Desmopressin as a Therapy for Bedwetting in Children With Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT02636387|
Recruitment Status : Terminated (Low recruitment)
First Posted : December 21, 2015
Last Update Posted : May 26, 2020
|Condition or disease||Intervention/treatment|
|Nocturnal Enuresis Anemia, Sickle Cell||Drug: Desmopressin|
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Desmopressin as a Therapy for Nocturnal Enuresis in Patients With Sickle Cell Disease|
|Actual Study Start Date :||August 26, 2015|
|Actual Primary Completion Date :||October 27, 2018|
|Actual Study Completion Date :||October 27, 2018|
0.2mg tablets, dose titrated to effect
Two desmopressin 0.2 mg tablets at bedtime for 14 days and monitoring if <50 % improvement
Other Name: DDAVP
- 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.
- 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.
- 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 in children ≥5 years of age, compared to the control group.
- Reduction in Daytime Fatigue [ Time Frame: Baseline and 4 weeks ]To determine if patients with sickle cell disease and nocturnal enuresis receiving desmopressin will have less daytime fatigue compared to the control group.
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
|United States, New York|
|Children's Hospital at Montefiore|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Kerry A Morrone, MD||Children's Hospital at Montefiore|