Using sildenafil to reduce urinary incontinence in spinal cord injury patients
Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries
This study is testing if sildenafil can help adults with spinal cord injuries who have trouble controlling their urine to see if it reduces leakage and improves their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 2 sites (College Station, Texas and 1 other locations) |
| Trial ID | NCT04565925 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of sildenafil in decreasing urine leakage among adults with spinal cord injuries who experience urinary incontinence. The trial will involve administering sildenafil citrate or a placebo to participants, with the goal of assessing improvements in urinary symptoms. Given the significant distress and quality of life issues associated with urinary incontinence in this population, the study seeks to provide a potential pharmacological solution where none currently exists. Participants will be monitored for changes in urinary leakage episodes and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with spinal cord injuries who experience at least three episodes of urinary incontinence per week.
Not a fit: Patients who are satisfied with their current quality of life regarding urinary symptoms or have certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with spinal cord injuries by reducing urinary incontinence.
How similar studies have performed: While sildenafil has been used for other indications, this specific application for urinary incontinence in spinal cord injury patients is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
College Station, Texas and 1 other locations
- Texas A&M University — College Station, Texas, United States (Active_not_recruiting)
- University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Kathy Vincent, MD — University of Texas
- Study coordinator: Kate M Randolph, BS
- Email: kmrandol@utmb.edu
- Phone: 409-223-7891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.