Original Title: Eficacia y seguridad de la terapia de vapor de agua y del sistema de liberación uretral para el tratamiento de los síntomas de la hiperplasia benigna de próstata

Authors' objectives: The aim of the report is to analyse the efficacy and safety of steam heat therapy and the urethral delivery system in the treatment of benign prostatic hyperplasia versus other therapeutic alternatives.

Authors' results and conclusions: CONCLUSIONS: The trials show that Rezum® and Urolift® procedures can improve LUTS in BPH, with significant results on the IPSS and BPHII scales versus sham treatment. However, Urolift® versus TURP does not show favourable results on these scales. No significant differences were found in the erectile function of patients treated with Rezum®, Urolift®, or TURP. However, ejaculation outcomes were favourable for Urolift® treatment versus TURP. Rezum® and Urolift® significantly improved patients’ quality of life compared to the sham procedure. However, treatment with Urolift® versus TURP does not show significant improvements in quality of life. The favourable results of Rezum® and Urolift® versus sham treatment in relation to LUTS, quality of life and sexual function appear to be maintained over time, at least for the first 5 years. The Rezum® and Urolift® procedures are safe treatments, with no relevant adverse events reported. The available cost-effectiveness studies show that the Urolift® and Rezum® procedures could be cost-effective in the management of patients with BPH, and treatment with Rezum® could lead to greater cost savings. Further studies are needed to better understand the efficacy and safety of the Rezum® and Urolift® procedures compared to the different therapeutic alternatives available. It would also be necessary to establish the profile of the patient who could benefit most from the treatments.

Authors' methods: A systematic review (SR) of the scientific literature was carried out. The following databases were consulted: Medline, EMBASE, and Cochrane Library, and the databases of international Health Technology Assessment Agencies such as the National Institute for Health and Care Excellence (NICE), the Canadian Agency for Drugs and Technologies in Health (CADTH), or the International Network of Agencies for Health Technology Assessment (INAHTA). Studies published in English, French and Spanish up to 15 October 2021 were included. The search strategy did not include study size restrictions. The PICO (Population, Intervention, Comparator and Outcome) criteria were followed for study inclusion. Randomised clinical trials (RCTs) and SRs involving patients with symptomatic BPH treated with the Rezum® or Urolift® procedures compared to any surgical intervention were included. Identification, selection and review of studies was carried out by two reviewers independently. Disagreements were resolved by consensus or in collaboration with another investigator. Tables were drawn up detailing the studies included and excluded in the review, justifying the reason for exclusion. The quality assessment of the SRs was evaluated with the AMSTAR-2 tool, and that of the RCTs with the Rob-2 tool of the Cochrane Collaboration. A narrative synthesis and evidence tables of the included studies were performed with the GRADE PRO tool. To determine the weight of evidence, data analysis was performed for the main measures of efficacy using Review Manager Software. The variables studied were: 1) Lower urinary tract symptoms (LUTS), using the International Prostate Symptom Score (IPSS) or American Urologic Association Symptom Index (AUASI), Postvoid Residual Volume (PVR), Bening Prostatic Hyperplasia Impact (BPHII), and maximum urine flow rate (Qmax) scales; 2) Quality of life, using the IPSS-QoL scale; 3) Sexual function symptoms including erectile function, using the Sexual Health Inventory for Men (SHIM) or International Index of Erectile Function (IIEF) scales; and ejaculatory function/discomfort using the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MHSQ-EjD) scale. The safety of the procedures was assessed by recording the occurrence of adverse effects and their severity. Data were collected on the economic impact of the technologies studied, and the relevant organizational and ethical impacts. Finally, the opinion and experience of patients with BPH was collected using a modified version of the template for collecting patient opinion in health technology assessment reports developed by the European Network of Health Technology Assessment Agencies (EUnetHTA).

Project Status: Completed

Year Published: 2023

URL for published report: https://repisalud.isciii.es/rest/api/core/bitstreams/03b054fc-a1a4-4689-9194-7fd253e09102/content

URL for additional information: https://redets.sanidad.gob.es/productos/buscarProductos.do?metodo=detalle&id=1200

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Agencia de Evaluacion de Tecnologias Sanitarias

Contact Address: Instituto de Salud "Carlos III", Calle Sinesio Delgado 6, Pabellon 4, 28029 Madrid, Spain. Tel: +34 9 1 822 2005; Fax: +34 9 1 387 7841;

Contact Name: Esther E. García Carpintero

Contact Email: eegarcia@isciii.es

Copyright: Agencia de Evaluacion de Tecnologias Sanitarias