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

January 10, 2025 updated by: Hossam Kandeel, Menoufia University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • State Or Province
      • Cairo, State Or Province, Egypt, 32511
        • Menofia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All patients with monosymptomatic nocturnal enuresis

Exclusion Criteria:

  • patients with day and night enuresis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omegapress 0.2
Omegapress 0.2 was been taken by the pt
Drug: Desmopressin Acetate 0.2 mg Tablets
3 groups of patients one received only desmopressin and group ginkobiloba ablnd group for both
Active Comparator: Ginkobiloba
Drug was taken by the pt
Drug: Ginkgobiloba
Group s take it as treatment of deep sleep in nectornal enuresis
Active Comparator: Omegapress+ ginkgobiloba
Both drugs were taken
Drug: Desmopressin Acetate 0.2 mg Tablets
3 groups of patients one received only desmopressin and group ginkobiloba ablnd group for both
Drug: Ginkgobiloba
Group s take it as treatment of deep sleep in nectornal enuresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To asses the effect of different drugs on number of bed time wetting
Time Frame: 3 months
Drugs were administrated to the patient and response was documented regarding to number of bed wetting timed
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5/2024UROL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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