Viagra drug could help spinal injury patients stop leaks
NCT ID NCT04565925
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
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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 Hide 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.
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Breathing brief Low-Oxygen bursts may boost sleep apnea treatment
- Pure oxygen tested as a switch for dormant nerves after spinal cord injury
- Spinal stimulation tested to help kids with spinal cord injuries sit taller
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- Can painless spinal zaps teach injured kids to walk again?