Level 2: Mid-level evidence
A randomized trial evaluated a self-management program in 140 men older than 40 years with uncomplicated lower urinary tract symptoms (LUTS) (BMJ. 2007;334:25; full-text available online without charge at: www.bmj.com/cgi/content/full/334/7583/25. Accessed April 17, 2007). Participants were randomized to the self-management program plus standard care or standard care alone. The self-management program was provided in small group sessions at one, two, and six weeks after randomization; sessions were attended by five to eight men and lasted 1.5-2 hours. Topics included lifestyle modification (e.g., fluid management, avoiding caffeine, avoiding alcohol in the evening if nocturia was bothersome) and specific behavior changes (e.g., bladder retraining [increasing time between voids to three hours], double voiding, urethral milking if post-micturition dribble).
Standard care consisted of watchful waiting, then medication or surgery at the discretion of the clinician and patient; all patients were given standard written information about LUTS. Clinicians were blinded to treatment assignment. Treatment failure was defined as an increase of three or more points on the International Prostate Symptom Score (IPSS), use of drugs to control LUTS, acute urinary retention, or surgical intervention. Information on treatment failure was available for 136 patients (97%) at three months, 133 (95%) at six months, and 115 (82%) at one year.
All outcomes favored the self-management program, compared with control, in intention-to-treat analysis. The rates of treatment failure were 7% vs. 27% at three months (P <.001, NNT 5), 13% vs. 39% at six months (P <.001, NNT 4), and 18% vs. 44% at 12 months (P <.001, NNT 4). Mean IPSS were similar at baseline (16.9 vs. 15.9) but significantly different at three months (10.7 vs. 16.4, P <.001), six months (10.4 vs. 16.9, P <.001), and 12 months (10.2 vs. 15.4, P <.001). The most common reason for treatment failure was increase in IPSS, followed by prescription of alpha blockers.