Back to resultsDesmopressin for Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Bladder Reconstruction
Primary Purpose
Nocturnal Enuresis
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Desmopressin
Sponsored by
About this trial
This is an interventional treatment trial for Nocturnal Enuresis
Eligibility Criteria
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.
Sites / Locations
- Institute of Urology, Rabin Medical Cetner
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Desmopressin
Arm Description
Outcomes
Primary Outcome Measures
Rate of improvement in Nocturnal incontinence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01582542
Brief Title
Desmopressin for Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Bladder Reconstruction
Official Title
Usage of Desmopressin fo Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Orthotopic Bladder Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Enuresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Desmopressin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Other Intervention Name(s)
Minerine, Nocturnal Enuresis
Intervention Description
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 Outcome Measure Information:
Title
Rate of improvement in Nocturnal incontinence
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofer Yossepowitch, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Urology, Rabin Medical Cetner
City
Petah Tiqva
State/Province
Petach Tiqva
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
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Desmopressin for Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Bladder Reconstruction
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