Desmopressin for Bedwetting in Children With SCD
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|ClinicalTrials.gov Identifier: NCT04420585|
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : May 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Nocturnal Enuresis Anemia, Sickle Cell||Drug: Desmopressin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Desmopressin as a Therapy for Nocturnal Enuresis in Pediatric Patients With Sickle Cell Disease|
|Actual Study Start Date :||July 7, 2020|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Experimental: Treatment Group
Desmopressin 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
- Change 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 appropriate.
- Impact of Bedwetting on day to day activities [ 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 their baseline. This will be measured using the PedsQL Measurement Model which measures health related quality of life in children with acute and chronic health conditions, like sickle cell. The scales focuses on areas such as activities, feelings, and school performance.
- Change 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 prior to initiating treatment with DDAVP. Patient's will track their nighttime awakenings using a study diary.
- Change 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 their baseline data. The PROMIS Pediatric Fatigue Short Form will be used to compare levels of fatigue from baseline to 4 weeks on the medication.
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): NCT04420585
|Contact: Kerry Morrone, MDemail@example.com|
|Contact: Deepa Manwani, MDfirstname.lastname@example.org|
|Principal Investigator:||Kerry Morrone, MD||Montefiore Medical Center|