Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactiv… (NCT06349694) | Clinical Trial Compass
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Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder
Turkey (Türkiye)60 participantsStarted 2024-04-22
Plain-language summary
Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (OAB). İn this study, we aimed to assess the efficacy of T-MPNS and TTNS added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. In addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated.
The main questions we aim to answer are:
Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 complate the voiding diary and QoL questionnaire
* The strength of PFM 3/5 and more
Exclusion Criteria:
* Women with stress urinary incontinence
* History of conservative therapy (BT, T-MPNS and TTNS/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/tibial nerve region on inner foot/ankle 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 urogyneceological surgery within 3 months
* Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
* Ultrasonographic evidence of PVR volume more than 100 ml
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement in incontinence episodes (positive response rate)
Timeframe: Change from baseline positive response rate at the 6th week after the treatment