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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00404638
Other study ID # 004192
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 28, 2006
Last updated November 28, 2006
Start date December 2006

Study information

Verified date November 2006
Source Rabin Medical Center
Contact Herman A Cohen, MD
Phone 972-3-9398203
Email hermanc@clalit.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 15 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Desmopresin

Behavioral:
Paula Method of Circular Muscle Exercise


Locations

Country Name City State
Israel Campus Rabin Petach- Tikva
Israel Campus Golda Hospital Petach-Tikva

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel,