Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Spinal Cord Injuries, Urinary Incontinence
In brief
The goal of this study is to determine whether administration of sildenafil will decrease urine leakage in patients with spinal cord injuries.
Key facts
- Study ID
- NCT04565925
- Run by
- The University of Texas Medical Branch, Galveston
- People needed
- 24
- Starts
- 2021-07-07
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-12-16
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Texas Medical Branch — Galveston, Texas, United States (enrolling)
- Texas A&M University — College Station, Texas, United States
Full record on ClinicalTrials.gov
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