Clinical trial NCT05495633: SteamOne - Prospective Database for Rezum Water Vapor Therapy of the Prostate
Official title: SteamOne - Prospective Database for Rezum Water Vapor Therapy of the Prostate
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Benign Prostate Obstruction (BPO)
Keywords: Lower Urinary Tract Symptoms (LUTS)
Rezum water vapor therapy
prostate
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2022-08-10
Enrollment: 1000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are treated with Rezum - water vapor therapy of the prostate due to benign prostate obstruction (BPO) or male lower urinary tract symptoms (LUTS) as part of routine clinical practice. Patients will be recruited within the participating study hospitals as part of regular patient care after an indication for Rezum treatment has been made independent of the study.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in International Prostate Symptom Score/ Quality of Life (IPSS/ QoL)
timeFrame: At baseline, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum
Secondary outcomes:
measure: Change of maximum urinary flow rate (Qmax) measured by uroflowmetry
timeFrame: At baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum
measure: Change of International Consultation on Incontinence Questionnaire for male lower urinary tract symptoms (ICIQ-MLUTS)
timeFrame: At baseline, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum
measure: Change of Male Sexual Health Questionnaire (MSHQ)
timeFrame: At baseline, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
measure: Change of International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ-MLUTSsex)
timeFrame: At baseline, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
measure: Patient's postoperative recovery by QoR-15
timeFrame: At baseline, at the first postoperative day and 2 weeks after treatment with Rezum
measure: Change in PROMIS Global Health 10 questionnaire
timeFrame: At baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
measure: Change in ICIQ-S (International Consultation on Incontinence - Satisfaction)
timeFrame: At 2 weeks, 6 weeks, 3 months, 6 months, 12 months and annually after treatment with Rezum
measure: Numeric pain Rating Scale (NRS)
timeFrame: At the first postoperative day
measure: Rezum side effects and Pain medication
timeFrame: At baseline, 2 weeks, 6 weeks and 3 months
measure: Patients' preferences and expectations of Rezum Treatment
timeFrame: At baseline, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
measure: Questionnaire: BPO (BPH)/LUTS medication
timeFrame: At 2 weeks, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
measure: Questionnaire: Reoperation
timeFrame: At 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
measure: Questionnaire: Bladder catheter
timeFrame: At 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
measure: Number of steam injections and injection points during Rezum treatment
timeFrame: At Baseline (on day of treatment with Rezum)
measure: Retreatment rate
timeFrame: Up to 5 years after treatment with Rezum
measure: Surgical safety by classification of intraoperative adverse events (ClassIntra®)
timeFrame: On day of treatment with Rezum
measure: 30-days postoperative complications by the Clavien-Dindo classification
timeFrame: Within 30-days after treatment with Rezum
measure: Antimicrobial prophylaxis
timeFrame: Within the first 30 days after treatment with Rezum
measure: Post voiding residual volume (PVR) measured by ultrasound
timeFrame: Baseline and up to 5 years after treatment with Rezum
measure: Change of prostate size
timeFrame: Baseline and up to 5 years after treatment with Rezum
measure: Change in bladder outlet obstruction index (BOOI)
timeFrame: Max. 6 months before Rezum and/or 3-6 months after Rezum treatment
measure: Change in bladder contractility index (BCI)
timeFrame: Max. 6 months before Rezum and/or 3-6 months after Rezum treatment
measure: Change in International Prostate Symptom Score (IPSS) for detrusor (bladder muscle) overactivity (DO)
timeFrame: Max. 6 months before Rezum and/or 3-6 months after Rezum treatment
measure: MRI (magnetic resonance imaging) data
timeFrame: Max. 12 months before Rezum and up to 5 years after treatment with Rezum
measure: Prostate cancer (PCa) detected by positive prostate biopsy
timeFrame: Max 12 months and up to 5 years after treatment with Rezum
measure: Doctors' preferences, motivations and reasons to use Rezum
timeFrame: Before treatment with Rezum
measure: Change in ICIQ-Lower Urinary Tract Symptoms Quality of Life (ICIQ-MLUTS) score for detrusor (bladder muscle) overactivity (DO)
timeFrame: Max. 6 months before Rezum and/or 3-6 months after Rezum treatment
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinikum Graz
city: Kiel
country: Germany
facility: Urologische Gemeinschaftspraxis Prüner Gang
city: Krefeld
country: Germany
facility: Krankenhaus Maria Hilf - Alexianer Krefeld
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Urology
city: Luzern
country: Switzerland
facility: Hirslanden Klinik St. Anna
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
affiliation: University Hospital Basel, Department of Urology
name: Jan Ebbing, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: