NCT04565925 · The University of Texas Medical Branch, Galveston
Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries
What this study is about
The goal of this study is to determine whether administration of sildenafil will decrease urine leakage in patients with spinal cord injuries.
View original scientific description
The goal of this study is to determine whether administration of sildenafil will decrease urine leakage in patients with spinal cord injuries.
Interventions
DRUG
Sildenafil Citrate
Sildenafil 20mg TID for 4 weeks
DRUG
Placebo
Placebo (Lactose) TID for 4 weeks
Primary outcome measures
Bladder Leakage as measured by 5 day bladder diary at Baseline
Time frame: baseline
Bladder leakage will be measured by bladder diary, which will be kept for five- 24 hours periods at baseline. Subjects will be asked to record the number of leaks each day. Data will be calculated by summing total number of leaks over the 5 day recording period and dividing the sum by 5, resulting in average leaks per day.
Bladder Leakage as measured by 5 day bladder diary after 4 weeks of Sildenafil Treatment
Time frame: after 4 weeks of sildenafil treatment
Bladder leakage will be measured by bladder diary, which will be kept for five 24 hours periods in the last week of the 4 weeks of sildenafil treatment.
Bladder Leakage as measured by 5 day bladder diary after 4 weeks of Placebo Treatment
Time frame: after 4 weeks of placebo treatment
Bladder leakage will be measured by bladder diary, which will be kept for five 24 hours periods in the last week of the 4 weeks of placebo treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- College Station, Texas
- Galveston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 16, 2025 · Source of record for eligibility and locations