CompletedNot Applicable

Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

United States16 participantsStarted 2017-10-25

Plain-language summary

The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Male subjects ≥ 18 years' old
✓. Visual confirmation of stricture via cystoscopy or urethrogram
✓. Single lesion anterior urethral stricture less than or equal to 3 cm
✓. Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual internal urethrotomy), but no prior urethroplasty
✓. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's (urinary tract infections).
✓. IPSS (International Prostate Symptom Score) score of 13 or higher
✓. Lumen diameter \<12F by urethrogram
✓. Able to complete validated questionnaire independently

Exclusion criteria

✕. Strictures greater than 3.0 cm long.
✕. Subjects that have more than 1 stricture.
✕. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
✕. Subjects who have a suprapubic catheter
✕. Previous urethroplasty within the anterior urethra
✕. Stricture due to bacterial urethritis or untreated gonorrhea
✕. Stricture dilated or incised within the last 3 months
✕. History of over active bladder or stress incontinence

What they're measuring

Safety- Rate of Device Related Serious Complications

Timeframe: 90 days

Trial details

NCT IDNCT03270384

SponsorUrotronic Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-01

View on ClinicalTrials.gov More Urethral Stricture trials