OBJECTIVE: To evaluate and compare the effects of behavioral treatment (BT) combined with pelvic floor muscle training (PFMT) versus BT and PFMT provided in isolation in women with overactive bladder syndrome (OAB). METHODS: Prospective, randomised, and controlled clinical trial with concealed allocation including 110 women with OAB were randomized into three groups: BT plus PFMT, BT, and PFMT. The intervention consisted of 3-month program: BT plus PFMT group received an educational program with lifestyle modifications, urgency suppression techniques, bladder training, and motivation strategies, combined with PFMT; BT and PFMT groups carried out the isolated interventions described above. The primary outcome was OAB cure defined by OAB-V8 questionnaire score < 8 and the absence of episodes of urgency urinary incontinence in the voiding diary. Secondary outcomes were urinary symptoms, pelvic floor muscle (PFM) function, outpatient and home adherence to the exercise sets, and subjective cure. RESULTS: Higher objective cure was observed in the BT plus PFMT group compared with isolated PFMT and BT in both per protocol and intention-to-treat analyses. In the per protocol analysis, women receiving BT plus PFMT were 5.5 times more likely to achieve objective cure than PFMT (OR 5.5; 95% CI 1.6 to 18.7) and 4.1 times more likely than BT (OR 4.1; 95% CI 1.3 to 12.8). For the intention-to-treat analysis considering losses as uncured, BT plus PFMT remained more effective than PFMT alone (OR 3.4; 95% CI 1.2 to 9.5). All groups improved PFM function (power, endurance, fast contractions, p < 0.001 for all), however PFMT and PFMT plus BT had better PFM function compared to BT group (p < 0.001 for all). CONCLUSIONS: The combination of BT with PFMT were more effective than isolated therapies in the management of female OAB.

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