WithdrawnNot Applicable

Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study

Stopped: Company Decision

0Started 2019-05-31

Plain-language summary

The ROBUST IV study is designed to collect and better understand "real-world" outcomes for men undergoing urethral dilation using the Optilume Drug Coated Balloon (DCB) for treatment of urethral stricture.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male subjects ≥ 18 years old
✓. Visual confirmation of stricture via cystoscopy or retrograde urethrogram
✓. Single lesion bulbar urethral stricture, less than or equal to 3.0 cm
✓. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTIs).
✓. IPSS score of 13 or higher
✓. Lumen diameter \<12F by urethrogram
✓. Able to complete validated questionnaire independently
✓. Qmax \<15 ml/sec

Exclusion criteria

✕. Strictures greater than 3.0 cm long
✕. Subjects with greater than 1 stricture.
✕. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
✕. Previous urethroplasty within the anterior urethra
✕. Stricture due to bacterial urethritis
✕. Stricture due to untreated gonorrhea
✕. Stricture due to Lichen Sclerosus, or balanitis xerotica obliterans (BXO)
✕. Stricture dilated or incised within the last 3 months (apart from subjects on self-catheterization)

What they're measuring

Stricture Recurrence Rate

Timeframe: 12 months

Rate of Serious Adverse Events

Timeframe: 3 months

Trial details

NCT IDNCT03851952

SponsorUrotronic Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-31

View on ClinicalTrials.gov More Urethral Stricture trials