CompletedNot Applicable

Intravaginal Electrical Stimulation With Different Treatment Frequency in Women With Idiopathic Overactive Bladder

Turkey (Türkiye)52 participantsStarted 2021-02-05

Plain-language summary

Electrical stimulation (ES) is one of the techniques used in urogynecological physiotherapy, which uses implanted or non-implanted electrodes. Intravaginal ES (IVES) is a conservative treatment option, described more than 40 years ago. IVES is used in patients with OAB and urge urinary incontinence (UUI), for detrusor inhibition. It has been suggested that IVES probably targets the detrusor muscle or pelvic floor muscle (PFM) or afferent innervation in UUI. According to the European Association Urology (EAU) Guidelines; in adults with urinary incontinence, ES may improve urinary incontinence compared to sham treatment. The IVES programs lasted between 4 weeks and 6 months in women with idiopathic OAB, although generally IVES was applied for 4-12 weeks. In most studies, IVES was applied 2-3 times a week, whereas in fewer studies it was applied more frequently. Despite that, no randomised studies compared different treatment frequencies in women with idiopathic OAB and thus, there is no evidence of which frequencies of treatment are the most effective ones. It should be kept in mind that different stimulation frequency may lead to different results. In addition, in the light of scientific evidence and our clinical experience, we think that this issue is still open for research. Better methodological quality studies are needed to obtain a higher level of scientific evidence and to know the optimal treatment frequency for OAB. Our study is the first prospective randomized controlled trial that compares the efficacy of IVES with different treatment frequency in women with idiopathic OAB. In this study, we aimed to assess the efficacy of 2 times and 5 times in a week IVES added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. The results of the our study will be of great benefit in deciding or preferring the treatment frequency and total treatment duration of IVES for the women with idiopathic OAB and their physicians.

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: * Women ≥ 18 years old with clinical diagnosis of idiopathic overactive bladder * Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks * Able to give written, informed consent * Able to understand the procedures, advantages and possible side effects * Willing and able to complete the voiding diary and quality of life questionnaire * The strength of pelvic floor muscle score 3/5 and more Exclusion Criteria: * Women with stress urinary incontinence * History of conservative therapy for idiopathic overactive bladder within 6 months * Pregnancy or intention to become pregnant during the study * Current vulvovaginitis or urinary tract infections or malignancy * History of urogynecological surgery within 3 months * Anatomic structural disorders of genital region that could not allow to apply the vaginal probe * More than stage 2 according to the pelvic organ prolapse quantification * Cardiac pacemaker or implanted defibrillator * Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology * Ultrasonographic evidence of post-void residual urine volume \> 100 ml * Allergy to condom or lubricant gel that is used with perineometer/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-Incontinence related outcome measure

Timeframe: 20 minutes

Trial details

NCT IDNCT04734301

SponsorPamukkale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Overactive Bladder trials