Systematized Quality Exercise Alternatives for Stress Incontinence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Systematized Quality Exercise Alternatives for Stress Incontinence

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

Intervention / Treatment
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* Behavioral: Pelvic Floor Physical Therapy
* Device: Home Biofeedback


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pelvic Floor Physical Therapy<br>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. | Behavioral: Pelvic Floor Physical Therapy<br>* Pelvic floor exercises for 3 months under instruction of physical therapist<br>* Other names: PFPT;|
| Experimental: Home Biofeedback<br>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. | Device: Home Biofeedback<br>* Pelvic floor exercises for 3 months using biofeedback device<br>* Other names: PeriCoach Kegel Exerciser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Function | 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. | 3 Months |