Study on Chinese and Western Medicine in MNE Children

NCT ID: NCT03733873

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-07-30

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.

Conditions

Monosymptomatic Nocturnal Enuresis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

desmopressin plus 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

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

take desmopressin for 3 months

Suoquan

Intervention Type: DRUG

take Suoquan mixture for 3 months

desmopressin

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

Group Type: ACTIVE_COMPARATOR

Desmopressin

Intervention Type: DRUG

take desmopressin for 3 months

Interventions

Desmopressin

take desmopressin for 3 months

Intervention Type: DRUG

Suoquan

take Suoquan mixture for 3 months

Intervention Type: DRUG

Other Intervention Names

Minirin; Suoquan mixture

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Hong Xu，MD.PhD

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Xu, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

Suoquan in MNE

Identifier Type: -

Identifier Source: org_study_id