NCT03851952

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 31, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

February 19, 2019

Last Update Submit

July 9, 2019

Conditions

Urethral StrictureUrethral Stricture, AnteriorLower Urinary Tract SymptomsAnterior Urethral Stricture

Outcome Measures

Primary Outcomes (2)

  • Stricture Recurrence Rate

    Stricture Free Rate

    12 months

  • Rate of Serious Adverse Events

    Major Device or Procedure Related Serious Adverse Events

    3 months

Secondary Outcomes (5)

  • Change in Uroflow

    3 and 12 months

  • Change in the International Prostate Symptom Score Questionnaire (IPSS)

    3 and 12 months

  • Change in the EQ-5D Quality of Life Questionnaire

    3 and 12 months

  • Change in the International Index of Erectile Function Questionnaire (IIEF)

    3 and 12 months

  • Change in the Male Sexual Health Questionnaire (MSHQ-EjD)

    3 and 12 months

Study Arms (1)

Optilume DCB

OTHER

Optilume Drug Coated Balloon (DCB) treatment for the treatment of urethral stricture as approved for use in Canada

Device: Optilume Drug Coated Balloon

Interventions

Optilume Drug Coated BalloonDEVICE

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.

Optilume DCB

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Strictures greater than 3.0 cm long
  • Subjects with greater than 1 stricture.
  • Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
  • Previous urethroplasty within the anterior urethra
  • Stricture due to bacterial urethritis
  • Stricture due to untreated gonorrhea
  • Stricture due to Lichen Sclerosus, or balanitis xerotica obliterans (BXO)
  • Stricture dilated or incised within the last 3 months (apart from subjects on self-catheterization)
  • Presence of local adverse factors (e.g. abnormal prostate, urethral false passage or fistula) making catheterization difficult
  • Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician
  • Diagnosis of untreated and unresolved severe BPH or bladder neck contracture (BNC), at the discretion of the physician
  • Prior diagnosis of overactive bladder (OAB)
  • Diagnosis of severe stress urinary incontinence (SUI), at the discretion of the physician
  • Previous radical prostatectomy that resulted in either unresolved bladder neck contracture (BNC) and/or unresolved incontinence
  • Previous pelvic radiation
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urethral StrictureLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ron Kodama, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 22, 2019

Study Start

May 31, 2019

Primary Completion

October 31, 2020

Study Completion

December 31, 2024

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share