Trial Outcomes & Findings for Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia (NCT NCT03472599)

NCT ID: NCT03472599

Last Updated: 2026-08-20

Results Overview

Leakage episodes (metric for incontinence) collected over the initial month of testing.

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

Collected over 1 month

Results posted on

2026-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Genital Nerve Stimulation Evaluate GNS (Genital Nerve Stimulation)
Overall Study STARTED	17
Overall Study Urodynamic Evaluation	17
Overall Study Initial Control and GNS	10
Overall Study 6 Month Follow up	5
Overall Study 1 Year Follow up	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Genital Nerve Stimulation n=17 Participants Evaluate GNS (Genital Nerve Stimulation)
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Injury Spinal Cord Injury	8 Participants n=5 Participants
Injury Multiple Sclerosis	6 Participants n=5 Participants
Injury Other	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Collected over 1 month

Population: Diary problems for 2 subjects

Leakage episodes (metric for incontinence) collected over the initial month of testing.

Outcome measures

Outcome measures
Measure	Genital Nerve Stimulation n=3 Participants Study participants in this arm will use take-home genital nerve stimulation for 24+ months in order to assess its effectiveness at decreasing urinary incontinence.
Incontinence Control	2.08 Events Standard Deviation 1.92
Incontinence Stimulation	0.88 Events Standard Deviation 0.33

PRIMARY outcome

Timeframe: Collected over 1 month

Population: Diary problems for 2 subjects

Urgency episodes collected over the initial month of testing.

Outcome measures

Outcome measures
Measure	Genital Nerve Stimulation n=4 Participants Study participants in this arm will use take-home genital nerve stimulation for 24+ months in order to assess its effectiveness at decreasing urinary incontinence.
Urgency Control	7.95 Events Standard Deviation 3.76
Urgency Stimulation	7.04 Events Standard Deviation 3.24

SECONDARY outcome

Timeframe: Collected over 1 month

The investigators will measure bladder capacity in mL during acute urodynamics trials

Outcome measures

Outcome measures
Measure	Genital Nerve Stimulation n=7 Participants Study participants in this arm will use take-home genital nerve stimulation for 24+ months in order to assess its effectiveness at decreasing urinary incontinence.
Bladder Capacity Control	346.1 ml Standard Deviation 129.2
Bladder Capacity Stimulation	520.9 ml Standard Deviation 143.2

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Genital Nerve Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kenneth J. Gustafson, PhD

Case Western Reserve University

Phone: 2163688626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place