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

Nocturnal Enuresis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01582542
• Other study ID #: 0366-11-RMC
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 19, 2012
• Last updated: April 19, 2012
• Start date: April 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2012
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis

Intervention

Drug:
• Desmopressin
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.

Locations

Country	Name	City	State
Israel	Institute of Urology, Rabin Medical Cetner	Petah Tiqva	Petach Tiqva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of improvement in Nocturnal incontinence		One month	No