Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)

This study is not yet open for participant recruitment.

Verified by Rabin Medical Center, November 2006

Sponsored by:	Rabin Medical Center
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00404638

Purpose

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.

Condition	Intervention
Monosymptomatic Enuresis Nocturna	Drug: Desmopresin Behavioral: Paula Method of Circular Muscle Exercise

MedlinePlus related topics: Exercise and Physical Fitness Toilet Training

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)

Further study details as provided by Rabin Medical Center:

Estimated Enrollment:	40
Study Start Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	5 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404638

Contacts

Contact: Herman A Cohen, MD

972-3-9398203

hermanc@clalit.org.il

Locations

Israel
Campus Golda Hospital
Petach-Tikva, Israel
Campus Rabin
Petach- Tikva, Israel

Sponsors and Collaborators

Rabin Medical Center

Investigators

Principal Investigator:

Herman A Cohen, MD

Schneider Children Hospital , Israel

More Information

Study ID Numbers:	004192
Study First Received:	November 28, 2006
Last Updated:	November 28, 2006
ClinicalTrials.gov Identifier:	NCT00404638
Health Authority:	Israel: Ministry of Health

Keywords provided by Rabin Medical Center:

Enuresis Nocturna
Paula Method
Circular muscle exercise
Sphincter

Study placed in the following topic categories:

Urologic Diseases
Nocturnal Enuresis
Mental Disorders
Urination Disorders

Enuresis
Mental Disorders Diagnosed in Childhood
Behavioral Symptoms

Additional relevant MeSH terms:

Elimination Disorders

ClinicalTrials.gov processed this record on January 14, 2009