Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis

Nocturnal Enuresis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02337413
• Other study ID #: rmc130342ctil
• Status: Withdrawn
• Phase: Phase 4
• First received: January 1, 2015
• Last updated: April 9, 2018
• Start date: June 2020
• Est. completion date: December 2020

Study information

• Verified date: April 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Aged 5-17 years at time of signing of informed consent.

2. MNE as defined by =3 wet nights/week without daytime incontinence

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.

Related Conditions & MeSH terms

• Constipation
• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

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.
• Urotherapy
Patients will be guided for appropriate drinking and toilet habits, and will start with timed voiding.

Locations

Country	Name	City	State
Israel	Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Hodges SJ, Anthony EY. Occult megarectum--a commonly unrecognized cause of enuresis. Urology. 2012 Feb;79(2):421-4. doi: 10.1016/j.urology.2011.10.015. Epub 2011 Dec 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of participants with adverse effects	Adverse effects of interventions as reported by patients/care givers during visits.	14 weeks