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Clinical Trials/NCT02636387
NCT02636387
Terminated
Not Applicable

Desmopressin as a Therapy for Nocturnal Enuresis in Patients With Sickle Cell Disease

Montefiore Medical Center1 site in 1 country14 target enrollmentAugust 26, 2015

Overview

Phase
Not Applicable
Intervention
Desmopressin
Conditions
Nocturnal Enuresis
Sponsor
Montefiore Medical Center
Enrollment
14
Locations
1
Primary Endpoint
Reduction in Bedwetting episodes
Status
Terminated
Last Updated
3 years ago

Overview

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 work is being continued on study ID: 2020-11268.

Registry
clinicaltrials.gov
Start Date
August 26, 2015
End Date
October 27, 2018
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kerry Morrone

Assistant Professor of Pediatrics

Montefiore Medical Center

Eligibility Criteria

Inclusion Criteria

  • Patients with Hemoglobin SS, SC, SB0thal or SB+thal
  • Patients with at least two episodes of primary nocturnal enuresis per week or four episodes over the two weeks prior to enrollment.
  • 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

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

Arms & Interventions

Desmopressin

0.2mg tablets, dose titrated to effect

Intervention: Desmopressin

Outcomes

Primary Outcomes

Reduction in Bedwetting episodes

Time Frame: Baseline and 4 weeks

To prospectively assess if the use of desmopressin in patients with sickle cell disease and nocturnal enuresis will decrease the number of nighttime episodes of enuresis by 50% after initiating DDAVP at 0.4 mg nightly dose with dose escalation as clinically indicated compared to the control group.

Secondary Outcomes

  • Quality of life measure(Baseline and 4 weeks)
  • Reduction in Nighttime awakenings(Baseline and 4 weeks)
  • Reduction in Daytime Fatigue(Baseline and 4 weeks)

Study Sites (1)

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