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

Primary Purpose

Overactive Bladder Syndrome, Urge Incontinence

Status
Active
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
study group
placebo (sham control)
Sponsored by
Ginekologija Dr. Franić, D.O.O.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring radiofrequency-overactive bladder-urge incontinence

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Damir Franić

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

study group

placebo group

Arm Description

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.

The patients were lying in the lithotomy position with the streched 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, with NO electricity was released to the bladder for 20 minutes

Outcomes

Primary Outcome Measures

changed symptoms specific for OAB
frequency of urination, nocturia, urgency, incontinence

Secondary Outcome Measures

Full Information

First Posted
June 22, 2023
Last Updated
October 10, 2023
Sponsor
Ginekologija Dr. Franić, D.O.O.
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1. Study Identification

Unique Protocol Identification Number
NCT06080217
Brief Title
RF in the Treatment OAB in UUI- a Prospective Randomized Placebo Controlled Study
Acronym
RFandOAB
Official Title
Radiofrequency as the New Opportunity in Treating Overactive Bladder and Urgent Urinary Incontinence - a Prospective Randomized Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ginekologija Dr. Franić, D.O.O.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome, Urge Incontinence
Keywords
radiofrequency-overactive bladder-urge incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo group
Arm Type
Sham Comparator
Arm Description
The patients were lying in the lithotomy position with the streched 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, with NO electricity was released to the bladder for 20 minutes
Intervention Type
Device
Intervention Name(s)
study group
Other Intervention Name(s)
Capenergy C100 (ref. 533001) with upgrade to C500 (ref. 533005)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
placebo (sham control)
Other Intervention Name(s)
Capenergy C100 (ref. 533001) with upgrade to C500 (ref. 533005)
Intervention Description
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,
Primary Outcome Measure Information:
Title
changed symptoms specific for OAB
Description
frequency of urination, nocturia, urgency, incontinence
Time Frame
2 weeks, 3 months, 6 months, 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
damir franić, MD PhD
Organizational Affiliation
Ginekologija Dr. Franić, D.O.O.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damir Franić
City
Rogaška Slatina
ZIP/Postal Code
3250
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
publication in the peer-review journal
IPD Sharing Time Frame
after competed the study together with 12 months follow-up
IPD Sharing URL
http://ginekologija.si

Learn more about this trial

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

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