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Prostate drug tested in women to prevent Post-Surgery urinary blockage

NCT ID NCT04232683

Prevention Sponsor: The Cleveland Clinic 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tested whether giving tamsulosin (a drug typically used for prostate issues) before pelvic floor surgery in women could prevent postoperative urinary retention. 100 women undergoing surgery for prolapse, with or without a sling procedure, were enrolled. The study compared tamsulosin to a placebo to see if it helped them pass a voiding trial after surgery.

What this could mean

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

Active substance
Tamsulosin
What this could lead to
If it works, this could offer a simple way to prevent a common complication after pelvic surgery in women.
What could go wrong
This is a very early, small trial (100 women) with limited evidence. The drug may not work better than placebo, and side effects like low blood pressure are possible.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

100 people

The number who actually took part.

Started

Dec 2019

Finished

Oct 2025

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: i. Patient undergoing surgery for prolapse with or without mid-urethral sling procedure. ii. Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings Exclusion Criteria: i. Diagnosis of urinary retention preoperatively (post void residual \>150ml) ii. Malignancy iii. History of neurological disease iv. History of spinal cord injuries v. Allergy to Tamsulosin vi. Perioperative complications requiring prolonged postoperative bladder drainage vii. Incontinence procedures other than mid-urethral slings

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Conditions

The condition(s) this trial relates to.

Urinary Retention

As listed by the trial registrant

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

Urinary retention

Contacts and locations

Locations

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

More trials for these conditions

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