Study on Chinese and Western Medicine in MNE Children

Study Overview
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Brief Summary
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Monosymptomatic nocturnal enuresis (MNE) is a common pediatric developmental disorder. MNE refers to urinary incontinence in the sleep state in children aged ≥5 years, without other LUT symptoms, and without bladder dysfunction. Its pathogenesis mainly include overnight polyuria, overactive bladder, sleep-arousal dysfunction, genetics, and abnormal secretion of anti-diuretic hormone (ADH). Desmopressin is a synthetic analog of ADH arginine-vasopressin (AVP), which is used to treat central diabetes insipidus and primary nocturnal enuresis (PNE). Desmopressin decreases urine production at night when taken at bedtime. Insufﬁcient ADH secretion at night will contribute to nocturnal polyuria, which is an important cause of NE. Therefore, desmopressin, a synthetic analog of ADH, is frequently used for NE and is an evidence-based therapy (grade ⅠA evidence). Some children, however, have desmopressin resistance and do not achieve the desired treatment goals. What's more,there's a high relapse rate of desmopressin after withdrawing. Suoquan mixture is a Chinese medicine commonly used to treat NE in children. It is composed of Cuscuta, Codonopsis, Psoralea corylifolia Linn ,Astragalus,mantis egg-case and ephedra. It has not only a certain cure rate but also has a lower relapse rate . However there's few evidence could prove that. In this study,the investigators compared the 3 month treatment response and relapse rate (RR) in the following 6 months of desmopressin and desmopressin plus suoquan, and observe if there will be a lower relapse rare in desmopressin plus Suoquan. Moreover, the investigators will try to explore the mechanism of Suoquan mixture in MNE.

Official Title
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Study on the Therapeutic Schedule and Mechanism of Suoquan Mixture Combined With Desmopressin to Children's Monosymptomatic Enuresis

Conditions
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Monosymptomatic Nocturnal Enuresis

Intervention / Treatment
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* Drug: Desmopressin
* Drug: Suoquan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: bedwetting occured ≥2nights/week,last for at least 3 months without other LUT symptoms without bladder dysfunction. no treatment in last 3 months signed the consent Exclusion Criteria: had other LUT symptoms with bladder dysfunction had treatment in last 3 months without the consent

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: group1 desmopressin group2 desmopressin plus Suoquan mixture
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: desmopressin plus Suoquan<br>Drug1. name:desmopressin form:tablet dosage:2-4mg frequency:qn duration:3 months Drug2 name:Suoquan mixture form:liquid dosage:10ml/time frequence:bid duration:3 months | Drug: Desmopressin<br>* take desmopressin for 3 months<br>* Other names: Minirin;Drug: Suoquan<br>* take Suoquan mixture for 3 months<br>* Other names: Suoquan mixture;|
| Active Comparator: desmopressin<br>name:desmopressin form:tablet dosage:2-4mg frequency:qn duration:3 months | Drug: Desmopressin<br>* take desmopressin for 3 months<br>* Other names: Minirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the relapse rate of MNE | If Suoquan mixture plus desmopressin could reduce the relapse rate of MNE | in 6 months after stopping drugs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nocturnal enuresischildren, Chinsese medicine, children, relapse rate