NCT05515198

Brief Summary

The overall goal is to improve diagnosis and non-operative management of urinary incontinence in women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 5, 2026

Completed
Last Updated

May 5, 2026

Status Verified

January 1, 2025

Enrollment Period

2.3 years

First QC Date

August 23, 2022

Results QC Date

December 23, 2025

Last Update Submit

April 14, 2026

Conditions

Urinary Incontinence

Keywords

womenfemaleurinary incontinenceempoweringEMPOWERprovidersbladder leakageincontinence

Outcome Measures

Primary Outcomes (2)

  • Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

    The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.

    Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each wave

  • Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

    The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.

    12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12)

Secondary Outcomes (19)

  • Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

    18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)

  • Change in Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI

    Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave

  • Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI

    12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12)

  • Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI

    18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)

  • Patient Empowerment as Measured by Number of Participants That Answered Yes to Speaking With Their Provider About UI.

    Baseline (immediately prior to start of intervention) in all Waves

  • +14 more secondary outcomes

Study Arms (3)

Arm 1

EXPERIMENTAL

Patient Education

Other: Patient Education

Arm 2

EXPERIMENTAL

Patient Education + Nurse Navigation

Other: Patient EducationOther: Nurse Navigation

Arm 3

EXPERIMENTAL

Patient Education + Nurse Navigation + ChatBot

Other: Patient EducationOther: Nurse NavigationOther: ChatBot

Interventions

Patient EducationOTHER

Patients will be provided educational opportunities.

Also known as: Education
Arm 1Arm 2Arm 3
Nurse NavigationOTHER

A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.

Arm 2Arm 3
ChatBotOTHER

A ChatBot will allow participants to directly and privately communicate through a smartphone (or other device) with an artificial intelligence-driven ChatBot, also known as a "conversational agent," that will provide education and encouragement to manage their symptoms.

Also known as: Behavioral/exercise via chatbot
Arm 3

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Patient Education as TopicEducational Status

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Limitations and Caveats

Means and standard deviations are based on the observed/non-missing responses. Between arm contrasts are based on linear mixed effects models including all 400 participants randomized in the trial (the intention to treat population), with non-structurally missing responses addressed via multiple imputation.

Results Point of Contact

Title
Dr. Adonis Hijaz
Organization
UH Cleveland Medical Center
Adonis.Hijaz@UHhospitals.org
216-844-3009

Study Officials

  • Adonis Hijaz, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

  • Goutham Rao, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair of Academics and Research for the Urology Institute

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 25, 2022

Study Start

September 6, 2022

Primary Completion

December 23, 2024

Study Completion

December 23, 2024

Last Updated

May 5, 2026

Results First Posted

May 5, 2026

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial will be made available after de-identification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Beginning 9 months and ending 36 months following publication.
Access Criteria
Researchers who provide a methodologically sound proposal may use the data for any purpose.

Locations

US(1)