Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study (ROBUST IV)

The ROBUST IV study is designed to collect and better understand "real-world" outcomes for men undergoing urethral dilation using the Optilume Drug Coated Balloon (DCB) for treatment of urethral stricture.

Study Overview

• Status: Withdrawn
• Conditions: Lower Urinary Tract Symptoms; Urethral Stricture; Urethral Stricture, Anterior; Anterior Urethral Stricture
• Intervention / Treatment: Device: Optilume Drug Coated Balloon

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male subjects ≥ 18 years old
2. Visual confirmation of stricture via cystoscopy or retrograde urethrogram
3. Single lesion bulbar urethral stricture, less than or equal to 3.0 cm
4. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTIs).
5. IPSS score of 13 or higher
6. Lumen diameter <12F by urethrogram
7. Able to complete validated questionnaire independently
8. Qmax <15 ml/sec
9. Guidewire must be able to cross the lesion

Exclusion Criteria:

1. Strictures greater than 3.0 cm long
2. Subjects with greater than 1 stricture.
3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
4. Previous urethroplasty within the anterior urethra
5. Stricture due to bacterial urethritis
6. Stricture due to untreated gonorrhea
7. Stricture due to Lichen Sclerosus, or balanitis xerotica obliterans (BXO)
8. Stricture dilated or incised within the last 3 months (apart from subjects on self-catheterization)
9. Presence of local adverse factors (e.g. abnormal prostate, urethral false passage or fistula) making catheterization difficult
10. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician
11. Diagnosis of untreated and unresolved severe BPH or bladder neck contracture (BNC), at the discretion of the physician
12. Prior diagnosis of overactive bladder (OAB)
13. Diagnosis of severe stress urinary incontinence (SUI), at the discretion of the physician
14. Previous radical prostatectomy that resulted in either unresolved bladder neck contracture (BNC) and/or unresolved incontinence
15. Previous pelvic radiation
16. Diagnosis of kidney, bladder, urethral or ureteral stones in the last 6 weeks or active stone passage in the past 6 weeks
17. Diagnosed with chronic renal failure, at the discretion of the physician
18. A dependence on Botox (onabotulinumtoxinA) in the urinary system
19. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate
20. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
21. Previous hypospadias repair
22. Diagnosis within the last 5 years of carcinoma of the bladder or prostate or suspicion of prostate cancer (e.g. abnormal DRE or high PSA) at the discretion of the physician
23. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires
24. Unwilling to use protected sex for ≥30 days post treatment
25. Unwilling to abstain or use protected sex for 90 days post treatment if sexual partner is of child bearing potential.
26. Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all the required follow-up requirements
27. Active infection in the urinary system
28. History of diabetes not controlled with a hemoglobin A1-C >7.0%
29. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function.
30. Visible hematuria with subject urine sample without known contributing factor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Optilume DCB; Optilume Drug Coated Balloon (DCB) treatment for the treatment of urethral stricture as approved for use in Canada	Device: Optilume Drug Coated Balloon; The Optilume 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stricture Recurrence Rate	Stricture Free Rate	12 months
Rate of Serious Adverse Events	Major Device or Procedure Related Serious Adverse Events	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Uroflow	Change in Qmax (peak flow rate)	3 and 12 months
Change in the International Prostate Symptom Score Questionnaire (IPSS)	IPSS Percent Responder (50% improvement in IPSS score or IPSS score of 11 or lower)	3 and 12 months
Change in the EQ-5D Quality of Life Questionnaire	Change in the EQ-5D at 3 and 12 months post-procedure compared to baseline. Subscales of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale of 1 (no problem) to 5 (extreme problems)	3 and 12 months
Change in the International Index of Erectile Function Questionnaire (IIEF)	Change in the IIEF at 3 and 12 months post-procedure compared to baseline on a scale of 5 (severe erectile dysfunction) to 25 (no erectile dysfunction)	3 and 12 months
Change in the Male Sexual Health Questionnaire (MSHQ-EjD)	Change in the MSHQ-EjD at 3 and 12 months post-procedure compared to baseline. Subscales of ejaculatory function from 1 (more ejaculatory dysfunction) to 15 (less ejaculation dysfunction) and bother from 0 (no bother with ejaculation) to 5 (greater bother with ejaculation)	3 and 12 months

Collaborators and Investigators

• Sponsor: Urotronic Inc.
• Investigators: Principal Investigator: Ron Kodama, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): May 31, 2019
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Lower Urinary Tract Symptoms; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: PR1117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes