Enuresis, NocturnalNCT03522818
Enuresis Alarm - Is a Manual Trigger System Beneficial?
A study testing Manual Trigger and Normal in people with Enuresis, Nocturnal, run by Gina Lockwood at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether the bedwetting alarm trigger activated by parents to wake their child, in addition to the moisture alarm, will improve treatment success compared to the moisture alarm alone. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Enuresis, Nocturnal
- What is being tested?
- Manual Trigger and Normal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2018to 12 Sep 2023
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children ages 5-15 years
- Diagnosis of Primary Monosymptomatic Nocturnal Enuresis
- >2 wet nights per week
- Score of 7 or below on questions 1-6 and 9-13 on Vancouver Dysfunctional Elimination Questionnaire
- Patients/parents compliance in recording data > 50% of nights
Who cannot join
- Known comorbid conditions: daytime incontinence, anatomic abnormalities (hydronephrosis, VUR), recurrent urinary tract infection, dysuria, neurogenic bladder, developmental delay, encopresis, diabetes insipidus, previous history of urologic surgery
- Concomitant DDAVP use, anticholinergic use, B3 agonist use
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Gina Lockwood, MD, MS, 319-353-8673, gina-lockwood@uiowa.edu
Denise Juhr, BS, (319) 356-1111 ext. Juhr, denise-juhr@uiowa.edu
About this study
The purpose of this study is to evaluate whether the bedwetting alarm trigger activated by parents to wake their child, in addition to the moisture alarm, will improve treatment success compared to the moisture alarm alone.
Read the detailed description
Nocturnal enuresis is a common issue in children, and use of bedwetting alarms has shown the best long-term success. However, use of alarms is very time-intensive, often taking months before yielding results. Researchers in the division of pediatric urology are initiating a randomized controlled study comparing a standard bedwetting alarm with a newly developed technology, with the hope that the new alarm will result in better, more rapid, and easier treatment for bedwetting.
Children between the ages of 5 to 15 years old who have issues with bedwetting after successful toilet training may qualify for the study.
Participants must first be evaluated by a pediatric urology specialist.
- Conditions
- Enuresis, Nocturnal
- Being tested
- Manual Trigger, Normal
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TriggerBehavioural
Will use the alarm as provided by the manufacture but parent has to manual trigger the alarm 1-2 hours after the child falls asleep.
NormalBehavioural
Will use the alarm as provided by the manufacture.
| Study group | Role | What they receive |
|---|---|---|
| Normal | Active comparator | Group will use the alarm as provided by the manufacture. Receives: Behavioral: Normal |
| Manual trigger | Experimental | Group will use the same model but will be instructed to manually trigger the alarm 1-2 hours after the child falls asleep. Receives: Behavioral: Manual Trigger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change and % reduction in mean number wet nights/week (>90%, 50-89%, <50%) of patients with treatment success with use of a manual trigger + moisture alarm vs. moisture alarm only
Bladder Diary (Participant self-reported)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start9 Mar 2018
- Primary completion12 Mar 2023 (estimated)
- Study completion12 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enuresis, NocturnalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gina Lockwood
- Sponsor type
- University, hospital or other
- Collaborators
- PottyMD
- Responsible party
- Sponsor-investigator, Gina Lockwood, University of Iowa
- Investigators
- Gina M Lockwood, MD, MS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522818
- Sponsor's protocol ID
- 201801703
- Status last verified
- Apr 2021
- First submitted
- 16 Mar 2018
- Last updated
- 28 Apr 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 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enuresis Alarm - Is a Manual Trigger System Beneficial?
- ClinicalTrials.gov ID
- NCT03522818
- Acronym / sponsor ID
- 201801703
- Conditions
- Enuresis, Nocturnal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Gina LockwoodUniversity, hospital or other
- Collaborators
- PottyMD
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 12 Mar 2023 (estimated)
- Study completion
- 12 Sep 2023 (estimated)
- First posted
- 11 May 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 purpose of this study is to evaluate whether the bedwetting alarm trigger activated by parents to wake their child, in addition to the moisture alarm, will improve treatment success compared to the moisture alarm alone.
Detailed description
Nocturnal enuresis is a common issue in children, and use of bedwetting alarms has shown the best long-term success. However, use of alarms is very time-intensive, often taking months before yielding results. Researchers in the division of pediatric urology are initiating a randomized controlled study comparing a standard bedwetting alarm with a newly developed technology, with the hope that the new alarm will result in better, more rapid, and easier treatment for bedwetting.
Children between the ages of 5 to 15 years old who have issues with bedwetting after successful toilet training may qualify for the study.
Participants must first be evaluated by a pediatric urology specialist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal | Active comparator | Behavioral: NormalGroup will use the alarm as provided by the manufacture. |
| Manual trigger | Experimental | Behavioral: Manual TriggerGroup will use the same model but will be instructed to manually trigger the alarm 1-2 hours after the child falls asleep. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children ages 5-15 years
- Diagnosis of Primary Monosymptomatic Nocturnal Enuresis
- >2 wet nights per week
- Score of 7 or below on questions 1-6 and 9-13 on Vancouver Dysfunctional Elimination Questionnaire
- Patients/parents compliance in recording data > 50% of nights
Key exclusion criteria (2 listed)
- Known comorbid conditions: daytime incontinence, anatomic abnormalities (hydronephrosis, VUR), recurrent urinary tract infection, dysuria, neurogenic bladder, developmental delay, encopresis, diabetes insipidus, previous history of urologic surgery
- Concomitant DDAVP use, anticholinergic use, B3 agonist use
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 |
|---|---|---|
| Manual TriggerWill use the alarm as provided by the manufacture but parent has to manual trigger the alarm 1-2 hours after the child falls asleep. | Behavioural | Manual trigger |
| NormalWill use the alarm as provided by the manufacture. | Behavioural | Normal |
Primary outcome
Evaluate the change and % reduction in mean number wet nights/week (>90%, 50-89%, <50%) of patients with treatment success with use of a manual trigger + moisture alarm vs. moisture alarm only
Time frame: one year
Bladder Diary (Participant self-reported)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Gina M Lockwood, MD, MS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Trigger and Normal in people with Enuresis, Nocturnal, run by Gina Lockwood at 1 site in United States.
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 2 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: status not confirmed, as of the sponsor's last update on 28 Apr 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gina M Lockwood, MD, MS ((319) 353-8673, gina-lockwood@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the change and % reduction in mean number wet nights/week (>90%, 50-89%, <50%) of patients with treatment success with use of a manual trigger + moisture alarm vs. moisture alarm only (time frame: one year). 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 28 Apr 2021.