Evaluation of the Optilume BPH Catheter System and the Rezum Water Vapor Therapy in Treating Benign Prostatic Hyperplasia

NCT06769997 | Recruiting FDA Device

• 1 other identifier: 2025-12549
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Lower urinary symptoms (LUTS) affect older men and their frequency and severity increase with age. According to Berry et al., the histological diagnosis of benign prostatic hyperplasia (BPH) increases from 25% in the group age between 40 to 49 years to 80% in the group age between 70 to 79 years (1). However, this hyperplasia can lead to a bladder outlet obstruction (BOO) secondary to benign prostatic enlargement (BPE), causing storage and voiding symptoms, associated with a considerable impairment of the quality of life (2). Surgical therapy of BPH has continuously evolved in recent years. The current gold standard for the endoscopic treatment of BPH is the transurethral resection of the prostate (TURP). Other innovative techniques were developed including Urolift, transurethral laser enucleation (holmium, thulium) and Aquablation therapy. One of the latest technologies for the management of BPH are Optilume BPH Catheter System (Optilume®, Urotronic Inc, Minneapolis, USA) and Rezum Water Vapor Therapy (Rezum System, Bostocn Scientific, Marlborough, MA). The purpose of the present study is to compare between patient experience, symptom relief and functional improvement when using the Optilume BPH Catheter System (Optilume®, Urotronic Inc, Minneapolis, USA) and Rezum Water Vapor Therapy (Rezum System, Boston Scientific, Marlborough, MA).

Conditions

Benign Prostatic Hyperplasia (BPH); Lower Urinary Track Symptoms

Keywords

Benign Prostatic Hyperplasia; Lower Urinary Track Symptoms; BPH; LUTS; Optilume; Rezum

Outcome Measures

Primary Outcomes (2)

• The rate of patients without a catheter (catheter free)

  The primary efficacy endpoint is defined as the rate of patients without a catheter (catheter free) 3 days after the procedure.

  3 days

• Frequency and severity of treatment related adverse events

  The primary safety endpoint is defined as the frequency and severity of treatment related adverse events reported using the Clavien-Dindo severity grading system.

  Through study completion, an average of 2 years

Other Outcomes (14)

• The change of the International Prostate Symptom Score (IPSS)

  Baseline, 1week, 3, 6, 12 months.

• International Prostate Symptom Score (IPSS) Quality of Life (QoL)

  Baseline, 1week, 3, 6, 12 months.

• Maximum Flow Rate (Qmax)

  Baseline, 1week, 3, 6, 12 months.

Study Arms (2)

Optilume® BPH Catheter System

ACTIVE COMPARATOR

Device: Optilume® BPH Catheter System

Rezum Water Vapor Therapy

ACTIVE COMPARATOR

Device: Rezum Water Vapor Therapy

Interventions

Optilume® BPH Catheter System DEVICE

The technology is based on a device/drug combination consisting of two catheters: the Optilume BPH Prostatic Pre-dilation Catheter which is a non-drug coated catheter used to start commissurotomy between the lateral lobes of the prostate and the Optilume BPH Prostatic Dilatation DCB Catheter which is a drug coated catheter used to complete the commissurotomy and transfers drug (paclitaxel) to the pre-dilated prostatic urethra and anterior commissure. Hence, the device applies a mechanical dilatation to open prostatic urethral lumen to increase urine flow, followed by the transfer of paclitaxel drug to inhibit cell proliferation and maintain this dilatation.

Optilume® BPH Catheter System

Rezum Water Vapor Therapy DEVICE

The Rezum system is minimally invasive therapy for LUTS secondary to BPH. The system injects water vapor at 103°C generated by radiofrequency to create thermal energy via a transurethral approach. The vapor disperses through the tissue interstices within the treatment zone (transition zone). The injection of vapor last for approximatively 9 seconds and the number of injections depends on the prostate volume and length of the prostatic urethra.

Rezum Water Vapor Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subject with symptomatic BPH.
• Prostate size 30-100g.
• Able to complete the study protocol.

You may not qualify if:

• Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements
• 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 (investigator opinion)
• Disease or other health condition that is not suitable for this study

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'université de Montréal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

Related Publications (11)

• Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.

  PMID: 9187685 BACKGROUND

• Dixon CM, Rijo Cedano E, Mynderse LA, Larson TR. Transurethral convective water vapor as a treatment for lower urinary tract symptomatology due to benign prostatic hyperplasia using the Rezum((R)) system: evaluation of acute ablative capabilities in the human prostate. Res Rep Urol. 2015 Jan 30;7:13-8. doi: 10.2147/RRU.S74040. eCollection 2015.

  PMID: 25674555 BACKGROUND

• Baker A, Simon N, Keshaviah A, Farabaugh A, Deckersbach T, Worthington JJ, Hoge E, Fava M, Pollack MP. Anxiety Symptoms Questionnaire (ASQ): development and validation. Gen Psychiatr. 2019 Dec 18;32(6):e100144. doi: 10.1136/gpsych-2019-100144. eCollection 2019.

  PMID: 31922090 BACKGROUND

• Rosen RC, Catania JA, Althof SE, Pollack LM, O'Leary M, Seftel AD, Coon DW. Development and validation of four-item version of Male Sexual Health Questionnaire to assess ejaculatory dysfunction. Urology. 2007 May;69(5):805-9. doi: 10.1016/j.urology.2007.02.036.

  PMID: 17482908 BACKGROUND

• Kang M, Ragan BG, Park JH. Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train. 2008 Apr-Jun;43(2):215-21. doi: 10.4085/1062-6050-43.2.215.

  PMID: 18345348 BACKGROUND

• McVary KT, Rogers T, Roehrborn CG. Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21.

  PMID: 30677455 BACKGROUND

• McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22.

  PMID: 26614889 BACKGROUND

• Kaplan SA, Moss J, Freedman S, Coutinho K, Wu N, Efros M, Elterman D, D'Anna R, Padron O, Robertson KJ, Lawindy S, Mistry S, Shore N, Spier J, Kaminetsky J, Mazzarella B, Cahn D, Jalkut M, Te A. The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2023 Sep;210(3):500-509. doi: 10.1097/JU.0000000000003568. Epub 2023 Aug 9.

  PMID: 37555604 BACKGROUND

• Optilume® BPH Catheter System - FDA SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED). FDA; 2023

  BACKGROUND

• Santos Dias J. Benign prostatic hyperplasia: clinical manifestations and evaluation. Tech Vasc Interv Radiol. 2012 Dec;15(4):265-9. doi: 10.1053/j.tvir.2012.09.007.

  PMID: 23244722 BACKGROUND

• Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9. doi: 10.1016/s0022-5347(17)49698-4.

  PMID: 6206240 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Naeem Bhojani, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naeem Bhojani, MD

CONTACT

514-890-8000; naeem.bhojani@gmail.com

Abbas Guennoun, MSc

CONTACT

abbas.guennoun.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized study

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: January 13, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)