Study on Chinese and Western Medicine in MNE Children

NCT03733873 | Completed

• 1 other identifier: Suoquan in MNE
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

nocturnal enuresischildren; Chinsese medicine; children; relapse rate

Outcome Measures

Primary Outcomes (1)

• the relapse rate of MNE

  If Suoquan mixture plus desmopressin could reduce the relapse rate of MNE

  in 6 months after stopping drugs

Study Arms (2)

desmopressin plus Suoquan

EXPERIMENTAL

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; Drug: Suoquan

desmopressin

ACTIVE COMPARATOR

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

Drug: Desmopressin

Interventions

Desmopressin DRUG

take desmopressin for 3 months

Also known as: Minirin

desmopressin; desmopressin plus Suoquan

Suoquan DRUG

take Suoquan mixture for 3 months

Also known as: Suoquan mixture

desmopressin plus Suoquan

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• had other LUT symptoms
• with bladder dysfunction
• had treatment in last 3 months
• without the consent

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Interventions

Deamino Arginine Vasopressin

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Hong Xu, MD.PhD.

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Model Details: group1 desmopressin group2 desmopressin plus Suoquan mixture

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 7, 2018
• Study Start: September 1, 2018
• Primary Completion: January 30, 2020
• Study Completion: July 30, 2020
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)