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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Diurnal Enuresis

Intervention / Treatment
-----------------
* Drug: polyethylene glycol 3350
* Behavioral: Constipation behavioral therapy
* Behavioral: Urotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 5-17 years at time of signing of informed consent. Lower urinary tract dysfunction (LUTD)-daytime/daytime and nighttime urinary incontinence as defined by a score of >11 on the Vancouver Questionnaire . Do not meet Rome III criteria for functional constipation. Exclusion Criteria: Inability to provide signed informed consent. Inability to comply with the study protocol. Neurogenic bladder Attention Deficit Disorder (ADD or ADHD) on medical treatment. Known significant sacral, perineal, or other congenital or surgical defect. 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) Patient taking medicinal drugs which can cause urinary incontinence or constipation.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower urinary tract dysfunction, constipation