Treatment of Enuresis Nocturna by Circular Muscle Exercis... | NCT00404638

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

NCT00404638

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Nov 29, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Monosymptomatic Enuresis Nocturna

Interventions

Desmopresin
Paula Method of Circular Muscle Exercise

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 28, 2006

First Submission Date that Met QC Criteria

Nov 28, 2006

First Posted Date

Nov 29, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2006

Last Update Posted Date

Nov 29, 2006Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Herman A Cohen, MD	Contact	972-3-9398203		hermanc@clalit.org.il

Overall Officials

Name	Affiliation	Role
Herman A Cohen, MD	Schneider Children Hospital , Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Campus Golda Hospital		Petah Tikva			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32364251	Derived	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.

ID	Term
D004775	Enuresis
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Name	Type	Description	Arm Group Labels	Other Names
Desmopresin	Drug
Paula Method of Circular Muscle Exercise	Behavioral