Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis

NCT06285006 | Recruiting DMC

• 1 other identifier: MScAZASTPED025/23/202/12/2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Nocturnal enuresis; Desmopressin; Monotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Desmopressin

EXPERIMENTAL

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.

Drug: Desmopressin

Interventions

Desmopressin 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.

Desmopressin

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• School age group (from 7 to 14 years)
• Primary monosymptomatic nocturnal enuresis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Alazhar university

Asyut, 11884, Egypt

RECRUITING

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Omnia Nassar, Dr

CONTACT

01010112054; omnianassar835@gmail.com

Hosny Elmasry, Prof

CONTACT

01010112054; omnianassar835@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: February 23, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 12, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)