A Randomized Trial to Examine the Utility of Mebeverine on the Early Return of Continence Following Orthotopic Bladder Substitution

Abstract

Purpose: We assessed the effect of mebeverine in the enhancement of the orthotopic bladder substitute continence.

Materials and methods: A randomized trial was carried out for incontinent adult male patients during the first year post-orthotopic bladder substitute surgery. Patients were allocated to receive mebeverine 135 mg or placebo 3 times a day for only 3 months. The primary outcome was to compare the continence improvement between groups, assessed by the urinary domain of the Bladder Cancer Index and sanitary pad use. The secondary outcomes were to assess the safety of the drugs used.

Results: In placebo group 47 and in mebeverine group 52 patients completed followup. The median (range) interval time between orthotopic bladder substitute surgery and starting treatment was 7 (3-10) months and 6.5 (3-10) months in the placebo and mebeverine group, respectively (p=0.3). Compared to the baseline evaluation, the 3-month urinary domain of Bladder Cancer Index scores improved in both groups with significant improvement in the mebeverine group. The mean±SD 3-month urinary domain of Bladder Cancer Index was 67.79±13.05 and 83.27±12.21 in the placebo and mebeverine group, respectively (p <0.001). Also, the 3-month patient pad use decreased to 30 (63.8%) and 19 (36.5%) patients in the placebo and mebeverine group, respectively (p=0.007). Constipation occurred in 1 (2.1%) and 3 (5.8%) patients in the placebo and mebeverine group, respectively; abdominal distention occurred in 2 (3.8%) in the mebeverine group (p=0.25).

Conclusions: Mebeverine accelerated continence development in male patients with ileal orthotopic bladder substitute during the first year post-orthotopic bladder substitute construction.

Keywords: ileum; reconstructive surgical procedures; urinary bladder; urinary incontinence.