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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-9vw39v |
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Date of registration:
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28/06/2012 |
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Primary sponsor: |
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Public title:
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Treatment of female urinary incontinence with electrical stimulation of vaginal muscle and evaluation of vaginal pH
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Scientific title:
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Stress urinary incontinence: treatment with intravaginal electric stimulation and vaginal pH evaluation |
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Date of first enrolment:
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01/01/2011 |
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Target sample size:
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78 |
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Recruitment status: |
recruitment completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-9vw39v/ |
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Study type:
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Study design:
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clinical trial single arm
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Mariana
Tirolli Rett |
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Address:
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Rua Claudio Batista s/n
49.060-100
Aracaju-SE
Brazil |
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Telephone:
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+55(79)81043005 |
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Email:
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marianatrb@gmail.com |
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Affiliation:
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Universidade Federal de Sergipe (UFS) |
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Name:
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Mariana
Tirolli Rett |
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Address:
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Rua Claudio Batista s/n
49.060-100
Aracaju-SE
Brazil |
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Telephone:
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+55(79)81043005 |
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Email:
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marianatrb@gmail.com |
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Affiliation:
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Universidade Federal de Sergipe (UFS) |
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Key inclusion & exclusion criteria
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Inclusion criteria: women with clinical symptoms of stress urinary incontinence and mixes urinary incontinence
Exclusion criteria: Women with the presence of an intrauterine dispositive, heart pacemaker, use of hormonal therapy, use of antibiotics, use of an intravaginal drug, urinary tract infection for less than two weeks, vaginal infection, severe pelvic organ prolapse (grade III), pregnancy, postpartum, leucorrhea, itching, pelvic pain, vulvar irritation, and/or other vaginal symptoms that could interfere with the results,urethral obstructions, neurogenic detrusor overactivity and detrusor hypocontractility
Age minimum:
18
Age maximum:
75
Gender:
F
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Health Condition(s) or Problem(s) studied
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urinary incontinence,vaginal infection
C12.777.934.852
C01.252.954
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Intervention(s)
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At the initial visit, the subjects individually received verbal information about pelvic floor anatomy, muscle localization and function. There were 2 sessions per week for 4 weeks giving a total of 8 sessions of . The QUARK Dualpex 961™ device with a cylindrical shaped electrode surrounded by four metal rings was used for intravaginal electrical stimulation (IVES).The IVES parameters were: a 35 Hertz fixed frequency, a 500 microsecond pulse, 20 minute of duration and current intensity varying according to patient tolerance. Each individual patient had their own electrode throughout the study.
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Primary Outcome(s)
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Changes of the vaginal microflora after intravaginal electrical stimulation: evaluated by bacterioscopy
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Secondary Outcome(s)
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Changes of pH after was measured before and after intravaginal electrical stimulation: evaluated by pH strip (values from 4 to 7)
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Quality of life after urinary incontinence treatment: evaluated by specific questionnaire (International Consultation on Incontinence Questionnaire-Short Form - ICIQ-SF)
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Secondary ID(s)
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0059.0.213.000-05
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0281.0.146.000-06
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Source(s) of Monetary Support
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PUC Minas - Betim, MG, Brazil
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Universidade Estadual de Campinas (UNICAMP) - Campinas, SP, Brazil
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