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Trial registered on ANZCTR
Registration number
ACTRN12609000118202
Ethics application status
Approved
Date submitted
6/11/2008
Date registered
18/02/2009
Date last updated
18/02/2009
Type of registration
Retrospectively registered
Titles & IDs
Public title
Comparing measurements obtained by three different brands of Perineometers(Neurodyn Evolution, SensuPower and Peritron) in nulliparae vonlunteers.
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Scientific title
Comparing measurements obtained by three different brands of
Perineometers(Neurodyn Evolution, SensuPower and Peritron) in nulliparae
vonlunteers.
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Strength of pelvic floor muscles in nulliparae healthy women.39460
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Condition category
Condition code
Physical Medicine / Rehabilitation4140414000
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Physiotherapy
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Musculoskeletal4141414100
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Normal musculoskeletal and cartilage development and function
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The intra-vagin*l pressure generated by the contraction of pelvic floor muscle (PFM)of the participants was assessed through three different brands of perineometers (Neurodyn Evolution, SensuPower and Peritron) each consisting of a vagin*l probe connected to an electronic device, which indicates the values of contraction.
the Neurodyn, SensuPower and Peritron models have latex, nontoxic PVC and silicone rubber probe respectively
Neurodyn Evolution: Probe Lengh: 9,3 cm, Probe Diameter: 3,2 cm, national equipment.
Sensu Power: Probe Lengh: 8,2cm, Probe Diameter: 3 cm, national equipment.
Peritron: Probe Lengh: 10,8 cm, Probe Diameter:2,8 cm, imported equipment.
Each volunteer was evaluated on three alternate days by a single investigator, using a single brand of perineometer daily. In the assessment was required to undertake maximum of 3 contractions of PFM, with an interval of 30 seconds between them, and sustained for 5 seconds.
The patients were evulueted through all three different brands of perineometers and the average peak value of the three contractions was used to compare the three equipments results between them.
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Intervention code [1]36600
Not applicable
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Comparator / control treatment
Comparison between measurements obtained from different equipment (perineometers: Neurodyn Evolution, SensuPower and Peritron)to measure the pressure vagin*l.
The Neurodyn, SensuPower and Peritron models have latex, nontoxic PVC and silicone rubber probe respectively
Neurodyn Evolution: Probe Lengh: 9,3 cm, Probe Diameter: 3,2 cm, national equipment.
Sensu Power: Probe Lengh: 8,2cm, Probe Diameter: 3 cm, national equipment.
Peritron: Probe Lengh: 10,8 cm, Probe Diameter:2,8 cm, imported equipment.
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Control group
Active
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Outcomes
Primary outcome [1]50310
Difference of measurements of vagin*l pressure between the three brands of perineometer.
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Timepoint [1]50310
Measurements obtained with the three perineometer
Each volunteer was evaluated on three alternate days, by a single examiner, through a single brand of perineometer on each day.
On the first day the equipment used was Neurodyn Evolution, on the second, Sensu Power and on the third, Peritron.
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Secondary outcome [1]84780
Comparison between national (Neurodyn Evolution e SensuPower) and imported equipment (Peritron) by elucidate the possibility to compare data obtained by using brazilian perineometers that have different units of measurements with an imported equipment, often used in international studies.
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Timepoint [1]84780
Difference of measurements of vagin*l pressure between national and imported equipment assessed on three alternate days, by a single examiner, through a single brand of perineometer on each day. On the first day the equipment used was Neurodyn Evolution, on the second, Sensu Power and on the third, Peritron
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Eligibility
Key inclusion criteria
The women met the following inclusion criteria: aged between 18 and 35 years, normal body mass index (BMI) <25kg / m²), nuliparous and not pregnant, without anatomical alterations and without any pelvic floor dysfunctions, having made at least one gynecological appointment in the past twelve months and having no symptoms of vagin*l infection such as itching, stinging and / or vagin*l discharge of fetid odor
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Minimum age
18Years
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Maximum age
35Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Women who did not attend the scheduled day of evaluation, which showed intolerance to the use of condoms which covers the perineometer vagin*l probe and / or allergy to the gel has been placed on condoms and intolerance in evaluation.
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Study design
Purpose
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
9/06/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]13530
Brazil
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State/province [1]13530
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Funding & Sponsors
Funding source category [1]42310
Hospital
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Name [1]42310
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
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Country [1]42310
Brazil
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Primary sponsor type
Hospital
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Name
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto
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Address
Av Bandeirantes 3900, Monte Alegre - Ribeirão Preto - SP
CEP: 14049-900
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Country
Brazil
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Secondary sponsor category [1]40660
None
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Name [1]40660
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Address [1]40660
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Country [1]40660
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]62850
Comite de Etica em Pesquisa do Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
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Ethics committee address [1]62850
Av Bandeirantes 3900, Monte Alegre - Ribeirao Preto- SP
CEP: 14049-900
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Ethics committee country [1]62850
Brazil
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Date submitted for ethics approval [1]62850
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Approval date [1]62850
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Ethics approval number [1]62850
12188/2007
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Summary
Brief summary
The objective of this study is to verify the correlation between measurements obtained by three different brands of equipment, which intends to elucidate the possibility to compare data obtained by using brazilian perineometers that have different units of measurements with an imported equipment, often used in international studies.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name291050
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Address291050
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Country291050
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Phone291050
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Fax291050
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Email291050
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Contact person for public queries
Name122620
Patricia B barbosa
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Address122620
Raul Quaresma, 306, Jardim Brasilia - São Bernardo do Campo - SP
CEP: 09862-030
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Country122620
Brazil
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Phone122620
55 11 4392652
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Fax122620
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Email122620
[emailprotected]
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Contact person for scientific queries
Name31900
Cristine Homsi Jorge Ferreira
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Address31900
Av Bandeirantes 3900, Monte Alegre - Ribeirao Preto- SP
CEP: 14049-900
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Country31900
Brazil
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Phone31900
55 16 36023058
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Fax31900
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Email31900
[emailprotected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
