Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis
Primary Purpose
Nocturnal Enuresis
Status
Withdrawn
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Polyethylene glycol 3350
Constipation behavioral therapy
Urotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Nocturnal Enuresis focused on measuring Constipation
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.
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
Urothearpy 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
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.
Secondary Outcome Measures
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.
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.
Number of participants with adverse effects
Adverse effects of interventions as reported by patients/care givers during visits.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02337413
Brief Title
Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis
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
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
June 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Enuresis
Keywords
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
Urothearpy 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)
Normalax
Intervention Description
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.
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 behavioral therapy including active sitting on the toilet to attempt defaction following meals.
Intervention Type
Behavioral
Intervention Name(s)
Urotherapy
Intervention Description
Patients will be guided for appropriate drinking and toilet habits, and will start with timed voiding.
Primary Outcome Measure Information:
Title
Number of participants with complete (no nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response at week 14
Description
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.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
14 weeks
Title
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.
Description
Sustained complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) response at 26 weeks.
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.
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.
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
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.
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Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis
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