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

Sponsors

Lead Sponsor: Rabin Medical Center

Source Rabin Medical Center
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.

Overall Status Withdrawn
Start Date January 2020
Completion Date December 2020
Primary Completion Date July 2020
Phase Phase 4
Study Type Interventional
Primary 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
Measure 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. 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
Condition
Intervention

Intervention Type: Drug

Intervention Name: polyethylene glycol 3350

Description: 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.

Arm Group Label: Urotherapy + Constipation Treatment

Intervention Type: Behavioral

Intervention Name: Constipation behavioral therapy

Description: 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.

Arm Group Label: Urotherapy + Constipation Treatment

Intervention Type: Behavioral

Intervention Name: Urotherapy

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

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.

Gender: All

Minimum Age: 5 Years

Maximum Age: 17 Years

Healthy Volunteers: No

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

Israel

Verification Date

April 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Rabin Medical Center

Investigator Full Name: Noam Zevit

Investigator Title: Pediatric Gastroenterologist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Urotherapy + Constipation Treatment

Type: Active Comparator

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

Label: Urotherapy alone

Type: Other

Description: This group will receive standard behavioral urotherapy alone.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov