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

Clalit Health Services

Status and phase: Withdrawn; Phase 4

Conditions: Diurnal Enuresis

Treatments: Behavioral: Urotherapy; Behavioral: Constipation behavioral therapy; Drug: polyethylene glycol 3350

Study type: Interventional

Funder types: Other

Identifiers

NCT02336906

rmc130348ctil

Details and patient eligibility

About

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.

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Urotherapy + Constipation Treatment

Active Comparator group

Description:

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

Treatment:

Behavioral: Urotherapy

Behavioral: Constipation behavioral therapy

Drug: polyethylene glycol 3350

Urotherapy alone

Other group

Description:

This group will receive standard behavioral urotherapy alone.

Treatment:

Behavioral: Urotherapy