Effects of electric stimulation cutaneous and vaginal in women with stress urinary lost

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-7gt9pb
• Date of registration: 04/01/2012
• Primary sponsor: Universidade Federal de São Carlos (UFSCar) - Brazil
• Public title: Effects of electric stimulation cutaneous and vaginal in women with stress urinary lost
• Scientific title: Comparison of the effects of intravaginal electrical stimulation and surface electrical stimulation in women with stress urinary incontinence
• Date of first enrolment: 20/09/2011
• Target sample size: 45
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-7gt9pb/
• Study design: Clinical trial, two arms, randomized-controlled and single blind.

Countries of recruitment

Brazil

Contacts

• Name: Grasiéla Correia
• Affiliation: Universidade Federal de São Carlos (UFSCar)

• Name: Patricia Driusso
• Affiliation: Universidade Federal de São Carlos (UFSCar)

Key inclusion & exclusion criteria

Inclusion criteria: Women older than 50 years of age; Complaint of stress urinary incontinence; Never have undergone physical therapy for UI treatment.
Exclusion criteria: Levels 3 or 4 pelvic prolapse; Urinary and vaginal infection; Cardiac pacemaker; Metallic implant in pelvis and femur; Pelvic radiotherapy; Pregnancy; Surgery for urinary incontinence; Cognitive dysfunction.

Age minimum: 50Y
Age maximum: 80Y
Gender: F

Health Condition(s) or Problem(s) studied

Urinary Incontinence
C12.777.934.852.249

Intervention(s)

The intervention groups will receive 16 sessions of electrostimulation, 2 time per week, with the equipament Dualpex 961 (Quark®). The parameter will be: Biphasic current, frequency of 50Hz, pulse width of 700 ms, time on:off 4:8 seconds, maximum intensity tolerated by volunteer and time of 20 minutes.
The group of intravaginal electrostimulation (15 volunteers) will receive the treatment with intravaginal electrode
The group of surface electrostimulation (15 volunteers) will realize the treatment with two channel and four surface electrodes. The electrodes will positioned bilaterally in the pubic symphysis and ischial tuberosity (Quadripolar Technical)
The control group (15 volunteers)will nor perform any treatment during the 16 session.

Primary Outcome(s)

One-hour pad test: The participants will be instructed to place a pad, previously weighed, and then drink 500ml of water. After 30 minutes, they started performing a series of provocative exercises. At the end of one hour, the pad will be removed, reweighed and the urinary loss will be calculated. Urinary loss greater than 1g, the test was considered positive for urinary incontinence

The quality of life with King´s Health Questionnaire is reliable instrument, specific to assess quality of life of women with UI and validated in Brazilian Portuguese. This questionnaire consists of 30 questions, divided into nine individually scored domains. These domains are: general health, incontinence impact, limitations of daily activities, physical limitations, social limitations, personal relationships, emotions, sleep and disposition and gravity. The total score ranges from 0 to 100; a score of 100 represents the worst possible quality of life, and 0 represents the best possible quality of life

Secondary Outcome(s)

Electromyography: will be used the equipment Myotrac infinity U control™. The volunteers will perform this protocol: 60 seconds of rest, five fast contraction of pelvic floor muscles, 60 seconds of rest, five contraction of five seconds, 60 segundos de intervalo e one contraction of 60 seconds

Perineometry: Will be used the perineometer Peritron (Cardio Design Australia), graded from 0 to 300cmH2O. Participants were placed at litotomy position and the vaginal probe will be introduced. Initially, participants performed two pelvic floor muscles contractions for familiarization with the procedures. After that, they will be performed a third contraction with three seconds of duration, which will be considered for data analysis.

Transperineal Ultrasound: three-dimensional ultrasound will be used to measure the tickness of the levator ani muscle during contraction and relaxation

Secondary ID(s)

405/2010

Source(s) of Monetary Support

Universidade Federal de São Carlos (UFSCar) - Brazil

Secondary Sponsor(s)

Universidade Federal de São Carlos (UFSCar) - Brazil