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

NCT06080217 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-12-01

No results posted yet for this study

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.

Conditions

  • Overactive Bladder Syndrome
  • Urge Incontinence

Interventions

DEVICE

study group

The patients were lying in the lithotomy position with the stretched lower extremities. Probes are placed on the lower part of the abdomen in the area of the bladder (active probe) and on the lumbar spine (passive probe). A capacitive probe in the "free treatment" / "power control" program was used, where high frequency electricity was released to the bladder for 20 minutes with a frequency of 1.0 MHz and energy to maximum 410 C. Initialy, maximum energy of 75% and a frequency of 0.8 MHz was applied, which was reduced depending on the heat that was pleasant for the patient. Then, the power was reduced to 50% and increased the frequency to 1.0 MHz, which also meant moderate energy absorption. The procedure with this energy was continued until the end, and the patients absorbed 18-19 kJ of energy in average.

DEVICE

placebo (sham control)

The patients were lying in the lithotomy position with the stretched lower extremities. Probes are placed on the lower part of the abdomen in the area of the bladder (active probe) and on the lumbar spine (passive probe). A capacitive probe in the "free treatment" / "power control" program was used, but without any energy transferred through the probe,

Sponsors & Collaborators

  • Ginekologija Dr. Franić, D.O.O.

    lead OTHER

Principal Investigators

  • damir franić, MD PhD · Ginekologija Dr. Franić, D.O.O.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2023-12-30
Completion
2024-03-31

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06080217 on ClinicalTrials.gov