Clinical Study of External Electrical Stimulation for Mal... | NCT06620419

Studies
Clinical Study of External Electrical Stimulation for Male Incontinence

NCT06620419

Sponsor

Elidah, Inc.

Status

Active, not recruiting

Last Update Posted

Jan 27, 2026Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Urinary Incontinence

Interventions

Perineal-applied electrical stimulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2024Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

May 16, 2024

First Submission Date that Met QC Criteria

Sep 27, 2024

First Posted Date

Oct 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2026

Last Update Posted Date

Jan 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental	Self-applied electrical stimulation for 6 weeks.	Device: Perineal-applied electrical stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Perineal-applied electrical stimulation	Device	Small controller that outputs stimulation for stress incontinence and OAB, attached to a male-anatomy thin GelPad placed in the perineal area.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in Leakage by Pad weight	24-hr pad weight	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety measured by no Adverse events	No adverse events	6 weeks
Quality of Life Improvement	Incontinence I-QoL survey	6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gloria Kolb, MS,MBA	Elidah, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elidah		Monroe	Connecticut	06468	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence
D018761	Multiple Endocrine Neoplasia Type 1

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided