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Trial registered on ANZCTR


Registration number
ACTRN12610000254099
Ethics application status
Approved
Date submitted
19/03/2010
Date registered
25/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physiotherapy for women with stress urinary incontinence: effects of kinesiotherapy, vaginal cones and electrical stimulation
Scientific title
Treatment with the use of kynesiotherapy, vaginal cones and electrical stimulation will improve stress urinary incontinence in women?
Secondary ID [1] 1530 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress urinary incontinence 257030 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257148 257148 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be divided into four treatment groups: treatment of individual kynesiotherapy; treatment of group kynesiotherapy, treatment with the use of vaginal cones and treatment with the use of electrical stimulation. The treatment will be 12 sessions lasting 30-60 minutes and supervised by a physiotherapist. In treatments of kynesiotherapy the strengthen the pelvic floor muscles will be accomplished through voluntary contraction in different positions (supine, sitting and standing). In the treatment with the use of vaginal cones the strengthen also be accomplished in different positions but with the introduction of progressive weight cones. In treatment with the use of an intravaginal electrical stimulation the electrode is inserted into the vagina of the participant inducing muscle contraction associated with voluntary contraction.
Intervention code [1] 256171 0
Rehabilitation
Intervention code [2] 256202 0
Treatment: Other
Comparator / control treatment
Women in the control group remain untreated by the time corresponding to 12 sessions and then receive appropriate treatment.
Control group
Active

Outcomes
Primary outcome [1] 258040 0
Evaluation of the function of the pelvic floor muscles through the digital evaluation of pelvic floor (PERFECT), classified by the Modified Oxford Scale and evaluation of the pressure of contraction of the pelvic floor with use of perineometer Perina (Quark).
Timepoint [1] 258040 0
At baseline and 12 sessions after randomization. Six weeks, three months and one year after the end of treatment.
Primary outcome [2] 258041 0
Isometric and isokinetic evaluation for the hip adductors and abductors muscle
will be assessed using a BIODEX 2 isokinetic dynamometer.
Timepoint [2] 258041 0
At baseline and 12 sessions after randomization.
Primary outcome [3] 258042 0
To measure the urine loss will be accomplish the pad test of 1 hour and applied voiding diary 3 days.
Timepoint [3] 258042 0
At baseline and 12 sessions after randomization. Six weeks, three months and one year after the end of treatment.
Secondary outcome [1] 263620 0
Quality of life and sexual function will be assessed through two questionnaires: King's Health Questionnaire (KHQ) and Arizona Sexual Experiences Scale (ASEX).
Timepoint [1] 263620 0
At baseline and 12 sessions after randomization. Six weeks, three months and one year after the end of treatment.

Eligibility
Key inclusion criteria
Women with urine loss
Minimum age
35 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of prolapse than grade II, vaginal or urinary infection, hypertension not controlled and neurologic or cognitive dysfunction.

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)
Randomization was carried out through sealed envelope. Each woman chose between five sealed envelopes that designated her for the groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by dice-rolling.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 2551 0
Brazil
State/province [1] 2551 0

Funding & Sponsors
Funding source category [1] 256702 0
Charities/Societies/Foundations
Name [1] 256702 0
Conselho Nacional de Pesquisa e Desenvolvimento Tecnologico
Country [1] 256702 0
Brazil
Primary sponsor type
Individual
Name
Patricia Driusso
Address
Physical Therapy department Federal University of Sao Carlos Via Washington Luis, km 235 Sao Carlos/SP - Brazil CEP: 13565-905
Country
Brazil
Secondary sponsor category [1] 255959 0
Individual
Name [1] 255959 0
Grasiela Nascimento Correia
Address [1] 255959 0
Av.Renato Toledo Porto, 389, Santa Marta. CEP: 13 564-190. Sao Carlos - SP
Country [1] 255959 0
Brazil
Secondary sponsor category [2] 255960 0
Individual
Name [2] 255960 0
Vanessa Santos Pereira
Address [2] 255960 0
Rua das Camelias, 91/11, Cidade Jardim. CEP: 13 566-538. Sao Carlos-SP
Country [2] 255960 0
Brazil
Secondary sponsor category [3] 255990 0
None
Name [3] 255990 0
Address [3] 255990 0
Country [3] 255990 0
Other collaborator category [1] 1156 0
Individual
Name [1] 1156 0
Mariana Chaves Aveiro
Address [1] 1156 0
Rua Espir Nicolau Bichuetti, 134 Bairro Sao Benedito. CEP: 38020-590. Uberaba-MG
Country [1] 1156 0
Brazil
Other collaborator category [2] 1157 0
Individual
Name [2] 1157 0
Mariana Vieira de Melo
Address [2] 1157 0
Rua Americo Jacomino Canhoto, 223/31, bl 2, Nova Santa Paula. CEP: 13564-350. Sao Carlos-SP
Country [2] 1157 0
Brazil
Other collaborator category [3] 1158 0
Individual
Name [3] 1158 0
Noemia Tahara
Address [3] 1158 0
Rua Quintino Bocaiuva, 1090, Boa Vista. CEP: 13574-003. Sao Carlos-SP
Country [3] 1158 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258698 0
Comite de Etica em Pesquisa em Seres Humanos
Ethics committee address [1] 258698 0
Ethics committee country [1] 258698 0
Brazil
Date submitted for ethics approval [1] 258698 0
Approval date [1] 258698 0
24/04/2008
Ethics approval number [1] 258698 0

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

Contacts
Principal investigator
Name 30959 0
Address 30959 0
Country 30959 0
Phone 30959 0
Fax 30959 0
Email 30959 0
Contact person for public queries
Name 14206 0
Grasiela Nascimento Correia
Address 14206 0
Av. Renato Toledo Porto, 389, Santa Marta. CEP: 13 564-190 Sao Carlos-SP
Country 14206 0
Brazil
Phone 14206 0
+55 16 3376 3718
Fax 14206 0
+55 16 3376 3718
Email 14206 0
[email protected]
Contact person for scientific queries
Name 5134 0
Grasiela Nascimento Correia
Address 5134 0
Av. Renato Toledo Porto, 389, Santa Marta. CEP: 13 564-190 Sao Carlos-SP
Country 5134 0
Brazil
Phone 5134 0
+55 16 3376 3718
Fax 5134 0
+55 16 3376 3718
Email 5134 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIIndividual and group pelvic floor muscle training versus no treatment in female stress urinary incontinence: a randomized controlled pilot study2011https://doi.org/10.1016/j.ejogrb.2011.09.003
N.B. These documents automatically identified may not have been verified by the study sponsor.