ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03851952

Urethral Stricture Urethral Stricture, Anterior Lower Urinary Tract Symptoms +1 more

WITHDRAWN NA

Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

NCT03270384

Urethral Stricture

COMPLETED NA

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

NCT03499964

Urethral Stricture

ACTIVE_NOT_RECRUITING NA

Treatment of Urethral Stricture With Urethral Drug Ball

NCT05812482

Urethral Stricture Less Than 2 cm

UNKNOWN NA

Treatment of Stress Urinary Incontinence by Injection of Autologous Muscle Fibers Into the Urethral Sphincter.

NCT01323426

Urinary Incontinence, Stress

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is designed to determine the safety and effectiveness for drug coated balloon (DCB).

Up to 50 subjects is planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Due to significantly higher prevalence of strictures in men vs. women and the etiology of those strictures being different, the study will focus on male subjects with single anterior urethral stricture. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stricture Urethra

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DCB Treatment

Stricture patients treated by DCB

Group Type EXPERIMENTAL

Urotronic Drug Coated Balloon (DCB)

Intervention Type COMBINATION_PRODUCT

Urotronic Drug Coated Balloon (DCB) is a catheter with a tapered atraumatic tip. The distal end of the catheter has a semi-compliant inflatable balloon coated with a proprietary coating containing the drug and carriers.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Urotronic Drug Coated Balloon (DCB)

Urotronic Drug Coated Balloon (DCB) is a catheter with a tapered atraumatic tip. The distal end of the catheter has a semi-compliant inflatable balloon coated with a proprietary coating containing the drug and carriers.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male subjects ≥ 18 years' old
2. Visual confirmation of stricture via cystoscopy or urethrogram
3. Single lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm
4. One to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) 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 UTI's.
6. IPSS score of 13 or higher
7. Lumen diameter \<12F by urethrogram
8. Able to complete validated questionnaire independently
9. Qmax \<10 ml/sec

Exclusion Criteria

1. Strictures greater than 2.0 cm long.
2. Subjects that have more than 1 stricture.
3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
4. Subjects who have a suprapubic catheter and are unable to complete study required testing, such as uroflowmetry
5. Previous urethroplasty within the anterior urethra
6. Stricture due to bacterial urethritis or untreated gonorrhea
7. Stricture dilated or incised within the last 3 months
8. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.
9. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture such as BPH at the discretion of the clinical investigator
10. Previous radical prostatectomy
11. Previous pelvic radiation
12. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
13. Diagnosed with chronic renal failure unless under hemodialysis or has a serum creatinine level greater than 2 mg/dL
14. 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.)
15. Use of Botox (onabotulinumtoxinA) in urinary system within the last 12 months

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No