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

A Controlled Randomized, Physician Blinded Study to Assess Isolated Uro-therapy vs. Urotherapy With Constipation Treatment for Patients With Lower Urinary Tract Dysfunction (LUTD) Not Meeting ROME-III Constipation Criteria

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.

Study Overview

• Status: Withdrawn
• Conditions: Diurnal Enuresis
• Intervention / Treatment: Drug: polyethylene glycol 3350; Behavioral: Constipation behavioral therapy; Behavioral: Urotherapy

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel, 49202
    • Institute of Gastroenterology, Nutrition, and Liver Diseases; Schneider Children's Medical Center of Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 5-17 years at time of signing of informed consent.
2. Lower urinary tract dysfunction (LUTD)-daytime/daytime and nighttime urinary incontinence as defined by a score of >11 on the Vancouver Questionnaire .
3. Do not meet Rome III criteria for functional constipation.

Exclusion Criteria:

1. Inability to provide signed informed consent.
2. Inability to comply with the study protocol.
3. Neurogenic bladder
4. Attention Deficit Disorder (ADD or ADHD) on medical treatment.
5. Known significant sacral, perineal, or other congenital or surgical defect.
6. 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)
7. Patient taking medicinal drugs which can cause urinary incontinence or constipation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Urotherapy + Constipation Treatment; 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; 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.; Other Names: PEG3350; Normalax; Behavioral: Constipation behavioral therapy; 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.; Behavioral: Urotherapy; The children will be guided for appropriate drinking and toilet habits, and will start with timed voiding.
Other: Urotherapy alone; This group will receive standard behavioral urotherapy alone.	Behavioral: Urotherapy; The children will be guided for appropriate drinking and toilet habits, and will start with timed voiding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention.	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response to therapy in those with radiological evidence of fecal loading on enrollment abdominal x-ray (as defined by rectal/pelvic outlet ratio, Leech score, and Barr score) compared to those who did not in the intervention group and the urotherapy group	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	Adverse effects of interventions as reported by patients/care givers during visits	14 weeks

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 1, 2015
• First Submitted That Met QC Criteria: January 8, 2015
• First Posted (Estimate): January 13, 2015

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: constipation; Lower urinary tract dysfunction
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Signs and Symptoms, Digestive; Urination Disorders; Elimination Disorders; Constipation; Enuresis; Diurnal Enuresis; Gastrointestinal Agents; Laxatives; Polyethylene glycol 3350
• Other Study ID Numbers: rmc130348ctil

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No