Ginko Biloba Versus Desmopressin in Treatment of Children With Monosymptomatic Nocturnal Enuresis

NCT06772584 | Completed

• 1 other identifier: 5/2024UROL
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Bedwetting among children is a common disorder, affecting 30% at age 4, 10% at age 6, 3% at age 12, and 1% at age.Untreated, the spontaneous cure rate is about 15% a year. Treatment is dominated by two approaches, enuresis alarm and drugs. Treatment with drugs has largely been focused on tricyclic antidepressants especially imipramine or, more recently, antidiuretic agents such as desmopressin . For imipramine the proportion of total remission is 10-50% during treatment and a long term cure in 5-40%.8 However, numerous reports of side effects, some lethal, have led to a decline in its use. Since Dimson in 1977 reported on the effects of desmopressinl" several double blind, placebo controlled studies have shown the efficacy of the drug often with rapid effect but also often with immediate relapse after ending treatment. While one of theory of nocturnal enuresis is deep sleep in children , this the main cornerstone in using Alarm as line of management . On the other hand drugs used in rehabitation of sleep rhythm seems to be with great benefits in management as GINKO BILOBA Ginkgo biloba leave extract is among the most widely sold herbal dietary supplements in the United States. Its purported biological effects include: scavenging free radical; lowering oxidative stress; reducing neural damages, reducing platelets aggregation; antiinflammation; anti-tumor activities; anti-aging , and improve night sleep rhythm

Conditions

Enuresis, Nocturnal

Keywords

Nectornal enuresis

Outcome Measures

Primary Outcomes (1)

• To asses the effect of different drugs on number of bed time wetting

  Drugs were administrated to the patient and response was documented regarding to number of bed wetting timed

  3 months

Study Arms (3)

Omegapress 0.2

ACTIVE COMPARATOR

Omegapress 0.2 was been taken by the pt

Drug: Desmopressin Acetate 0.2 mg Tablets

Ginkobiloba

ACTIVE COMPARATOR

Drug was taken by the pt

Drug: Ginkgobiloba

Omegapress+ ginkgobiloba

ACTIVE COMPARATOR

Both drugs were taken

Drug: Desmopressin Acetate 0.2 mg Tablets; Drug: Ginkgobiloba

Interventions

Desmopressin Acetate 0.2 mg Tablets DRUG

3 groups of patients one received only desmopressin and group ginkobiloba ablnd group for both

Omegapress 0.2; Omegapress+ ginkgobiloba

Ginkgobiloba DRUG

Group s take it as treatment of deep sleep in nectornal enuresis

Ginkobiloba; Omegapress+ ginkgobiloba

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with monosymptomatic nocturnal enuresis

You may not qualify if:

• patients with day and night enuresis

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menofia university

Cairo, State Or Province, 32511, Egypt

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of urology

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

EG (1)