'Tamsulosin and Darifenacin' Versus 'Tamsulosin Monotherapy' for 'BPH with Accompanying Overactive Bladder'.

PURPOSE

To evaluate the efficacy/safety of 'tamsulosin and darifenacin' (TD) vs. 'tamsulosin and placebo' (TP) for patients with symptomatic benign prostrate hyperplasia (BPH) with accompanying overactive bladder (OAB) symptoms.

MATERIALS AND METHODS

This study included symptomatic patients of BPH with one or more of the following OAB symptoms; micturition frequency >8, nocturnal frequency > 2, urgency > 1 per 24 hour between November 2012 and February 2014. After protocol approval by ethics committee and obtaining informed consent, patients were randomly assigned to receive tamsulosin 0.4mg plus placebo (TP) (n=30) or tamsulosin 0.4 mg plus darifenacin 7.5 mg (TD) (n=30) for 8 weeks. The mean change from baseline in urinary frequency and incontinence episodes/24 hour (primary end points), and nocturnal frequency; mean change in PVR and changes in IPSS (secondary end points) were compared between groups at 0/eight week using voiding diary and ultrasonography.

RESULTS

The mean change in frequency, incontinence, nocturnal frequency/24 hour and IPSS (International prostrate symptom score) were (-4.83 vs. -3.93, p=0.023), (-1.50 vs. 1.08, p=0.001), (-2.20 vs. -1.87, p<0.001) and (-7.90 vs. -6.27, p<0.001) in the TD/TP group respectively (significant). Apart from some minor side effects (12 vs. 9) all interventions appeared to be safe and well tolerated. The mean change in the PVR (Postvoid residual) was marginal (+10.84ml and -16.93) and the incidence of urinary retention was 13% and 3% in the TD and TP groups respectively (p=0.35).

CONCLUSION

Treatment with tamsulosin and darifenacin for 8 weeks is an effective and safe treatment modality in select patients of BPH with accompanying OAB symptoms.