Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis

NCT02337413 | Withdrawn Phase 4

• 1 other identifier: rmc130342ctil
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Constipation treatment has been found to ameliorate symptoms in some patients with nocturnal enuresis (bed wetting at night). This study aims to explore if treatment of patients without overt constipation (As defined by the ROME III criteria) will also respond to stool softening and GI behavioral therapy with reduction of their urinary tract symptoms when added to standard urotherapy.

Conditions

Nocturnal Enuresis

Keywords

Constipation

Outcome Measures

Primary Outcomes (1)

• Number of participants with complete (no nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response at week 14

  Proportion of patients with uro-therapy + constipation treatment with complete (No nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response in comparison to the isolated urotherapy group.

  14 weeks

Secondary Outcomes (3)

• Number of participants with complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) response of enuresis to treatment in patient subgroups with fecal loading compared to those without fecal loading.

  14 weeks

• Number of participants with sustained complete (no nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response 12 weeks after the end of the intervention.

  26 weeks

• Number of participants with adverse effects

  14 weeks

Study Arms (2)

Urotherapy + Constipation Treatment

ACTIVE COMPARATOR

This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction.

Drug: Polyethylene glycol 3350; Behavioral: Constipation behavioral therapy; Behavioral: Urotherapy

Urothearpy alone

OTHER

This group will receive standard behavioral urotherapy alone

Behavioral: Urotherapy

Interventions

Polyethylene glycol 3350 DRUG

Patients will initially receive three days of high dose PEG3350 treatment (1.5gr/kg up to 100gr maximum) and then will be stepped down to 0.8gr/kg subsequently and tapered accoriding to stool consistency and frequency.

Also known as: Normalax

Urotherapy + Constipation Treatment

Constipation behavioral therapy BEHAVIORAL

Patients in the active group will receive dietary instruction as to fiber content, as well as behavioral therapy including active sitting on the toilet to attempt defaction following meals.

Urotherapy + Constipation Treatment

Urotherapy BEHAVIORAL

Patients will be guided for appropriate drinking and toilet habits, and will start with timed voiding.

Urothearpy alone; Urotherapy + Constipation Treatment

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 5-17 years at time of signing of informed consent.
• MNE as defined by ≥3 wet nights/week without daytime incontinence
• Do not meet Rome III criteria for functional constipation

You may not qualify if:

• Inability to provide signed informed consent.
• Inability to comply with the study protocol.
• Neurogenic bladder
• Attention Deficit Disorder (ADD or ADHD) on medical treatment.
• Known significant sacral, perineal, or other congenital or surgical defect.
• Known orthopedic/neurological disease which may affect urinary continence, cause constipation, or affect reading of abdominal x-rays. (e.g. spastic cerebral palsy, severe scoliosis)
• Patient taking medicinal drugs which can cause urinary incontinence or constipation.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

Related Publications (1)

• Hodges SJ, Anthony EY. Occult megarectum--a commonly unrecognized cause of enuresis. Urology. 2012 Feb;79(2):421-4. doi: 10.1016/j.urology.2011.10.015. Epub 2011 Dec 14.

  PMID: 22173180 BACKGROUND

MeSH Terms

Conditions

Nocturnal Enuresis; Constipation

Interventions

polyethylene glycol 3350

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; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Gastroenterologist

Study Record Dates

• First Submitted: January 1, 2015
• First Posted: January 13, 2015
• Study Start: June 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

IL (1)