Effect of Long Acting Anticholinergic on Nocturnal Incontinence After Radical Cystectomy and Orthotopic Neobladder

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Cholinergic Antagonists; Tolterodine Tartrate

Criteria

Inclusion Criteria:

• Patients who passed at least one year follow up after the procedure.

• Patients who have no symptoms or signs of oncological failure (local recurrence or distant metastasis).

• Presence of NI with normal daytime continence assessed by the Arabic version of short form International Consultation on Incontinence questionnaire (ICIQ-UI Short Form).18

• Normal renal function (eGFR ˃50 ml/min /1.73m2) calculated by the Modification Of Diet in Renal Disease study equation.

• Ability to provide informed consent.

Exclusion Criteria:

• Patients who did not pass one year postoperative.

• Presence of oncological failure.

• Totally continent patient or who has daytime incontinence or chronic urine retention.

• Impaired renal function.

• Uncontrolled DM or hypertension.