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

NCT ID: NCT06772584

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-01

Brief Summary

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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

Detailed Description

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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

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Enuresis, Nocturnal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omegapress 0.2

Omegapress 0.2 was been taken by the pt

Group Type ACTIVE_COMPARATOR

Desmopressin Acetate 0.2 mg Tablets

Intervention Type DRUG

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

Ginkobiloba

Drug was taken by the pt

Group Type ACTIVE_COMPARATOR

Ginkgobiloba

Intervention Type DRUG

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

Omegapress+ ginkgobiloba

Both drugs were taken

Group Type ACTIVE_COMPARATOR

Desmopressin Acetate 0.2 mg Tablets

Intervention Type DRUG

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

Ginkgobiloba

Intervention Type DRUG

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

Interventions

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Desmopressin Acetate 0.2 mg Tablets

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

Intervention Type DRUG

Ginkgobiloba

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients with monosymptomatic nocturnal enuresis

Exclusion Criteria

* patients with day and night enuresis
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Hossam Kandeel

Assistant lecturer of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menofia university

Cairo, State Or Province, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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5/2024UROL

Identifier Type: -

Identifier Source: org_study_id

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