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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01582542
First received: April 19, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Nocturnal Enuresis
 Drug: Desmopressin
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Usage of Desmopressin fo Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Orthotopic Bladder Reconstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Rate of improvement in Nocturnal incontinence [ Time Frame: One month ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desmopressin 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.
Other Names:
  • Minerine
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582542

Locations
Israel
Institute of Urology, Rabin Medical Cetner
Petah Tiqva, Petach Tiqva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Ofer Yossepowitch, MD Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01582542     History of Changes
Other Study ID Numbers: 0366-11-RMC
Study First Received: April 19, 2012
Last Updated: April 19, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Enuresis
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Deamino Arginine Vasopressin
 Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013