Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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.
Query!
Scientific title
Comparing measurements obtained by three different brands of
Perineometers(Neurodyn Evolution, SensuPower and Peritron) in nulliparae
vonlunteers.
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Strength of pelvic floor muscles in nulliparae healthy women.
3946
0
Query!
Condition category
Condition code
Physical Medicine / Rehabilitation
4140
4140
0
0
Query!
Physiotherapy
Query!
Musculoskeletal
4141
4141
0
0
Query!
Normal musculoskeletal and cartilage development and function
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
3660
0
Not applicable
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
5031
0
Difference of measurements of vaginal pressure between the three brands of perineometer.
Query!
Assessment method [1]
5031
0
Query!
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.
Query!
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.
Query!
Assessment method [1]
8478
0
Query!
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
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
35
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose
Query!
Duration
Cross-sectional
Query!
Selection
Convenience sample
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
9/06/2008
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
20
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
1353
0
Brazil
Query!
State/province [1]
1353
0
Query!
Funding & Sponsors
Funding source category [1]
4231
0
Hospital
Query!
Name [1]
4231
0
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Query!
Address [1]
4231
0
Av Bandeirantes 3900, Monte Alegre -Ribeirao Preto- SP
CEP: 14049-900
Query!
Country [1]
4231
0
Brazil
Query!
Primary sponsor type
Hospital
Query!
Name
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto
Query!
Address
Av Bandeirantes 3900, Monte Alegre - Ribeirão Preto - SP
CEP: 14049-900
Query!
Country
Brazil
Query!
Secondary sponsor category [1]
4066
0
None
Query!
Name [1]
4066
0
Query!
Address [1]
4066
0
Query!
Country [1]
4066
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
6285
0
Comite de Etica em Pesquisa do Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Query!
Ethics committee address [1]
6285
0
Av Bandeirantes 3900, Monte Alegre - Ribeirao Preto- SP
CEP: 14049-900
Query!
Ethics committee country [1]
6285
0
Brazil
Query!
Date submitted for ethics approval [1]
6285
0
Query!
Approval date [1]
6285
0
Query!
Ethics approval number [1]
6285
0
12188/2007
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
29105
0
Query!
Address
29105
0
Query!
Country
29105
0
Query!
Phone
29105
0
Query!
Fax
29105
0
Query!
Email
29105
0
Query!
Contact person for public queries
Name
12262
0
Patricia B barbosa
Query!
Address
12262
0
Raul Quaresma, 306, Jardim Brasilia - São Bernardo do Campo - SP
CEP: 09862-030
Query!
Country
12262
0
Brazil
Query!
Phone
12262
0
55 11 4392652
Query!
Fax
12262
0
Query!
Email
12262
0
[email protected]
Query!
Contact person for scientific queries
Name
3190
0
Cristine Homsi Jorge Ferreira
Query!
Address
3190
0
Av Bandeirantes 3900, Monte Alegre - Ribeirao Preto- SP
CEP: 14049-900
Query!
Country
3190
0
Brazil
Query!
Phone
3190
0
55 16 36023058
Query!
Fax
3190
0
Query!
Email
3190
0
[email protected]
Query!
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.
Download to PDF