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Early Feasibility Study of Non-Ablative Cryogen-Co ...
Early Feasibility Study of Non-Ablative Cryogen-Cooled Monopolar Radiofrequency Treatment For Stress Urinary Incontinence (SUI): 12-Month Results - Bruce B. Allan, PhD, MD, FRCS(C)
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A study was conducted to evaluate the efficacy and safety of a non-surgical cryogen-cooled monopolar radiofrequency (CMRF) treatment for stress urinary incontinence (SUI) in women. The study included women diagnosed with mild-moderate SUI and randomized them into two groups. Group A received one treatment, while Group B received two treatments six weeks apart. <br /><br />The efficacy of the CMRF treatment was evaluated using objective measurements such as the 1-hour pad weight test and the 7-day bladder voiding diary, as well as subjective measurements including validated SUI-related patient reported outcomes (PROs). The results showed a significant improvement in SUI symptoms, as indicated by a reduction in leakage volume on the pad weight test and a decrease in daily incontinence episodes.<br /><br />The CMRF treatment was well tolerated, and no treatment-related adverse events were reported. The study also assessed PROs such as the Urinary Distress Index (UDI-6), Incontinence Impact Questionnaire (IIQ-7), and ICIQ-Incontinence Module, Short Form (ICIQ-UI-SF). The results demonstrated improvements in these PROs, suggesting that the treatment had a positive impact on SUI-related quality of life.<br /><br />Overall, the study findings suggest that CMRF treatment for SUI is effective in reducing leakage volume and daily incontinence episodes. It is also well tolerated by patients, without any reported adverse events. The sustained benefit of the treatment offers a potential alternative to surgical interventions for SUI, providing another option for women seeking treatment for this condition.
Keywords
CMRF treatment
stress urinary incontinence
SUI
randomized groups
leakage volume
incontinence episodes
adverse events
patient reported outcomes
quality of life
surgical interventions
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