CompletedPhase 1

Two Devices for Reflex Voiding Following Spinal Cord Injury

United States3 participantsStarted 2008-10

Plain-language summary

The purpose of this investigation is to evaluate methods in spinal cord injured individuals to improve reflex urination. Anal dilation will be investigated to reduce high urethral resistance and a vibrator on the patient's bottom will be tested to induce more sustained bladder contractions for better bladder emptying.

Who can participate

Age range

18 Years – 70 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Male Veterans using Hines VA Hospital SCI Service that have upper motor neuron injuries Exclusion Criteria: * Can voluntarily control their urination * Surgically removed external urethral sphincter in men or replaced bladder * Any implanted devices in the lower urinary tract * Female * Urinary tract infection in the prior 3 months or untreated urinary tract infection, or bladder pathology such as a tumor or stones * History of autonomic dysreflexia * Anal inflammation or pathology * Use of Indwelling (Foley) catheter as the primary method of bladder management; note patients will be included if they only occasionally use a Foley catheters; for example, during traveling * Not under 18 or over 70 years old and in good health * Less than 3-months after injury and before the return of bladder reflexes * Lower motor neuron spinal cord injury * Not competent to understand the study and the consent and willing to participate in study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With a Change in Bladder Pressure

Timeframe: 3 hour recording session

Number of Participants With a Change in External Urethral Pressure

Timeframe: 3 hour recording session

Number of Participants With a Change in Anal Sphincter Pressure

Timeframe: 3 hour recording session

Number of Participants With a Urethral Sphincter Contractions

Timeframe: 3 hour recording session

Trial details

NCT IDNCT00662207

SponsorUS Department of Veterans Affairs

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2009-10

Results submitted2014-11-04

View on ClinicalTrials.gov More Spinal Cord Injury trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With a Change in Bladder Pressure

Timeframe: 3 hour recording session

Number of Participants With a Change in External Urethral Pressure

Timeframe: 3 hour recording session

Number of Participants With a Change in Anal Sphincter Pressure

Timeframe: 3 hour recording session

Number of Participants With a Urethral Sphincter Contractions

Timeframe: 3 hour recording session