Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH) (SUMMIT)
Primary Purpose
Benign Prostatic Hyperplasia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optilume Catheter System
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Optilume, MIST
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
- Able to complete the study protocol in the opinion of the investigator
Exclusion Criteria:
- Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements
- 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
- Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
- Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
- Confirmed or suspected malignancy of prostate or bladder
- Active urinary tract infection (UTI) confirmed by culture
- History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable
- 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.)
- History of chronic urinary retention (e.g. PVR ≥300mL on two separate occasions, or catheter dependent drainage)
- Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
- Significant obstruction from median lobe in the opinion of the investigator
- Disease or other health condition that is not suitable for this study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Optilume Catheter System
Outcomes
Primary Outcome Measures
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)
Safety (adverse events)
Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system.
Secondary Outcome Measures
Change in IPSS & IPSS QoL (questionnaire)
IPSS & IPSS QoL questionnaire
Change in Qmax (maximum flow rate)
Uroflow to measure maximum flow rate
Change in PVR (post-void residual)
Bladder scanner to measure post-void residual
Change in sexual function (International Index of Erectile Function, IIEF questionnaire)
IIEF questionnaire. Lower score in IIEF means worse in erectile dysfunction.
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.
Quality of Recovery (QoR) Visual Analogue Scale (VAS) score at 30 days.
QoR VAS questionnaire. Higher score means good in recovery.
Health care usage
Procedure time
Health care usage
Readmission rate within 30days
Rate of repeat surgical intervention
Number of participants that need repeated surgical intervention
Full Information
NCT ID
NCT05567666
First Posted
September 29, 2022
Last Updated
September 30, 2022
Sponsor
Dean Elterman
Collaborators
Urotronic Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05567666
Brief Title
Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dean Elterman
Collaborators
Urotronic Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Optilume, MIST
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Optilume Catheter System
Intervention Type
Device
Intervention Name(s)
Optilume Catheter System
Intervention Description
Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter
Primary Outcome Measure Information:
Title
Efficacy: Responder Rate at 12 months
Description
≥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)
Time Frame
12 months post treatment
Title
Safety (adverse events)
Description
Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system.
Time Frame
Within 12 months post treatment
Secondary Outcome Measure Information:
Title
Change in IPSS & IPSS QoL (questionnaire)
Description
IPSS & IPSS QoL questionnaire
Time Frame
12 months post treatment
Title
Change in Qmax (maximum flow rate)
Description
Uroflow to measure maximum flow rate
Time Frame
12 months post treatment
Title
Change in PVR (post-void residual)
Description
Bladder scanner to measure post-void residual
Time Frame
12 months post treatment
Title
Change in sexual function (International Index of Erectile Function, IIEF questionnaire)
Description
IIEF questionnaire. Lower score in IIEF means worse in erectile dysfunction.
Time Frame
12 months post treatment
Title
Change in sexual function (Male Sexual Health Questionnaire ejaculatory dysfunction, MSHQ-EjD questionnaire)
Description
MSHQ-EjD questionnaire. Lower score in MSHQ-EjD means worse in ejaculation function.
Time Frame
12 months post treatment
Title
Quality of Recovery (QoR) Visual Analogue Scale (VAS) score at 30 days.
Description
QoR VAS questionnaire. Higher score means good in recovery.
Time Frame
30 days post treatment
Title
Health care usage
Description
Procedure time
Time Frame
30 days post treatment
Title
Health care usage
Description
Readmission rate within 30days
Time Frame
30 days post treatment
Title
Rate of repeat surgical intervention
Description
Number of participants that need repeated surgical intervention
Time Frame
12 months post treatment
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Able to complete the study protocol in the opinion of the investigator
Exclusion Criteria:
Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements
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
Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
Confirmed or suspected malignancy of prostate or bladder
Active urinary tract infection (UTI) confirmed by culture
History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable
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.)
History of chronic urinary retention (e.g. PVR ≥300mL on two separate occasions, or catheter dependent drainage)
Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
Significant obstruction from median lobe in the opinion of the investigator
Disease or other health condition that is not suitable for this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Chan
Phone
416-603-5800
Ext
5033
Email
iris.chan2@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Dean Elterman
Email
dean.elterman@uhn.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)
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