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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03443687
Other study ID # SQEASI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date March 3, 2020

Study information

Verified date December 2023
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 54
Est. completion date March 3, 2020
Est. primary completion date March 3, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
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: - 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

Study Design


Intervention

Behavioral:
Pelvic Floor Physical Therapy
Pelvic floor exercises for 3 months under instruction of physical therapist
Device:
Home Biofeedback
Pelvic floor exercises for 3 months using biofeedback device

Locations

Country Name City State
United States University of New Mexico Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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