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

Part of paid clinical trials in College Station, Texas.

Sponsor
The University of Texas Medical Branch, Galveston
Study ID
NCT04565925
Phase
PHASE2
Status
Recruiting
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Conditions

  • Spinal Cord Injuries
  • Urinary Incontinence

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Sildenafil Citrate — DRUG
    Sildenafil 20mg TID for 4 weeks
  • Placebo — DRUG
    Placebo (Lactose) TID for 4 weeks

Study Details

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

Key Dates

Start date
Jul 7, 2021
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sildenafil 20mg TID then Placebo TID
    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.
  • Experimental: Placebo TID then Sildenafil 20mg TID
    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.

Primary Outcome Measure

Bladder Leakage as measured by 5 day bladder diary at Baseline [ Time Frame: baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Texas A&M UniversityCollege StationTexas77843-
University of Texas Medical BranchGalvestonTexas77555
Kathleen Vincent, MD
[email protected]
409-772-2610
Lauren Dawson, BS
[email protected]
409-354-9792

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By research site
Texas A&M University· College Station, TXUniversity of Texas Medical Branch· Galveston, TX

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