Benign Prostatic Hyperplasia
Conditions
Keywords
Optilume, MIST
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.
Interventions
DEVICEOptilume Catheter System
Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter
Sponsors
Dean Elterman
Urotronic Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter.
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Responder Rate at 12 months | 12 months post treatment | ≥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) |
| Safety (adverse events) | Within 12 months post treatment | Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery (QoR) Visual Analogue Scale (VAS) score at 30 days. | 30 days post treatment | QoR VAS questionnaire. Higher score means good in recovery. |
| Health care usage | 30 days post treatment | Procedure time |
| Rate of repeat surgical intervention | 12 months post treatment | Number of participants that need repeated surgical intervention |
| Change in sexual function (International Index of Erectile Function, IIEF questionnaire) | 12 months post treatment | IIEF questionnaire. Lower score in IIEF means worse in erectile dysfunction. |
| Change in Qmax (maximum flow rate) | 12 months post treatment | Uroflow to measure maximum flow rate |
| Change in PVR (post-void residual) | 12 months post treatment | Bladder scanner to measure post-void residual |
| Change in IPSS & IPSS QoL (questionnaire) | 12 months post treatment | IPSS \& IPSS QoL questionnaire |
| Change in sexual function (Male Sexual Health Questionnaire ejaculatory dysfunction, MSHQ-EjD questionnaire) | 12 months post treatment | MSHQ-EjD questionnaire. Lower score in MSHQ-EjD means worse in ejaculation function. |
Countries
Canada
Outcome results
None listed