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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).
Full description
A- Background 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. 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.
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 Optilume BPH Catheter System was approved by the FDA in 2023. 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.
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.
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).
B-Clinical experience
-Optilume® BPH Catheter System: The PINNACLE study was conducted by Kaplan et al. to evaluate the safety and efficacy of Optilume BPH when compared to a sham surgical procedure. The study was designed as a prospective, randomized, double-blinded, sham-controlled clinical trial. Eighteen participating centers in the United States and Canada recruited 148 patients over 50 years old with symptomatic BPH and a prostate size from 20 cc to 80 cc. Randomization assigned 100 patients to the Optilume BPH group and 48 patients to the sham procedure group. The primary endpoint was the comparison of the improvement in IPSS from baseline to 1 year in the Optilume BPH arm against 3 months in the sham arm. Other measurements included uroflowmetry, quality of life (QoL) and sexual function assessments. A blinded and independent clinical events committee prospectively collected data regarding adverse events (AE).
At one year, IPSS improved by 11.5 +/- 7.8 points in the Optilume BPH arm, which was significantly greater than the sham arm at 3 months (8.0 +/- 8.3). Additionally, QoL, sexual function, peak flow rate (Qmax) and post-void residual (PVR) significantly improved trough 1 year. Five serious adverse events probably related to the study device occurred including four hematuria and 1 urethral false passage. Other non-serious AEs included hematuria, urinary tract infection (UTI), dysuria, incontinence, bladder spasms, elevated PSA and urinary urgency. Ejaculatory dysfunction occurred in four patients in the Optilume arm and in 1 patient in the sham arm and no de novo erectile dysfunction was reported.
At the 3 months, the water vapor thermal therapy showed an IPSS reduction of 50% whereas the reduction was only 20% in the control group (p<0.0001). Moreover, other measurements such as Qmax, Qol (p<0.0001) and BHPII (p=0.0003) significantly improved in the Rezum therapy group when compared to the control group. Three serious adverse events (AE) occurred in two patients. One patient had de novo extended urinary retention and the second patient had nausea and vomiting. Moderate to severe AEs resolved within 3 weeks.
A 4-year outcomes of this trial was reported. Improvement of LUTS remain durable throughout 4 years with a reduction of 47% of the IPSS, 43% of the quality of life (QoL), and 52% of the Benign Prostatic Hyperplasia Impact Index. In addition, the retreatment rate was 4.4% at 4 years with no disturbances of sexual function.
C- Clinical investigation design
Objectives: The primary objective of the present study is to evaluate and compare patient experience, symptom relief and functional improvement when using Optilume® BPH Catheter System and RezumTM Water Vapor Therapy within 100 patients through several timepoints.
Sample size: OptiZum is a prospective, single center (Centre hospitalier Universitaire de Montréal), randomized, blinded clinical trial. We expect to recruit 100 participants with a block randomization methodology to either Optilume® BPH Catheter System or RezumTM Water Vapor Therapy (50 participants in each arm).
Study duration: Enrollment is expected to take 12 months. Each participant will be followed post-operatively through 1 year with 1 week, 1 month, 3 months, 6 months and 12 months follow-up visits.
Number of sites: 1 site (Centre Hospitalier de l'Université de Montréal)
Point of enrollment: Each patient will be assigned a study ID after signing the informed consent form.
An informed consent form must be signed by each patient prior to study enrollment. Informed consent will be obtained according to the Declaration of Helsinki ("Ethical Principles for Medical Research Involving Human Subjects", The World Medical Association Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013), requirements of the standard ISO 14155:2020 ("Clinical investigation of medical devices for human subjects-Good clinical practice"), and individual institution guidelines.
Re-consent will be required where changes are implemented, new information becomes available, or as required by regulations, and re-consent is needed.
Study visits and exams:
6.1. Study visits:
-Screening and baseline : Potential participants will undergo screening at the study center. Any study specific testing for eligibility determination that goes beyond standard care must be performed after REB approved study specific informed consent form is signed by the patients.
Baseline tests and questionnaires will be completed 3 months maximum prior to the procedure.
First follow-up visit will be performed 7 days +/- 5 days (1week follow-up visit). Second follow-up visit will be performed 28 days +/- 7 days (1 month follow-up visit). Third, fourth and fifth (3, 6 and 12 months follow-up visit) will be performed 90 days +/- 10 days , 180 days +/- 30 days and 360 days +/- 30 days).
6.2. Study assessments :
Several tests and questionnaires will be completed during this trial:
IPSS, QoL, IIEF, MSHQ-EjD, uroflowmetry and TRUS are standard of care tests and questionnaires.
D- Risk/benefit analysis
The FDA summary of safety and effectiveness data (SSED) of the Optilume BPH Catheter System reported possible risks related to the use of the device. According to the report, potential AEs are similar to standard cystoscopic procedures and mechanical dilation. Potential AEs includes and are not limited to the following:
Additionally, some AEs can occur secondary to the use of paclitaxel coating. Systematic effects of this medication are not anticipated, however, intravenous paclitaxel used in chemotherapy is responsible of AEs. They include and are not limited to:
Allergic reaction
Alopecia
Anemia
Gastrointestinal symptoms
Hematological dyscrasia (including leucopenia, neutropenia, thrombocytopenia)
Hepatic enzyme changes
Myalgia/arthralgia
Myelosuppression
Peripheral neuropathy
Surgical retreatment rate: after 5 years, only 4.4% of patients needed another surgery for BPH symptoms
Does not typically require general anesthesia
No permanent implant
Preserves sexual function
Symptom relief that lasts
However, potential risks include and are not limited to:
E- Ethical oversight:
This study will be conducted in accord with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2014), as well as in respect of the requirements set out in the applicable standard operation procedures of the Research Institute of the University of Montreal Health Care Center and of the University of Montreal Health Care Center Research Ethics Board. The University of Montreal Health Care Center Research Ethics Board will review this study and will be responsible for monitoring it.
F- Data collection and storage: REDCap (a secure online software designed to manage surveys and e-consent forms) and Case report forms (CRFs) will be used to collect all subject data during the study. Data will be stored for 10 years as per institution requirements.
G- Funding: The present study in funded by Laborie (Urotronic).
H- Conflict of interest: Although this is an investigator-initiated study, it should be noted that the principal investigator (Dr Naeem Bhojani) is a consultant for Laborie/Urotronic.
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100 participants in 2 patient groups
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Central trial contact
Naeem Bhojani, MD; Abbas Guennoun, Msc candidate
Data sourced from clinicaltrials.gov
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