Stricture Urethra
Conditions
Keywords
reduced urine flow rate, low peak flow rate, urinary tract infections
Brief summary
Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.
Detailed description
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.
Interventions
COMBINATION_PRODUCTUrotronic 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.
Sponsors
Urotronic Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Treatment Related Serious Complication | 90 days post-procedure | * urethral formation of fistula * de novo severe urinary retention lasting \> 14 consecutive days' post-treatment * unresolved de novo stress urinary incontinence (requiring \>1 pad/day) at 90 days or earlier * urethra rupture or burst. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stricture Recurrence Rate | 90 days post-procedure | * IPSS score of greater than 11 at the 90-day follow-up, or * if a subject had a second DCB treatment (retreatment), or * if a subject exited the study early due to treatment failure (IPSS \>11 without cystoscopically confirmed anatomical success at the time of exit or receiving additional stricture treatment with an alternative therapy). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DCB Treatment Stricture patients treated by DCB
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. | 53 |
| Total | 53 |
Baseline characteristics
| Characteristic | DCB Treatment |
|---|---|
| Age, Continuous | 50.7 years STANDARD_DEVIATION 15.5 |
| Race/Ethnicity, Customized Black or African Origin | 8 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 44 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 37 / 53 |
| serious Total, serious adverse events | 5 / 53 |
Outcome results
Primary
Rate of Treatment Related Serious Complication
* urethral formation of fistula * de novo severe urinary retention lasting \> 14 consecutive days' post-treatment * unresolved de novo stress urinary incontinence (requiring \>1 pad/day) at 90 days or earlier * urethra rupture or burst.
Time frame: 90 days post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DCB Treatment | Rate of Treatment Related Serious Complication | 0 percentage of participants |
Secondary
Stricture Recurrence Rate
* IPSS score of greater than 11 at the 90-day follow-up, or * if a subject had a second DCB treatment (retreatment), or * if a subject exited the study early due to treatment failure (IPSS \>11 without cystoscopically confirmed anatomical success at the time of exit or receiving additional stricture treatment with an alternative therapy).
Time frame: 90 days post-procedure
Population: Subjects reporting 3 month IPSS outcomes or meeting the definition of treatment failure prior to the 3 month visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Treatment | Stricture Recurrence Rate | 8 Participants |
p-value: <0.0011-sample binomial z-test