RECRUITING

Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.

Official Title

Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

Quick Facts

Study Start:2024-02-07

Study Completion:2031-02-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06312722

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male subject ≥ 50 years old 2. Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH) 3. Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use 4. Prostate volume \< 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS) 5. International Prostate Symptom Score (IPSS) ≥ 13 6. Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL 7. Willing to provide informed consent and comply with protocol required follow-up	1. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure 2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate 3. Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate 4. Confirmed or suspected malignancy of prostate or bladder. Negative prostate biopsy required within 6 months of enrollment if PSA at baseline is \> 4 ng/mL with free PSA \< 25%. 5. Active urinary tract infection (UTI) confirmed by culture 6. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function 7. History of overt urinary incontinence requiring the use of pads 8. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms 9. Current post-void residual volume (PVR) \> 300 mL or catheter dependent bladder drainage 10. Known poor detrusor muscle function (e.g., Qmax \< 5 mL/sec) 11. Active bladder, ureteral, or urethral stones or stone passage within the last 3 months 12. Current poorly controlled diabetes (i.e., hemoglobin A1c ≥ 8%) 13. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System 14. Obstructive median lobe in the opinion of the investigator

Inclusion Criteria

Exclusion Criteria

1. Male subject ≥ 50 years old
2. Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH)
3. Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use
4. Prostate volume \< 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS)
5. International Prostate Symptom Score (IPSS) ≥ 13
6. Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL
7. Willing to provide informed consent and comply with protocol required follow-up

1. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
3. Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
4. Confirmed or suspected malignancy of prostate or bladder. Negative prostate biopsy required within 6 months of enrollment if PSA at baseline is \> 4 ng/mL with free PSA \< 25%.
5. Active urinary tract infection (UTI) confirmed by culture
6. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
7. History of overt urinary incontinence requiring the use of pads
8. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
9. Current post-void residual volume (PVR) \> 300 mL or catheter dependent bladder drainage
10. Known poor detrusor muscle function (e.g., Qmax \< 5 mL/sec)
11. Active bladder, ureteral, or urethral stones or stone passage within the last 3 months
12. Current poorly controlled diabetes (i.e., hemoglobin A1c ≥ 8%)
13. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
14. Obstructive median lobe in the opinion of the investigator

Contacts and Locations

Study Contact

Jill Moland

CONTACT

612-245-6434

jmoland@laborie.com

Brandon Shuler

CONTACT

701-220-1710

bshuler@laborie.com

Principal Investigator

Steven Kaplan, MD, FACS

PRINCIPAL_INVESTIGATOR

Professor of Urology

Study Locations (Sites)

Arkansas Urology

Little Rock, Arkansas, 72211

United States

Florida Urology Partners, LLP

Tampa, Florida, 33615

United States

Ochsner LSU Health Shreveport - Regional Urology

Shreveport, Louisiana, 71106

United States

Sheldon Freedman MD, Ltd

Las Vegas, Nevada, 89144

United States

Midtown Urology Associates

Austin, Texas, 78705

United States

Collaborators and Investigators

Sponsor: Urotronic Inc.

Steven Kaplan, MD, FACS, PRINCIPAL_INVESTIGATOR, Professor of Urology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-07

Study Completion Date2031-02-07

Study Record Updates

Study Start Date2024-02-07

Study Completion Date2031-02-07

Terms related to this study

Additional Relevant MeSH Terms

Benign Prostatic Hyperplasia