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Viagra drug could help spinal injury patients stop leaks

NCT ID NCT04565925

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This study tests whether sildenafil (the drug in Revatio, similar to Viagra) can reduce urine leakage in people with spinal cord injuries. Twenty-four adults who have at least three leaks per week will take either sildenafil or a placebo for four weeks. Researchers will track how many leaks they have each day using a bladder diary.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sildenafil Citrate (Revatio)
What this could lead to
If it works, this could offer a new, simple treatment to reduce bladder leaks and improve daily life for people with spinal cord injuries.
What could go wrong
This is a small, early-phase trial with only 24 people. It may not show a clear benefit, and results might not apply to everyone with spinal cord injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults with spinal cord injury (SCI), 18-75 years of age, at the time of consent * Have urinary incontinence (UI), with at least 3 leakage episodes/week * Have urodynamics assessment on file with their provider in past 3 years. If no historical data on file, subject may complete prior to study visit 1. * Willing and able to comply with study procedures * Willing and able to provide written informed consent Exclusion Criteria: * In phone prescreen, delighted or pleased with current quality of life due to urinary symptoms. * Indwelling catheter * History of greater than 4 urinary tract infections per year * Multiple sclerosis * Significant heart, liver, kidney, pulmonary, blood, autoimmune or peripheral vascular disease * Systolic blood pressure \<90 or \>170, diastolic blood pressure \<50 or \>110 after repeated evaluation with proper cuff. This range is the acceptable range stated in the prescribing information for sildenafil (\>90/50 and \<170/110) * Active cancer * HIV, Hepatitis B, or Hepatitis C * Use of systemic nitrates, anabolic steroids, corticosteroids, or long acting PDE5 inhibitors in the past 1 month * Use of short acting PDE5 inhibitors in the past 1 week * Use of alpha blockers, anticholinergic agents, bethanechol, or other UI treatment within the past 2 weeks ( 3 weeks for long acting muscarinic receptor antagonists) * Known allergic reaction to any agent under investigation or required by the protocol * Females who are pregnant or lactating * Atonic bladder or high detrusor and high pelvic floor muscle pressure based on previous cystometrogram (CMG) (on file with their provider) that would place subjects at risk for kidney injury * Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation

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Conditions

The condition(s) this trial relates to.

spinal cord injury Urinary Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Texas A&M University

    College Station, Texas, 77843, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

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