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Sildenafil for Urinary Incontinence in Spinal Cord Injury

This study is looking at whether sildenafil citrate (Viagra) can help reduce urine leakage in people with spinal cord injuries. Urinary incontinence (UI) is a common and distressing problem for many people with spinal cord injuries, affecting their quality of life. This study will compare sildenafil citrate to a placebo (an inactive pill) over 4 weeks. You might be able to join if you are an adult between 18 and 70 years old, have a spinal cord injury, and experience at least three urine leakage episodes per week. The main goal is to see if sildenafil reduces the number of leakage episodes, which will be tracked using a bladder diary. The study plans to enroll 24 participants, but its current status is unclear.

Study design
This is an interventional study comparing sildenafil citrate to a placebo in 24 participants. It is not specified if participants or researchers will know which treatment is being given.
What's involved
Participants will take either sildenafil 20mg or a placebo three times a day for 4 weeks. They will also keep a 5-day bladder diary at the start and end of the treatment period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 4 weeks, with bladder leakage measured at the end of this period.

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NCT04565925

Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries

Recruiting
PHASE2Ages 18–70InterventionalTreatment
The University of Texas Medical Branch, Galveston
~24 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Sildenafil CitratePlacebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bladder Leakage as measured by 5 day bladder diary at Baseline
Measured over baseline
+2 more outcomes measured

Conditions

Spinal Cord Injuries
Urinary Incontinence

Explore related trials

Spinal Cord InjuryUrinary Incontinence

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Kathy Vincent, MD · PRINCIPAL_INVESTIGATOR · University of Texas

Who to contact

Kate M Randolph, BS
[email protected]
409-223-7891
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Bladder Leakage as measured by 5 day bladder diary at Baselinebaseline

    Bladder leakage will be measured by bladder diary, which will be kept for five- 24 hours periods at baseline. Subjects will be asked to record the number of leaks each day. Data will be calculated by summing total number of leaks over the 5 day recording period and dividing the sum by 5, resulting in average leaks per day.

  • Bladder Leakage as measured by 5 day bladder diary after 4 weeks of Sildenafil Treatmentafter 4 weeks of sildenafil treatment

    Bladder leakage will be measured by bladder diary, which will be kept for five 24 hours periods in the last week of the 4 weeks of sildenafil treatment.

  • Bladder Leakage as measured by 5 day bladder diary after 4 weeks of Placebo Treatmentafter 4 weeks of placebo treatment

    Bladder leakage will be measured by bladder diary, which will be kept for five 24 hours periods in the last week of the 4 weeks of placebo treatment.