Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries

NCT04565925 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 20-0197
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to determine whether administration of sildenafil will decrease urine leakage in patients with spinal cord injuries.

Conditions

Spinal Cord Injuries; Urinary Incontinence

Outcome Measures

Primary Outcomes (3)

• Bladder Leakage as measured by 5 day bladder diary at 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.

  baseline

• Bladder Leakage as measured by 5 day bladder diary 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.

  after 4 weeks of sildenafil treatment

• Bladder Leakage as measured by 5 day bladder diary 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.

  after 4 weeks of placebo treatment

Secondary Outcomes (18)

• Blood sildenafil levels as measured by Liquid Chromatography Mass Spectrometry (LCMS) at baseline

  baseline

• Blood sildenafil levels as measured by Liquid Chromatography Mass Spectrometry (LCMS) after 4 weeks of sildenafil treatment

  after 4 weeks of sildenafil treatment

• Blood sildenafil levels as measured by Liquid Chromatography Mass Spectrometry (LCMS) after 4 weeks of placebo treatment

  after 4 weeks of placebo treatment

• Post void residual urine volume as measured by ultrasound bladder scanner at baseline

  baseline

• Post void residual urine volume as measured by ultrasound bladder scanner after 4 weeks of sildenafil treatment

  after 4 weeks of sildenafil treatment

Study Arms (2)

Sildenafil 20mg TID then Placebo TID

EXPERIMENTAL

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.

Drug: Sildenafil Citrate; Drug: Placebo

Placebo TID then Sildenafil 20mg TID

EXPERIMENTAL

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.

Drug: Sildenafil Citrate; Drug: Placebo

Interventions

Sildenafil Citrate DRUG

Sildenafil 20mg TID for 4 weeks

Also known as: Revatio

Placebo TID then Sildenafil 20mg TID; Sildenafil 20mg TID then Placebo TID

Placebo DRUG

Placebo (Lactose) TID for 4 weeks

Also known as: Lactose

Placebo TID then Sildenafil 20mg TID; Sildenafil 20mg TID then Placebo TID

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Active cancer
• HIV, Hepatitis B, or Hepatitis C
• Use of systemic nitrates, anabolic steroids, corticosteroids, or long acting PDE5 inhibitors in the past 1 month
• Use of short acting PDE5 inhibitors in the past 1 week
• Use of alpha blockers, anticholinergic agents, bethanechol, or other UI treatment within the past 2 weeks ( 3 weeks for long acting muscarinic receptor antagonists)
• Known allergic reaction to any agent under investigation or required by the protocol
• Females who are pregnant or lactating
• Atonic bladder or high detrusor and high pelvic floor muscle pressure based on previous cystometrogram (CMG) (on file with their provider) that would place subjects at risk for kidney injury
• Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (2)

Texas A&M University

College Station, Texas, 77843, United States

ACTIVE NOT RECRUITING

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Incontinence

Interventions

Sildenafil Citrate; Lactose

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; 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; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Kathy Vincent, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate M Randolph, BS

CONTACT

409-223-7891; kmrandol@utmb.edu

Kathy Vincent, MD

CONTACT

409-772-2610; klvincen@utmb.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the subjects and the investigators will be blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject will be administered both sildenafil 20mg TID for 4 weeks and placebo (lactose) TID for 4 weeks in a crossover fashion with a 2 week washout period between treatments.

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: July 7, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)