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Clinical Trials/NCT03733873
NCT03733873
Completed
Not Applicable

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

Children's Hospital of Fudan University1 site in 1 country400 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Desmopressin
Conditions
Monosymptomatic Nocturnal Enuresis
Sponsor
Children's Hospital of Fudan University
Enrollment
400
Locations
1
Primary Endpoint
the relapse rate of MNE
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
July 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hong Xu,MD.PhD

chief physician

Children's Hospital of Fudan University

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

Arms & Interventions

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

Intervention: Desmopressin

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

Intervention: Suoquan

desmopressin

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

Intervention: Desmopressin

Outcomes

Primary Outcomes

the relapse rate of MNE

Time Frame: in 6 months after stopping drugs

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

Study Sites (1)

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