Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease (ROBUST-II)

Urotronic

Status: Completed

Conditions: Urethral Stricture

Treatments: Device: Urotronic Drug Coated Balloon (DCB)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03270384

PR1032

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Treatment

Experimental group

Description:

Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB)

Treatment:

Device: Urotronic Drug Coated Balloon (DCB)