The New Possibility of Treating Overactive Bladder With Radiofrequency (RF and OAB)

February 10, 2026 updated by: Damir Franic, University Maribor

The New Possibility of Treating Overactive Bladder With Radiofrequency - a Prospective, Randomized, Placebo Controlled (Single-blind) Clinical Trial

A prospective, randomized, single-blind, placebo-controlled study was conducted from June 2023 to May 2025. The study enrolled 95 women (N=48 in the study group; N=47 in the placebo group) who presented with confirmed symptoms of OAB and UUI prior to enrollment. Symptom severity and quality of life were assessed using validat-ed questionnaires from the International Consultation on Incontinence Questionnaires (ICIQ), specifically ICIQ-OAB, ICIQ-OABqol, and ICIQ-FLUTSsex. A higher score on these questionnaires indicated a worse quality of life, while a lower score indicated im-provement. Symptomatology was monitored at 3, 6, and 12 months post-RF applica-tion, at which points women completed all three validated questionnaires again. Prior to study commencement, all subjects provided informed consent. Before the initial RF treatment, urine analysis and urine culture were performed on all patients to rule out urinary infections. The study protocol was approved by the National Ethical Committee of the Republic of Slovenia (No.0120-184/2023-2711-15). The study was also submitted to Clinical Trials.gov (NCT 06080217), although it was not completed as RF is not yet an approved device for treating OAB.

2.1. Inclusion Criteria Women with clear signs of OAB who were not currently using pharmacological treatment (antimuscarinics/beta-3 agonists) were included. Patients who had previously used OAB medications but had discontinued them (due to side effects or ineffective-ness) at least 3 months prior to enrollment were also eligible for this study.

2.2. Exclusion Criteria Exclusion criteria included an inserted heart pacemaker, unexplained vaginal bleeding, inflammation of the vagina and/or uterus or uterine appendages, bacterial or viral infections (including urinary tract infections), impaired immune system, sclero-dermia, previous radiation treatment, or burns in the treatment area. Women with stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) were also ex-cluded from this study. Patients were positioned in the lithotomy position with extended lower extremities. Probes were placed on the lower abdomen, in the bladder area (active probe), and on the lumbar spine (passive probe). A capacitive probe, operating in the "free treat-ment"/"power control" program, delivered high-frequency electricity to the bladder for 20 minutes at a frequency of 1.0 MHz. The energy output was limited to achieve a maximum temperature of 41 °C. Initially, a maximum energy of 75% and a frequency of 0.8 MHz were applied. These parameters were adjusted downward based on patient comfort regarding the amount of heat experienced. Subsequently, the power was re-duced to 50%, and the frequency was increased to 1.0 MHz, which resulted in moderate energy absorption. This energy level was maintained throughout the procedure, with patients absorbing an average of 18-19 kJ of energy.

The placebo (sham) group was also connected to the RF device, with an active probe placed on the bladder area and a passive probe on the lumbar area. The device was activated for 20 minutes but did not emit electricity. Patients in the placebo group were blinded to the fact that their energy had not been delivered. Following the study's conclusion, participants in the placebo group were informed of their random as-signment and were offered the active RF procedure.The primary endpoint was to confirm the statistically significant reduction in OAB and/or UUI symptoms observed in a prior pilot study. The secondary endpoint aimed to determine the optimal frequency for RF reapplication to achieve good Quality of Life (QoL) and maintain minimal symptomatologyPower analysis Based on literature data and our pilot study, we assume that the success rate for RF will be 60% and for placebo 25%. Considering these figures, we assume that we will need 30 patients for each group, but we must take into account the dropout during the study group, as well as in placebo gorup, so we included more patients per group in the study, so a total of 95 patients were included for randomization.

2.4.1. Statistics methods To assess the general characteristics of both groups, either the Student's t-test or the Mann-Whitney U test was employed, depending on data distribution.Statistical analy-sis was performed using generalized estimating equations (GEE) to account for the cor-relation of repeated measurements within subjects. A linear GEE model incorporating an identity link function and a Gaussian distribution was fitted. The primary predictors included time, group (study vs. control), and their interaction (time × group), with ad-ditional adjustment for the baseline covariate BMI. The interaction term was specifically included to evaluate whether the effect of time varied between the groups. Separate es-timates of the time effect within each group were derived by combining main and in-teraction effects, and their statistical significance was determined using z-tests.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Frequency refers to the wavelength of the oscillation. Various frequencies are em-ployed in diathermy. Given that tissue absorption generally increases with frequency, it is often posited that lower frequencies yield better transfer efficiency. A frequency of 1 MHz has been proposed to effectively overcome cell membrane resistance and induce intracellular effects

. Power, or energy, is a fundamental component of electromag-netic fields. Electromagnetic waves transmit energy to a system through their electric and magnetic fields; greater field strength correlates with increased work capacity and higher energy transfer.

This energy desensitizes the bladder, thereby increasing its capacity, enhancing blood flow, and reducing the formation of free radicals, all of which contribute to im-proving the symptoms of OAB and UUI. Furthermore, the observation of an associated increase in the production of both epithelial and vascular growth factors-which pro-mote healing and angiogenesis, thereby augmenting blood circulation-offers a new perspective on this treatment.

Additionally, another mechanism by which high-power radiofrequency treats OAB and UUI involves a diathermic process. This process, generated by electromagnetic radiation, leads to an immediate retraction of existing collagen and subsequent activation of fibroblasts, ultimately resulting in non ablative neocollagenesis. Radiofrequency waves effectively penetrate to a depth sufficient to induce collagen production throughout the urethra, suggesting that these mechanisms can ameliorate OAB and UUI symptoms .

The RF application protocol employed in this study involved two weekly sessions of 20 minutes each, administered over a two-week period. Treatment efficacy was eval-uated by re-administering the questionnaires at 3, 6, and 12 . Randomization Method Randomization was conducted according to the guidelines of Fleiss , employ-ing a computer-generated sequence to allocate participants in a 1:1 ratio to either the in-tervention or control group. An independent statistician generated the allocation se-quence and had no involvement in participant enrollment.

post-treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Rogaška Slatina, Slovenia, 3250
        • Damir Franić

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ICIQ-OAB criteria to determinate OAB

Exclusion Criteria:

  • women with pacemaker, active malignancy, urinary infection, sclerodermia, active radioth., women with stress urinary incontinence, women who used pharmocological treatment for OAB less than 3 months before the RF, immunodeficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: radiofrequency as the novel option for treating OAB and UUI
We include 80 women with syptoms of OAb adn UUI, using validated q ICIQ-OAB, ICIQ-flutsex; ICIQ-OABQoL. Half of them were recruited in study group and half of them in placebo group. Follow-up was at 3,6 adn 12 months. That was the frist part of the study. After that we aplied RF for the women who were in placebo group with the same protocol
Device: radiofrequency - TECAR
applied RF for 20 minutes with active probe oaver the bladder and pasive probe on the lumbar region. We applied 4 treatment 2 times/weekly
Active Comparator: we aplied RF for the women who were in placebo group with the same protocol -"cross-over study"
Device: radiofrequency - TECAR
applied RF for 20 minutes with active probe oaver the bladder and pasive probe on the lumbar region. We applied 4 treatment 2 times/weekly

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
number of participants with treatment is 95 divided in two groups- study and placebo related adverse events as assessed by CTCAEv4.o - there were NO adverse events the study satisfied the criteria of "Safety" change from baseline was reported in study g
Time Frame: from enrollment to the end of treatment at two weeks, then we repeat the symptomatology changes using validated questionnaires at 3-6-12 months
A prospective, randomized, single-blind, placebo-controlled study was conducted from June 2023 to May 2025. The study enrolled 95 women (N=48 in the study group; N=47 in the placebo group) who presented with confirmed symptoms of OAB and UUI prior to enrollment. Symptom severity and quality of life were assessed using validated questionnaires from the International Consultation on Incontinence Questionnaires (ICIQ), specifically ICIQ-OAB, ICIQ-OABqol, and ICIQ-FLUTSsex. A higher score on these questionnaires indicated a worse quality of life, while a lower score indicated improvement. Symptomatology was monitored at 3, 6, and 12 months post-RF application, at which points women completed all three validated questionnaires again. Prior to study commencement, all subjects provided informed consent. Before the initial RF treatment, urine analysis and urine culture were performed on all patients to rule out urinary infections.
from enrollment to the end of treatment at two weeks, then we repeat the symptomatology changes using validated questionnaires at 3-6-12 months
radiofrequency in treating overactive bladder and urge urinary incontinence
Time Frame: 3-6-12 months
The primary endpoint was to confirm the statistically significant reduction in OAB and/or UUI symptoms observed in a prior pilot study.
3-6-12 months
The primary endpoint was to confirm the statistically significant reduction in OAB and/or UUI symptoms observed in a prior pilot study
Time Frame: 3-6-12 months
A higher score on these questionnaires indicated a worse symptomatology, while a lower score indicated improvement.
3-6-12 months
the influence of RF on OAB and UUI
Time Frame: the follow up was 3, 6 and 12 months, so the study was terminated after that period of time. For the QoL ICIQ-OABQol was used.
to prove the efficacy of using RF in treating OAB and UUI in prospective randomized placebo control trial
the follow up was 3, 6 and 12 months, so the study was terminated after that period of time. For the QoL ICIQ-OABQol was used.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
how many times needs to fullfill optimal QoL and cessation of symptoms
Time Frame: 3-6-12 months
The secondary endpoint aimed to determine the optimal frequency for RF reapplication to achieve good Quality of Life (QoL) and maintain minimal symptomatology. A higher score on these questionnaires indicated a worse quality of life, while a lower score indicated improvement.
3-6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Maribor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ginek dr franic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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