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 |
Trial Parameters
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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