Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

NCT ID: NCT03423979

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-19
• Study Completion Date: 2024-05-25

Brief Summary

A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years.

The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.

Detailed Description

A prospective, non-randomized, multi-center study. The study will enroll up to 85 subjects to be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. Subjects will be followed up post-treatment at Foley removal, and up to 1 year. The subjects may choose to be followed-up annually for 5 years or until study close, whichever comes first.

Study device is Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System.

Study primarily outcomes are measured by 1). Change in IPSS score at 3-month post-procedure follow-up; 2). Major device or procedure related complications at 3-month post-procedure follow-up.

Conditions

Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optilume™ BPH Prostatic DCB Dilation Catheter

Optilume™ BPH Prostatic DCB treatment procedure

Group Type: EXPERIMENTAL

Optilume™ BPH Prostatic DCB Dilation Catheter

Intervention Type: DEVICE

BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).

Paclitaxel

Intervention Type: DRUG

paclitaxel will release to adjacent tissue after the balloon inflated in the urethra

Interventions

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).

Intervention Type: DEVICE

Paclitaxel

paclitaxel will release to adjacent tissue after the balloon inflated in the urethra

Intervention Type: DRUG

Other Intervention Names

BPH Prostatic DCB; drug coated balloon

Eligibility Criteria

Inclusion Criteria

1. Male subject > 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy

2. LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH)

3. Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml

4. Post-void residual (PVR) ≤ 250 ml

5. Prostate volume 20 - 80 gm as determined by TRUS

6. Prostatic urethra length is 35 - 55 mm as determined by TRUS

7. Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria

1. Interested in maintaining fertility and unwilling to use protected sex for the first 30 days post treatment

2. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential

3. Presence of a penile implant or stent(s) in the urethra or prostate

4. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate

5. PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy

6. Confirmed or suspected malignancy of prostate or bladder

7. Active or history of epididymitis within the past 3 months

8. Previous pelvic irradiation or radical pelvic surgery

9. Documented active urinary tract infection (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catheterization specimen)

10. Visible hematuria with subject urine sample without known contributing factor

11. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function

12. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms

13. Use of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week prior to treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes)

14. Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior to treatment

15. Use of 5-alpha reductase inhibitor within 6 months prior to treatment

16. Incidence of spontaneous urinary retention within 6 months prior to baseline assessment

17. Post-void residual volume > 250 ml or catheter dependent bladder drainage

18. Overactive bladder (OAB) or urge incontinence

19. Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)

20. Current bladder stones or prostatic calculi

21. Biopsy of prostate within 30 days prior to procedure or planned within 30 days following the procedure

22. History of cancer in non-genitourinary system which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years

23. History of clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal [serum creatinine > 2.0 mg/dl], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or have a risk to subject per investigator's opinion

24. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires

25. Expected life expectancy < one year

26. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements

27. Currently enrolled in or plan to enroll in another investigational clinical trial for any disease except for observational only study

28. In the opinion of the investigator, it is not in the subject's best interest to participate in the study

29. Current treatment with anti-coagulants (e.g., warfarin or enoxaparin) or anti-platelet medications other than aspirin (e.g., clopidogrel)

30. Anatomy, e.g. presence of false passage or size of meatus, is not suitable for treatment in this study

31. Device that corresponds with the subject's prostate size per the IFU is not available

32. Intravesical prostatic protrusion (IPP) > 1 cm

33. Current uncontrolled diabetes (hemoglobin A1c > 7%)

34. Unable or unwilling to provide all the protocol-required semen samples

35. Sensitivity to paclitaxel, on medication that may have negative interaction with paclitaxel, or contraindicated for systemic paclitaxel

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Urotronic Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jill Moland

Role: STUDY_DIRECTOR

Urotronic Inc.

Locations

Union Medica Hospital

Santiago de los Caballeros, Santiago Province, Dominican Republic

Urolaser SRL

Santo Domingo Oeste, Santo Domingo Province, Dominican Republic

Centro Medico Dr. Canela, SRL

La Romana, , Dominican Republic

Consultorios Royal Center

Panama City, Urbanización Marbella Ciudad de Panamá, Panama

Centro Especializado San Fernando

Panama City, , Panama

Countries

Dominican Republic; Panama

References

Pichardo M, Rijo E, Espino G, Lay RR, Estrella R, Gonzalez C, Fernandez M, Soriano D, Peralta IM, Kaplan SA. Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study. World J Urol. 2023 Aug;41(8):2209-2215. doi: 10.1007/s00345-023-04473-1. Epub 2023 Jun 24.

Reference Type: DERIVED

PMID: 37354260 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PR1051

Identifier Type: -

Identifier Source: org_study_id