N/A
Completed N=54
Systematized Quality Exercise Alternatives for Stress Incontinence
Stress Urinary Incontinence · Pelvic Floor; Weak · Incontinence, Urinary · quality of life
Source: ClinicalTrials.gov NCT03443687 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Change in Quality of Life — 4.73; 3.95 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Life |
4.73; 3.95 | — |
| SECONDARY Sexual Function |
0.42; 1.81 | — |
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. Informational only — not medical advice.