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

Diurnal Enuresis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02336906
• Other study ID #: rmc130348ctil
• Status: Withdrawn
• Phase: Phase 4
• First received: January 1, 2015
• Last updated: April 9, 2018
• Start date: January 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 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.

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• Status: Withdrawn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. 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.

Related Conditions & MeSH terms

• Constipation
• Diurnal Enuresis
• Enuresis

Intervention

Drug:
• polyethylene glycol 3350
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.

Behavioral:
• Constipation behavioral therapy
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.
• Urotherapy
The children 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 (2)

Afshar K, Mirbagheri A, Scott H, MacNeily AE. Development of a symptom score for dysfunctional elimination syndrome. J Urol. 2009 Oct;182(4 Suppl):1939-43. doi: 10.1016/j.juro.2009.03.009. Epub 2009 Aug 20. — View Citation

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	Complete (Vancouver score - =90% of screening value) or Partial (Vancouver score = 50% screening value) response at the end of intervention.		14 weeks
Secondary	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
Secondary	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
Secondary	Number of participants with adverse effects	Adverse effects of interventions as reported by patients/care givers during visits	14 weeks