L M Sánchez-Gómez1, M Polo-deSantos2, F Gómez-Sancha3, S Luengo-Matos2. 1. Agencia de Evaluación de Tecnologías Sanitarias (AETS), Instituto de Salud Carlos III (ISCIII), Ministerio de Economía y Competitividad, Madrid, España; Instituto de Investigación Sanitaria del Hospital Universitario de La Princesa (IP), Madrid, España; Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC). Electronic address: luism.sanchez@isciii.es. 2. Agencia de Evaluación de Tecnologías Sanitarias (AETS), Instituto de Salud Carlos III (ISCIII), Ministerio de Economía y Competitividad, Madrid, España. 3. Instituto de Cirugía Urológica Avanzada, Clínica CEMTRO, Madrid, España.
Abstract
CONTEXT: Interest in having alternatives in the treatment of benign prostate hyperplasia. OBJECTIVES: To assess the efficacy and safety of the Urolift® system for treating the symptoms of benign prostate hyperplasia. ACQUISITION OF EVIDENCE: Systematic review of the literature through searches on PubMed, Cochrane Library, CRD, Clinical Trials and EuroScan, collecting indicators of efficacy and safety. SUMMARY OF THE EVIDENCE: We included 5 case series and one clinical trial. The patients' mean age ranged from 65-74.3 years, and the mean prostate volume was 41-55cm3. The mean number of Urolif® implants was 3.7-5.5. The maximum follow-up in months was 24, 12 (3 studies) and one (2 studies). Improvements were found in lower urinary tract symptoms, as measured with the International Prostate Symptom Score, Benign Prostatic Hyperplasia Impact Index (BPHII), maximum urinary flow (Qmax) and postvoid residual (PVR) volume. Improvements were in found sexual dysfunction symptoms, as measured with the Sexual Health Inventory for Men (SHIM) and the Male Sexual Health Questionnaire or Ejaculatory Dysfunction (MHSQ-EjD), and in quality of life (QoL). In the clinical trial, the differences were significant for International Prostate Symptom Score, BPHII, Qmax and QoL (p<.05). The adverse effects were mild. CONCLUSIONS: Although the quality of evidence is low, Urolift® constitutes a good therapeutic alternative for patients with benign prostate hyperplasia. The short to medium-term results show that the technique contributes to improving lower urinary tract symptoms, with no relevant side effects, does not affect sexual function and improves quality of life. Further research is required, especially on long-term results.
CONTEXT: Interest in having alternatives in the treatment of benign prostate hyperplasia. OBJECTIVES: To assess the efficacy and safety of the Urolift® system for treating the symptoms of benign prostate hyperplasia. ACQUISITION OF EVIDENCE: Systematic review of the literature through searches on PubMed, Cochrane Library, CRD, Clinical Trials and EuroScan, collecting indicators of efficacy and safety. SUMMARY OF THE EVIDENCE: We included 5 case series and one clinical trial. The patients' mean age ranged from 65-74.3 years, and the mean prostate volume was 41-55cm3. The mean number of Urolif® implants was 3.7-5.5. The maximum follow-up in months was 24, 12 (3 studies) and one (2 studies). Improvements were found in lower urinary tract symptoms, as measured with the International Prostate Symptom Score, Benign Prostatic Hyperplasia Impact Index (BPHII), maximum urinary flow (Qmax) and postvoid residual (PVR) volume. Improvements were in found sexual dysfunction symptoms, as measured with the Sexual Health Inventory for Men (SHIM) and the Male Sexual Health Questionnaire or Ejaculatory Dysfunction (MHSQ-EjD), and in quality of life (QoL). In the clinical trial, the differences were significant for International Prostate Symptom Score, BPHII, Qmax and QoL (p<.05). The adverse effects were mild. CONCLUSIONS: Although the quality of evidence is low, Urolift® constitutes a good therapeutic alternative for patients with benign prostate hyperplasia. The short to medium-term results show that the technique contributes to improving lower urinary tract symptoms, with no relevant side effects, does not affect sexual function and improves quality of life. Further research is required, especially on long-term results.