The New Possibility of Treating Overactive Bladder With Radiofrequency

NCT07398014 | Completed

• 1 other identifier: ginek dr franic
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overactive Bladder and Urge Urinary Incontinence

Keywords

overactive bladder; urge urinary incontinence; radiofrequency treatment; quality of life

Outcome Measures

Primary Outcomes (4)

• the influence of RF on OAB and UUI

  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.

• 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

  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

• The primary endpoint was to confirm the statistically significant reduction in OAB and/or UUI symptoms observed in a prior pilot study

  A higher score on these questionnaires indicated a worse symptomatology, while a lower score indicated improvement.

  3-6-12 months

• radiofrequency in treating overactive bladder and urge urinary incontinence

  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

Secondary Outcomes (1)

• how many times needs to fullfill optimal QoL and cessation of symptoms

  3-6-12 months

Study Arms (2)

radiofrequency as the novel option for treating OAB and UUI

PLACEBO COMPARATOR

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

we aplied RF for the women who were in placebo group with the same protocol -"cross-over study"

ACTIVE COMPARATOR

Device: radiofrequency - TECAR

Interventions

radiofrequency - TECAR DEVICE

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

radiofrequency as the novel option for treating OAB and UUI; we aplied RF for the women who were in placebo group with the same protocol -"cross-over study"

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICIQ-OAB criteria to determinate OAB

You may not qualify if:

• 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

Sponsors & Collaborators

• University Maribor: lead

Study Sites (1)

Damir Franić

Rogaška Slatina, 3250, Slovenia

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist. prof. MD PhD, director

Model Details: prospective randomized placebo control study

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: February 9, 2026
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)