Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

Benign Prostatic Hyperplasia Clinical Trial

— EVEREST-I  

Official title:

Evaluation of Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter in the Treatment of Moderate-to-Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03423979
• Other study ID #: PR1051
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 19, 2017
• Est. completion date: March 30, 2024

Study information

• Verified date: June 2023
• Source: Urotronic Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: March 30, 2024
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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, Rezum, 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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Benign Prostatic Hypertrophy
• Hyperplasia
• Hypertrophy
• Prostatic Hyperplasia

Intervention

Device:
• 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).

Drug:
• Paclitaxel
paclitaxel will release to adjacent tissue after the balloon inflated in the urethra

Locations

Country	Name	City	State
Dominican Republic	Centro Medico Dr. Canela, SRL	La Romana
Dominican Republic	Union Medica Hospital	Santiago De Los Caballeros	Santiago
Dominican Republic	Urolaser SRL	Santo Domingo Oeste	Santo Domingo
Panama	Centro Especializado San Fernando	Ciudad de Panamá
Panama	Consultorios Royal Center	Panama City,	Urbanización Marbella Ciudad De Panamá

Sponsors (1)

Lead Sponsor	Collaborator
Urotronic Inc.

Countries where clinical trial is conducted

Dominican Republic,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic Responder at 3 Months	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.	90 days
Primary	Major Device/Procedure Related Complications	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.	90 days