NCT05567666

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 5, 2022

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

September 29, 2022

Last Update Submit

September 30, 2022

Conditions

Benign Prostatic Hyperplasia

Keywords

OptilumeMIST

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (9)

  • Change in IPSS & IPSS QoL (questionnaire)

    12 months post treatment

  • Change in Qmax (maximum flow rate)

    12 months post treatment

  • Change in PVR (post-void residual)

    12 months post treatment

  • Change in sexual function (International Index of Erectile Function, IIEF questionnaire)

    12 months post treatment

  • Change in sexual function (Male Sexual Health Questionnaire ejaculatory dysfunction, MSHQ-EjD questionnaire)

    12 months post treatment

  • +4 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Optilume Catheter System

Device: Optilume Catheter System

Interventions

Optilume Catheter SystemDEVICE

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

Treatment

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Iris Chan

CONTACT

416-603-5800iris.chan2@uhn.ca

Dean Elterman

CONTACT

dean.elterman@uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lead Principal Investigator

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 5, 2022

Study Start

November 15, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 5, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share