Study on Chinese and Western Medicine in MNE Children

Not Applicable

Completed

• Conditions: Monosymptomatic Nocturnal Enuresis
• Interventions: Drug: Desmopressin; Drug: Suoquan

• Registration Number: NCT03733873
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-07
• Primary Completion: 2020-01-30
• Study Completion: 2020-07-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
desmopressin plus Suoquan	Desmopressin	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
desmopressin plus Suoquan	Suoquan	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
desmopressin	Desmopressin	name:desmopressin form:tablet dosage:2-4mg frequency:qn duration:3 months

Primary Outcome Measures

Name	Time	Method
the relapse rate of MNE	in 6 months after stopping drugs	If Suoquan mixture plus desmopressin could reduce the relapse rate of MNE

Trial Locations

Locations (1)

Children's hospital of Fudan university; 🇨🇳 Shanghai, Shanghai, China