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Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis

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ClinicalTrials.gov Identifier: NCT02337413
Recruitment Status : Withdrawn (Changes in departmental staff have led to a cut in research alotments.)
First Posted : January 13, 2015
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Noam Zevit, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Nocturnal Enuresis Drug: Polyethylene glycol 3350 Behavioral: Constipation behavioral therapy Behavioral: Urotherapy Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Urotherapy + Constipation Treatment
This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction.
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.
Other Name: Normalax

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.

Urothearpy alone
This group will receive standard behavioral urotherapy alone
Behavioral: Urotherapy
Patients will be guided for appropriate drinking and toilet habits, and will start with timed voiding.




Primary Outcome Measures :
  1. Number of participants with complete (no nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response at week 14 [ Time Frame: 14 weeks ]
    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 :
  1. 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. [ Time Frame: 14 weeks ]
    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.

  2. 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. [ Time Frame: 26 weeks ]
    Sustained complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) response at 26 weeks.

  3. Number of participants with adverse effects [ Time Frame: 14 weeks ]
    Adverse effects of interventions as reported by patients/care givers during visits.



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337413


Locations
Israel
Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel
Petach Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center

Publications:
Responsible Party: Noam Zevit, Pediatric Gastroenterologist, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02337413     History of Changes
Other Study ID Numbers: rmc130342ctil
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Noam Zevit, Rabin Medical Center:
Constipation

Additional relevant MeSH terms:
Constipation
Enuresis
Urinary Incontinence
Nocturnal Enuresis
Signs and Symptoms, Digestive
Signs and Symptoms
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents