UnknownNot Applicable

RF in the Treatment OAB in UUI- a Prospective Randomized Placebo Controlled Study

Slovenia80 participantsStarted 2023-07-10

Plain-language summary

Until now, OAB with or without UUI has been treated mainly in two ways: with behavioral methods and/or patient education or using antimuscarinic drugs and/or beta 3 adrenergic receptor agonists. Unfortunately, the drugs might cause side effects in some women or were insufficiently effective, so the patients abandoned them. Methods In prospective, randomized, placebo controlled study, 80 women were enrolled, using radiofrequency in treating OAB and UUI. Based on ICIQ-OAB, ICIQ-OAB QoL, and ICIQ-FLUTSsex questionnaires, severity of OAB symptoms, QoL and detailed evaluation of female sexual matters associated with their lower urinary tract symptoms. RF was applied 4 times for 20 minutes, once a week. Two week after the completion of the treatment,as well as 3, 6 and 12 months, the level of OAB and UUI was reassessed and processed it statistically and evaluated the treatment effect.

Who can participate

Age range

30 Years – 80 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: * clear signs of OAB * did not use drugs for the treatment of OAB (antimuscarinics/beta-3 agonists) * women who have taken drugs for the treatment of OAB in the past, but stopped at least 3 months prior the entering the study. Exclusion Criteria: * Inserted heart pacemaker, * unexplained bleeding from the vagina, * inflammation of the vagina and/or uterus or uterine appendages. * Bacterial or viral infection, * weakened immune system, * sclerodermia, * radiation treatment, * burns in the treatment area, * stress urinary incontinence (SUI) or mixed urinary incontinence

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

changed symptoms specific for OAB

Timeframe: 2 weeks, 3 months, 6 months, 12 months

Trial details

NCT IDNCT06080217

SponsorGinekologija Dr. Franić, D.O.O.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

View on ClinicalTrials.gov More Overactive Bladder Syndrome trials