Trial Outcomes & Findings for ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease (NCT NCT03014726)

Last Updated: 2024-03-22

Results Overview

* 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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

53 participants

Primary outcome timeframe

90 days post-procedure

Results posted on

2024-03-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	53
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DCB Treatment n=53 Participants 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.
Race/Ethnicity, Customized Hispanic or Latino	44 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants
Age, Continuous	50.7 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Race/Ethnicity, Customized Black or African Origin	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days post-procedure

Outcome measures

Outcome measures
Measure	DCB Treatment n=53 Participants 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.
Rate of Treatment Related Serious Complication	0 percentage of participants Interval 0.0 to 6.7

SECONDARY outcome

Timeframe: 90 days post-procedure

Population: Subjects reporting 3 month IPSS outcomes or meeting the definition of treatment failure prior to the 3 month visit.

* 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).

Outcome measures

Outcome measures
Measure	DCB Treatment n=51 Participants 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.
Stricture Recurrence Rate	8 Participants

Adverse Events

DCB Treatment

Serious events: 5 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DCB Treatment n=53 participants at risk 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.
Infections and infestations Urinary Tract Infection	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
General disorders Other: Fall	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
General disorders Abdominal Pain	1.9% 1/53 • Number of events 2 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Renal and urinary disorders Other: Prostatic Adenocarcinoma	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Cardiac disorders Myocardial Infarction, Angina, Ischemia	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up

Other adverse events

Other adverse events
Measure	DCB Treatment n=53 participants at risk 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.
Renal and urinary disorders Dysuria	9.4% 5/53 • Number of events 7 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Reproductive system and breast disorders Erectile Dysfunction	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Renal and urinary disorders Renal Colic	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Renal and urinary disorders Urinary Retention	13.2% 7/53 • Number of events 8 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Renal and urinary disorders Urethral Stricture	17.0% 9/53 • Number of events 11 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Renal and urinary disorders Hematuria	5.7% 3/53 • Number of events 4 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Renal and urinary disorders Urine Flow Decreased	5.7% 3/53 • Number of events 3 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Renal and urinary disorders Urethral Injuary	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Renal and urinary disorders Renal Caculi	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Reproductive system and breast disorders Benign Prostatic Hyperplasia	7.5% 4/53 • Number of events 4 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Infections and infestations Urinary Tract Infection	18.9% 10/53 • Number of events 12 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Infections and infestations COVID-19	3.8% 2/53 • Number of events 2 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Infections and infestations Other: Orchitis	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Infections and infestations Appendicitis	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Gastrointestinal disorders Hemorrhoids	3.8% 2/53 • Number of events 2 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Gastrointestinal disorders Toothache	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Gastrointestinal disorders Constipation	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
General disorders Fever	9.4% 5/53 • Number of events 6 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
General disorders Flu-Like Symptoms	1.9% 1/53 • Number of events 2 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
General disorders Pain	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
General disorders Infusion Site Extravastation	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Immune system disorders Allergic Reaction	3.8% 2/53 • Number of events 2 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Investigations Alanine Aminotransferase	7.5% 4/53 • Number of events 4 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Musculoskeletal and connective tissue disorders Back Pain	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Vascular disorders Headaches	5.7% 3/53 • Number of events 3 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up
Hepatobiliary disorders Hepatobiliary Disorders	1.9% 1/53 • Number of events 1 • Adverse events were collected any time after the treatment has been initated through 5-year follow-up

Additional Information

Ian Schorn, Vice President of Clinical Affairs

Urotronic, Inc.

Phone: 320.282.6312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place