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The Efficacy of Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder

Turkey (Türkiye)48 participantsStarted 2022-07-01

Plain-language summary

In this study, it was aimed to compare the effectiveness of intravaginal electrical stimulation (IVES) added to bladder training (BT) on quality of life (QoL) and clinical parameters related to overactive bladder (OAB) in antimuscarinic naive and refractory women. The results of this study would make it easier to understand the place of IVES among the treatment options in women with idiopathic OAB.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Over the age of 18 with the clinical diagnosis of idiopathic OAB * Who could able to give written informed consent and understand the procedures Exclusion Criteria: * Women who had stress urinary incontinence * A history of conservative therapy (BT, ES) for OAB within 6 months * Urogynecological surgery within 3 months * Current vulvovaginitis or urinary tract infections or malignancy * Pregnancy * Cardiac pacemaker or implanted defibrillator * Anatomic structural disorders of the genital region that did not allow to apply the vaginal probe * The strength of PFM less than 3/5 (graded as modified Oxford scale, min:0-max:5) * The pelvic organ prolapse quantification (POP-Q) (stage 2 or more) * Neurogenic bladder * The peripheral or central neurologic pathology * Ultrasonographic evidence of post-void residual urine volume more than 100 ml * Allergy to condom or lubricant gel that is used with vaginal probe

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incontinence episodes (positive response rate)

Timeframe: Change from baseline at the 8th week after the treatment

Trial details

NCT IDNCT05416450

SponsorPamukkale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-15

Contact for this trial

Burak Unal, M. D.

+905466033240 burakunal_3293@hotmail.com

View on ClinicalTrials.gov More Urinary Bladder, Overactive trials