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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00404638
First received: November 28, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)

Resource links provided by NLM:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Rabin Recruiting
Petach- Tikva, Israel
Campus Golda Hospital Not yet recruiting
Petach-Tikva, Israel
Contact: Herman A Cohen, MD    972-3-9398203    hermanc@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Herman A Cohen, MD Schneider Children Hospital , Israel
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Enuresis
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014