NCT02983461

Use of Sildenafil for Treatment of Urinary Incontinence

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DRUG	Sildenafil	Sildenafil, 20mg x 3 times a day for 10 weeks
DRUG	Placebo	Placebo oral tablet, 3 times a day for 10 weeks

Timeline

• Start date: 2017-03-10
• Primary completion: 2020-03-01
• Completion: 2027-07-01
• First posted: 2016-12-06
• Last updated: 2025-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study