SUMMARY
SUMMARY: This prospective case study evaluates the safety and efficacy of a combination three-treatment protocol of transvaginal bipolar RF with FormaV, EMS pelvic floor rehabilitation with VTone, and patient education in 31 females with moderate MUI. A series of RF and EMS procedures was administered three times, 2 weeks apart, in conjunction with educating patients on how to utilize pelvic floor muscles. Clinically and statistically significant improvements were observed in participants’ pre-treatment baseline at 3 and 6 months, with post-treatment improvements remaining stable at 6 months.
In addition to being asked to describe their symptom burden, study participants were asked to quantify what they would be willing to pay to receive these treatments. This is an important question because novel technologies like bipolar RF are not typically covered by any health insurance plans, and many plans provide little to no coverage for EMS and other physical therapy interventions. Participants indicated a willingness to pay between $250 and $500 per treatment session throughout the study, for a hypothetical anticipated total cost of treatment of $700–$ 1,500 over 6 weeks.
CONCLUSION: The authors concluded that this treatment regimen can successfully improve MUI symptoms in a safe and minimally invasive manner, delivering high patient satisfaction and an improvement in quality of life.
TOPICS COVERED
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Study Objective: Evaluate the safety and efficacy of combining FormaV bipolar radiofrequency (RF), VTone electrical muscle stimulation (EMS), and patient education for treating mixed urinary incontinence (MUI) in women.
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Treatment Protocol: Three sessions of intravaginal bipolar RF (FormaV) and EMS (VTone) administered two weeks apart, alongside pelvic floor training and education.
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Clinical Outcomes: Significant improvements in incontinence symptoms, pad weight, quality of life (iQOL), sexual function (FsFI), and pelvic floor strength at 3–6 months.
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Patient Satisfaction: 82% of participants reported improvement; most were willing to pay $250–$500 per session, with no reported adverse effects.
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Conclusion: The combination of RF, EMS, and education is a safe, effective, and minimally invasive treatment for MUI with potential quality-of-life benefits.
