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

NCT01582542 | Unknown Phase 4 DMC

• 1 other identifier: 0366-11-RMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturnal Enuresis

Outcome Measures

Primary Outcomes (1)

• Rate of improvement in Nocturnal incontinence

  One month

Study Arms (1)

Desmopressin

EXPERIMENTAL

Drug: Desmopressin

Interventions

Desmopressin 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.

Also known as: Minerine, Nocturnal Enuresis

Desmopressin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18
• Able to give informed consent
• Patients afte radical cystectomy with orthotopic bladder reconstruction with night time incontinence

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Institute of Urology, Rabin Medical Cetner

Petah Tikva, Petach Tiqva, 49100, Israel

Location

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Ofer Yossepowitch, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

IL (1)