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Study aim
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The comparison between Per cutaneous posterior tibial nerve stimulation and Biofeedback-assisted pelvic floor muscle training on quality of life and episode of voiding in women with overactive bladder
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Design
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This clinical trial study has two parallel groups, without blinding, randomized with closed envelopes, which is performed on 60 female patients with symptoms of bladder hyperactivity referred to the pelvic floor clinic of Rouhani Hospital in Babol.
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Settings and conduct
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In the biofeedback group, a vaginal electrode is placed inside the vagina and then the patient is asked to perform the desired movements.
Electrical stimulation of the posterior tibial nerve, using a TENS device, one electrode is placed in the arch of the sole of the foot and the other 5 cm above the inner ankle.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria for this study: Married female patients aged 18 to 45 years with overactive bladder. Exclusion criteria also include urinary stress incontinence, pacemaker use, cognitive impairment, superficial or deep infection at the electrode site, urinary tract infection, Neurological diseases and urinary congestion, bladder stones, prolapse of the uterus above the second degree according to the POP-Q system, pregnancy or suspected pregnancy or planning for it and cesarean delivery, uncontrolled diabetes mellitus, history of surgeries to control urinary incontinence Botulinum toxin injection.
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Intervention groups
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This study has two treatment groups. For the first group, pelvic floor muscles will be retrained with the help of a biofeedback device. For the second group, posterior tibial nerve electrical stimulation will be used along with Kegel exercises as in the first group.
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Main outcome variables
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Quality of Life;
Number of daily urination;
Number of nocturnal urination;
Frequent urinary incontinence;
Frequent sense of urgency to urinate