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Efficacy of a Non-Invasive Radiofrequency Device f ...
Efficacy of a Non-Invasive Radiofrequency Device for the Treatment of Stress Urinary Incontinence - Mickey M. Karram, MD
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This case series enrolled 23 patients with stress urinary incontinence (SUI) symptoms. The patients underwent three treatments with a non-invasive radiofrequency (RF) device at 6-week intervals. A high percentage of patients reported a pain score of 0/10 or 1-2/10 after treatment. Most patients completed all three treatments. Follow-up was conducted at 6 weeks, 12 weeks, and 6 months, with a high percentage of patients returning. The patients showed significant improvement after two treatments, with continued improvement at the 6-week follow-up. UDI-6 scores improved by 61% at 6 months, and IQOL scores improved by 46%.<br /><br />SUI is characterized by involuntary urine loss during activity and can be caused by damage to the urethra. RF energy is commonly used to stimulate collagen production. The device used in this study is FDA-cleared and provides heating for medical conditions. The treatment involves applying RF energy to the vaginal wall with minimal discomfort. The treatment effects were evaluated up to 6 months.<br /><br />The primary objective of the study was to compare the frequency of diary-reported stress and mixed incontinence episodes from baseline to 6 months post-treatment. Secondary objectives included evaluating changes in quality of life, distress inventory, cough stress test, patient global impression of improvement, and physician satisfaction. The treatment was found to reduce incontinence episodes and improve quality of life with sustained relief at 6 months post-treatment.<br /><br />Most patients reported improvement in symptoms after treatment, with only one patient reporting worsening. Average weekly accidental leaks reduced significantly from baseline to 6 months. Physician satisfaction with patient improvement was high at both 6 weeks and 6 months post-treatment.
Keywords
stress urinary incontinence
non-invasive radiofrequency device
pain score
treatment
follow-up
UDI-6 scores
IQOL scores
urethra damage
collagen production
FDA-cleared device
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