Overview

This trial is active, not recruiting.

Condition nocturnal enuresis
Treatment desmopressin
Phase phase 4
Sponsor Rabin Medical Center
Start date April 2012
End date December 2013
Trial size 50 participants
Trial identifier NCT01582542, 0366-11-RMC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
desmopressin Minerine
Patients after radical cystectomy with orthotopic bladder reconstruction that suffer from night time urinary incontinence will be enrolled in the study. They will be given for a period of one month after informed consent, Desmopressin At a dosage of 0.1 M"G per day. The rate of improvement of night time urinary incontinence will be measured.

Primary Outcomes

Measure
Rate of improvement in Nocturnal incontinence
time frame: One month

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Usage of Desmopressin fo Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Orthotopic Bladder Reconstruction
Principal investigator Ofer Yossepowitch, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Rabin Medical Center.