Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000702112p
Ethics application status
Submitted, not yet approved
Date submitted
26/04/2019
Date registered
9/05/2019
Date last updated
9/05/2019
Date data sharing statement initially provided
9/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Squatting exercises for children who wet the bed
Scientific title
Effect of squatting-based exercises which target directional pelvic floor muscles on bed wetting frequency in children with bed wetting incontinence
Secondary ID [1] 298059 0
NIL KNOWN
Universal Trial Number (UTN)
U1111-1232-3307
Trial acronym
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
bed wetting at night 312548 0
Condition category
Condition code
Renal and Urogenital 311078 311078 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 squats every day, morning and evening, ongoing. Squatting fully and pushing upwards.
Compliance by parent, and recorded in a special book.
Review by principal investigator and an independent doctor in the clinic at 4 weeks and again at 6 months.
Each to sign in the hospital notes with co-signature of a parent and a stamp from the hospital
The duration of the study is 12 months
Intervention code [1] 314291 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319854 0

Assessment of bedwetting cure at hospital OPD by principal investigator, and independent doctor also, the results to be entered in the hospital OPD notes, with co-signatures of the principal investigator, an independent doctor and the parent, with a dated hospital stamp.
Initial review at 4 weeks, then 3 and 6 months
Proportion of participants with no bed wetting for at least 4 weeks /
If not cured, to state improvement. For example from wetting every night , 7 nights per week to 3 times per week or no cure at all.
Timepoint [1] 319854 0
Cure of bedwetting at 4 weeks,
Secondary outcome [1] 369723 0
none
Timepoint [1] 369723 0
none

Eligibility
Key inclusion criteria
all children ages 5-14 who wet bed daily or 2nd daily
Minimum age
5 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bedwetting beyond 2nd daily

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
none
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
none. All patients presenting to enuresis clinic with bedwetting
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis
Paired binary response data (per-patient presence/absence
of a specific sign/symptom before vs. after squats)
in the total study cohort to be analyzed with a McNemar’s
test, with a null hypothesis of no treatment effect.
The GraphPad Quickcalcs platform to be used for this analysis
(http://graphpad.com/quickcalcs/mcNemar1/). The sample
size (https://www.statstodo.com/SSizMcNemar_Pgm.php)
deemed sufficient to assume a Chi-squared distribution.
The Chi-square calculated with one degree of freedom.
Post-hoc estimation of the study power performed,
assuming an alpha error equal to 0.01 (https://www.statstodo.
com/SSizMcNemar_Pgm.php). In all cases the estimated
power for this comparison exceeded 0.95

The VassarStats platform used for this analysis
(www.vassarstats.net).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2019
Actual
Date of last participant enrolment
Anticipated
2/12/2019
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 21434 0
Argentina
State/province [1] 21434 0
Cordoba

Funding & Sponsors
Funding source category [1] 302591 0
Hospital
Name [1] 302591 0
Primer Instituto Privado de Neonatología y Pediatría de Córdoba
Country [1] 302591 0
Argentina
Primary sponsor type
Hospital
Name
Primer Instituto Privado De Neonatologia Y Pediatria de Cordoba
Address
DEAN FUNES 454CP/Localidad:5000 Córdoba
Country
Argentina
Secondary sponsor category [1] 302649 0
None
Name [1] 302649 0
Address [1] 302649 0
Country [1] 302649 0
Other collaborator category [1] 280666 0
Individual
Name [1] 280666 0
Peter Petros
Address [1] 280666 0
University of Western Australia, School of Mechanical Engineering , Stirling Highway Crawley Western Australia 6009
Country [1] 280666 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303228 0
IRB First Pediatric Hospital Cordoba Argentina
Ethics committee address [1] 303228 0
Primer Instituto Privado De Neonatologia Y Pediatria
DEAN FUNES 454CP/Localidad:5000 Córdoba Argentina
Ethics committee country [1] 303228 0
Argentina
Date submitted for ethics approval [1] 303228 0
01/02/2019
Approval date [1] 303228 0
Ethics approval number [1] 303228 0

Summary
Brief summary
The purpose of the trial is to strengthen the pelvic floor muscles which control urinary continence. The basis for this trial is the 1990 Integral Theory' discovery that three involuntary muscle forces control bladder continence and evacuation. It is known that squatting strengthens the muscles and the ligaments against which they contract. The hypothesis is that this non-invasive method will strengthen the closure forces and their respective ligaments and so restore continence at night.
Trial website
Not yet established
Trial related presentations / publications
None yet
Public notes
None yet

Contacts
Principal investigator
Name 92926 0
Prof Angel Fernandez Garcia
Address 92926 0

Universidad Nacional De Cordoba (Argentina)
Urología Infantil- Neurourología- · Abordaje Medico Integral del piso pélvico infantil y neurogenico · Córdoba, Argentina
Calle Haya de La Torre s/n | Pabellon Argentina - Ciudad Universitaria, Cordoba X5000GYA, Argentina
Country 92926 0
Argentina
Phone 92926 0
+55 16 99640-0506
Fax 92926 0
Email 92926 0
agarciafernandez00@gmail.com
Contact person for public queries
Name 92927 0
Prof Peter Emanuel Petros
Address 92927 0
Organization
University of Western Australia
Stirling Highway
Crawley
Perth WA
6009
Country 92927 0
Australia
Phone 92927 0
+61 411 181 731
Fax 92927 0
Email 92927 0
pp@kvinno.com
Contact person for scientific queries
Name 92928 0
Prof Peter Emanuel Petros
Address 92928 0
Dept of Mechanical Engineering
University of Western Australia
Stirling Highway
Crawley WA
6009
Country 92928 0
Australia
Phone 92928 0
+61 411 181 731
Fax 92928 0
Email 92928 0
pp@kvinno.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Clinical data validated by two clinicians and parent statement with hospital stamp and date
When will data be available (start and end dates)?
may 2019 to May 2020
Available to whom?
anyone who requests it
Available for what types of analyses?
statistical and descriptive
How or where can data be obtained?
by email to Peter Petros pp@kvinno.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4122Plain language summaryNo Aim To strengthen the three reflex pelvic muscles ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA follow-up study confirms day/night enuresis cure in children by squatting-based exercises.2021https://dx.doi.org/10.34057/PPj.2021.40.01.006
N.B. These documents automatically identified may not have been verified by the study sponsor.