Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis

Study Overview
=================
Brief Summary
-----------------
Constipation treatment has been found to ameliorate symptoms in some patients with nocturnal enuresis (bed wetting at night). This study aims to explore if treatment of patients without overt constipation (As defined by the ROME III criteria) will also respond to stool softening and GI behavioral therapy with reduction of their urinary tract symptoms when added to standard urotherapy.

Official Title
-----------------
A Controlled Randomized, Physician Blinded Study to Assess Isolated Uro-therapy vs. Urotherapy With Constipation Treatment for Patients With Moderate-severe Monosymptomatic Nocturnal Enuresis (MNE) Not Meeting ROME-III Constipation Criteria

Conditions
-----------------
Nocturnal 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. MNE as defined by ≥3 wet nights/week without daytime incontinence 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 then will be stepped down to 0.8gr/kg subsequently and tapered accoriding 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 behavioral therapy including active sitting on the toilet to attempt defaction following meals.<br>Behavioral: Urotherapy<br>* Patients will be guided for appropriate drinking and toilet habits, and will start with timed voiding.<br>|
| Other: Urothearpy alone<br>This group will receive standard behavioral urotherapy alone | Behavioral: Urotherapy<br>* Patients 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 |
| --- | --- | --- |
| Number of participants with complete (no nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response at week 14 | Proportion of patients with uro-therapy + constipation treatment with complete (No nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response in comparison to the isolated urotherapy group. | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) response of enuresis to treatment in patient subgroups with fecal loading compared to those without fecal loading. | Complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) 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 | 
| Number of participants with sustained complete (no nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response 12 weeks after the end of the intervention. | Sustained complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) response at 26 weeks. | 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
-----------------
Constipation