- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01582542
Desmopressin for Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Bladder Reconstruction
Usage of Desmopressin fo Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Orthotopic Bladder Reconstruction
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Petach Tiqva
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Petah Tiqva, Petach Tiqva, Israel, 49100
- Institute of Urology, Rabin Medical Cetner
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of improvement in Nocturnal incontinence
Time Frame: One month
|
One month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ofer Yossepowitch, MD, Rabin Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Urinary Incontinence
- Enuresis
- Nocturnal Enuresis
- Physiological Effects of Drugs
- Natriuretic Agents
- Hemostatics
- Coagulants
- Antidiuretic Agents
- Deamino Arginine Vasopressin
Other Study ID Numbers
- 0366-11-RMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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