Desmopressin for Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Bladder Reconstruction

Phase 4

• Conditions: Nocturnal Enuresis
• Interventions: Drug: Desmopressin

• Registration Number: NCT01582542
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Status Verified: 2012-04
• Study Start: 2012-04
• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-04-19
• Last Update Submitted: 2012-04-19
• Study First Posted: 2012-04-20
• Last Update Posted: 2012-04-20
• Primary Completion: 2013-12
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Desmopressin	Desmopressin	-

Primary Outcome Measures

Name	Time	Method
Rate of improvement in Nocturnal incontinence	One month

Trial Locations

Locations (1)

Institute of Urology, Rabin Medical Cetner; 🇮🇱 Petah Tiqva, Petach Tiqva, Israel