Premium
Vesomni improves the quality of life in men with lower urinary tract symptoms in routine clinical practice in Europe
Author(s) -
Rees Jonathan,
Foley Steve,
Huang Moses,
Rosa Arias José,
Skoumal René,
Walters Carien,
Yavuz Yalcin,
Wachter Stefan
Publication year - 2019
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.23944
Subject(s) - medicine , overactive bladder , lower urinary tract symptoms , international prostate symptom score , quality of life (healthcare) , tamsulosin , solifenacin , visual analogue scale , confidence interval , prostatitis , urology , clinical endpoint , clinical practice , clinical trial , prostate , physical therapy , hyperplasia , alternative medicine , nursing , pathology , cancer
Abstract Aim To evaluate the impact of Vesomni/Urizia/Volutsa, a fixed‐dose combination tablet containing 6 mg solifenacin (antimuscarinic) and 0.4 mg tamsulosin (α‐blocker), on health‐related quality of life (HRQoL) and treatment satisfaction in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in routine clinical practice. Methods EUROPA was a noninterventional study of men with LUTS/BPH not responding to monotherapy who were prescribed Vesomni in routine clinical practice. Data were collected retrospectively (1 year) and prospectively (1 year). Assessments were performed at baseline, weeks 4 to 8, weeks 9 to 18 (optional), weeks 19 to 39 (optional), and Weeks 40 to 52. The primary endpoint was change from baseline in HRQoL, as assessed by the Overactive Bladder Questionnaire (OAB‐q) symptom bother subscale score. Change from baseline in OAB‐q total and coping, sleep, and social interaction subscale scores, treatment satisfaction‐visual analog scale (TS‐VAS), International Prostate Symptom Score (IPSS), and European Quality of Life 5‐Dimension‐5‐Level (EQ‐5D‐5L) questionnaire were also evaluated. Results Five hundred and eighty‐nine patients were enrolled. The mean changes in adjusted mean (95% confidence interval [CI]) OAB‐q symptom bother subscale scores were −16.40 (−24.31, −8.49) at weeks 4 to 8 and −19.59 (−28.26, −10.92) at weeks 40 to 52; at weeks 40 to 52, changes were clinically meaningful in 84.6% of patients. Adjusted mean (95% CI) change from baseline to weeks 40 to 52 were 15.02 (7.35, 22.69), 19.37 (10.86, 27.89), 18.65 (7.44, 29.86), 9.85 (3.90, 15.81), and 16.09 (9.07, 23.11) for concern, coping, sleep, social interaction, and total, respectively. TS‐VAS, IPSS, and EQ‐5D‐5L all improved, and treatment persistence at weeks 40 to 52 was 77.1%. Urinary retention was reported in four (0.7%) patients. Conclusions Vesomni was well‐tolerated and improved HRQoL and treatment satisfaction in patients with LUTS/BPH.