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Non-Operative Management Approaches for Urinary Incontinence

N/A
Waitlist Available
Led By Goutham Rao, MD
Research Sponsored by Adonis Hijaz, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months (waves 1 and 2)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing different approaches to improve diagnosis and non-operative management of urinary incontinence in women.

Who is the study for?
This trial is for women over 18 who are experiencing urinary incontinence and have visited the University Hospitals Cleveland Primary Care Institute. Participants should score at least 1 on a specific questionnaire about incontinence.
What is being tested?
The EMPOWER study aims to enhance the diagnosis and non-surgical treatment of urinary incontinence among women, using patient education, nurse-led guidance, and a ChatBot to provide support.
What are the potential side effects?
Since this trial focuses on educational interventions rather than medications or surgeries, side effects are not typical but may include discomfort from discussing personal health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months (waves 1 and 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months (waves 1 and 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Urinary Incontinence
Secondary study objectives
Change in impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol
Change in overactive bladder symptom severity as measured by the OABSS
Change in patient empowerment as measured by a patient survey
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3Experimental Treatment3 Interventions
Patient Education + Nurse Navigation + ChatBot
Group II: Arm 2Experimental Treatment2 Interventions
Patient Education + Nurse Navigation
Group III: Arm 1Experimental Treatment1 Intervention
Patient Education

Find a Location

Who is running the clinical trial?

Adonis Hijaz, MDLead Sponsor
Goutham Rao, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Media Library

Arm 1 Clinical Trial Eligibility Overview. Trial Name: NCT05515198 — N/A
Urinary Incontinence Research Study Groups: Arm 1, Arm 2, Arm 3
Urinary Incontinence Clinical Trial 2023: Arm 1 Highlights & Side Effects. Trial Name: NCT05515198 — N/A
Arm 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT05515198 — N/A
~0 spots leftby Dec 2024