NCT02337413

Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nocturnal Enuresis

Interventions

Type	Name	Description
DRUG	Polyethylene glycol 3350	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.
BEHAVIORAL	Constipation behavioral therapy	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.
BEHAVIORAL	Urotherapy	Patients will be guided for appropriate drinking and toilet habits, and will start with timed voiding.

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-07-01
• Completion: 2020-12-01
• First posted: 2015-01-13
• Last updated: 2018-04-11

Locations

1 site across 1 country: Israel