CompletedEarly Phase 1

ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

United States53 participantsStarted 2016-11

Plain-language summary

Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.

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.

✓. Male subjects ≥ 18 years' old
✓. Visual confirmation of stricture via cystoscopy or urethrogram
✓. Single lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm
✓. One to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) including DVIU (Direct Vision 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.
✓. IPSS score of 13 or higher
✓. Lumen diameter \<12F by urethrogram
✓. Able to complete validated questionnaire independently

✕. Strictures greater than 2.0 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 and are unable to complete study required testing, such as uroflowmetry
✕. Previous urethroplasty within the anterior urethra
✕. Stricture due to bacterial urethritis or untreated gonorrhea
✕. Stricture dilated or incised within the last 3 months
✕. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.

Rate of Treatment Related Serious Complication

Timeframe: 90 days post-procedure

NCT IDNCT03014726

SponsorUrotronic Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10

Results submitted2023-09-19

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.

✓. Male subjects ≥ 18 years' old
✓. Visual confirmation of stricture via cystoscopy or urethrogram
✓. Single lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm
✓. One to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) including DVIU (Direct Vision 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.
✓. IPSS score of 13 or higher
✓. Lumen diameter \<12F by urethrogram
✓. Able to complete validated questionnaire independently

✕. Strictures greater than 2.0 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 and are unable to complete study required testing, such as uroflowmetry
✕. Previous urethroplasty within the anterior urethra
✕. Stricture due to bacterial urethritis or untreated gonorrhea
✕. Stricture dilated or incised within the last 3 months
✕. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.