Trial Outcomes & Findings for Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter (NCT NCT03423979)

Last Updated: 2025-11-26

Results Overview

The proportion of subjects experiencing at least a 40% improvement in International Prostate Symptom Score (IPSS) scores from baseline to 3 months. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

90 days

Results posted on

2025-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	Optilume™ BPH Prostatic DCB Dilation Catheter Optilume™ BPH Prostatic DCB treatment procedure Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
Overall Study STARTED	80
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Optilume™ BPH Prostatic DCB Dilation Catheter Optilume™ BPH Prostatic DCB treatment procedure Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
Overall Study Death	5
Overall Study Adverse Event	4
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	16

Baseline Characteristics

Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Optilume™ BPH Prostatic DCB Dilation Catheter n=80 Participants Optilume™ BPH Prostatic DCB treatment procedure Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
Age, Continuous	65.8 Years STANDARD_DEVIATION 7.8 • n=492 Participants
Sex: Female, Male Female	0 Participants n=492 Participants
Sex: Female, Male Male	80 Participants n=492 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black/African Origin	10 Participants n=492 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	2 Participants n=492 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic/Latino	68 Participants n=492 Participants
Prostate Volume (g)	35.9 grams STANDARD_DEVIATION 13.2 • n=492 Participants
Presence of Intravesical Prostatic Protrusion	10 Participants n=492 Participants

PRIMARY outcome

Timeframe: 90 days

Population: In the primary analysis, a worst-case approach was used where those missing 3 month IPSS scores were imputed as non-responders

Outcome measures

Outcome measures
Measure	Optilume™ BPH Prostatic DCB Dilation Catheter n=80 Participants Optilume™ BPH Prostatic DCB treatment procedure Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
Therapeutic Responder at 3 Months	65 Participants

PRIMARY outcome

Timeframe: 90 days

The proportion of subjects reporting a composite of device/procedure related severe urinary retention (lasting \>14 days), unresolved stress urinary incontinence, or bleeding requiring transfusion.

Outcome measures

Outcome measures
Measure	Optilume™ BPH Prostatic DCB Dilation Catheter n=80 Participants Optilume™ BPH Prostatic DCB treatment procedure Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
Major Device/Procedure Related Complications	2 Participants

Adverse Events

Optilume™ BPH Prostatic DCB Dilation Catheter

Serious events: 25 serious events

Other events: 50 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Optilume™ BPH Prostatic DCB Dilation Catheter n=80 participants at risk Optilume™ BPH Prostatic DCB treatment procedure Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
Renal and urinary disorders Urinary Incontinence	2.5% 2/80 • Number of events 2 • 5 years
Renal and urinary disorders Hematuria	10.0% 8/80 • Number of events 8 • 5 years
Renal and urinary disorders Urethral Stenosis	5.0% 4/80 • Number of events 4 • 5 years
Renal and urinary disorders Urinary Retention	1.2% 1/80 • Number of events 1 • 5 years
Nervous system disorders Cerebrovascular Accident	3.8% 3/80 • Number of events 3 • 5 years
Injury, poisoning and procedural complications Anesthetic Complication (Pulmonary)	1.2% 1/80 • Number of events 1 • 5 years
General disorders Complication of Device Removal	2.5% 2/80 • Number of events 2 • 5 years
Renal and urinary disorders Stress Urinary Incontinence	1.2% 1/80 • Number of events 1 • 5 years
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	1.2% 1/80 • Number of events 1 • 5 years
Gastrointestinal disorders Intestinal Obstruction	1.2% 1/80 • Number of events 1 • 5 years
Renal and urinary disorders Urethral Perforation	1.2% 1/80 • Number of events 1 • 5 years
Gastrointestinal disorders Rectal Perforation	1.2% 1/80 • Number of events 1 • 5 years
Infections and infestations COVID-19	1.2% 1/80 • Number of events 1 • 5 years
Gastrointestinal disorders Inguinal Hernia	1.2% 1/80 • Number of events 1 • 5 years
Vascular disorders Death related to heart failure/Thrombosis	1.2% 1/80 • Number of events 1 • 5 years
Vascular disorders High Blood Pressure	1.2% 1/80 • Number of events 1 • 5 years
Gastrointestinal disorders Oral lesion (cancer)	1.2% 1/80 • Number of events 1 • 5 years

Other adverse events

Other adverse events
Measure	Optilume™ BPH Prostatic DCB Dilation Catheter n=80 participants at risk Optilume™ BPH Prostatic DCB treatment procedure Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
Renal and urinary disorders Hematuria	18.8% 15/80 • Number of events 15 • 5 years
Renal and urinary disorders Urinary Retention	11.2% 9/80 • Number of events 10 • 5 years
Renal and urinary disorders Urinary Incontinence	13.8% 11/80 • Number of events 13 • 5 years
Renal and urinary disorders Dysuria	12.5% 10/80 • Number of events 10 • 5 years
Reproductive system and breast disorders Ejaculation Disorder	10.0% 8/80 • Number of events 8 • 5 years
Infections and infestations Urinary Tract Infection	17.5% 14/80 • Number of events 15 • 5 years

Additional Information

Sr. Clinical Project Manager

Urotronic, Inc

Phone: 612-245-6434

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place