The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of T-MPNS vs placebo in women with idiopathic OAB.
The main questions aimed to be answered are:
What are the effects of Transcutaneous Medial Plantar Nerve Stimulation (T-MPSS) on clinical parameters related to incontinence and quality of life compared to the placebo group in women with idiopathic overactive bladder (OAB)? Participants (n:40) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive T-MPSS (n:20) and the second group will receive placebo T-MPSS (n:20). Measurements will be performed twice in total, before and at the end of treatment (6th week).
Women over the age of 18 with clinical diagnosis of idiopathic OAB
Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks
Able to understand the procedures, advantages and possible side effects
Willing and able to complete the voiding diary and QoL questionnaire
Women with stress urinary incontinence
History of conservative therapy (T-MPNS and Transcutaneous Tibial Nerve Stimulation/PTNS) within 6 months
Pregnancy or intention to become pregnant during the study
Current vulvovaginitis or urinary tract infections or malignancy
Parallel
Transcutaneous medial plantar nerve stimulation (T-MPNS)
Other interventionT-MPNS will be conducted unilaterally in the supine position using the electrotherapy device with surface electrodes. Two round self-adhesive electrodes will be positioned, with the negative electrode near the metatarsal-phalangeal joint of the great toe on the medial aspect of the foot and the positive electrode approximately 2 cm inferior-posterior to the medial malleolus (in front of the Medio-Malleolar-Calcaneal axis). Channel 1 will provide active stimulation, while channel 2 will remain inactive.
Sham Transcutaneous medial plantar nerve stimulation (T-MPNS)
Other interventionSham T-MPNS group will be stimulated using the same electrotherapy device, with patients positioned identically and electrodes placed in the same positions as in the T-MPNS group. The current characteristics (pulse frequency 20 Hz and pulse width 200 ms) will also remain consistent across both channels. The second channel of the stimulation device will be designated as the channel connected to the patient but without delivering stimulation.
Improvement in incontinence episodes
Reduction in incontinence episodes will be collected. Women with ≥50% reduction in incontinence episodes will be considered positive responders
The severity of incontinence
The 24-hour pad test was carried out to evaluate the severity of incontinence
Symptom severity
Overactive Bladder Questionnaire (OAB-V8) will be used to evaluate symptom severity in women with OAB in the study. The OAB-V8 consists of 8 questions in which patients can be classified as symptom severity: none (0), very little (1), a little (2), quite a few (3), very (4), and too many (5). The total score ranges from 0-40.
Frequency of voiding, nocturia, number of pads
The frequency of voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary.
The Quality of Life
The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will be used to assess specific QoL related to incontinence
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