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New treatment option for Spinal Cord Injuries
Official title Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries
ClinicalTrials.gov ID: NCT04565925
What this study is testing
What is Sildenafil Citrate?
Sildenafil Citrate is an investigational medicine, given as an once-daily, being studied as a potential treatment for spinal cord injuries.
Also referred to as Revatio.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to determine whether administration of sildenafil will decrease urine leakage in patients with spinal cord injuries.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
You likely can't join if
- 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 \ 170, diastolic blood pressure \ 110 after repeated evaluation with proper cuff. This range is the acceptable range stated...
See the full 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 \ 170, diastolic blood pressure \ 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 people at risk for kidney injury
- Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation
The study team makes the final eligibility decision.
Where it's taking place
- College Station, Texas, United States
- Galveston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include College Station, Texas, United States; Galveston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.