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

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.

• Change of maximum urinary flow rate (Qmax) measured by uroflowmetry [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: At baseline, at the first postoperative day and 2 weeks after treatment with Rezum]
• Change in PROMIS Global Health 10 questionnaire [Time frame: 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) [Time frame: At 2 weeks, 6 weeks, 3 months, 6 months, 12 months and annually after treatment with Rezum]
• Numeric pain Rating Scale (NRS) [Time frame: At the first postoperative day]
• Rezum side effects and Pain medication [Time frame: At baseline, 2 weeks, 6 weeks and 3 months]
• Patients' preferences and expectations of Rezum Treatment [Time frame: 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 [Time frame: 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 [Time frame: At 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum]