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Effect of Long Acting Anticholinergic on Nocturnal Incontinence After Radical Cystectomy and Orthotopic Neobladder. A Randomized Placebo-controlled Crossover Study
It is a prospective randomized- placebo control crossover study to evaluate the effect of long acting tolterodine (anticholinergic) in improving and treating nocturnal incontinence in patient after radical cystectomy and orthotopic urinary diversion. patients will be randomly allocated into two groups. one will receive the drug and the other will receive placebo. continence status will be evaluated before and 4 weeks after treatment by the number of pads used and the ICIQ-UI short form questionnaire. This is followed by two weeks of drug washout then reevaluation of the continence status and each group will be crossed over and lastly will be evaluated again.
Details
| Lead sponsor | Mansoura University |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2016-05 |
| Completion | 2017-12 |
Conditions
- Nocturnal Incontinence
Interventions
- long acting tolterodine 4 mg
- placebo
Primary outcomes
- improvement of nocturnal incontinence — 10 weeks
the score of ICIQ- UI short form questionnaire