Use of Sildenafil for Treatment of Urinary Incontinence

The investigators goal is to develop medical treatments for stress/mixed urinary incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and strength and to decrease muscle fatigue. The investigators believe that it will improve muscular atrophy in the pelvic floor, thus improving symptoms of urinary incontinence related to pelvic floor dysfunction.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Drug: Placebo; Drug: Sildenafil

Detailed Description

Aim: To determine the effect of sildenafil on urinary incontinence.

1. Episodes of urinary incontinence will be recorded using a 3 day bladder diary.
2. Quantitative assessment of urinary incontinence will be performed at baseline and after treatment using a Pad Test.
3. Muscle strength will be assessed through use of a perineometer.
4. To evaluate macrocirculatory blood flow in pelvic organs, women will be assessed with noninvasive imaging before and after randomization to sildenafil.
5. Secondary outcomes will include evaluation of muscle and vaginal mucosal thickness.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Postmenopausal females, 50-80 years of age, at the time of consent
• Have stress or mixed urinary incontinence, with at least 3 episodes/week
• Willing and able to comply with study procedures
• Willing and able to provide written informed consent

Exclusion Criteria:

• Significant heart, liver, kidney, pulmonary, blood, autoimmune or peripheral vascular disease (history of Hashimoto's thyroiditis is not exclusionary if stable and thyroid replacement is being administered. Thyroid testing will be performed at screening and as needed during study visits. )
• 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
• Active cancer
• Currently using and planning to continue use of urinary incontinence medications during study period
• BMI > 40
• HIV, Hepatitis B, or Hepatitis C
• Use of systemic nitrates, anabolic steroids or corticosteroids in the past 6 months
• Use of alpha blockers
• Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
• Known allergic reaction to any agent under investigation or required by the protocol.
• History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
• Females who are pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Double Blind Placebo 3 times a day for 10 weeks.	Drug: Placebo; Placebo oral tablet, 3 times a day for 10 weeks
Active Comparator: Sildenafil; Double Blind Sildenafil, 20mg x 3 times a day, 10 weeks.	Drug: Sildenafil; Sildenafil, 20mg x 3 times a day for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Incontinence as measured by Pad Test	Pad tests quantitatively measures urine leakage	10 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Kathleen L Vincent, MD, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (Estimated): December 6, 2016

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: August 5, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: urinary incontinence; pelvic floor dysfunction
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; Purines; Sulfonamides; Sulfones; Piperazines; Sildenafil Citrate
• Other Study ID Numbers: 15-0121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No