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Clinical Trials/NCT06620419
NCT06620419Active, not recruitingNot Applicable

Clinical Evaluation of Perineal Electrical Stimulation for Urinary Incontinence in Men

Elidah, Inc.1 site in 1 country30 target enrollmentStarted: May 15, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Reduction in Leakage by Pad weight
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this research is to evaluate the effectiveness of the Elidah neuromuscular stimulation treatment to reduce incontinence in men post-prostatectomy.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Scheduled for robotic-assisted laparoscopic prostatectomy
  • •Read and speak English
  • •Predominant SUI of at least 1 pad/day

Exclusion Criteria

  • •History or symptoms of urinary incontinence, urinary retention, extra-urethral incontinence, overflow incontinence
  • •Complete denervation of the pelvic floor
  • •Severe Obesity as defined by BMI >= 40
  • •Has undergone pre-op pelvic floor exercise strengthening
  • •Pelvic pain/painful bladder syndrome
  • •Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
  • •History of epilepsy
  • •Underlying neurologic/neuromuscular disorder
  • •Metal implants in the abdomen or pelvic area
  • •Chronic coughing
  • •Impaired decision making, suicidal thoughts, or drug/alcohol dependence
  • •Uncontrolled intercurrent illness that would limit compliance with study requirements
  • •Lacks capacity to adhere with study requirements
  • •Lacks capacity to consent for themselves.

Arms & Interventions

Treatment group

Experimental

Self-applied electrical stimulation for 6 weeks.

Intervention: Perineal-applied electrical stimulation (Device)

Outcomes

Primary Outcomes

Reduction in Leakage by Pad weight

Time Frame: 6 weeks

24-hr pad weight

Secondary Outcomes

  • Safety measured by no Adverse events(6 weeks)
  • Reduction in leakage at Night(6 weeks)
  • Quality of Life Improvement(6 weeks)
  • Reduction in leakage(6 weeks)

Investigators

Sponsor
Elidah, Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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