RFandOAB: RF in the Treatment OAB in UUI- a Prospective Randomized Placebo Controlled Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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: 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.
Other Names:
|
| Sham Comparator: placebo group 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 |
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.
Other Names:
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,
Other Names:
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Outcome Measures
Primary Outcome Measures
- changed symptoms specific for OAB [2 weeks, 3 months, 6 months, 12 months]
frequency of urination, nocturia, urgency, incontinence
Eligibility Criteria
Criteria
Inclusion Criteria:
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clear signs of OAB
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did not use drugs for the treatment of OAB (antimuscarinics/beta-3 agonists)
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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:
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Inserted heart pacemaker,
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unexplained bleeding from the vagina,
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inflammation of the vagina and/or uterus or uterine appendages.
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Bacterial or viral infection,
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weakened immune system,
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sclerodermia,
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radiation treatment,
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burns in the treatment area,
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stress urinary incontinence (SUI) or mixed urinary incontinence
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Damir Franić | Rogaška Slatina | Slovenia | 3250 |
Sponsors and Collaborators
- Ginekologija Dr. Franić, D.O.O.
Investigators
- Principal Investigator: damir franić, MD PhD, Ginekologija Dr. Franić, D.O.O.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ginek dr franic