Study on Chinese and Western Medicine in MNE Children

Monosymptomatic Nocturnal Enuresis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03733873
• Other study ID #: Suoquan in MNE
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: March 2021
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Monosymptomatic Nocturnal Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Drug:
• Desmopressin
take desmopressin for 3 months
• Suoquan
take Suoquan mixture for 3 months

Locations

Country	Name	City	State
China	Children's hospital of Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the relapse rate of MNE	If Suoquan mixture plus desmopressin could reduce the relapse rate of MNE	in 6 months after stopping drugs