Clinical trial NCT03443687: Systematized Quality Exercise Alternatives for Stress Incontinence
Official title: Systematized Quality Exercise Alternatives for Stress Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Pelvic Floor; Weak
Incontinence, Urinary
Quality of Life
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Quality of Life
timeFrame: 3 months
Secondary outcomes:
measure: Sexual Function
timeFrame: 3 Months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico HSC, Department of Obstetrics and Gynecology
name: Gena Dunivan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.