Use of Sildenafil for Treatment of Urinary Incontinence

NCT02983461 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 15-0121
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence

Keywords

urinary incontinence; pelvic floor dysfunction

Outcome Measures

Primary Outcomes (1)

• Urinary Incontinence as measured by Pad Test

  Pad tests quantitatively measures urine leakage

  10 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Double Blind Placebo 3 times a day for 10 weeks.

Drug: Placebo

Sildenafil

ACTIVE COMPARATOR

Double Blind Sildenafil, 20mg x 3 times a day, 10 weeks.

Drug: Sildenafil

Interventions

Sildenafil DRUG

Sildenafil, 20mg x 3 times a day for 10 weeks

Sildenafil

Placebo DRUG

Placebo oral tablet, 3 times a day for 10 weeks

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kathleen L Vincent, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 6, 2016
• Study Start: March 10, 2017
• Primary Completion: March 1, 2020
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

US (1)