Study on Chinese and Western Medicine in MNE Children

Fudan University

Status

Completed

Conditions

Monosymptomatic Nocturnal Enuresis

Treatments

Drug: Suoquan

Drug: Desmopressin

Study type

Interventional

Funder types

Other

Identifiers

NCT03733873

Suoquan in MNE

Details and patient eligibility

About

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.

Enrollment

400 patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

400 participants in 2 patient groups

desmopressin plus Suoquan

Experimental group

Description:

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

Treatment:

Drug: Desmopressin

Drug: Suoquan

desmopressin

Active Comparator group

Description:

name:desmopressin form:tablet dosage:2-4mg frequency:qn duration:3 months

Treatment:

Drug: Desmopressin