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Purpose

This study assesses if using the medication desmopressin will decrease nightime bedwetting in children with sickle cell disease.

Conditions

Eligibility

Eligible Ages
Between 8 Years and 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Group 		Desmopressin 0.2mg tablets, dose titrated to effect
  • Drug: Desmopressin
    Two desmopressin 0.2 mg tablets at bedtime for 14 days and monitoring if <50 % improvement
    Other names:
    • DDAVP

More Details

Status
Terminated
Sponsor
Montefiore Medical Center

Study Contact

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. This trial will inform pediatric sickle cell doctors if desmopressin is an appropriate treatment for bed wetting in the investigators patients. This is an edited continuation of study ID: 2014-3768.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.