Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis

Nocturnal Enuresis Clinical Trial

Official title:

Predictors of Success and Relapse After Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285006
• Other study ID #: MScAZASTPED025/23/202/12/2021
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2024
• Est. completion date: May 12, 2024

Study information

• Verified date: April 2024
• Source: Al-Azhar University
• Contact: Omnia Nassar, Dr
• Phone: 01010112054
• Email: omnianassar835[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years. NE is a common problem that causes distress to both children and their families. It has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. In Egypt, the prevalence of NE in primary school children is about 15.4%. The family history was seen to have had a markedly significant impact on the occurrence of NE in the studied children. The mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of MNE, disturbed bladder dysfunction in the child with NMNE, and instructions about therapeutic strategies. Alarm therapy and desmopressin are effective in randomized trials. Children with NMNE first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 12, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

Inclusion Criteria:

• School age group (from 7 to 14 years)
• Primary monosymptomatic nocturnal enuresis Exclusion Criteria: Patients with one or more of the following will be excluded from the study.
• Diurnal enuresis
• Urinary tract infection within the preceding 3 months
• Diabetes mellitus
• History of renal disease, hypertension or genitourinary abnormality, neurological disease, or psychological disease.
• Post-micturition residual urine >1/3 expected bladder capacity.
• Each patient will be subjected to the following.

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Drug:
• Desmopressin
Desmopressin is a synthetic analogue of ADH released by the posterior pituitary gland that reduces urine production by increasing water reabsorption by the collecting tubules.

Locations

Country	Name	City	State
Egypt	Alazhar university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of episodes per week after desmopressin treatment	Patients will be evaluate by no. of episodes per week after desmopressin treatment.	After the end of the treatment for one month.