NCT03270384CompletedNot Applicable
Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Urotronic Inc.
- Enrollment
- 16
- Locations
- 10
- Primary Endpoint
- Safety- Rate of Device Related Serious Complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
- •Qmax <12 ml/sec
- •Guidewire must be able to cross the lesion
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
- •Previous radical prostatectomy
- •Previous pelvic radiation
- •Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
- •Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate
- •Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
Outcomes
Primary Outcomes
Safety- Rate of Device Related Serious Complications
Time Frame: 90 days
Secondary Outcomes
- Efficacy- Stricture Recurrence Rate(6 months)
- Safety- Change in IIEF (International Index of Erectile Function)(90 days)
Investigators
Study Sites (10)
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