Perineal versus intravaginal electrical stimulation for idiopathic overactive bladder in women
Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder
This study will test whether adding intravaginal or perineal electrical stimulation to bladder training helps women with idiopathic overactive bladder reduce urgency and leakage compared with bladder training alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Pamukkale University Academic / other |
| Locations | 1 site (Denizli) |
| Trial ID | NCT07366918 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 18 or older with idiopathic overactive bladder who are intolerant of or unresponsive to antimuscarinic or mirabegron therapy (off these drugs for at least 4 weeks) and who have pelvic floor muscle strength of at least 3/5 are ideal candidates.
Not a fit: Patients with pure stress urinary incontinence, recent conservative therapy for OAB, pregnancy, active vaginal or urinary infection, cancer, recent urogynecologic surgery, genital conditions preventing use of vaginal probes or perineal electrodes, or very weak pelvic floor muscles are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, the approach could offer a non-drug option that reduces urgency and leakage and improves quality of life for women with idiopathic OAB.
How similar studies have performed: Previous randomized trials and meta-analyses of pelvic electrical stimulation (including intravaginal and perineal approaches) have shown symptom improvement for some women with OAB, though results are mixed and effect sizes vary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Denizli
- Pamukkale University — Denizli, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Rabia Melis Gundogan M.D.
- Email: r.melisgun@gmail.com
- Phone: +902584444747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.