NCT07366918 Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder
| NCT ID | NCT07366918 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pamukkale University |
| Condition | Urinary Bladder, Overactive |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 63 participants in total. It began in 2025-12-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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
Contact & Investigator
Necmettin YILDIZ Prof.
STUDY DIRECTOR
Pamukkale University
Frequently Asked Questions
Who can join the NCT07366918 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Urinary Bladder, Overactive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07366918 currently recruiting?
Yes, NCT07366918 is actively recruiting participants. Contact the research team at r.melisgun@gmail.com for enrollment information.
Where is the NCT07366918 trial being conducted?
This trial is being conducted at Denizli, Turkey (Türkiye).
Who is sponsoring the NCT07366918 clinical trial?
NCT07366918 is sponsored by Pamukkale University. The principal investigator is Necmettin YILDIZ Prof. at Pamukkale University. The trial plans to enroll 63 participants.