NCT07668063

Brief Summary

Urinary incontinence, bladder frequency, and bladder urgency are significant medical problems for people with overactive bladder (OAB) or neurogenic bladder overactivity (NDO). Affected individuals typically experience reflex bladder contractions in response to bladder filling at low volumes, resulting in urinary incontinence and decreased bladder capacity. This project will advance a new device for administering noninvasive electrical stimulation in order to improve bladder control.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
19mo left

Started Jun 2028

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 1, 2028

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

June 10, 2026

Last Update Submit

June 18, 2026

Conditions

Neurogenic Bladder

Keywords

Neurogenic detrusor overactivitySpinal cord injuryGenital nerve stimulation

Outcome Measures

Primary Outcomes (1)

  • Bladder Capacity

    Change in bladder capacity (in mL) in response to genital nerve stimulation will serve as the primary outcome measure for this study.

    Day 1

Secondary Outcomes (2)

  • Usability Metrics

    Day 1

  • Electrical Impedance

    Day 1

Study Arms (1)

Genital Nerve Stimulation

EXPERIMENTAL

Study participants will don the device at the beginning of the experiment session. An initial clinical urodynamics test will be performed to confirm that the participant has neurogenic bladder. The investigators will select stimulation parameters that effectively inhibit reflexive bladder contractions. Serial cystometrograms will then be conducted. Each fill will be conducted either 1) without stimulation (control runs) or 2) with stimulation.

Device: Noninvasive electrical stimulation device to improve bladder control

Interventions

Noninvasive electrical stimulation device to improve bladder controlDEVICE

Genital nerve stimulation (GNS) will be applied using a wearable, transcutaneous neurostimulator and sleeve electrode that targets the genital nerve reflex pathway for the treatment of neurogenic bladder associated with spinal cord injury.

Genital Nerve Stimulation

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsDevice has been developed for male anatomy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suprasacral SCI
  • Neurologically stable
  • Skeletally mature
  • Presence of reflex bladder contractions
  • At least 12 months post SCI

You may not qualify if:

  • Active sepsis
  • Open pressure sores on or around pelvis
  • Bleeding diathesis
  • Significant urethral trauma, erosion, or stricture
  • Indwelling catheter for over 1 year AND bladder capacity less than 100 mL
  • Significant history of autonomic dysreflexia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

MeSH Terms

Conditions

Urinary Bladder, NeurogenicSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Dennis Bourbeau, PhD

    Louis Stokes VA Medical Center, Cleveland, OH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Bourbeau, PhD

CONTACT

(216) 791-3800Dennis.Bourbeau@va.gov

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a pilot study to evaluate the efficacy of a prototype device to improve bladder control in persons with spinal cord injury and neurogenic bladder dysfunction. Each participant will serve as their own control.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 25, 2026

Study Start (Estimated)

June 1, 2028

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)