PURPOSE - To evaluate change in quality of life (QoL) and symptoms in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) in conditions of current clinical practice.
METHODS - Prospective, longitudinal, multicenter open-label study was carried out in urology outpatient clinics.
Patients were ≥40 years of age with an International Prostate Symptom Score (IPSS) score ≥8. QoL and symptoms were measured at baseline and 6 months using the Benign Prostatic Hyperplasia Impact Index (BII) and the IPSS.
RESULTS - 1713 patients were included for analysis. Mean (SD) IPSS and BII scores at baseline were 16. 8 (5. 4) and 6. 8 (2. 6), respectively. 8. 9 % (n = 153) of study participants did not receive treatment (watchful waiting, WW), 70. 3 % (n = 1204) were prescribed monotherapy (alpha-adrenergic blockers [AB]; phytotherapy [PT, of which 95. 2 % was the hexanic extract of Serenoa repens, HESr]; or 5-alpha-reductase inhibitors [5ARI]), and 20. 8 % (n = 356) received combined treatment (AB + 5ARI; AB + HESr; others). At 6 months, improvements in QoL were similar across the different medical treatment (MT) groups, both for monotherapy (AB: mean improvement [SD] of 2. 4 points [2. 4]; PT: 1. 9 [2. 4]; 5ARI: 2. 5 [2. 3]) and combined therapy (AB + 5ARI: 3. 1 [2. 9]; AB + PT: 3. 1 [2. 5]). There were no clinically significant differences between MT groups and all showed significant improvement over WW (p < 0. 05). HESr showed similar efficacy to AB and 5ARI both as monotherapy and in combination with AB. Results on the IPSS were similar.
CONCLUSIONS - Improvements in QoL and symptoms were equivalent across the medical treatments most widely used in real-life practice to manage patients with moderate or severe LUTS. HESr showed an equivalent efficacy to AB and 5ARI with fewer side effects.
International urology and nephrology. 2016 Jan 25 [Epub ahead of print]
Antonio Alcaraz, Joaquín Carballido-Rodríguez, Miguel Unda-Urzaiz, Rafael Medina-López, José L Ruiz-Cerdá, Federico Rodríguez-Rubio, Darío García-Rojo, Francisco J Brenes-Bermúdez, José M Cózar-Olmo, Víctor Baena-González, José Manasanch
Urology Department, Hosp. Clínic Univ. , IDIBAPS, Barcelona, Spain. , Urology Department, Hosp. Univ. Puerta de Hierro, Majadahonda, Madrid, Spain. , Urology Department, Hosp. Univ. Basurto, Bilbao, Spain. , Urology Department, Hosp. Univ. Virgen del Rocío, Sevilla, Spain. , Urology Department, Hosp. Univ. La Fe, Valencia, Spain. , Urology Department, Hosp. Univ. Puerto Real, Cádiz, Spain. , Urology Department, Hosp. Univ. Parc Taulí Sabadell, Sabadell, Barcelona, Spain. , Llefià Primary Care Center, Badalona, Barcelona, Spain. , Urology Department, Complejo Hospitalario Universitario de Granada, Granada, Spain. , Urology Department, Hosp. Univ. Carlos Haya, Málaga, Spain. , Pierre Fabre Ibérica S. A. , Ramon Trias Fargas, 7-11, 3º, 08005, Barcelona, Spain.