Current partner codePEPTIDESDE
NCT03733873·Not applicable·INTERVENTIONAL

Study on Chinese and Western Medicine in MNE Children

Status

Completed

Phase

Not applicable

Enrollment

400

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Desmopressin

take desmopressin for 3 months

DRUG

Suoquan

take Suoquan mixture for 3 months

Timeline

From registration to results.

  1. First posted

    Nov 7, 2018

  2. Study start

    Sep 1, 2018

  3. Primary completion

    Jan 30, 2020

  4. Study completion

    Jul 30, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Mar 11, 2021

Outcomes

What the study measures.

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
5 Years
Maximum age
18 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Desmopressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.