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 31, 2022
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|Condition or disease||Intervention/treatment|
|Nocturnal Enuresis Anemia, Sickle Cell||Drug: Desmopressin|
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.
|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.
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|Ages Eligible for Study:||8 Years to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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)
- 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).
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|
|Responsible Party:||Kerry Morrone, Assistant Professor of Pediatrics, Montefiore Medical Center|
|Other Study ID Numbers:||
|First Posted:||December 21, 2015 Key Record Dates|
|Last Update Posted:||May 31, 2022|
|Last Verified:||May 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Lower Urinary Tract Symptoms
Deamino Arginine Vasopressin
Physiological Effects of Drugs