Nocturnal EnuresisPhase 4NCT03510975
A New Check-list Method for Nocturnal Enuresis
A Phase 4 study testing desmopressin melt form 120 μg, Verbal behavioral therapy and Behavioral therapy with written check-list in people with Nocturnal Enuresis, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study is aimed to demonstrate the benefits of newly formed written check-list of behavioral instructions and investigate its effects on parent's awareness, consciousness and motivation toward MNE. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- desmopressin melt form 120 μg, Verbal behavioral therapy and Behavioral therapy with written check-list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2015to 1 Mar 2018
- Phase
- Phase 4
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- monosymptomatic nocturnal enuresis
- bed-wetting frequency of 3 or more nights per week for at last 14 days
Who cannot join
- active urinary tract infection
- non-monosymptomatic nocturnal enuresis
- endocrinologic disease like diabetes mellitus or diabetes insipidus which can cause polyuria
- presence or history of renal disease
- hypertension
- genitourinary abnormality
- neurological or psychological disease
- previous medical or alarm therapy for nocturnal enuresis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, 06340
About this study
Official title: A New Check-list Method Enhances the Treatment Compliance and Response of Simple Behavioral Therapy for Primary Monosymptomatic Nocturnal Enuresis. Prospective Randomised Controlled Trial.
The study is aimed to demonstrate the benefits of newly formed written check-list of behavioral instructions and investigate its effects on parent's awareness, consciousness and motivation toward MNE.
The parents with children who complain of bed-wetting 3 or more nights per week for at last 14 days, they was randomly divided into three groups. The parents in Group I were instructed only a verbal behavioral therapy, the parents in Group II were instructed a behavioral therapy with a written formed check-list for parents to fulfill and the children in Group III will received desmopressin treatment plus verbal behavioral therapy. All participants were analysed the compliance and response rate of treatment over time period of 8 week.
Read the detailed description
Monosymptomatic Nocturnal Enuresis (MNE) is defined as involuntarily nighttime bed-wetting after the age of 5 years without any other lower urinary tract symptoms and without a history of bladder dysfunction. MNE can lead to developmental and psychosocial problems on child and negative impact of the family life. It has been recommended that consisting of collaboration with children and their parents is very crucial point to tackle this disturbing condition.
Behavioral therapy can be effective and these should be first-line treatment for MNE on the basis of the attitude of the child and parents. The behavioral therapy is composed of a lot of verbal recommendations including urination before going to sleep at night, a monitorisation daily fluid intake, a restriction of fluid volume before bedtime, rewards for dry nights, etc. However, we have noticed that these instructions have not been documented as a written list yet. We have analysed the literature and composed several recommendations were formed as a written check-list for parents to instruct.
In this present study, we aimed to investigate the efficiency of check-list that are newly formed by a number of written behavioral instructions and demonstrate whether this rises awareness, consciousness and motivation of child's parents toward MNE.
This study was conducted as a prospective randomized study at the Urology Department, Ankara Training and Research Hospital, Medical Science University, Ankara, Turkey Of ninety six children and their parents, seventy-five were randomly selected from the Urology outpatient clinic complaining of MNE. They were divided into three groups according to the therapy which were defined by the investigators before recruitment. Twenty-five children and their parents were instructed only a verbal behavioral therapy, 25 were instructed a behavioral therapy with a written check-list form and 25 children received desmopressin treatment plus verbal behavioral therapy were randomly included in the study. Each participants in this study was recorded medical history, demographic data including age of children and parents, number of children, educational and economic status of parents, wet nights. Economic status of family was defined by the hunger and the poverty limits from data of Turkish Statistical Institute All children were done detailed physical examination to rule out abnormal physical development, presence of genitourinary or neurological diseases. Urine analysis, serum creatinine, blood urine nitrogen, sodium, potassium, complete blood count, ultrasonography or plain X ray if necessary were measured.
The parents in Group I were received verbal behavioral instruction. 25 parents in Group II were instructed to fulfill a check-list that were composed of written instructions during a 8 week period. Also children had to register their wet nights via daily voiding diary. 25 children in Group III were received desmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) once daily before going to bed for 2 months plus verbal behavioral instructions. Details and instructions about the drug and its use were given to the all children and their parents. All participants were checked every 2 weeks to control compliance rate of behavioral therapy (written or verbal) or medical treatment and analyse the response of the children with daily voiding diary.
- Conditions
- Nocturnal Enuresis
- Being tested
- desmopressin melt form 120 μg, Verbal behavioral therapy, Behavioral therapy with written check-list
- Keywords
- behavioural therapy, mono symptomatic nocturnal enuresis, compliance, response
- Medical subject headings
- Nocturnal Enuresis, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desmopressin melt form 120 μgDrug
desmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) once daily before going to bed
Verbal behavioral therapyBehavioural
Verbal behavioral therapy includes reward system, restriction excessive fluid intake, lifting and waking after sleep to urinate, keeping daily voiding diary
Behavioral therapy with written check-listBehavioural
Behavioral therapy with written check-list includes reward system, restriction excessive fluid intake, lifting and waking after sleep to urinate, keeping daily voiding diary, ensuring optimal posture to facilitate good bladder function and bowel movements, avoding holding urine, encouring healthy diet
| Study group | Role | What they receive |
|---|---|---|
| Verbal Behavioral Therapy | Sham comparator | All children and their parents were instructed only a verbal behavioral therapy Receives: Behavioral: Verbal behavioral therapy |
| Check-list | Experimental | All participants were instructed a behavioral therapy with a written formed check-list for parents to complete Receives: Behavioral: Behavioral therapy with written check-list |
| Desmopressin plus verbal therapy | Active comparator | All children in Group III received desmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) plus verbal behavioral therapy. Receives: Drug: desmopressin melt form 120 μg; Behavioral: Verbal behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
dry nights
dry nights were checked by daily voiding diary
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Jan 2015
- Primary completion31 Dec 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants were divided into three groups. Twenty-five children and their parents were instructed only a verbal behavioral therapy, 25 were instructed a behavioral therapy with a written check-list form and 25 children received desmopressin treatment plus verbal behavioral therapy were randomly included in the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Fatih Kilinc, Ankara Training and Research Hospital
- Investigators
- Ahmet M Hascicek, M.D., Principal investigator, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510975
- Sponsor's protocol ID
- 014
- Status last verified
- Apr 2018
- First submitted
- 18 Apr 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Caldwell PH, Nankivell G, Sureshkumar P. Simple behavioural interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2013 Jul 19;2013(7):CD003637. doi: 10.1002/14651858.CD003637.pub3.
PubMed 23881652Haid B, Tekgul S. Primary and Secondary Enuresis: Pathophysiology, Diagnosis, and Treatment. Eur Urol Focus. 2017 Apr;3(2-3):198-206. doi: 10.1016/j.euf.2017.08.010. Epub 2017 Sep 6.
PubMed 28888814
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Check-list Method Enhances the Treatment Compliance and Response of Simple Behavioral Therapy for Primary Monosymptomatic Nocturnal Enuresis. Prospective Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03510975
- Acronym / sponsor ID
- 014
- Conditions
- Nocturnal Enuresis
- Keywords
- behavioural therapy, mono symptomatic nocturnal enuresis, compliance, response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 27 Apr 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.
The study is aimed to demonstrate the benefits of newly formed written check-list of behavioral instructions and investigate its effects on parent's awareness, consciousness and motivation toward MNE.
The parents with children who complain of bed-wetting 3 or more nights per week for at last 14 days, they was randomly divided into three groups. The parents in Group I were instructed only a verbal behavioral therapy, the parents in Group II were instructed a behavioral therapy with a written formed check-list for parents to fulfill and the children in Group III will received desmopressin treatment plus verbal behavioral therapy. All participants were analysed the compliance and response rate of treatment over time period of 8 week.
Detailed description
Monosymptomatic Nocturnal Enuresis (MNE) is defined as involuntarily nighttime bed-wetting after the age of 5 years without any other lower urinary tract symptoms and without a history of bladder dysfunction. MNE can lead to developmental and psychosocial problems on child and negative impact of the family life. It has been recommended that consisting of collaboration with children and their parents is very crucial point to tackle this disturbing condition.
Behavioral therapy can be effective and these should be first-line treatment for MNE on the basis of the attitude of the child and parents. The behavioral therapy is composed of a lot of verbal recommendations including urination before going to sleep at night, a monitorisation daily fluid intake, a restriction of fluid volume before bedtime, rewards for dry nights, etc. However, we have noticed that these instructions have not been documented as a written list yet. We have analysed the literature and composed several recommendations were formed as a written check-list for parents to instruct.
In this present study, we aimed to investigate the efficiency of check-list that are newly formed by a number of written behavioral instructions and demonstrate whether this rises awareness, consciousness and motivation of child's parents toward MNE.
This study was conducted as a prospective randomized study at the Urology Department, Ankara Training and Research Hospital, Medical Science University, Ankara, Turkey Of ninety six children and their parents, seventy-five were randomly selected from the Urology outpatient clinic complaining of MNE. They were divided into three groups according to the therapy which were defined by the investigators before recruitment. Twenty-five children and their parents were instructed only a verbal behavioral therapy, 25 were instructed a behavioral therapy with a written check-list form and 25 children received desmopressin treatment plus verbal behavioral therapy were randomly included in the study. Each participants in this study was recorded medical history, demographic data including age of children and parents, number of children, educational and economic status of parents, wet nights. Economic status of family was defined by the hunger and the poverty limits from data of Turkish Statistical Institute All children were done detailed physical examination to rule out abnormal physical development, presence of genitourinary or neurological diseases. Urine analysis, serum creatinine, blood urine nitrogen, sodium, potassium, complete blood count, ultrasonography or plain X ray if necessary were measured.
The parents in Group I were received verbal behavioral instruction. 25 parents in Group II were instructed to fulfill a check-list that were composed of written instructions during a 8 week period. Also children had to register their wet nights via daily voiding diary. 25 children in Group III were received desmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) once daily before going to bed for 2 months plus verbal behavioral instructions. Details and instructions about the drug and its use were given to the all children and their parents. All participants were checked every 2 weeks to control compliance rate of behavioral therapy (written or verbal) or medical treatment and analyse the response of the children with daily voiding diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- All participants were divided into three groups. Twenty-five children and their parents were instructed only a verbal behavioral therapy, 25 were instructed a behavioral therapy with a written check-list form and 25 children received desmopressin treatment plus verbal behavioral therapy were randomly included in the study.
| Arm | Type | Receives |
|---|---|---|
| Verbal Behavioral Therapy | Sham comparator | Behavioral: Verbal behavioral therapyAll children and their parents were instructed only a verbal behavioral therapy |
| Check-list | Experimental | Behavioral: Behavioral therapy with written check-listAll participants were instructed a behavioral therapy with a written formed check-list for parents to complete |
| Desmopressin plus verbal therapy | Active comparator | Drug: desmopressin melt form 120 μg, Behavioral: Verbal behavioral therapyAll children in Group III received desmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) plus verbal behavioral therapy. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- monosymptomatic nocturnal enuresis
- bed-wetting frequency of 3 or more nights per week for at last 14 days
Key exclusion criteria (8 listed)
- active urinary tract infection
- non-monosymptomatic nocturnal enuresis
- endocrinologic disease like diabetes mellitus or diabetes insipidus which can cause polyuria
- presence or history of renal disease
- hypertension
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 |
|---|---|---|
| desmopressin melt form 120 μgdesmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) once daily before going to bed | Drug | Desmopressin plus verbal therapy |
| Verbal behavioral therapyVerbal behavioral therapy includes reward system, restriction excessive fluid intake, lifting and waking after sleep to urinate, keeping daily voiding diary | Behavioural | Desmopressin plus verbal therapy, Verbal Behavioral Therapy |
| Behavioral therapy with written check-listBehavioral therapy with written check-list includes reward system, restriction excessive fluid intake, lifting and waking after sleep to urinate, keeping daily voiding diary, ensuring optimal posture to facilitate good bladder function and bowel movements, avoding holding urine, encouring healthy diet | Behavioural | Check-list |
Primary outcome
dry nights
Time frame: 8 weeks
dry nights were checked by daily voiding diary
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 1 May 2018.
- Results publication: PubMed 23881652Caldwell PH, Nankivell G, Sureshkumar P. Simple behavioural interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2013 Jul 19;2013(7):CD003637. doi: 10.1002/14651858.CD003637.pub3.
- Results publication: PubMed 28888814Haid B, Tekgul S. Primary and Secondary Enuresis: Pathophysiology, Diagnosis, and Treatment. Eur Urol Focus. 2017 Apr;3(2-3):198-206. doi: 10.1016/j.euf.2017.08.010. Epub 2017 Sep 6.
- Individual participant dataSharing planned: Undecided
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Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
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Potential Adjuvant Therapies for Children With Primary Nocturnal Enuresis
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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.
Ahmet M Hascicek, M.D. principal investigator
Ankara Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing desmopressin melt form 120 μg, Verbal behavioral therapy and Behavioral therapy with written check-list in people with Nocturnal Enuresis, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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 1 May 2018. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
dry nights (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03510975, which also lists 2 linked publications.
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 1 May 2018.