Urotherapy vs. Urotherapy With Constipation Treatment for Children With Lower Urinary Tract Dysfunction

NCT02336906 | Withdrawn Phase 4

• 1 other identifier: rmc130348ctil
• 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 lower urinary tract dysfunction (including day time or combined day time/night time urinary incontinence). This study aims to explore if treatment of patients without overt constipation (As defined by the ROME III criteria) will also respond to anti-constipation treatment with reduction of their urinary tract symptoms. Assessment of severity and response of lower urinary tract dysfunction will be based on the Vancouver NULTD/DES questionnaire.

Conditions

Diurnal Enuresis

Keywords

Lower urinary tract dysfunction; constipation

Outcome Measures

Primary Outcomes (1)

• Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention.

  14 weeks

Secondary Outcomes (3)

• Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response in patient subgroups with fecal loading compared to those without fecal loading.

  14 weeks

• Sustained Response - Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response 12 weeks after intervention has ended.

  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

Urotherapy 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 the stepped down to 0.8gr/kg subsequently tapered according to stool consistency and frequency.

Also known as: PEG3350, Normalax

Urotherapy + Constipation Treatment

Constipation behavioral therapy BEHAVIORAL

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

Urotherapy + Constipation Treatment

Urotherapy BEHAVIORAL

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

Urotherapy + Constipation Treatment; Urotherapy alone

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.
• Lower urinary tract dysfunction (LUTD)-daytime/daytime and nighttime urinary incontinence as defined by a score of \>11 on the Vancouver Questionnaire .
• 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 (2)

• Afshar K, Mirbagheri A, Scott H, MacNeily AE. Development of a symptom score for dysfunctional elimination syndrome. J Urol. 2009 Oct;182(4 Suppl):1939-43. doi: 10.1016/j.juro.2009.03.009. Epub 2009 Aug 20.

  PMID: 19695637 BACKGROUND

• 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

Diurnal 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: January 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)