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

Launched by THE UNIVERSITY OF TEXAS MEDICAL BRANCH, GALVESTON · Sep 21, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called sildenafil can help reduce urine leakage in adults who have spinal cord injuries and experience urinary incontinence. The study is currently looking for participants aged 18 to 75 who have at least three episodes of urine leakage each week. To be eligible, participants need to have had a specific test related to their bladder control in the past three years and be willing to follow the study's procedures and provide written consent.

Participants in the trial can expect to receive sildenafil and will be monitored throughout the study to see if it helps improve their condition. It’s important to note that some individuals may not qualify, such as those with certain medical conditions, those who have frequent urinary tract infections, or those currently using specific medications for urinary incontinence. This trial aims to help find new solutions for managing urinary issues in people with spinal cord injuries, potentially improving their quality of life.

Gender

ALL

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