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Use of Sildenafil for Treatment of Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Sildenafil

Placebo

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, pelvic floor dysfunction

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Sildenafil

Arm Description

Double Blind Placebo 3 times a day for 10 weeks.

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

Outcomes

Primary Outcome Measures

Urinary Incontinence as measured by Pad Test

Pad tests quantitatively measures urine leakage

Secondary Outcome Measures

Full Information

NCT ID

NCT02983461

First Posted

December 2, 2016

Last Updated

June 22, 2023

Sponsor

The University of Texas Medical Branch, Galveston

1. Study Identification

Unique Protocol Identification Number

NCT02983461

Brief Title

Use of Sildenafil for Treatment of Urinary Incontinence

Official Title

Use of Sildenafil for Treatment of Urinary Incontinence

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 10, 2017 (Actual)

Primary Completion Date

March 1, 2020 (Actual)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence

Keywords

urinary incontinence, pelvic floor dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Double Blind Placebo 3 times a day for 10 weeks.

Arm Title

Sildenafil

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo oral tablet, 3 times a day for 10 weeks

Primary Outcome Measure Information:

Title

Urinary Incontinence as measured by Pad Test

Description

Pad tests quantitatively measures urine leakage

Time Frame

10 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen L Vincent, MD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Medical Branch

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Use of Sildenafil for Treatment of Urinary Incontinence

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