N/A
N=54
Systematized Quality Exercise Alternatives for Stress Incontinence
Stress Urinary Incontinence · Pelvic Floor; Weak · Incontinence, Urinary · Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT03443687 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change in Quality of Life — 4.73; 3.95 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pelvic Floor Physical Therapy (Behavioral); Home Biofeedback (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of New Mexico
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Life |
4.73; 3.95 | — |
| SECONDARY Sexual Function |
0.42; 1.81 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03443687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.