Urethral Stricture
Conditions
Keywords
early feasibility, non-randomized
Brief 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.
Interventions
The Urotronic Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.
Sponsors
Urotronic Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety- Rate of Device Related Serious Complications | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety- Change in IIEF (International Index of Erectile Function) | 90 days |
| Efficacy- Stricture Recurrence Rate | 6 months |
Countries
United States
Outcome results
None listed