Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT04565925

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

Led by The University of Texas Medical Branch, Galveston · Updated on 2025-12-16

24

Participants Needed

2

Research Sites

281 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this study is to determine whether administration of sildenafil will decrease urine leakage in patients with spinal cord injuries.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with spinal cord injury aged 18 to 75 years at the time of consent
  • Experience urinary incontinence with at least 3 leakage episodes per week
  • Have urodynamics assessment on file from the past 3 years or complete one before study visit 1
  • Willing and able to comply with all study procedures
  • Willing and able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Pleased with current urinary symptoms quality of life during phone prescreen
  • Use of an indwelling catheter
  • History of more than 4 urinary tract infections per year
  • Diagnosis of multiple sclerosis
  • Significant heart, liver, kidney, lung, blood, autoimmune, or peripheral vascular disease
  • Blood pressure outside 90/50 to 170/110 mmHg range after repeated measurements
  • Active cancer
  • Infection with HIV, Hepatitis B, or Hepatitis C
  • Use of systemic nitrates, anabolic steroids, corticosteroids, or long-acting PDE5 inhibitors in the past month
  • Use of short-acting PDE5 inhibitors in the past week
  • Use of alpha blockers, anticholinergic agents, bethanechol, or other urinary incontinence treatments within the past two weeks (three weeks for long-acting muscarinic receptor antagonists)
  • Known allergy to study medications or required agents
  • Females who are pregnant or breastfeeding
  • Atonic bladder or high detrusor and pelvic floor muscle pressure placing risk for kidney injury
  • Any medical condition that increases risk for participation as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Texas A&M University

College Station, Texas, United States, 77843

Active, Not Recruiting

2

University of Texas Medical Branch

Galveston, Texas, United States, 77555

Actively Recruiting

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Research Team

K

Kate M Randolph, BS

CONTACT

K

Kathy Vincent, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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