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Urethral StrictureROBUST IVNCT03851952

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

A study testing Optilume Drug Coated Balloon in people with Urethral Stricture and Urethral Stricture, Anterior, run by Urotronic Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Optilume Drug Coated Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
31 May 2019to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Able to complete validated questionnaire independently
  • Qmax <15 ml/sec
  • Guidewire must be able to cross the lesion

Who cannot join

  • 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
Show all 30Show fewer
  • 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
  • Diagnosis of kidney, bladder, urethral or ureteral stones in the last 6 weeks or active stone passage in the past 6 weeks
  • Diagnosed with chronic renal failure, at the discretion of the physician
  • A dependence on Botox (onabotulinumtoxinA) in the urinary system
  • Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate
  • Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
  • Previous hypospadias repair
  • 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
  • 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
  • Unwilling to use protected sex for ≥30 days post treatment
  • Unwilling to abstain or use protected sex for 90 days post treatment if sexual partner is of child bearing potential.
  • Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all the required follow-up requirements
  • Active infection in the urinary system
  • History of diabetes not controlled with a hemoglobin A1-C >7.0%
  • 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.
  • Visible hematuria with subject urine sample without known contributing factor

About this study

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.

Being tested
Optilume Drug Coated Balloon
Medical subject headings
Urethral Stricture, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03851952
Study groupRoleWhat they receive
Optilume DCBOtherOptilume Drug Coated Balloon (DCB) treatment for the treatment of urethral stricture as approved for use in Canada
Receives: Device: Optilume Drug Coated Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stricture Recurrence Rate

    Stricture Free Rate

    Measured: 12 months

  2. Rate of Serious Adverse Events

    Major Device or Procedure Related Serious Adverse Events

    Measured: 3 months

Secondary outcomes (5)

  1. Change in Uroflow

    Change in Qmax (peak flow rate)

    Measured: 3 and 12 months

  2. Change in the International Prostate Symptom Score Questionnaire (IPSS)

    IPSS Percent Responder (50% improvement in IPSS score or IPSS score of 11 or lower)

    Measured: 3 and 12 months

  3. 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)

    Measured: 3 and 12 months

  4. 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)

    Measured: 3 and 12 months

  5. 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)

    Measured: 3 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study start31 May 2019 (estimated)
  3. Primary completion31 Oct 2020 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Why it stopped: Company Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03851952
Sponsor's protocol ID
PR1117
Acronym
ROBUST IV
Status last verified
Jul 2019
First submitted
19 Feb 2019
Last updated
12 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Optilume Drug Coated Balloon in people with Urethral Stricture and Urethral Stricture, Anterior, run by Urotronic Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stricture Recurrence Rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03851952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.

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