The short-term effects of tolterodine on nocturnal incontinence after ileal orthotopic neobladder: a randomised crossover placebo-controlled study.

OBJECTIVES

To assess the effect of tolterodine in the treatment of nocturnal urinary incontinence (NUI) after ileal orthotopic neobladder (ONB).

PATIENTS AND METHODS

This is a prospective randomised placebo-controlled crossover study (clinicaltrials.gov: NCT02877901). Patients with NUI after ONB were randomly allocated into two equal groups. Group T received 4 mg extended-release tolterodine at bed-time and Group P received placebo for 4 weeks followed by 2 weeks of washout, then crossed over to the alternate therapy for 4 weeks. Patients were assessed by the number of pads used per night (PPN) and with the Arabic version of the International Consultation on Incontinence Modular Questionnaire-Short Form (ICIQ-SF) at both phases of the study. The outcomes were the rate of NUI improvement and medication adverse events.

RESULTS

Out of 172 patients, 150 and 122 patients were evaluated at both phases of the study. The mean ICIQ-SF scores and PPN were significantly decreased in Group T compared to Group P in both study phases (P < 0.001). In Group T, 15 (10%) and 11 (9%) patients became dry after the first allocation and crossover, respectively. In Group T, 60 (77.9%) patients reported improvement vs four (5.5%) in Group P (P < 0.001) after the first allocation. Similarly, 46 (73%) and seven (11.9%) patients showed improvement in groups T and P after the crossover, respectively (P < 0.001). Dry mouth occurred in 31 (20.8%) patients.

CONCLUSIONS

Tolterodine seems to be a good choice for treatment of NUI after radical cystectomy and ONB. However, further studies are needed to delineate the long-term effects and the associated urodynamic characteristics.