- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00404638
Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)
November 28, 2006 updated by: Rabin Medical Center
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Herman A Cohen, MD
- Phone Number: 972-3-9398203
- Email: hermanc@clalit.org.il
Study Locations
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Petach- Tikva, Israel
- Campus Rabin
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Petach-Tikva, Israel
- Campus Golda Hospital
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Contact:
- Herman A Cohen, MD
- Phone Number: 972-3-9398203
- Email: hermanc@clalit.org.il
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Herman A Cohen, MD, Schneider Children Hospital , Israel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Study Registration Dates
First Submitted
November 28, 2006
First Submitted That Met QC Criteria
November 28, 2006
First Posted (Estimate)
November 29, 2006
Study Record Updates
Last Update Posted (Estimate)
November 29, 2006
Last Update Submitted That Met QC Criteria
November 28, 2006
Last Verified
November 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 004192
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Ferring PharmaceuticalsCompleted
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