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

NCT ID: NCT02336906

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2020-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

polyethylene glycol 3350

Intervention Type: 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.

Constipation behavioral therapy

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Urotherapy alone

This group will receive standard behavioral urotherapy alone.

Group Type: OTHER

Urotherapy

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Urotherapy

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

Intervention Type: BEHAVIORAL

Other Intervention Names

PEG3350; Normalax

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Noam Zevit

Pediatric Gastroenterologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Petah Tikva, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 19695637 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22173180 (View on PubMed)

Other Identifiers

rmc130348ctil

Identifier Type: -

Identifier Source: org_study_id