Abstract

Objective: Few studies describe the effect of non muscle-invasive bladder cancer (NMIBC) on health-related quality of life (HRQL), although patients are mostly diagnosed at this stage of the disease. Taking into account this current evidence gap and the high incidence rates in Spain, we aimed to describe the evolution over time of HRQL in Spanish patients with NMIBC and to examine the clinical and treatment related factors associated with HRQL change during the first year of management. Methods and materials: Observational multicenter prospective inception cohort study conducted in urology departments of 7 Spanish hospitals. A consecutive sample of 244 patients with anatomopathologically confirmed NMIBC, recruited from October 2010 to September 2011, was followed during the diagnostic process, and 6 and 12 months later. HRQL was assessed by generic and disease-specific instruments: the Short Form-36 (covering physical and mental health) and the Bladder Cancer Index, measuring urinary, bowel, and sexual domains (summary scores: 0-100). Bivariate analysis was performed and generalized estimating equation models were constructed to assess HRQL score change. Results:,Almost 52% of the patients were diagnosed at stage I. and 84% were men. The number of patients treated only with transurethral resection (TUR) was 144, and 82 also received intravesical therapy with bacillus Calmette-Guerin (BCG) or mitomycin C. Mental health was significantly worse than Short Form-36 reference norms at diagnosis (mean of 49.7 vs. 53.3, 95% CI: 52.5-54.2). Urinary domain improved significantly from diagnosis (85.2, 95% CI: 82.9-87.4) to 12-month evaluation (90.2, 95% CI: 87.7-92.8), whereas sexual domain showed deterioration from 56.4 (95% (I: 52.8-59.9) to 53.7 (95% (I: 50.0-57.4). Adjusted HRQL score changes from baseline to 12 month follow-up estimated with generalized estimating equation models showed improvement on the following parameters: urinary domain after TUR with or without intravesical therapy (+3.9, 95% CI: 0.1-7.7), bowel domain among patients treated with TUR and BCG (+7.0, 95% CI: 2.4-11.5), and sexual domain among those treated with TUR and mitomycin C (+13.1, 95% CI: 5.9-20.2). Conclusions: For the first time, a distinctive HRQL pattern of bladder cancer treatment benefits emerges for TUR alone, and in combination with BCG or mitomycin C. which deserves further research. Treatment differences cannot be interpreted in terms of efficacy but can be useful to generate hypotheses to test in future studies. (C) 2014 Elsevier Inc. All rights reserved.