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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Benign Prostate Obstruction (BPO)

Intervention / Treatment
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* Other: Collection and evaluation of clinical (CROMs) and patient-reported outcomes (PROMs)
* Other: Analysis of uroflowmetry data by Kesem Health iUFlow medical uroflowmetry device


Participation Criteria
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Eligibility Criteria
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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 in German language or mentally by oneself (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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Collection and evaluation of clinical (CROMs) and patient-reported outcomes (PROMs)|The study uses a web-based German-language registry database called heartbeat ONE by heartbeat medical solutions GmbH (Berlin, Germany) that provides both clinical reported outcome measures (CROMs) and patient-reported outcome measures (PROMs). PROMs are investigated by validated questionnaires: IPSS/QoL, ICIQ-MLUTS, MSHQ, ICIQ-MLUTSsex, QoR-15GE, PROMIS Global Health 10, ICIQ-S, NRS, and by home urine flow measurement (iUFlow) as well as by self-designed questionnaires to assess patients´ preferences and expectations for Rezum and for surgical therapy of the prostate, satisfaction with the Rezum therapy, side effects of the Rezum therapy, (re)medication to treat BPO and LUTS, and reoperations after Rezum therapy.|
|Other: Analysis of uroflowmetry data by Kesem Health iUFlow medical uroflowmetry device|If patients have a smartphone with app function (Android or Apple), they will be provided with a certified and approved home uroflowmetry medical device (iUFlow from Kesem Health) at study entry. This should enable patients to measure their urine flow conveniently from home and thus be independent of the medical consultation (automated home bladder monitoring solution). iUFlowTM is marketed by Kesem Health Pty Ltd, 5A Hartnett Cl, Mulgrave VIC 3170, Australia. The Device is FDA and CE approved and is approved to be used in the EU and Switzerland. Every time a patient is using the device urine flow measurement data and additional voluntary parameters entered by the patient (micturition protocol, drinking protocol) will be sent to the study database.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Prostate Symptom Score/ Quality of Life (IPSS/ QoL) | The IPSS is an eight-item validated questionnaire, consisting of seven symptom questions and one QoL question. The IPSS score is categorised as 'asymptomatic' (0 points), 'mildly symptomatic' (1-7 points), 'moderately symptomatic' (8-19 points), and 'severely symptomatic' (20-35 points). | At baseline, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of maximum urinary flow rate (Qmax) measured by uroflowmetry | Self-measured by patients at home using the iUFlow device (Kesem Health). | At baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum | 
| Change of International Consultation on Incontinence Questionnaire for male lower urinary tract symptoms (ICIQ-MLUTS) | The ICIQ-MLUTS is a widely used and validated patient-completed questionnaire including incontinence questions and bother for each symptom. It contains thirteen items (including incontinence questions and bother for each symptom), with subscales for nocturia and overactive bladder (OAB). | At baseline, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum | 
| Change of Male Sexual Health Questionnaire (MSHQ) | The MSHQ long form includes 3 domains: Erection scale (3 items), Ejaculation scale (7 items), Sexual satisfaction scale (6 items) (additional 2 items measuring bothersome linked to erection and ejaculation). Additional Items (Sexual Activity and Desire) are not to be collected. | At baseline, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum | 
| Change of International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ-MLUTSsex) | The ICIQ-MLUTSsex is a patient-completed questionnaire for detailed evaluation of male sexual matters associated with their lower urinary tract symptoms and impact on quality of life (QoL). It is composed of 4 sections (erection, ejaculation, pain/discomfort during ejaculation, impact of urinary symptoms). | At baseline, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum | 
| Patient's postoperative recovery by QoR-15 | Investigation of type of anesthesia (general anesthesia, spinal anesthesia, local anesthesia, analgosedation) incl. reason for type of anesthesia and postoperative recovery using the validated German version of the Quality-of-Recovery-Score (QoR-15GE). | At baseline, at the first postoperative day and 2 weeks after treatment with Rezum | 
| Change in PROMIS Global Health 10 questionnaire | Changes in Quality of Life associated with Rezum treatment using the PROMIS Global Health 10 questionnaire. It is a measure of overall health-related quality of life. The questionnaire consists of a combination of 10 questions that assess both the physical and mental health status of adult patients independent of their individual medical situation. The items are measured using a five-point response matrix that includes physical function, fatigue, pain, emotional distress and social health. | 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 | 
| Change in ICIQ-S (International Consultation on Incontinence - Satisfaction) | The ICIQ-S (International Consultation on Incontinence - Satisfaction) will be used to evaluate patient satisfaction after urological surgery. Question items consist of: outcome success, comparison of symptoms, return to normal life, same situation, same choice, recommend, current symptoms, preparation for surgery, satisfaction of explanation, pain after surgery, satisfaction of pain relief, current pain, complications/side effects, result of surgery and satisfaction with surgery. | At 2 weeks, 6 weeks, 3 months, 6 months, 12 months and annually after treatment with Rezum | 
| Numeric pain Rating Scale (NRS) | Investigation of patients' perception of pain during Rezum procedure in case of local anesthesia and/or analgosedation and after Rezum treatment using NRS. The NRS has the following scale: from 0 - 10 (no pain - worst pain imaginable). | At the first postoperative day | 
| Rezum side effects and Pain medication | This questionnaire is self-designed. Typical side effects must be seen and investigated independently of treatment complications in order to provide patients with the best possible advice and information. The need for pain medication will be evaluated in a time context as well. | At baseline, 2 weeks, 6 weeks and 3 months | 
| Patients' preferences and expectations of Rezum Treatment | This self-designed questionnaire considers measurement tools related to BPO/male LUTS treatment and aims to investigate patients' motivations, expectations and preferences for surgical desobstruction of the prostate due to BPO in general but also in particular concerning the Rezum treatment. This will attempt to better understand patient attitudes in order to improve future counseling of patients regarding minimally invasive procedures for the treatment of BPO-related male LUTS. | At baseline, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum | 
| Questionnaire: BPO (BPH)/LUTS medication | This self-designed questionnaire aims to evaluate the need for BPO (BPH)/LUTS medication. | At 2 weeks, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum | 
| Questionnaire: Reoperation | This self-designed questionnaire aims to evaluate the need for urological reoperation. | At 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum | 
| Questionnaire: Bladder catheter | This self-designed questionnaire aims to evaluate the need for bladder catheterization. | At 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum | 
| Number of steam injections and injection points during Rezum treatment | Investigation of the influence of the number of steam injections and Injection points on outcome parameters, micturition parameters, sexual function, prostate size, side effects and complications. | At Baseline (on day of treatment with Rezum) | 
| Retreatment rate | Number of retreatments (medical (drugs), bladder catheter and surgical) after Rezum treatment. | Up to 5 years after treatment with Rezum | 
| Surgical safety by classification of intraoperative adverse events (ClassIntra®) | The classification defines intraoperative adverse events as any surgery or anesthesia-related deviation from the ideal intraoperative course occurring between begin of anesthesia and end of anesthesia. Surgical safety is investigated by analyzing intraoperative complications classified by ClassIntra (from Grade 0: No deviation from the ideal intraoperative course to Grade 5: Any deviation from the ideal intraoperative course with intraoperative death of the patient). | On day of treatment with Rezum | 
| 30-days postoperative complications by the Clavien-Dindo classification | The classification defines postoperative adverse events occurring after the patient has left the recovery room until 30 days after surgery (from Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological intervention to Grade V: Death of a patient). | Within 30-days after treatment with Rezum | 
| Antimicrobial prophylaxis | Investigation of the effectiveness of the chosen antimicrobial prophylaxis by analyzing the rate of postoperative symptomatic urinary tract infections (UTI) within the first 30 days after surgery as part of the Clavien-Dindo classification. Definition of symptomatic UTI is based on clinical diagnosis supported by measured bacteriuria of ≥105 cfu/ml treated with antimicrobial agents. | Within the first 30 days after treatment with Rezum | 
| Post voiding residual volume (PVR) measured by ultrasound | Change of post voiding residual volume (PVR) measured by ultrasound is a simple test that can raise or lower the suspicion of bladder outlet obstruction (BOO). | Baseline and up to 5 years after treatment with Rezum | 
| Change of prostate size | Measured by ultrasound or magnetic resonance imaging (MRI). | Baseline and up to 5 years after treatment with Rezum | 
| Change in bladder outlet obstruction index (BOOI) | BOOI is represented by the equation: BOOI = Pdet @ Qmax - 2 x Qmax (Pdet = detrusor pressure; Qmax = maximum flow rate). BOOI > 40 = obstructed; BOOI 20-40 = equivocal; and BOOI < 20 = unobstructed. | Max. 6 months before Rezum and/or 3-6 months after Rezum treatment | 
| Change in bladder contractility index (BCI) | The BCI is represented by the following formula: BCI = Pdet @ Qmax + 5 x Qmax. Using this formula, contractility can be divided into strong > 150, normal 100-150, and weak < 100. | Max. 6 months before Rezum and/or 3-6 months after Rezum treatment | 
| Change in International Prostate Symptom Score (IPSS) for detrusor (bladder muscle) overactivity (DO) | Urodynamic analysis of detrusor overactivity (DO) during storage phase and correlation of pre- and postoperative DO with PROMs (IPSS). The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Max. 6 months before Rezum and/or 3-6 months after Rezum treatment | 
| MRI (magnetic resonance imaging) data | MRI data not older than 12 months at time of Rezum treatment and MRI data in the follow-up period of 5 years are investigated in terms of prostate size, ablative lesions (lesions caused by Rezum) and PI-RADS (prostate imaging-reporting and data system) lesions. | Max. 12 months before Rezum and up to 5 years after treatment with Rezum | 
| Prostate cancer (PCa) detected by positive prostate biopsy | The proportion of patients who receive Rezum treatment with a history of prostate cancer or who develop histologically confirmed prostate cancer during the post-treatment course. | Max 12 months and up to 5 years after treatment with Rezum | 
| Doctors' preferences, motivations and reasons to use Rezum | Investigation of doctors' reasons for preference/choice of using Rezum in a patient using a self-designed questionnaire. | Before treatment with Rezum | 
| Change in ICIQ-Lower Urinary Tract Symptoms Quality of Life (ICIQ-MLUTS) score for detrusor (bladder muscle) overactivity (DO) | Urodynamic analysis of detrusor overactivity (DO) during storage phase and correlation of pre- and postoperative DO with PROMs (ICIQ-MLUTS). The ICIQ-MLUTS is a questionnaire for evaluating male lower urinary tract symptoms and impact on quality of life (QoL). 1-84 overall score with greater values indicating increased symptom severity. | Max. 6 months before Rezum and/or 3-6 months after Rezum treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower Urinary Tract Symptoms (LUTS), Rezum water vapor therapy, prostate