This is a clinical trial whose objective is to compare the efficacy of transcutaneous electrostimulation of the posterior tibial nerve with intravaginal electrostimulation in the treatment of women with symptoms of idiopathic overactive bladder. The volunteers will be randomly randomized into three study groups: posterior tibial group, vaginal group and control group. They are evaluated at three times: before the start of treatment, at the end of 6 weeks of treatment and after 1 month (follow up). The evaluation will occur through a voiding diary and a quality of life questionnaire. For the treatment groups will be used depolarized biphasic current with frequency of 10 Hz and pulse width of 200 μs, and intensity according to the tolerance of the patient. The hypothesis of the study is that the two forms of electrostimulation for treatment of idiopathic overactive bladder will be effective, but transcutaneous electrostimulation of the posterior tibial nerve will be more effective than intravaginal.
Objective: To compare the efficacy between intravaginal and transcutaneous electrostimulation of the posterior tibial nerve in the treatment of women with symptoms of idiopathic overactive bladder or mixed urinary incontinence. METHODS: This is a randomized, controlled, single-blind clinical trial with comparative analysis between study groups and a control, performed at three moments: pre and post clinical intervention and one month after the end of treatment. Vaginal electrostimulation group (GV), transcutaneous electrostimulation group of the posterior tibial nerve (GTP) and control group (CG - without intervention). The intervention groups will be treated with biphasic current with a frequency of 10 Hz and a pulse width of 200 μs for 12 sessions of 30 minutes each. Participants will be evaluated and reevaluated by means of a general data questionnaire, 3-day urinary diary and an International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB). Statistical analysis will be performed using SPSS version 22 and the level of significance adopted will be p \<0.05.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
67
Electrostimulation with asymmetric and depolarized biphasic current with a frequency of 10Hz and a pulse width of 200μs.
Change from baseline miccional emergency at 6 weeks after starting treatment and at 1 month after the end of treatment.
Sudden and uncontrollable desire to urinate checked through the voiding diary.
Time frame: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Change from baseline urinary frequency at 6 weeks after starting treatment and at 1 month after the end of treatment.
Urinating often (more than 8 events / 24h)
Time frame: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Change from baseline nocturia at 6 weeks after starting treatment and at 1 month after the end of treatment.
The necessity wake up 1 or more times during the night to urinate.
Time frame: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Change from baseline urge-incontinence at 6 weeks after starting treatment and at 1 month after the end of treatment.
Involuntary loss accompanied or preceded by urine in the immediate aftermath of an emergency episode.
Time frame: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Change from baseline quality of life related to the symptoms of overactive bladder at 6 weeks after starting treatment and at 1 month after the end of treatment.
The impact of overactive bladder symptoms on the quality of life of the volunteers will be verified through the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB), which is a brief questionnaire with a high psychometric capacity to specifically evaluate overactive bladder. The ICIQ-OAB score ranges from 0 to 16 on a progressive scale, as well as an analog scale from zero to ten to quantify the discomfort caused by each symptom, the higher the score the worse the quality of life.
Time frame: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
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