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

• Status: Withdrawn
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Treatments: Polyethylene glycol 3350

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.