Benign Prostatic HyperplasiaSUMMITNCT05567666
Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)
A study testing Optilume Catheter System in people with Benign Prostatic Hyperplasia, run by Dean Elterman at 1 site in Canada.
Trial summary
A post-marketing study using Optilume Catheter System for benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Optilume Catheter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 7 Mar 2023to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
A post-marketing study using Optilume Catheter System for benign prostatic hyperplasia.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Optilume Catheter System
- Keywords
- Optilume, MIST
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optilume Catheter SystemDevice
Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Optilume Catheter System Receives: Device: Optilume Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months post treatment
Safety (adverse events)
Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system.
Measured: Within 12 months post treatment
Secondary outcomes (9)
Change in IPSS & IPSS QoL (questionnaire)
IPSS \& IPSS QoL questionnaire
Measured: 12 months post treatment
Change in Qmax (maximum flow rate)
Uroflow to measure maximum flow rate
Measured: 12 months post treatment
Change in PVR (post-void residual)
Bladder scanner to measure post-void residual
Measured: 12 months post treatment
Change in sexual function (International Index of Erectile Function, IIEF questionnaire)
IIEF questionnaire. Lower score in IIEF means worse in erectile dysfunction.
Measured: 12 months post treatment
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.
Measured: 12 months post treatment
Quality of Recovery (QoR) Visual Analogue Scale (VAS) score at 30 days.
QoR VAS questionnaire. Higher score means good in recovery.
Measured: 30 days post treatment
Health care usage
Procedure time
Measured: 30 days post treatment
Health care usage
Readmission rate within 30days
Measured: 30 days post treatment
Rate of repeat surgical intervention
Number of participants that need repeated surgical intervention
Measured: 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start7 Mar 2023
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dean Elterman
- Sponsor type
- University, hospital or other
- Collaborators
- Urotronic Inc.
- Responsible party
- Sponsor-investigator, Dean Elterman, Can-Am HIFU Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567666
- Sponsor's protocol ID
- SUMMIT (Protocol no.: 1001)
- Acronym
- SUMMIT
- Status last verified
- Aug 2026
- First submitted
- 29 Sep 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05567666
- Acronym / sponsor ID
- SUMMIT / SUMMIT (Protocol no.: 1001)
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Optilume, MIST
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dean EltermanUniversity, hospital or other
- Collaborators
- Urotronic Inc.
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Optilume Catheter SystemOptilume Catheter System |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optilume Catheter SystemOptilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter | Device | Treatment |
Primary outcome
Efficacy: Responder Rate at 12 months
Time frame: 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)
Time frame: Within 12 months post treatment
Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system.
9 secondary outcomes
Change in IPSS & IPSS QoL (questionnaire)
Time frame: 12 months post treatment
Change in Qmax (maximum flow rate)
Time frame: 12 months post treatment
Change in PVR (post-void residual)
Time frame: 12 months post treatment
Change in sexual function (International Index of Erectile Function, IIEF questionnaire)
Time frame: 12 months post treatment
Change in sexual function (Male Sexual Health Questionnaire ejaculatory dysfunction, MSHQ-EjD questionnaire)
Time frame: 12 months post treatment
Quality of Recovery (QoR) Visual Analogue Scale (VAS) score at 30 days.
Time frame: 30 days post treatment
Health care usage
Time frame: 30 days post treatment
Health care usage
Time frame: 30 days post treatment
Rate of repeat surgical intervention
Time frame: 12 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optilume Catheter System in people with Benign Prostatic Hyperplasia, run by Dean Elterman at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Responder Rate at 12 months (time frame: 12 months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.