Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idio… (NCT07366918) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder
Turkey (Türkiye)63 participantsStarted 2025-12-01
Plain-language summary
The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of IVES vs perineal ES in women with idiopathic OAB.
The main questions aimed to be answered are:
Is Intravaginal Electrical Stimulation (IVES) or perineal ES more effective on clinical parameters related to incontinence and quality of life in women with idiopathic overactive bladder (OAB)? Participants (n:63) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 3 groups using a randomization table. The first group will receive IVES and bladder training (n:21), second group will receive perineal ES and bladder training (n:21) and third group will receive bladder training (n=21) . Measurements will be performed twice in total, before and at the end of treatment (8th week).
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 a clinical diagnosis of idiopathic OAB
* Intolerant or unresponsive to antimuscarinic or oral β3 adrenoceptor agonist (mirabegron) medications and not using them for at least 4 weeks
* Ability to understand the procedures, advantages, and potential side effects
* Ability to provide written, informed consent
* Pelvic floor muscle (PFM) strength of 3/5 or higher (modified Oxford scale, minimum: 0 - maximum: 5)
Exclusion Criteria:
* Women with pure stress urinary incontinence
* History of conservative treatment for OAB within the last 6 months (MI, IVES, perineal ES, etc.)
* Pregnant or planning to become pregnant at the time of the study
* Diagnosis of vaginal infection, urinary tract infection, or cancer
* Women with urinary incontinence within the last 3 months Those who have undergone urogynecological surgery
* Those with genital area disorders that may preclude the use of a vaginal probe or perineal electrode
* Those diagnosed with stage 2 or higher according to the Pelvic Organ Prolapse Assessment (POP-Q)
* Those with a pacemaker or implanted defibrillator
* Those with neurogenic bladder or a history of neurological disease
* Those with a urine residual of more than 100 ml detected by ultrasound (using an ultrasound device)
* Those with allergies to condoms or lubricating gels used with a vaginal probe or perineometer
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
Timeframe: Change from baseline Improvement in incontinence episodes at the 8th week after the treatment