Systematized Quality Exercise Alternatives for Stress Incontinence (SQEASI)

University of New Mexico (UNM)

Status: Completed

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

Treatments: Device: Home Biofeedback; Behavioral: Pelvic Floor Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03443687

SQEASI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Pelvic Floor Physical Therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Pelvic Floor Physical Therapy

Home Biofeedback

Experimental group

Description:

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.

Treatment:

Device: Home Biofeedback