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

Description

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

Conditions

Spinal Cord Injuries, Urinary Incontinence

Study Overview

Study Details

Study overview

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

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

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

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

College Station

Texas A&M University, College Station, Texas, United States, 77843

Galveston

University of Texas Medical Branch, Galveston, Texas, United States, 77555

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Medical Branch, Galveston,

Kathy Vincent, MD, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

2025-12-01