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.