Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder

Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Double-blind Placebo Controlled Trial

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).

Inclusion Criteria:

• 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
• The strength of pelvic floor muscles 3/5 and more

Exclusion Criteria:

• 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
• Anatomic or posttraumatic malformations/skin disorders of medial plantar nerve region on inner foot that cannot allow to apply the electrodes
• More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
• Cardiac pacemaker, implanted defibrillator
• Previous urogynecological surgery within 3 months
• Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
• Ultrasonographic evidence of post-void residual volume more than 100 ml