Clinical trial NCT05567666: Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Optilume
MIST
Lead sponsor: Can-Am HIFU Inc.
Sponsor class: OTHER
Collaborators: name: Urotronic Inc.
First posted: 2022-10-05
Enrollment: 30
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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, Rezūm, 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

Primary outcomes:
measure: Efficacy: Responder Rate at 12 months
timeFrame: 12 months post treatment
measure: Safety (adverse events)
timeFrame: Within 12 months post treatment
Secondary outcomes:
measure: Change in IPSS & IPSS QoL (questionnaire)
timeFrame: 12 months post treatment
measure: Change in Qmax (maximum flow rate)
timeFrame: 12 months post treatment
measure: Change in PVR (post-void residual)
timeFrame: 12 months post treatment
measure: Change in sexual function (International Index of Erectile Function, IIEF questionnaire)
timeFrame: 12 months post treatment
measure: Change in sexual function (Male Sexual Health Questionnaire ejaculatory dysfunction, MSHQ-EjD questionnaire)
timeFrame: 12 months post treatment
measure: Quality of Recovery (QoR) Visual Analogue Scale (VAS) score at 30 days.
timeFrame: 30 days post treatment
measure: Health care usage
timeFrame: 30 days post treatment
measure: Health care usage
timeFrame: 30 days post treatment
measure: Rate of repeat surgical intervention
timeFrame: 12 months post treatment
Other outcomes:
Locations:
Study officials:
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