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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00404638
Recruitment Status : Unknown
Verified November 2006 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 29, 2006
Last Update Posted : November 29, 2006
Information provided by:
Rabin Medical Center

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.

Condition or disease Intervention/treatment
Monosymptomatic Enuresis Nocturna Drug: Desmopresin Behavioral: Paula Method of Circular Muscle Exercise

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)
Study Start Date : December 2006

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. age- 7 to 15 years old suffering from monosymptomatic enuresis nocturna
  2. informed consent

Exclusion Criteria:

  1. UTI
  2. neurological diseases or syndromes
  3. metabolic disesaes
  4. congenital disease or malformation of the urinary tract

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 identifier (NCT number): NCT00404638

Contact: Herman A Cohen, MD 972-3-9398203

Campus Rabin Recruiting
Petach- Tikva, Israel
Campus Golda Hospital Not yet recruiting
Petach-Tikva, Israel
Contact: Herman A Cohen, MD    972-3-9398203   
Sponsors and Collaborators
Rabin Medical Center
Principal Investigator: Herman A Cohen, MD Schneider Children Hospital , Israel Identifier: NCT00404638     History of Changes
Other Study ID Numbers: 004192
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: November 29, 2006
Last Verified: November 2006

Keywords provided by Rabin Medical Center:
Enuresis Nocturna
Paula Method
Circular muscle exercise

Additional relevant MeSH terms:
Urinary Incontinence
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms