NCT00404638

Brief Summary

Several treatment modalities for children suffering from monosymptomathic nocturnal enuresis are available including drugs, alarms, acupuncture, pelvic floor training and biofeedback. The aim of this study is to to test if Paula Method (circular muscle exercise) can be an another treatment modality.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
Last Updated

November 29, 2006

Status Verified

November 1, 2006

First QC Date

November 28, 2006

Last Update Submit

November 28, 2006

Conditions

Monosymptomatic Enuresis Nocturna

Keywords

Enuresis NocturnaPaula MethodCircular muscle exerciseSphincter

Interventions

DesmopresinDRUG
Paula Method of Circular Muscle ExerciseBEHAVIORAL

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age- 7 to 15 years old suffering from monosymptomatic enuresis nocturna
  • informed consent

You may not qualify if:

  • UTI
  • neurological diseases or syndromes
  • metabolic disesaes
  • congenital disease or malformation of the urinary tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Campus Golda Hospital

Petah Tikva, Israel

Location

Campus Rabin

Petah Tikva, Israel

Location

Related Publications (1)

  • Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.

    PMID: 32364251DERIVED

MeSH Terms

Conditions

Nocturnal Enuresis

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Officials

  • Herman A Cohen, MD

    Schneider Children Hospital , Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Herman A Cohen, MD

CONTACT

972-3-9398203hermanc@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 29, 2006

Study Start

December 1, 2006

Last Updated

November 29, 2006

Record last verified: 2006-11

Locations

IL(2)