Clinical trial NCT04420585: Desmopressin for Bedwetting in Children With SCD
Official title: Desmopressin as a Therapy for Nocturnal Enuresis in Pediatric Patients With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Nocturnal Enuresis
Anemia, Sickle Cell
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 8
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 study expanded upon a previously terminated study which had separately registered (NCT02636387, ID: 2014-3768).

Eligibility 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).

Primary outcomes:
measure: Change in Bedwetting Episodes
timeFrame: Baseline and ~1 month
Secondary outcomes:
measure: Impact of Bedwetting on Day to Day Activities
timeFrame: Baseline and 4 weeks
measure: Change in Nighttime Awakenings
timeFrame: Baseline and ~1 month
measure: Change in Daytime Fatigue
timeFrame: Baseline and ~1 month
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Kerry Morrone, MD
role: PRINCIPAL_INVESTIGATOR
References:
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