NCT04565925 Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries
| NCT ID | NCT04565925 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Texas Medical Branch, Galveston |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2021-07-07 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2021-07-07 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to determine whether administration of sildenafil will decrease urine leakage in patients with spinal cord injuries.
Eligibility Criteria
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
Contact & Investigator
Kathy Vincent, MD
PRINCIPAL INVESTIGATOR
University of Texas
Frequently Asked Questions
Who can join the NCT04565925 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04565925 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04565925 currently recruiting?
Yes, NCT04565925 is actively recruiting participants. Contact the research team at kmrandol@utmb.edu for enrollment information.
Where is the NCT04565925 trial being conducted?
This trial is being conducted at College Station, United States, Galveston, United States.
Who is sponsoring the NCT04565925 clinical trial?
NCT04565925 is sponsored by The University of Texas Medical Branch, Galveston. The principal investigator is Kathy Vincent, MD at University of Texas. The trial plans to enroll 24 participants.