Monosymptomatic Nocturnal EnuresisNCT03733873
Study on Chinese and Western Medicine in MNE Children
A study testing Desmopressin and Suoquan in people with Monosymptomatic Nocturnal Enuresis, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Monosymptomatic Nocturnal Enuresis
- What is being tested?
- Desmopressin and Suoquan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- had other LUT symptoms
- with bladder dysfunction
- had treatment in last 3 months
- without the consent
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan university
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Study on the Therapeutic Schedule and Mechanism of Suoquan Mixture Combined With Desmopressin to Children's Monosymptomatic Enuresis
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
- Being tested
- Desmopressin, Suoquan
- Keywords
- nocturnal enuresischildren, Chinsese medicine, children, relapse rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Also called Minirin
take desmopressin for 3 months
SuoquanDrug
Also called Suoquan mixture
take Suoquan mixture for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Desmopressin; Drug: Suoquan |
| desmopressin | Active comparator | name:desmopressin form:tablet dosage:2-4mg frequency:qn duration:3 months Receives: Drug: Desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the relapse rate of MNE
If Suoquan mixture plus desmopressin could reduce the relapse rate of MNE
Measured: in 6 months after stopping drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Sep 2018
- Primary completion30 Jan 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monosymptomatic Nocturnal EnuresisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group1 desmopressin group2 desmopressin plus Suoquan mixture
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Xu，MD.PhD, Children's Hospital of Fudan University
- Investigators
- Hong Xu, MD.PhD., Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733873
- Sponsor's protocol ID
- Suoquan in MNE
- Status last verified
- Mar 2021
- First submitted
- 6 Nov 2018
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Therapeutic Schedule and Mechanism of Suoquan Mixture Combined With Desmopressin to Children's Monosymptomatic Enuresis
- ClinicalTrials.gov ID
- NCT03733873
- Acronym / sponsor ID
- Suoquan in MNE
- Conditions
- Monosymptomatic Nocturnal Enuresis
- Keywords
- nocturnal enuresischildren, Chinsese medicine, children, relapse rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- group1 desmopressin group2 desmopressin plus Suoquan mixture
| Arm | Type | Receives |
|---|---|---|
| desmopressin plus Suoquan | Experimental | Drug: Desmopressin, Drug: SuoquanDrug1. 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 |
| desmopressin | Active comparator | Drug: Desmopressinname:desmopressin form:tablet dosage:2-4mg frequency:qn duration:3 months |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- had other LUT symptoms
- with bladder dysfunction
- had treatment in last 3 months
- without the consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesmopressinAlso: Minirintake desmopressin for 3 months | Drug | desmopressin, desmopressin plus Suoquan |
| SuoquanAlso: Suoquan mixturetake Suoquan mixture for 3 months | Drug | desmopressin plus Suoquan |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Monosymptomatic Nocturnal Enuresis
Recruiting
Effectiveness of Individualized Pelvic Floor Muscle Rehabilitation in Addition to Standard Urotherapy and Alarm Therapy in Children With Primary Monosymptomatic Nocturnal Enuresis
Primary Monosymptomatic Nocturnal Enuresis
Active, not recruitingPhase 3
Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children
Treatment of Non-monosymptomatic Nocturnal Enuresis
Recruiting
Bedtime Device Restriction and Desmopressin in PMNE.
Primary Monosymptomatic Nocturnal Enuresis
Not yet recruitingObservational study
Causes and Types of Nocturnal Enuresis in Children
Nocturnal Enuresis, Nocturnal Enuresis in Children
Not yet recruitingObservational study
Serum Copeptin as Biomarker for Diagnosis and Classification of Polyuric Primary Monosymptomatic Nocturnal Enuresis
Primary Monosymptomatic Nocturnal Enuresis, Copeptin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Xu, MD.PhD. principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desmopressin and Suoquan in people with Monosymptomatic Nocturnal Enuresis, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the relapse rate of MNE (time frame: in 6 months after stopping drugs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.