Urinary IncontinencePhase 1NCT02983461
Use of Sildenafil for Treatment of Urinary Incontinence
A Phase 1 study testing Sildenafil in people with Urinary Incontinence, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2017to Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
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.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- Sildenafil, Placebo
- Keywords
- urinary incontinence, pelvic floor dysfunction
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Sildenafil, 20mg x 3 times a day for 10 weeks
PlaceboDrug
Placebo oral tablet, 3 times a day for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Double Blind Placebo 3 times a day for 10 weeks. Receives: Drug: Placebo |
| Sildenafil | Active comparator | Double Blind Sildenafil, 20mg x 3 times a day, 10 weeks. Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Incontinence as measured by Pad Test
Pad tests quantitatively measures urine leakage
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start10 Mar 2017
- Primary completion1 Mar 2020
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen L Vincent, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983461
- Sponsor's protocol ID
- 15-0121
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2016
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Sildenafil for Treatment of Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02983461
- Acronym / sponsor ID
- 15-0121
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, pelvic floor dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- Jul 2028 (estimated)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboDouble Blind Placebo 3 times a day for 10 weeks. |
| Sildenafil | Active comparator | Drug: SildenafilDouble Blind Sildenafil, 20mg x 3 times a day, 10 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilSildenafil, 20mg x 3 times a day for 10 weeks | Drug | Sildenafil |
| PlaceboPlacebo oral tablet, 3 times a day for 10 weeks | Drug | Placebo |
Primary outcome
Urinary Incontinence as measured by Pad Test
Time frame: 10 weeks
Pad tests quantitatively measures urine leakage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen L Vincent, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sildenafil in people with Urinary Incontinence, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Incontinence as measured by Pad Test (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.