SteamOne - Prospective Database for Rezum Water Vapor Therapy of the Prostate

University Hospital Basel

Status: Enrolling

Conditions: Benign Prostate Obstruction (BPO)

Treatments: Other: Analysis of uroflowmetry data by EmanoFlow Mobile Application (App) and Emano Clinic Portal; Other: Collection and evaluation of clinical (CROMs) and patient-reported outcomes (PROMs)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05495633

2022-00544 bb21Ebbing;

Details and patient eligibility

About

This study is to assess the clinical data of Rezum (water vapor therapy) in patients with BPO (benign prostate obstruction) and male LUTS (lower urinary tract symptoms) in terms of efficacy, durability and safety in a large, prospective, multi-center cohort consisting of 1000 "real-life" patients with a follow-up of 5 years.

Full description

Prostate water vapor therapy (Rezum) is an approved treatment procedure for the management of lower urinary tract symptoms in men caused by benign prostatic obstruction (BPO). Rezum is performed transurethrally by steam injections into the central or transition zone of the enlarged prostate. The 103°C hot steam is generated by a generator and injected into the prostate tissue via a disposable handpiece with a retractable needle. Approximately 1 injection is required per 10 ml of prostate tissue to achieve desobstruction. The single injection takes only 9 seconds. The thermal energy contained in the water vapor is able to develop evenly and freely in the intercellular space of the prostate by convection. This represents a unique technique in surgical desobstruction of the prostate. The steam condenses and releases the stored heat energy to the cell membranes, which then denature. As a result, the prostate tissue shrinks by about 30% in the first three months after the Rezum treatment. The shrinkage process therefore does not take place immediately, but with a time delay. The minimally invasive nature of the procedure results from the short surgical time, the potential of Rezum to preserve sexual function (both ejaculation and erection), and the possibility of performing Rezum even under local anesthesia or analgesia. Data on efficacy, durability of efficacy, safety/complications, and indication groups are still limited. "Real life" data are important to determine the role of Rezum water vapor therapy in the treatment of BPO and male LUTS. The aim of this study is to prospectively enroll and follow Rezum patients in a multicenter, German-language, web-based database. Patient-reported outcome measures (PROMs) and clinical-reported outcome measures/data (CROMs) on various subgroups of patients treated with Rezum as a routine clinical treatment option for BPO-related male LUTS will be recorded in terms of procedure efficacy, functional outcomes (e.g. sexual function) and surgical safety. Further aspects of interest are recovery from the procedure, patients' expectations towards Rezum treatment, patients' satisfaction with Rezum treatment, and impact of Rezum on quality of life.

Enrollment: 1,000 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All male patients who are treated with Rezum due to prostate obstruction and LUTS in the participating study centers can be included if certain inclusion criteria are met and some exclusion criteria are not present.
• The indication to perform Rezum needs to be made independently from the study. The decision for Rezum treatment is the responsibility of each individual practitioner and patient.
• Age ≥ 18 years
• Operated or supervision of surgery by a certified urologist
• Subgroups of special interest are e.g. catheter-dependent patients, patients with oral anticoagulation, patients with preoperative urodynamic pressure-flow investigation (not older than 6 months) or patients with prostates bigger than 80 ml

Exclusion criteria

• Missing informed consent
• Lack of ability to answer questionnaires due to laguage problems or mental incapacity (e.g. in dementia, mental disability)
• Patient does not have a personal email address available and the survey cannot be completed via a relative's email address and the patient is not willing to complete the survey on the tablet at the clinic
• Known or suspected neurogenic bladder dysfunction in e.g. Parkinson's disease, multiple sclerosis or other neurological diseases with possible effects on bladder function
• History of malignant bladder tumor in the last two years (including CIS) or currently present malignant bladder tumor at time of Rezum treatment (including CIS)
• Previous operation(s) on the prostate, except prostate biopsy, if this was performed more than 4 weeks ago at time of Rezum treatment
• Previous operation(s) on the bladder neck
• Presence of bladder neck stenosis requiring treatment at time of Rezum treatment
• Planned combination of Rezum treatment concurrently with another urologic (*) or non-urologic procedure

(*) also the combination with a planned transurethral procedure is not allowed except for bladder stone removal

Trial design