Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis

NCT ID: NCT06285006

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-23
• Study Completion Date: 2024-05-12

Brief 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.

Conditions

Nocturnal Enuresis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Hosny Mohamed Ahmed Elmasry

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alazhar university

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Omnia Nassar, Dr

Role: CONTACT

omnianassar835@gmail.com

01010112054

Hosny Elmasry, Prof

Role: CONTACT

omnianassar835@gmail.com

01010112054

Facility Contacts

Omnia Nassar, Dr

Role: primary

omnianassar835@gmail.com

01010112054

Hosny Elmasry, Prof

Role: backup

omnianassar835@gmail.com

01010112054

Other Identifiers

MScAZASTPED025/23/202/12/2021

Identifier Type: -

Identifier Source: org_study_id