ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

Urethral Stricture Clinical Trial

— ROBUST-III  

Official title:

ROBUST III - Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease - A Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03499964
• Other study ID #: PR1076
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 22, 2018
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: Urotronic Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).

Description:

ROBUST III is a prospective, multi-center, single blind randomized controlled clinical trial in a 2:1 allocation of treatment versus control device.

This study is an adaptive design with an interim analysis for sample size re-estimation performed after 60 subjects have been enrolled. The interim analysis will be be undertaken following completion of the 6-month follow-up data from these subjects. Based on the results of the interim analysis, the final total sample size required for the study will be re-estimated. A minimum of 140 subjects, and a maximum of 200 subjects (pending the re-estimation) will be enrolled in the study. A Data Monitoring Committee (DMC) will review the interim analysis results, including the sample size re-estimation and make recommendations related to trial continuation to the sponsor.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 127
• Est. completion date: December 2025
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male subjects = 18 years' old

2. Visual confirmation of stricture via cystoscopy or urethrogram

3. Single, tandem or diffuse anterior urethral stricture(s), less than or equal to 3.0 cm total length measured by retrograde urethrogram. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture).

4. Two or more prior dilation treatments of the same stricture, including DVIU (Direct Vision 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 urinary tract infections (UTI's).

6. International Prostrate Symptoms Score (IPSS) score of 11 or higher (assumed to be "35" if suprapubic catheter is present)

7. Lumen diameter = 12F by urethrogram

8. Qmax <15 ml/sec (assumed to be "0" if suprapubic catheter is present)

9. Guidewire must be able to cross the lesion

Exclusion Criteria:

1. Subjects with diffuse stricture length, greater than 3.0 cm in total length. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture).

2. Subjects with a history of hypersensitivity reactions to TAXOL, on medication that may have negative interaction with paclitaxel, with solid tumors who have a baseline neutrophil counts of <1500 cells/mm3 or subjects with AIDS-related Kaposi's sarcoma with baseline neutrophile counts of <1000 cells/mm3.

3. Subjects who had an indwelling suprapubic catheter longer than three (3) months total prior to enrollment.

4. Previous urethroplasty within the anterior urethra

5. Stricture dilated or incised within the last six (6) weeks (urethral catheterization is not considered dilation)

6. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.

7. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician

8. Diagnosis of untreated and unresolved BPH or BNC

9. Untreated stress urinary incontinence (SUI).

10. History of diagnosed radiation cystitis.

11. Diagnosis of carcinoma of the urethra, bladder or prostate within the last two (2) years

12. Active kidney, bladder, urethral or ureteral stone passage in the last six (6) weeks or concern of stone passage in the next 6 weeks at the discretion of the investigator.

13. Diagnosis of chronic renal failure and treatment with hemodialysis

14. New diagnosis of OAB (overactive bladder) within the last six (6) months

15. Use of alpha blockers, beta blockers, OAB (Overactive Bladder) medication, anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures), and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months.)

16. Dependence on Botox (onabotulinumtoxinA) in urinary system

17. Presence of an artificial urinary sphincter, slings, or stent(s) in the urethra or prostate

18. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function

19. Diagnosed with Lichen Sclerosus, or stricture due to balanitis xerotica obliterans (BXO)

20. Previous hypospadias repair

21. History of cancer in non-genitourinary system which is not considered in complete remission (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered in complete remission if there has been no evidence of cancer within two (2) years of enrollment

22. 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

23. Unwilling to use protected sex for thirty (30) days' post treatment

24. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential.

25. Inability to provide Informed Consent Form (ICF) and/or comply with all the required follow-up requirements

26. Participation in other pre-market studies or treatment with an investigational drug or device. Long term follow up or post market study of an approved device is allowed.

27. Current active infection in the urinary system

28. Current uncontrolled diabetes (hemoglobin A1c > 8.0%) or evidence of poor wound healing due to diabetes

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 in subject's urine sample without known contributing factor

31. Invisible hematuria (or significant microscopic hematuria, i.e. hematuria of = 3 RBC's/HPF) that may be caused by a clinically significant disease unless it is attributed to the urethral stricture disease or other causes which are benign and not requiring treatment.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture

Intervention

Device:
• Optilume Drug Coated Balloon (DCB)
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.
• Control Treatment
A control subject may be dilated with either a rod, uncoated balloon or DVIU until the desired result is reached, based on standard of care for the clinical site and treating physician

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital, Glen Site	Montreal	Quebec
United States	Chesapeake Urology Research	Annapolis	Maryland
United States	Western New York Urology Associates	Cheektowaga	New York
United States	Carolina Urology Partners	Concord	North Carolina
United States	UT Southwestern	Dallas	Texas
United States	Advanced Urology Institute	Daytona Beach	Florida
United States	Chesapeake Urology	Hanover	Maryland
United States	University of Iowa	Iowa City	Iowa
United States	Arkansas Urology	Little Rock	Arkansas
United States	University of Minnesota Department of Urology	Minneapolis	Minnesota
United States	Columbia University Medical Center/New York-Presbyterian Hospital	New York	New York
United States	Iris Cantor Men's Health Center	New York	New York
United States	Integrated Medical Professionals OBP	North Hills	New York
United States	Adult & Pediatric Urology, PC	Omaha	Nebraska
United States	Academic Urology and Urogynecology of Arizona	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Urology San Antonio	San Antonio	Texas
United States	University of Washington Harborview Medical Center	Seattle	Washington
United States	Oregon Urology Institute	Springfield	Oregon
United States	Urology of Virginia	Virginia Beach	Virginia
United States	New Jersey Urology	Voorhees	New Jersey
United States	Minnesota Urology	Woodbury	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Urotronic Inc.	ClinLogix. LLC

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Elliott SP, Coutinho K, Robertson KJ, D'Anna R, Chevli K, Carrier S, Aube-Peterkin M, Cantrill CH, Ehlert MJ, Te AE, Dann J, DeLong JM, Brandes SB, Hagedorn JC, Levin R, Schlaifer A, DeSouza E, DiMarco D, Erickson BA, Natale R, Husmann DA, Morey A, Olsson — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Stricture Free	The percentage of subjects deemed to be stricture free will be compared between arms. Stricture free subjects are those for which a 16F flexible cystoscope or 14F Foley catheter is able to be passed through the treated stricture without significant resistance.	6 months
Primary	Safety: Rate of Major Device or Procedure Related Complications	Rate of Major Device or Procedure Related complications	3 months
Secondary	Change in Qmax (Peak Flow Rate)	Change in peak urinary flow rate (Qmax) from baseline to 6 months post treatment. Positive values indicate an increase in Qmax from baseline to 6 months, while negative values indicate a decrease in Qmax.	6 months
Secondary	IPSS Percent Responder (50% Improvement in IPSS Score)	The proportion of subjects considered to be therapeutic responders, defined as an improvement of greater than or equal to 50% in the International Prostate Symptom Score [IPSS] without repeat intervention, in the Optilume DCB arm at 12 months will be compared to a performance goal of 50%. The IPSS was developed to measure symptom severity for bladder outlet obstruction, with a range of 0 (no symptoms) to 35 (worst possible symptoms).	12 months