Randomised Controlled Trial To Investigate The Effectiveness of The Self-Management After Radiotherapy (SMaRT) Intervention To Ameliorate Lower Urinary Tract Symptoms in Men Treated for Prostate Cancer

Abstract

Purpose To evaluate the effectiveness of the self-management after radiotherapy (SMaRT) intervention to improve urinary symptoms in men with prostate cancer. Methods The randomised controlled trial (RCT) recruited men from one radiotherapy centre in the UK after curative radiotherapy or brachytherapy and moderate urinary symptoms defined as the International Prostate Symptom Score (IPSS) ≥ 8. 63 men were randomised either to SMaRT, a 10-week self-management intervention including group support, education, pelvic floor muscle exercises, or care-as-usual. The primary outcome was the IPSS at 6 months. Secondary outcomes were IPSS at 3 months, and International Continence Society Male Short Form (ICS), European Organisation for Research and Treatment of Cancer Quality of Life prostate scale (EORTC QLQ-PR25), EORTC QLQ-30 and Self-Efficacy for Symptom Control Inventory (SESCI) at 3 and 6 months. Analysis of covariance (ANCOVA) was used to analyse the effect of the intervention. Results SMaRT did not improve urinary symptoms as measured by IPSS at 6 months. The adjusted difference was − 2.5 [95%CI -5.0 to 0.0], p = 0.054. Significant differences were detected at 3 months in ICS voiding symptoms (-1.1 [-2.0 to -0.2], p = 0.017), ICS urinary incontinence (-1.0 [-1.8 to -0.1], p = 0.029) and SESCI managing symptoms domain (13.5 [2.5 to 24.4], p = 0.017). No differences were observed at 6 months. Conclusions SMaRT provided short-term benefit in urinary voiding and continence, and helped men manage symptoms but was not effective long-term. Face-to-face and supervised approaches may provide more benefit.