Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)
Primary Purpose
Monosymptomatic Enuresis Nocturna
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Desmopresin
Paula Method of Circular Muscle Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Monosymptomatic Enuresis Nocturna focused on measuring Enuresis Nocturna, Paula Method, Circular muscle exercise, Sphincter
Eligibility Criteria
Inclusion Criteria:
- age- 7 to 15 years old suffering from monosymptomatic enuresis nocturna
- informed consent
Exclusion Criteria:
- UTI
- neurological diseases or syndromes
- metabolic disesaes
- congenital disease or malformation of the urinary tract
Sites / Locations
- Campus Rabin
- Campus Golda Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00404638
First Posted
November 28, 2006
Last Updated
November 28, 2006
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00404638
Brief Title
Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)
Official Title
Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
4. Oversight
5. Study Description
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.
Detailed Description
Paula method is based on circular muscle exercises. The theory behind the Paula method is that all sphincters in the human body work simultaneosly, mutually affecting one another possibly mediated by "oscillation" of the spinal cord. According to this theory, exercising the ring muscles in a certain area of the body will result in strengthening the circular muscles in other areas. This method was found to to be efficacious for treatment of urinary stress incontinence in women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monosymptomatic Enuresis Nocturna
Keywords
Enuresis Nocturna, Paula Method, Circular muscle exercise, Sphincter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Desmopresin
Intervention Type
Behavioral
Intervention Name(s)
Paula Method of Circular Muscle Exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age- 7 to 15 years old suffering from monosymptomatic enuresis nocturna
informed consent
Exclusion Criteria:
UTI
neurological diseases or syndromes
metabolic disesaes
congenital disease or malformation of the urinary tract
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Herman A Cohen, MD
Phone
972-3-9398203
Email
hermanc@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herman A Cohen, MD
Organizational Affiliation
Schneider Children Hospital , Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campus Rabin
City
Petach- Tikva
Country
Israel
Facility Name
Campus Golda Hospital
City
Petach-Tikva
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herman A Cohen, MD
Phone
972-3-9398203
Email
hermanc@clalit.org.il
12. IPD Sharing Statement
Citations:
PubMed Identifier
32364251
Citation
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.
Results Reference
derived
Learn more about this trial
Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)
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