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Behavioural Intervention

1/Elidah Device for Benign Prostatic Hyperplasia

Phase 2
Recruiting
Led By Deborah E Citrin, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be male.
Participants must have moderate urinary incontinence defined as 1-5 leaks per day and use at least 1 pad per day by self-report at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and within 2 weeks after completing treatment
Awards & highlights

Study Summary

This trial tests the efficacy of the Elidah device for reducing urinary incontinence in men following prostate cancer treatment.

Who is the study for?
Men who have experienced urinary incontinence for at least 6 months following prostate cancer treatment are eligible. They must suffer from stress or urge urinary incontinence, with moderate severity of 1-5 leaks per day and use at least one pad daily. Candidates should be able to read/write English, be over 18 years old, and have a reasonable level of physical fitness.Check my eligibility
What is being tested?
The trial is evaluating the Elidah device's effectiveness on male urinary incontinence post-prostate cancer treatment. Participants will use this FDA-cleared electrical stimulation device designed to strengthen pelvic floor muscles at home for six weeks, followed by assessments to measure improvements.See study design
What are the potential side effects?
Potential side effects may include discomfort or skin irritation where the Elidah device attaches, muscle fatigue from contractions induced by the device, and possible interference with other medical devices if present.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am male.
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I experience 1-5 urinary leaks daily and use at least 1 pad a day.
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I have had urinary incontinence for over 6 months after my prostate cancer treatment.
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I have stress or urge urinary incontinence.
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I am able to get out of my bed or chair and move around.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at end of treatment visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at end of treatment visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To describe the efficacy of the Elidah device treatment on male urinary incontinence
Secondary outcome measures
To assess alternative measures of efficacy of Elidah device on male urinary incontinence and bother
To assess participant-reported outcomes of Elidah device use for male urinary incontinence
To assess the safety of the Elidah device in men with urinary incontinence
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1/Elidah DeviceExperimental Treatment1 Intervention
Elidah device application.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,728 Previous Clinical Trials
40,965,972 Total Patients Enrolled
Deborah E Citrin, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
736 Total Patients Enrolled
~20 spots leftby Dec 2024
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