
Behavioral: Pelvic Floor Physical Therapy

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Home Biofeedback	Home Biofeedback	If randomized to this arm, women will complete demographic forms and questionnaires. They will then be given a pelvic floor exercise device that is bluetooth linked to a smartphone application. They will be instructed on how to use the device daily for 3 months and their intervention will be to perform daily exercises with the device in place. At 3 months they will return for a follow up visit and complete questionnaires.
Pelvic Floor Physical Therapy	Pelvic Floor Physical Therapy	If randomized to this arm, women will complete demographic forms and questionnaires. They will then undergo the intervention of 4 pelvic floor physical therapy visits over 3 months. At that time they will return for a follow up visit and complete questionnaires.

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.