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Phosphodiesterase Type 5 Inhibitor

Sildenafil for Urinary Incontinence

Phase 1
Waitlist Available
Led By Kathleen L 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
Postmenopausal females, 50-80 years of age, at the time of consent
Have stress or mixed urinary incontinence, with at least 3 episodes/week
Must not have
Systolic blood pressure <100 or >150, diastolic blood pressure <60 or >90 after repeated evaluation with proper cuff. This range is smaller than the acceptable range stated in the prescribing information for sildenafil (>90/50 and <170/110)
Diabetes mellitus or other untreated endocrine disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks

Summary

This trial is testing whether sildenafil can improve urinary incontinence by improving blood flow and muscle mass in the pelvic floor.

Who is the study for?
This trial is for postmenopausal women aged 50-80 with stress or mixed urinary incontinence, experiencing at least three episodes a week. Participants should be able to follow the study procedures and provide consent. Excluded are those with significant health issues like heart or liver disease, active cancer, untreated endocrine diseases, high BMI (>40), certain infections (HIV/Hepatitis), or on conflicting medications.
What is being tested?
The trial is testing Sildenafil's effectiveness against urinary incontinence by improving pelvic floor muscle function. Women will either receive Sildenafil or a placebo to see if there's an improvement in their symptoms compared to those not receiving the drug.
What are the potential side effects?
Sildenafil may cause side effects such as headaches, flushing, indigestion, nasal congestion, dizziness, and visual disturbances. It can also potentially affect blood pressure and interact with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 50-80 and have gone through menopause.
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I experience urinary leaks due to stress or mixed reasons at least 3 times a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is either below 100/60 or above 150/90.
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I have diabetes or another hormone-related condition that isn't being treated.
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My cancer is currently active.
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I do not have HIV, Hepatitis B, or Hepatitis C.
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I am currently taking alpha blockers.
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I am currently taking and plan to keep taking medication for urinary incontinence.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Urinary Incontinence as measured by Pad Test

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: SildenafilActive Control1 Intervention
Double Blind Sildenafil, 20mg x 3 times a day, 10 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Double Blind Placebo 3 times a day for 10 weeks.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
254 Previous Clinical Trials
57,231 Total Patients Enrolled
2 Trials studying Urinary Incontinence
72 Patients Enrolled for Urinary Incontinence
Kathleen L Vincent, MDPrincipal InvestigatorUniversity of Texas
2 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Sildenafil (Phosphodiesterase Type 5 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02983461 — Phase 1
Urinary Incontinence Research Study Groups: Sildenafil, Placebo
Urinary Incontinence Clinical Trial 2023: Sildenafil Highlights & Side Effects. Trial Name: NCT02983461 — Phase 1
Sildenafil (Phosphodiesterase Type 5 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02983461 — Phase 1
~3 spots leftby Dec 2025
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