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Could a blood flow drug strengthen pelvic muscles to curb incontinence?

NCT ID NCT02983461

Disease control Sponsor: The University of Texas Medical Branch, Galveston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests whether sildenafil, a drug that improves blood flow and muscle strength, can help postmenopausal women with stress or mixed urinary incontinence. The idea is that sildenafil may reduce pelvic floor muscle atrophy, improving symptoms. Participants take sildenafil or a placebo three times daily for 10 weeks, and urine leakage is measured with a pad test.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sildenafil
What this could lead to
If sildenafil strengthens pelvic floor muscles, it could offer a new, non-surgical treatment for urinary incontinence in postmenopausal women.
What could go wrong
This is a small, early-phase trial. The drug may not improve incontinence, and side effects are possible. Results may not apply to all women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2017

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

female stress incontinence Urinary Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary incontinence

Contacts and locations

Locations

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.