Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder
Recruiting now · Not applicable
Conditions studied: Urinary Bladder, Overactive
In brief
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).
Key facts
- Study ID
- NCT07366918
- Run by
- Pamukkale University
- People needed
- 63
- Starts
- 2025-12-01
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Pamukkale University — Denizli, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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