SteamOne - Prospective Database for Rezum Water Vapor Therapy of the Prostate
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 35
- 主要终点
- Change in International Prostate Symptom Score/ Quality of Life (IPSS/ QoL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in International Prostate Symptom Score/ Quality of Life (IPSS/ QoL)
时间窗: At baseline, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum
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).
次要结局
- Change of maximum urinary flow rate (Qmax) measured by uroflowmetry(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)(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)(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)(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(At baseline, at the first postoperative day and 2 weeks after treatment with Rezum)
- Change in PROMIS Global Health 10 questionnaire(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)(At 2 weeks, 6 weeks, 3 months, 6 months, 12 months and annually after treatment with Rezum)
- Numeric pain Rating Scale (NRS)(At the first postoperative day)
- Rezum side effects and Pain medication(At baseline, 2 weeks, 6 weeks and 3 months)
- Patients' preferences and expectations of Rezum Treatment(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(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(At 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum)
- Questionnaire: Bladder catheter(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(At Baseline (on day of treatment with Rezum))
- Retreatment rate(Up to 5 years after treatment with Rezum)
- Surgical safety by classification of intraoperative adverse events (ClassIntra®)(On day of treatment with Rezum)
- 30-days postoperative complications by the Clavien-Dindo classification(Within 30-days after treatment with Rezum)
- Antimicrobial prophylaxis(Within the first 30 days after treatment with Rezum)
- Post voiding residual volume (PVR) measured by ultrasound(Baseline and up to 5 years after treatment with Rezum)
- Change of prostate size(Baseline and up to 5 years after treatment with Rezum)
- Change in bladder outlet obstruction index (BOOI)(Max. 6 months before Rezum and/or 3-6 months after Rezum treatment)
- Change in bladder contractility index (BCI)(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)(Max. 6 months before Rezum and/or 3-6 months after Rezum treatment)
- MRI (magnetic resonance imaging) data(Max. 12 months before Rezum and up to 5 years after treatment with Rezum)
- Prostate cancer (PCa) detected by positive prostate biopsy(Max 12 months and up to 5 years after treatment with Rezum)
- Doctors' preferences, motivations and reasons to use Rezum(Before treatment with Rezum)
- Change in ICIQ-Lower Urinary Tract Symptoms Quality of Life (ICIQ-MLUTS) score for detrusor (bladder muscle) overactivity (DO)(Max. 6 months before Rezum and/or 3-6 months after Rezum treatment)