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N/A N=400 Treatment

Improving Care for Women With Urinary Incontinence (EMPOWER)

Urinary Incontinence

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

OutcomeResultp-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

View full record on ClinicalTrials.gov →

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.

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