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Trial record 21 of 163 for:    Recruiting, Not yet recruiting, Available Studies | "Enuresis"

Desmopressin as a Therapy for Bedwetting in Children With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02636387
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Kerry Morrone, Montefiore Medical Center

Brief Summary:
This study assesses if using the medication desmopressin will decrease nightime bedwetting in children with sickle cell disease. Half of the children will receive placebo and half of the children will receive desmopressin, with the option to prescribe desmopressin as soon as the study is completed.

Condition or disease Intervention/treatment Phase
Nocturnal Enuresis Anemia, Sickle Cell Drug: Desmopressin Drug: Placebo Phase 3

Detailed Description:
Night time bedwetting is a common complication of sickle cell disease, and affects up to 30 % of children . Desmopressin is an oral medication that increases water reabsorption in the kidneys. Studies have shown that it is effective in decreasing bedwetting episodes in children without sickle cell disease. Chronic sickling episodes causing damage to the kidneys could cause permanent damage and may make this treatment ineffective in sickle cell disease. The investigators designed this trial to definitively answer this question by randomizing the patients to give half of the children placebo and the other half titrated doses of desmopressin. This trial will inform pediatric sickle cell doctors if desmopressin is an appropriate treatment for bed wetting in the investigators patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Desmopressin as a Therapy for Nocturnal Enuresis in Patients With Sickle Cell Disease
Study Start Date : January 2016
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025


Arm Intervention/treatment
Placebo Comparator: Placebo
0.2 mg tablets, dose titrated to effect
Drug: Placebo
Sugar pill manufactured to mimic 0.2 pill of desmopressin. Take two pills at bedtime, if no improvement in 14 days then will take 3 pills at bedtime for an additional 14 days

Experimental: Desmopressin
0.2mg tablets, dose titrated to effect after
Drug: Desmopressin
Two desmopressin 0.2 mg tablets at bedtime for 14 days and if <50 % improvement then increase to three 0.2 mg tablets at bedtime for 14 days




Primary Outcome Measures :
  1. Reduction in Bedwetting episodes [ Time Frame: Baseline and 4 weeks ]
    The investigators primary endpoint is to detect a 50 % difference between placebo and desmopressin treatment groups in number of wet nights after treatment implementation. This will be assessed by patient study diary.


Secondary Outcome Measures :
  1. Quality of life measure [ Time Frame: Baseline and 4 weeks ]
    To determine if patients with sickle cell disease and nocturnal enuresis receiving desmopressin will have an improved quality of life compared to the control group. The investigators will assess quality of life by administering the Promis Fatigue Scale prior to administering the study drug and 4 weeks after the intervention.

  2. Reduction in Nighttime awakenings [ Time Frame: Baseline and 4 weeks ]
    To determine if the use of desmopressin in patients with nocturnal enuresis improves rates of nocturia, defined as episodes of nighttime awakening to void, compared to placebo.



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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with Hemoglobin SS, SC, SB0thal or SB+thal
  2. Patients with at least two episodes of primary nocturnal enuresis per week or four episodes over the two weeks prior to enrollment.
  3. Patients with secondary enuresis who have been evaluated and cleared by a pediatric urologist as not having other etiologies of enuresis (e.g. overactive detrusor activity, a genitourinary anatomic abnormality)

Exclusion Criteria:

  1. Patients with developmental delay or neurologic dysfunction secondary to stroke.
  2. Patients with hypertension or underlying renal disease.
  3. Patients with genitourinary anatomic abnormalities. Any prior renal ultrasound showing normal genitourinary anatomy is sufficient to clear a patient for the study.
  4. Patients with daytime urinary incontinence
  5. Patients with glucosuria on urinalysis.
  6. Patients with secondary nocturnal enuresis who have not been evaluated by a pediatric urologist to rule out other etiologies of enuresis.
  7. Patients who are pregnant.
  8. Patients receiving another medicine for nocturnal enuresis (e.g. imipramine).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636387


Contacts
Contact: Kerry A Morrone, MD 718-741-2342 kmorrone@montefiore.org
Contact: Deepa Manwani, MD 718-741-2342 dmanwani@montefiore.org

Locations
United States, New York
Children's Hospital at Montefiore Recruiting
Bronx, New York, United States, 1
Contact: Kerry Morrone, MD    718-741-2342    kmorrone@montefiore.org   
Contact: Deepa Manwani, MD    718-741-2342    dmanwani@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Kerry A Morrone, MD Children's Hospital at Montefiore

Publications:

Responsible Party: Kerry Morrone, Assistant Professor of Pediatrics, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02636387     History of Changes
Other Study ID Numbers: 2014-3768
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Each individual

Additional relevant MeSH terms:
Enuresis
Urinary Incontinence
Nocturnal Enuresis
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs