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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at end of treatment visit

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,405 Total Patients Enrolled

Deborah E Citrin, M.D.Principal InvestigatorNational Cancer Institute (NCI)

11 Previous Clinical Trials

734 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities currently available to join this clinical venture?

"According to the information provided by clinicaltrials.gov, this medical experiment is not currently recruiting candidates. Initially posted on August 1st 2024 and last updated on December 1st 2023, unfortunately it isn't accepting new participants at this time; however, there are 1530 other studies actively seeking enrolment now."

Answered by AI

What safety protocols are in place for the 1/Elidah Device?

"Our team has assessed the safety of 1/Elidah Device as a 2, given that this is currently a Phase 2 trial. This indicates some evidence for safety but none yet for efficacy."

Answered by AI