Objective: Measuring the treatment effectiveness from the patients' perspectives is recommended in managing benign prostatic hyperplasia (BPH). The purpose of this study was to validate the US English Patient Perception of Study Medication Questionnaire (PPSMQ) administered to BPH patients in a randomized clinical trial. Methods: Patients with moderate-to-severe BPH completed three disease-specific instruments at baseline and at follow-up visits: the International Prostate Symptom Score (IPSS, a 7-item urinary symptom severity scale), the BPH Impact Index (BII, a 4-item well-being scale associated with BPH) and the PPSMQ (a 12-item instrument measuring patient satisfaction in control of urinary symptoms, strength of urinary stream, pain of urination and effect on usual activities due to the pharmacotherapy). The psychometric performance, including reliability, validity and responsiveness, of the PPSMQ was analyzed. Results: The mean age of the study sample was 66.7 years (n=879). The PPSMQ demonstrated good internal consistency (Cronbach's alpha=0.88 to 0.96) and reliability (intraclass coefficient=0.37 to 0.40). Convergent validity of the PPSMQ subscale and total scores measured by the Pearson coefficient ranged from 0.48 to 0.58 for the IPSS and 0.31 to 0.45 for the BII, suggesting correlations between the PPSMQ and another two logically-related instruments. The PPSMQ also demonstrated discriminant validity against the IPSS, IPSS QoL item and BII (F=52.5, 42.3, and 26.9, respectively, p-values<0.001). The PPSMQ detected treatment differences between the monotherapy and combination therapy arms: total scores at baseline for the combination therapy, dutasteride and tamsulosin treatment groups were 25.6, 25.8, and 25.7 (higher scores indicating lower satisfaction), respectively; at two years, the scores were 17.8, 20.3, and 20.4, respectively. Conclusion: The PPSMQ demonstrated good reliability, validity and responsiveness in measuring patient satisfaction with the pharmacology treatments for BPH. The PPSMQ may be an important addition to the existing outcome measures used to assess BPH symptoms and their treatments.