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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
Trial registered on ANZCTR


Registration number
ACTRN12610000820000
Ethics application status
Approved
Date submitted
26/09/2010
Date registered
30/09/2010
Date last updated
30/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of neuromuscular electrical stimulation procedures used in treatment of female stress urinary incontinence
Scientific title
A two group, single-blind, randomised controlled study to assess the effectiveness of two intravaginal neuromuscular electrical stimulation procedures on perineal pressure and voiding in women with stress urinary incontinence.
Secondary ID [1] 252762 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
female stress urinary incontinence 258264 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258456 258456 0 0
Physiotherapy
Renal and Urogenital 258482 258482 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The volunteers will be randomly distributed in two groups: group 1 will be treated with medium frequency current - 2000Hz of frequency, 100 microseconds of pulse width, 4:8 seconds of on:off - and group 2 with low frequency current - 50Hz of frequency, 700 microseconds of pulse width, 4:8 seconds of on:off (neuromuscular electrical stimulation using vaginal electrodes). The duration of each session was 20 minute twice per week during six weeks.
Intervention code [1] 257278 0
Rehabilitation
Comparator / control treatment
Not applicable.
Control group
Active

Outcomes
Primary outcome [1] 259289 0
perineal pressure assessed by a perineometer
Timepoint [1] 259289 0
baseline and after fourth, sixth, eight, tenth and twelve (last) sessions
Primary outcome [2] 259290 0
one-hour pad test to assess the amount of urine loss. After drinking the water woman using a previously weighed absorbent, do some exercises, such as lowering and lifting, climbing stairs, washing hands under running water etc.
Timepoint [2] 259290 0
baseline and after sixth and twelve (last) sessions
Primary outcome [3] 259291 0
One-week voiding diary
Timepoint [3] 259291 0
Baseline and after treatment
Secondary outcome [1] 265718 0
Urinary incontinence discomfort as assessed using a Visual Analogue Scale
Timepoint [1] 265718 0
baseline and after sixth and twelve (last) sessions

Eligibility
Key inclusion criteria
stress urinary incontinence and female gender
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pelvic organ prolapse;
pregnancy;
vaginal and/or urinary tract infection;
present history of urogynecologic surgery in the last 6 months;
pacemaker;
instability of detrusor muscle;
intrinsic sphincter deficiency;
hormonal replacement therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
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] 2936 0
Brazil
State/province [1] 2936 0
Piracicaba, Sao Paulo

Funding & Sponsors
Funding source category [1] 257713 0
Self funded/Unfunded
Name [1] 257713 0
Address [1] 257713 0
Country [1] 257713 0
Primary sponsor type
Individual
Name
Elaine Caldeira De Oliveira Guirro
Address
Universidade de Sao Paulo (University of Sao Paulo) – Faculdade de Medicina de Ribeirao Preto - Department of Biomechanics, Medicine and Rehabilitation of the Locomotor System, Av. dos Bandeirantes, 3900, Monte Alegre – Ribeirao Preto, SP, Brasil, CEP (Zip Code): 14049-900
Country
Brazil
Secondary sponsor category [1] 256931 0
None
Name [1] 256931 0
Address [1] 256931 0
Country [1] 256931 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259753 0
Methodis Univerty of Piracicaba Ethic Committee
Ethics committee address [1] 259753 0
Ethics committee country [1] 259753 0
Brazil
Date submitted for ethics approval [1] 259753 0
Approval date [1] 259753 0
Ethics approval number [1] 259753 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31696 0
Address 31696 0
Country 31696 0
Phone 31696 0
Fax 31696 0
Email 31696 0
Contact person for public queries
Name 14943 0
Elaine Caldeira de Oliveira Guirro
Address 14943 0
Universidade de Sao Paulo (University of Sao Paulo) – Faculdade de Medicina de Ribeirao Preto - Department of Biomechanics, Medicine and Rehabilitation of the Locomotor System, Av. dos Bandeirantes, 3900, Monte Alegre – Ribeirao Preto, SP, Brasil, CEP (Zip Code): 14049-900
Country 14943 0
Brazil
Phone 14943 0
+ 55 16 36024584
Fax 14943 0
Email 14943 0
ecguirro@fmrp.usp.br
Contact person for scientific queries
Name 5871 0
Elaine Caldeira de Oliveira Guirro
Address 5871 0
Universidade de Sao Paulo (University of Sao Paulo) – Faculdade de Medicina de Ribeirao Preto - Department of Biomechanics, Medicine and Rehabilitation of the Locomotor System, Av. dos Bandeirantes, 3900, Monte Alegre – Ribeirao Preto, SP, Brasil, CEP (Zip Code): 14049-900
Country 5871 0
Brazil
Phone 5871 0
+ 55 16 36024584
Fax 5871 0
Email 5871 0
ecguirro@fmrp.usp.br

No information has been provided regarding IPD availability
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