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

Primary Purpose

Diurnal Enuresis

Status
Withdrawn
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
polyethylene glycol 3350
Constipation behavioral therapy
Urotherapy
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diurnal Enuresis focused on measuring Lower urinary tract dysfunction, constipation

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Gastroenterology, Nutrition, and Liver Diseases; Schneider Children's Medical Center of Israel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Urotherapy + Constipation Treatment

Urotherapy alone

Arm Description

This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction.

This group will receive standard behavioral urotherapy alone.

Outcomes

Primary Outcome Measures

Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention.

Secondary Outcome Measures

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
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.
Number of participants with adverse effects
Adverse effects of interventions as reported by patients/care givers during visits

Full Information

First Posted
January 1, 2015
Last Updated
April 9, 2018
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02336906
Brief Title
Urotherapy vs. Urotherapy With Constipation Treatment for Children With Lower Urinary Tract Dysfunction
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Changes in departmental staff have led to a cut in research alotments.
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diurnal Enuresis
Keywords
Lower urinary tract dysfunction, constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Urotherapy + Constipation Treatment
Arm Type
Active Comparator
Arm Description
This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction.
Arm Title
Urotherapy alone
Arm Type
Other
Arm Description
This group will receive standard behavioral urotherapy alone.
Intervention Type
Drug
Intervention Name(s)
polyethylene glycol 3350
Other Intervention Name(s)
PEG3350, Normalax
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Constipation behavioral therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Urotherapy
Intervention Description
The children will be guided for appropriate drinking and toilet habits, and will start with timed voiding.
Primary Outcome Measure Information:
Title
Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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
Time Frame
14 weeks
Title
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.
Time Frame
26 weeks
Title
Number of participants with adverse effects
Description
Adverse effects of interventions as reported by patients/care givers during visits
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Institute of Gastroenterology, Nutrition, and Liver Diseases; Schneider Children's Medical Center of Israel
City
Petach Tikva
ZIP/Postal Code
49202
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
19695637
Citation
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.
Results Reference
background
PubMed Identifier
22173180
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.
Results Reference
background

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

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