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Sildenafil for Urinary Incontinence

Phase 2
Recruiting
Led By Kathy Vincent, MD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have urinary incontinence (UI), with at least 3 leakage episodes/week
Adults with spinal cord injury (SCI), 18-75 years of age, at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 4 weeks of placebo treatment
Awards & highlights

Study Summary

This trial is testing whether sildenafil can help people with spinal cord injuries by reducing urine leakage.

Who is the study for?
This trial is for adults aged 18-75 with spinal cord injuries who experience urinary incontinence, having at least three leakage episodes per week. Participants must have a urodynamics assessment and be willing to follow study procedures. Excluded are those satisfied with their current quality of life due to urinary symptoms, using certain medications or treatments recently, pregnant or lactating women, and individuals with significant health issues like heart disease or active cancer.Check my eligibility
What is being tested?
The study aims to see if sildenafil can reduce urine leakage in patients with spinal cord injuries compared to a placebo. It's designed as an experiment where participants don't know if they're getting the actual drug or a dummy pill (placebo).See study design
What are the potential side effects?
Sildenafil may cause headaches, flushing, indigestion, nasal congestion, dizziness, vision changes like increased sensitivity to light or blurred vision. These side effects aren't guaranteed but are possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience urinary leaks at least 3 times a week.
Select...
I am between 18 and 75 years old with a spinal cord injury.
Select...
I experience urinary leakage at least 3 times a week.
Select...
I am between 18 and 75 years old with a spinal cord injury.
Select...
I experience urinary leaks at least 3 times a week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 4 weeks of sildenafil treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 4 weeks of sildenafil treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bladder Leakage as measured by 5 day bladder diary after 4 weeks of Placebo Treatment
Bladder Leakage as measured by 5 day bladder diary after 4 weeks of Sildenafil Treatment
Bladder Leakage as measured by 5 day bladder diary at Baseline
Secondary outcome measures
Bladder dysfunction as measured by the Neurogenic Bladder Symptom Score after 4 weeks of placebo treatment
Bladder dysfunction as measured by the Neurogenic Bladder Symptom Score after 4 weeks of sildenafil treatment
Bladder dysfunction as measured by the Neurogenic Bladder Symptom Score at baseline
+15 more

Side effects data

From 2013 Phase 4 trial • 105 Patients • NCT00323297
14%
Diarrhoea
14%
Oedema peripheral
14%
Headache
10%
Vertigo
10%
Bronchitis
10%
Flushing
10%
Palpitations
10%
Nasopharyngitis
8%
Respiratory tract infection
6%
Pulmonary hypertension
6%
Depression
6%
Presyncope
6%
Dyspnoea
6%
Right ventricular failure
6%
Vision blurred
4%
Pulmonary arterial hypertension
4%
Upper respiratory tract infection
4%
Bronchopneumonia
4%
Anaemia
2%
Hypertension
2%
Cough
2%
Acute coronary syndrome
2%
Inguinal hernia
2%
Asthenia
2%
Cardiovascular disorder
2%
Mitral valve incompetence
2%
Gangrene
2%
Respiratory syncytial virus infection
2%
Urinary tract infection
2%
Walking distance test abnormal
2%
Breast cancer
2%
Uterine haemorrhage
2%
Haemoptysis
2%
Hypoxia
2%
Skin ulcer
2%
Nausea
2%
Back pain
2%
Death
2%
General physical health deterioration
2%
Circulatory collapse
2%
Cardiac failure
2%
Coronary artery disease
2%
Chest discomfort
2%
Pancreatic neoplasm
2%
Haemoglobin decreased
2%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sildenafil

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sildenafil 20mg TID then Placebo TIDExperimental Treatment2 Interventions
Subjects will be administered Sildenafil 20mg TID for 4 weeks. There will be a 2 week washout period then subjects will be administered Placebo (lactose) TID for 4 weeks.
Group II: Placebo TID then Sildenafil 20mg TIDExperimental Treatment2 Interventions
Subjects will be administered Placebo (lactose) TID for 4 week. There will be a 2 week washout period and then subjects will be administered Sildenafil 20mg TID for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sildenafil Citrate
2021
Completed Phase 4
~1590
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
244 Previous Clinical Trials
56,777 Total Patients Enrolled
Kathy Vincent, MDPrincipal InvestigatorUniversity of Texas

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04565925 — Phase 2
Spinal Cord Injury Research Study Groups: Placebo TID then Sildenafil 20mg TID, Sildenafil 20mg TID then Placebo TID
Spinal Cord Injury Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04565925 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04565925 — Phase 2
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT04565925 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks could be associated with Sildenafil Citrate use?

"Safety analysis of sildenafil citrate was rated a 2, as this is only in phase 2 trials and while there is evidence backing its safety, efficacy data remains lacking."

Answered by AI

What is the upper-limit for participant inclusion in this medical experiment?

"Absolutely. According to clinicaltrials.gov, this investigative trial is still recruiting patients from a single site; the study was initiated on July 7th 2021 and last modified November 2nd 2022. Currently, 24 individuals need to be enrolled in total."

Answered by AI

What maladies can Sildenafil Citrate be utilized to address?

"Sildenafil Citrate is commonly prescribed to treat asthma, however it has also been used therapeutically for premature ejaculation and some types of pulmonary arterial hypertension. It may even help patients with thyroid cancer manage the progression of their illness."

Answered by AI

Does this medical experiment permit adults beyond the age of 75 to participate?

"The eligibility requirements for this trial stipulate that patients must between the ages of 18 and 70. As a corollary, 166 trials exist specifically for minors while 874 are available to seniors."

Answered by AI

Are there any opportunities currently available to sign up for this medical experiment?

"Affirmative. Clinicaltrials.gov attests to the fact that this medical research, which was first announced on July 7th 2021, is recruiting participants. A total of 24 individuals must be enrolled from one site for the study to proceed properly."

Answered by AI

What are the main aims of this experiment?

"The primary aim of this trial, evaluated over the baseline period, is to determine Bladder Leakage through a 5-day bladder diary after 4 weeks of Sildenafil Treatment. Secondary objectives include assessing Urinary Symptoms Interference as measured by Pelvic Floor Impact Questionnaire (PFIQ-7) and Post void residual urine volume via ultrasound scanner following placebo treatment or sildenafil administration. Results are reported on three respective scales ranging from 0 - 100 with lower scores indicating less effect on quality of life; summary PFIQ-7 score ranges from 0 - 300."

Answered by AI

Would I qualify for enrollment in this trial?

"A total of 24 participants, aged 18-70 and with a spinal cord injury, are being admitted into this trial. In addition to these criteria, they must have recently undergone urodynamics assessment or be willing to do so; suffer from urinary incontinence (3+ leakage episodes per week); and agree to completely follow the prescribed study procedures."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Texas A&M University
University of Texas Medical Branch
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm very interested in treating my urinary incontinence.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of Texas Medical Branch: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries
2021. "Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04565925.
All > Urinary Incontinence > Viagra
~8 spots leftby Dec 2025
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