N/A
N=400
Improving Care for Women With Urinary Incontinence (EMPOWER)
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT05515198 ↗Enrolled (actual)
400
Serious AEs
2.5%
Results posted
May 2026
Primary outcome: Primary: Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) — 8.4; 9.0; 9.9; 8.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Education (Other); Nurse Navigation (Other); ChatBot (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) |
8.4; 9.0; 9.9; 8.9; 7.2; 7.1 | — |
| PRIMARY Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) |
8.7; 6.5; 8.7 | <0.001 sig |
| SECONDARY Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) |
8.7; 6.5; 8.7 | <0.001 sig |
| SECONDARY Change in Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI |
18.2; 18.2; 18.2; 18.8; 20.4; 21.0 | — |
| SECONDARY Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI |
18.3; 19.9; 23.9 | — |
| SECONDARY Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI |
18.3; 19.9; 23.9 | — |
| SECONDARY Patient Empowerment as Measured by Number of Participants That Answered Yes to Speaking With Their Provider About UI. |
24; 25; 22 | — |
| SECONDARY Change in Overactive Bladder Symptom Severity as Measured by the OABSS |
6.2; 6.07; 6.53; 5.4; 4.6; 3.7 | — |
| SECONDARY Overactive Bladder Symptom Severity as Measured by the OABSS |
4.4; 4.2; 5.0 | — |
| SECONDARY Overactive Bladder Symptom Severity as Measured by the OABSS |
4.4; 4.2; 5.0 | — |
| SECONDARY Change in Urinary Symptoms as Measured by the UDI-6 |
39; 38; 43; 33; 26; 25 | — |
| SECONDARY Urinary Symptoms as Measured by the UDI-6 |
26; 24; 32 | — |
| SECONDARY Urinary Symptoms as Measured by the UDI-6 |
26; 24; 32 | — |
| SECONDARY Change in Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol |
35; 34; 37; 34; 30; 31 | — |
| SECONDARY Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol |
35; 29; 33 | — |
| SECONDARY Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol |
35; 29; 33 | — |
| SECONDARY Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale. |
1; 10; 5 | — |
| SECONDARY Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale. |
1; 10; 5 | — |
| SECONDARY Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale. |
1; 10; 5 | — |
| SECONDARY Number of Practices That Maintain a UI Management Intervention as Measured by the Practice Survey |
3; 2; 2 | — |
| SECONDARY Number of Practices That Implement a UI Point Person as Measured by the Practice Survey |
2; 0; 2 | — |
Summary
The overall goal is to improve diagnosis and non-operative management of urinary incontinence in women.
Eligibility Criteria
Inclusion Criteria
- Female patient having a primary care provider visit at University Hospitals (UH) Cleveland Primary Care Institute (PCI)
- ≥ 18 years old
- Scores 1 or higher on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT05515198). 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.