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Neuromuscular Stimulation

Electrical Stimulation for Urinary Incontinence

N/A
Recruiting
Led By Gloria Kolb, MS,MBA
Research Sponsored by Elidah, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for robotic-assisted laparoscopic prostatectomy
Predominant SUI of at least 1 pad/day
Must not have
Lacks capacity to adhere with study requirements
History or symptoms of urinary incontinence, urinary retention, extra-urethral incontinence, overflow incontinence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a treatment called Elidah neuromuscular stimulation can help reduce incontinence in men after prostate surgery.

Who is the study for?
This trial is for men who are experiencing incontinence, specifically after having surgery to remove the prostate (post-prostatectomy). The study aims to help those struggling with bedwetting or urinary incontinence.
What is being tested?
The trial is testing a treatment called Elidah neuromuscular stimulation. It involves applying electrical stimulation externally at the perineum area to see if it can reduce symptoms of incontinence.
What are the potential side effects?
Potential side effects may include discomfort at the site of stimulation, skin irritation, and muscle twitching due to the electrical current used during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a robotic-assisted surgery to remove my prostate.
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I use at least one pad a day due to urine leakage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot follow the study's requirements.
Select...
I have a history or symptoms of problems controlling my bladder.
Select...
My pelvic floor muscles have been completely denervated.
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My BMI is 40 or higher.
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I experience pelvic pain or have painful bladder syndrome.
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I have a heart condition, such as an untreated arrhythmia or an implanted cardiac device.
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I have a condition that affects my nerves or muscles.
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I have metal implants in my abdomen or pelvic area.
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I am unable to make my own medical decisions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in Leakage by Pad weight
Secondary study objectives
Quality of Life Improvement
Reduction in leakage
Reduction in leakage at Night
+1 more

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention
Self-applied electrical stimulation for 6 weeks.

Find a Location

Who is running the clinical trial?

Elidah, Inc.Lead Sponsor
2 Previous Clinical Trials
52 Total Patients Enrolled
1 Trials studying Urinary Incontinence
40 Patients Enrolled for Urinary Incontinence
Gloria Kolb, MS,MBAPrincipal InvestigatorElidah, Inc.
~4 spots leftby Jan 2025
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