Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)

Benign Prostatic Hyperplasia Clinical Trial

— SUMMIT  

Official title:

A Real-word, Clinical Study to Evaluate the Performance of the Optilume® BPH Catheter System in Men With Symptomatic Benign Prostatic Hyperplasia (BPH)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05567666
• Other study ID #: SUMMIT (Protocol no.: 1001)
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2022
• Source: Can-Am HIFU Inc.
• Contact: Iris Chan
• Phone: 416-603-5800
• Email: iris.chan2[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A post-marketing study using Optilume Catheter System for benign prostatic hyperplasia.

Description:

This is a post-marketing study for using Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter, to treat benign prostatic hyperplasia. Participants will go through screening process which include uroflow test (measure the strength of urine flow), post-void residual volume by bladder scan, questionnaires and transrectal ultrasound (TRUS) to determine the eligibility to the study. Participants will be followed up for 1 year after Optilume treatment procedure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Male subject with symptomatic BPH NOTE: Symptomatic BPH is defined as an International Prostate Symptom Score (IPSS) = 13 and peak urinary flow rate (Qmax) of =15 mL/sec

2. Prostate dimensions suitable for treatment with the Optilume BPH Catheter System in accordance with the approved Instructions for Use NOTE: Prostate volume between 20 to 80 gm and prostatic urethral length between 32 mm and 55 mm as determined by TRUS

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

Exclusion Criteria:

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

2. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and a highly effective contraceptive for at least 6 months post-procedure

3. Presence of an artificial urinary sphincter 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. Confirmed or suspected malignancy of prostate or bladder

6. Active urinary tract infection (UTI) confirmed by culture

7. History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable

8. Presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g. urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.)

9. History of chronic urinary retention (e.g. PVR =300mL on two separate occasions, or catheter dependent drainage)

10. Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System

11. Significant obstruction from median lobe in the opinion of the investigator

12. Disease or other health condition that is not suitable for this study

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• Optilume Catheter System
Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dean Elterman	Urotronic Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Responder Rate at 12 months	=30% improvement in International Prostate Symptom Score (IPSS) score without the need of an additional surgical or minimally invasive procedure. IPSS score ranges from 0-35 (higher score means worse symptoms)	12 months post treatment
Primary	Safety (adverse events)	Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system.	Within 12 months post treatment
Secondary	Change in IPSS & IPSS QoL (questionnaire)	IPSS & IPSS QoL questionnaire	12 months post treatment
Secondary	Change in Qmax (maximum flow rate)	Uroflow to measure maximum flow rate	12 months post treatment
Secondary	Change in PVR (post-void residual)	Bladder scanner to measure post-void residual	12 months post treatment
Secondary	Change in sexual function (International Index of Erectile Function, IIEF questionnaire)	IIEF questionnaire. Lower score in IIEF means worse in erectile dysfunction.	12 months post treatment
Secondary	Change in sexual function (Male Sexual Health Questionnaire ejaculatory dysfunction, MSHQ-EjD questionnaire)	MSHQ-EjD questionnaire. Lower score in MSHQ-EjD means worse in ejaculation function.	12 months post treatment
Secondary	Quality of Recovery (QoR) Visual Analogue Scale (VAS) score at 30 days.	QoR VAS questionnaire. Higher score means good in recovery.	30 days post treatment
Secondary	Health care usage	Procedure time	30 days post treatment
Secondary	Health care usage	Readmission rate within 30days	30 days post treatment
Secondary	Rate of repeat surgical intervention	Number of participants that need repeated surgical intervention	12 months post treatment