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

NCT ID: NCT01582542

Last Updated: 2012-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Nocturnal Enuresis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Desmopressin

Group Type EXPERIMENTAL

Desmopressin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Minerine Nocturnal Enuresis

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ofer Yossepowitch, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

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Institute of Urology, Rabin Medical Cetner

Petah Tikva, Petach Tiqva, Israel

Site Status

Countries

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Israel

Other Identifiers

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0366-11-RMC

Identifier Type: -

Identifier Source: org_study_id

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