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New balloon coated with drug may help men with narrowed urethra

NCT ID NCT03270384

Disease control Sponsor: Urotronic Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special balloon coated with the drug paclitaxel to treat urethral stricture, a narrowing of the tube that carries urine out of the body. Sixteen men with recurrent strictures received the balloon treatment. The goal was to see if the device is safe and can help prevent the stricture from coming back.

What this could mean

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

Active substance
paclitaxel-coated balloon
What this could lead to
If it works, this could offer a less invasive treatment option for recurrent urethral stricture, potentially reducing the need for repeat procedures.
What could go wrong
This was a very small early study with only 16 participants, so results may not apply to everyone. The drug coating (paclitaxel) could cause side effects, and the stricture might still come back.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

16 people

The number who actually took part.

Started

Oct 2017

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Male subjects ≥ 18 years' old 2. Visual confirmation of stricture via cystoscopy or urethrogram 3. Single lesion anterior urethral stricture less than or equal to 3 cm 4. Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual internal urethrotomy), but no prior urethroplasty 5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's (urinary tract infections). 6. IPSS (International Prostate Symptom Score) score of 13 or higher 7. Lumen diameter \<12F by urethrogram 8. Able to complete validated questionnaire independently 9. Qmax \<12 ml/sec 10. Guidewire must be able to cross the lesion Exclusion Criteria: 1. Strictures greater than 3.0 cm long. 2. Subjects that have more than 1 stricture. 3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel 4. Subjects who have a suprapubic catheter 5. Previous urethroplasty within the anterior urethra 6. Stricture due to bacterial urethritis or untreated gonorrhea 7. Stricture dilated or incised within the last 3 months 8. History of over active bladder or stress incontinence 9. Previous radical prostatectomy 10. Previous pelvic radiation 11. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months. 12. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate 13. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function

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Conditions

The condition(s) this trial relates to.

urethral stricture

As listed by the trial registrant

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

Urethral stricture

Contacts and locations

Locations

  • Chesapeake Urology

    Hanover, Maryland, 21076, United States

  • Metro Urology

    Woodbury, Minnesota, 55125, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • Urology of Virginia

    Virginia Beach, Virginia, 23462, United States

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