RF in the Treatment OAB in UUI- a Prospective Randomized Placebo Controlled Study (RFandOAB)
Overactive Bladder Syndrome, Urge Incontinence
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring radiofrequency-overactive bladder-urge incontinence
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
Sites / Locations
- Damir Franić
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
study group
placebo 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.
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