Perineal versus intravaginal electrical stimulation for idiopathic overactive bladder in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, double-blind, placebo-controlled comparison enrolling 63 women with idiopathic overactive bladder who are intolerant of or unresponsive to oral OAB medications. Participants are randomized into three groups (intravaginal electrical stimulation plus bladder training, perineal electrical stimulation plus bladder training, or bladder training alone) and treated over an 8-week period. Clinical measures related to incontinence and quality of life are recorded before and after the treatment period. The study aims to determine whether one stimulation approach provides superior symptom relief and life-quality benefit compared with bladder training alone.

Why it matters

Who can join: the full rules

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

Where it's running

• Pamukkale University
  Denizli, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Rabia Melis Gundogan M.D.
• Email: r.melisgun@gmail.com
• Phone: +902584444747

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.