Recruiting

Enuresis Alarm

Sponsor:

Gina Lockwood

Code:

NCT03522818

Conditions

Enuresis, Nocturnal

Eligibility Criteria

Sex: All

Age: 5 - 15

Healthy Volunteers: Not accepted

Interventions

Manual Trigger

Normal

Study Details

Brief 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.

Conditions

Enuresis, Nocturnal

Study ID

NCT03522818

Start date

Mar 9, 2018

Status verified date

Apr, 2021

Completion date

Sep 12, 2023

Anticipated

Primary completion date

Mar 12, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 15

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Normal

Group will use the alarm as provided by the manufacture.

experimental: Manual trigger

Group will use the same model but will be instructed to manually trigger the alarm 1-2 hours after the child falls asleep.

Interventions

Manual Trigger

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.

Normal

Will use the alarm as provided by the manufacture.

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 ]

Central Contacts and Locations

Central contacts

Gina M Lockwood, MD, MS

(319) 353-8673gina-lockwood@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Gina Lockwood, MD, MS

319-353-8673gina-lockwood@uiowa.edu

Denise Juhr, BS

(319) 356-1111denise-juhr@uiowa.edu

Principal Investigator:

Gina Lockwood, MD

More Information

Sponsor

Gina Lockwood

Last update posted

Apr 28, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gina Lockwood on 2021-04-28.