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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Sildenafil Citrate

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