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Tests treatment safety and results for Urinary Bladder, Overactive
Official title Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder
ClinicalTrials.gov ID: NCT07366918
What this study is testing
- What it's testing
- 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)?
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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 likely can't join 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Denizli, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denizli, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.