The Role of Timed Awakening in Treatment of Enuresis

NCT06586476 | Not Yet Recruiting

• 1 other identifier: CHLA-23-00080
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of nightly timed awakening in the treatment of nocturnal enuresis in children aged 6-17. The main questions it aims to:

• Determine feasibility of nightly timed awakenings
• Determine the role, if any, of comorbidities on resolution of enuresis
• Determine incidence of daytime accidents
• Obtain patient and parental satisfaction scores Researchers will compare a control group to treatment groups to see if there is any impact on nocturnal enuresis. Participants will be woken up by parents in the middle of the night to use the restroom. In addition, participants will receive 30 minute psychotherapy sessions using telehealth.

Conditions

Nocturnal Enuresis; Voiding Dysfunction

Keywords

Lifting; Incontinence; Bedwetting

Outcome Measures

Primary Outcomes (1)

• Mean number of wet nights reported in electronic survey weekly for 12-weeks

  All study participants will report bed wetting via redcap electronic survey 1x/week for a 12-week period.

  Baseline to 12-weeks

Secondary Outcomes (5)

• Mean change from baseline in the number of wet nights/week reported in electronic survey

  Baseline to 12-weeks

• Percentage of patients with increased number of wet nights at 24-week follow-up as reported in electronic survey.

  24-weeks post-intervention

• Mean number of nights reported weekly in electronic survey with timed awakening for 12-week period for intervention arm.

  Baseline to 12-weeks

• Mean number of daytime accidents/week at baseline, end of 12-weeks and 24-weeks follow-up.

  Baseline to 24-week follow-up

• Mean satisfaction score obtained from patient and parental satisfaction questionnaire.

  Baseline to 12-weeks

Study Arms (2)

Control

NO INTERVENTION

Standard of care, which includes in-clinic urotherapy at evaluation and 30-minutes psychotherapy sessions (every 3 weeks).

Nightly Timed Awakening

EXPERIMENTAL

Control-arm therapy plus a nightly timed-awakening intervention.

Behavioral: Nightly Timed Awakening

Interventions

Nightly Timed Awakening BEHAVIORAL

Patients in this arm will be awakened 1-hr after going to bed by their caregiver(s) to use the restroom and then returned to sleep. This awakening will occur every night.

Also known as: Lifting

Nightly Timed Awakening

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• aged 6-17
• referred to the urology clinic for enuresis (Enuresis in our study is defined as nocturnal or diurnal enuresis (more than 1 bedwetting episode/week) for greater than 3 months)

You may not qualify if:

• Diagnosis of enuresis with comorbid diagnosis of diabetes mellitus (type 1 and 2), diabetes insipidus, chronic kidney disease, polyuria and/or polydipsia
• Structural urologic disease (evaluated via baseline imaging)
• Diagnosis of neurodevelopmental delays or conditions (i.e. celebral palsy, autism spectrum disorder) that hinders inability to follow age-appropriate instructions
• Not potty trained
• Improved or resolved enuresis for patients recently evaluated (within the past 6 months)
• Non-English speaking
• Patients currently on any over-active-bladder (OAB) medications (b3- agonists, antichloingerics) or alpha blockers for urinary symptoms (i.e. alfuzosin, tamsulosion, etc) or anti-diurectic medications for urinary symptoms (i.e.: desmopression (DDAVP))
• Patients currently using bed-wetting alarms
• Patients and families who are actively seeing Pediatric Clinical Urologic Psychologist.
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent or participate in the study

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Lifting

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Evalynn Vasquez, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Do, DrPH

CONTACT

3233612247; cdo1@chla.usc.edu

Jonathan Olais

CONTACT

3233612247; jolais@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff/USC Faculty CWR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)