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

"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."

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.