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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.
Scientific title
Comparing measurements obtained by three different brands of
Perineometers(Neurodyn Evolution, SensuPower and Peritron) in nulliparae
vonlunteers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Strength of pelvic floor muscles in nulliparae healthy women. 3946 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4140 4140 0 0
Physiotherapy
Musculoskeletal 4141 4141 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The intra-vaginal 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 vaginal 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.
Intervention code [1] 3660 0
Not applicable
Comparator / control treatment
Comparison between measurements obtained from different equipment (perineometers: Neurodyn Evolution, SensuPower and Peritron)to measure the pressure vaginal.
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.
Control group
Active

Outcomes
Primary outcome [1] 5031 0
Difference of measurements of vaginal pressure between the three brands of perineometer.
Timepoint [1] 5031 0
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.
Secondary outcome [1] 8478 0
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.
Timepoint [1] 8478 0
Difference of measurements of vaginal 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

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 vaginal infection such as itching, stinging and / or vaginal discharge of fetid odor
Minimum age
18 Years
Maximum age
35 Years
Gender
Females
Can healthy volunteers participate?
Yes
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 vaginal probe and / or allergy to the gel has been placed on condoms and intolerance in evaluation.

Study design
Purpose
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1353 0
Brazil
State/province [1] 1353 0

Funding & Sponsors
Funding source category [1] 4231 0
Hospital
Name [1] 4231 0
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Address [1] 4231 0
Av Bandeirantes 3900, Monte Alegre -Ribeirao Preto- SP
CEP: 14049-900
Country [1] 4231 0
Brazil
Primary sponsor type
Hospital
Name
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto
Address
Av Bandeirantes 3900, Monte Alegre - Ribeirão Preto - SP
CEP: 14049-900
Country
Brazil
Secondary sponsor category [1] 4066 0
None
Name [1] 4066 0
Address [1] 4066 0
Country [1] 4066 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6285 0
Comite de Etica em Pesquisa do Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ethics committee address [1] 6285 0
Av Bandeirantes 3900, Monte Alegre - Ribeirao Preto- SP
CEP: 14049-900
Ethics committee country [1] 6285 0
Brazil
Date submitted for ethics approval [1] 6285 0
Approval date [1] 6285 0
Ethics approval number [1] 6285 0
12188/2007

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29105 0
Address 29105 0
Country 29105 0
Phone 29105 0
Fax 29105 0
Email 29105 0
Contact person for public queries
Name 12262 0
Patricia B barbosa
Address 12262 0
Raul Quaresma, 306, Jardim Brasilia - São Bernardo do Campo - SP
CEP: 09862-030
Country 12262 0
Brazil
Phone 12262 0
55 11 4392652
Fax 12262 0
Email 12262 0
patricia_brentegani@yahoo.com.br
Contact person for scientific queries
Name 3190 0
Cristine Homsi Jorge Ferreira
Address 3190 0
Av Bandeirantes 3900, Monte Alegre - Ribeirao Preto- SP
CEP: 14049-900
Country 3190 0
Brazil
Phone 3190 0
55 16 36023058
Fax 3190 0
Email 3190 0
cristine@fmrp.usp.br

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary