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

NCT ID: NCT00404638

Last Updated: 2006-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Monosymptomatic Enuresis Nocturna

Keywords

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Enuresis Nocturna Paula Method Circular muscle exercise Sphincter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Desmopresin

Intervention Type DRUG

Paula Method of Circular Muscle Exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Herman A Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Schneider Children Hospital , Israel

Locations

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Campus Golda Hospital

Petah Tikva, , Israel

Site Status

Campus Rabin

Petah Tikva, , Israel

Site Status

Countries

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Israel

Central Contacts

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Herman A Cohen, MD

Role: CONTACT

Phone: 972-3-9398203

Email: [email protected]

Facility Contacts

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Herman A Cohen, MD

Role: primary

References

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Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.

Reference Type DERIVED
PMID: 32364251 (View on PubMed)

Other Identifiers

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004192

Identifier Type: -

Identifier Source: org_study_id