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

Lower Urinary Tract Symptoms Clinical Trial

— ROBUST IV  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03851952
• Other study ID #: PR1117
• Status: Withdrawn
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2019
• Source: Urotronic Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 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 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

Related Conditions & MeSH terms

• Anterior Urethral Stricture
• Constriction, Pathologic
• Lower Urinary Tract Symptoms
• Urethral Stricture
• Urethral Stricture, Anterior

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Urotronic Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stricture Recurrence Rate	Stricture Free Rate	12 months
Primary	Rate of Serious Adverse Events	Major Device or Procedure Related Serious Adverse Events	3 months
Secondary	Change in Uroflow	Change in Qmax (peak flow rate)	3 and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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