Systematized Quality Exercise Alternatives for Stress Incontinence (SQEASI)

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.

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.

Participants will be randomized to either Pelvic Floor Physical Therapy (PFPT) or home biofeedback. The therapy allocation will then be carried out with each arm completing 3 months of 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.

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.

Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score between the women who undergo PFPT compared to those to those who undergo home biofeedback therapy for stress urinary incontinence

Incontinence Severity Index (ISI) will be used to assess change in incontinence severity over the study period

Comparative analysis of cost between PFPT treatment and home biofeedback for stress predominant incontinence

We will only recruit natal females who have stress urinary incontinence as device designed for females.

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

Barnes KL, Cichowski S, Komesu YM, Jeppson PC, McGuire B, Ninivaggio CS, Dunivan GC. Home Biofeedback Versus Physical Therapy for Stress Urinary Incontinence: A Randomized Trial. Female Pelvic Med Reconstr Surg. 2021 Oct 1;27(10):587-594. doi: 10.1097/SPV.0000000000000993.