Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-03-07 @ 11:01 PM
Study NCT ID:
NCT02983461
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2016-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Sildenafil for Treatment of Urinary Incontinence
Sponsor:
The University of Texas Medical Branch, Galveston
Organization:
Study Overview
Official Title:
Use of Sildenafil for Treatment of Urinary Incontinence
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: