Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

Not Applicable

Active, not recruiting

• Conditions: Urethral Stricture
• Interventions: Device: Urotronic Drug Coated Balloon (DCB)

• Registration Number: NCT03270384
• Lead Sponsor: Urotronic Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-01
• Study Start: 2017-10-25
• Primary Completion: 2019-11-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Urotronic Drug Coated Balloon (DCB)	Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB)

Primary Outcome Measures

Name	Time	Method
Safety- Rate of Device Related Serious Complications	90 days

Secondary Outcome Measures

Name	Time	Method
Efficacy- Stricture Recurrence Rate	6 months
Safety- Change in IIEF (International Index of Erectile Function)	90 days

Trial Locations

Locations (5)

Urology of Virginia; 🇺🇸 Virginia Beach, Virginia, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Chesapeake Urology; 🇺🇸 Hanover, Maryland, United States

Metro Urology; 🇺🇸 Woodbury, Minnesota, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States