Treatment satisfaction with tadalafil or tamsulosin vs placebo in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH): results from a randomised, placebo-controlled study.
BJU Int
; 114(4): 568-75, 2014 Oct.
Article
en En
| MEDLINE
| ID: mdl-24612148
OBJECTIVES: To assess treatment satisfaction with tadalafil or tamsulosin vs placebo in a 12-week, randomised, double-blind study of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). PATIENTS AND METHODS: After a 4-week placebo lead-in period, men aged ≥45 years with an International Prostate Symptom Score (IPSS) of ≥13 and a maximum urinary flow rate of ≥4 to ≤15 mL/s received placebo (172 men), tadalafil 5 mg (171), or tamsulosin 0.4 mg (168) once daily for 12 weeks. Treatment Satisfaction Scale-BPH (TSS-BPH) responses were assessed based on median treatment differences using the van Elteren test. RESULTS: Overall treatment satisfaction was greater for tadalafil vs placebo (P = 0.005), based on greater satisfaction with efficacy (P = 0.003); neither overall treatment satisfaction nor satisfaction with efficacy was greater for tamsulosin vs placebo (P ≥ 0.409). For individual questions, 66.5% of men rated tadalafil treatment as 'effective/very effective' (Question 1, Q1) vs placebo (P = 0.011), 72.6% would 'definitely/probably recommend their treatment' (Q3; P = 0.043), 71.8% were generally 'very satisfied/satisfied with their medication' (Q8; P < 0.003), and 65.0% would 'definitely/probably continue therapy' (Q10; P = 0.035). With tamsulosin, differences vs placebo were not statistically significant. Subgroup analyses of overall TSS-BPH by baseline age (≤65/>65 years), history of erectile dysfunction (yes/no), LUTS/BPH severity (IPSS
Asunto(s)Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Hiperplasia Prostática
/
Sulfonamidas
/
Carbolinas
/
Síntomas del Sistema Urinario Inferior
/
Agentes Urológicos
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Prognostic_studies
Límite:
Aged
/
Aged80
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
BJU Int
Asunto de la revista:
UROLOGIA
Año:
2014
Tipo del documento:
Article
País de afiliación:
Alemania
Pais de publicación:
Reino Unido
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Hiperplasia Prostática
/
Sulfonamidas
/
Carbolinas
/
Síntomas del Sistema Urinario Inferior
/
Agentes Urológicos
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Prognostic_studies
Límite:
Aged
/
Aged80
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
BJU Int
Asunto de la revista:
UROLOGIA
Año:
2014
Tipo del documento:
Article
País de afiliación:
Alemania
Pais de publicación:
Reino Unido