Clinical trial NCT03270384: Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Official title: Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urethral Stricture
Keywords: early feasibility
non-randomized
Lead sponsor: Urotronic Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-01
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety- Rate of Device Related Serious Complications
timeFrame: 90 days
Secondary outcomes:
measure: Safety- Change in IIEF (International Index of Erectile Function)
timeFrame: 90 days
measure: Efficacy- Stricture Recurrence Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Hanover
country: United States
facility: Chesapeake Urology
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Woodbury
country: United States
facility: Metro Urology
state: Minnesota
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
Study officials:
affiliation: University of Minnesota
name: Sean Elliott, MD
role: PRINCIPAL_INVESTIGATOR
References: