Use of Sildenafil for Treatment of Urinary Incontinence

Sponsor

The University of Texas Medical Branch, Galveston (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02983461

Collaborator

(none)

Enrollment

Location

Arms

83.7

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Drug: Sildenafil Drug: Placebo	Phase 1

Detailed Description

Aim: To determine the effect of sildenafil on urinary incontinence.

Episodes of urinary incontinence will be recorded using a 3 day bladder diary.
Quantitative assessment of urinary incontinence will be performed at baseline and after treatment using a Pad Test.
Muscle strength will be assessed through use of a perineometer.
To evaluate macrocirculatory blood flow in pelvic organs, women will be assessed with noninvasive imaging before and after randomization to sildenafil.
Secondary outcomes will include evaluation of muscle and vaginal mucosal thickness.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Use of Sildenafil for Treatment of Urinary Incontinence

Actual Study Start Date :

Mar 10, 2017

Actual Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Double Blind Placebo 3 times a day for 10 weeks.	Drug: Placebo Placebo oral tablet, 3 times a day for 10 weeks
Active Comparator: Sildenafil Double Blind Sildenafil, 20mg x 3 times a day, 10 weeks.	Drug: Sildenafil Sildenafil, 20mg x 3 times a day for 10 weeks

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Double Blind Placebo 3 times a day for 10 weeks.

Drug: Placebo

Placebo oral tablet, 3 times a day for 10 weeks

Active Comparator: Sildenafil

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

Drug: Sildenafil

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

Outcome Measures

Primary Outcome Measures

Urinary Incontinence as measured by Pad Test [10 weeks]
Pad tests quantitatively measures urine leakage

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Significant heart, liver, kidney, pulmonary, blood, autoimmune or peripheral vascular disease (history of Hashimoto's thyroiditis is not exclusionary if stable and thyroid replacement is being administered. Thyroid testing will be performed at screening and as needed during study visits. )
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Medical Branch	Galveston	Texas	United States	77555

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

Investigators

Principal Investigator: Kathleen L Vincent, MD, University of Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Texas Medical Branch, Galveston

ClinicalTrials.gov Identifier:

NCT02983461

Other Study ID Numbers:

15-0121

First Posted:

Dec 6, 2016

Last Update Posted:

May 31, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The University of Texas Medical Branch, Galveston

urinary incontinence

pelvic floor dysfunction

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Sildenafil Citrate

Study Results

No Results Posted as of May 31, 2022