Usage of Desmopressin fo Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Orthotopic Bladder Reconstruction

Rabin Medical Center1 site in 1 country50 target enrollmentApril 2012

ConditionsNocturnal Enuresis

InterventionsDesmopressin

DrugsDesmopressin

Overview

Phase: Phase 4
Intervention: Desmopressin
Conditions: Nocturnal Enuresis
Sponsor: Rabin Medical Center
Enrollment: 50
Locations: 1
Primary Endpoint: Rate of improvement in Nocturnal incontinence
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to prospectively assess whether Desmopressin, given for a period of month to patients after radical cystectomy with orthotopic bladder reconstruction, improves and lowers the rate of nocturnal enuresis.

Detailed Description

We will prospectively assess the utilization of Desmopressin in improving nocturnal enuresis in patients after radical cystectomy with orthotopic bladder reconstruction. Patients after radical cystectomy with neobladder reconstruction will be given Desmopressin 0.1 mg once a day for a duration of one month. Before beginning treatment patients will be given the NNES-Q questionnaire to assess severity of nocturnal enuresis. At the end of treatment, the same questionnaire will be given to all patients to assess if nocturnal enuresis improved. Sodium levels will be tested before treatment, 2 weeks after beginning treatment and at the end of treatment.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

March 2014

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Rabin Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age above 18
•Able to give informed consent
•Patients afte radical cystectomy with orthotopic bladder reconstruction with night time incontinence

Exclusion Criteria

•Patients with after radical cystectomy with orthotopic bladder reconstruction with daytime urinary incontinence
•Patients already treated with Desmopressin due to other reasons.
•Patients with an allergy or insensitivity to Desmopressin.
•Patients with known hyponatremia
•Patients with severe chronic renal failure and creatinine clearance of below 50 cc/sec.
•Patients with severe congestive heart failure
•Patients with active urinary tract infection
•Patients taking drug therapy which can interact with Desmopressin and affect it's action.Examples include Diuretics, Tricyclic antidepressants, Carbamezapine and Chlorpropamide AND Indomethacin.
•Patients with an indwelling urinary catheter.