Abstract
This pilot clinical trial was performed to evaluate the safety and impact on quality of life and incontinence episode frequency of nonsurgical radiofrequency energy (RF) tissue micro-remodeling in women with stress urinary incontinence (SUI). The palpation-guided treatment produces focal denaturation of submucosal collagen, resulting in reduced luminal wall compliance without luminal narrowing. Forty-one women suffering from SUI associated with urethral hypermobility were enrolled into four treatment groups which differed in total number and lower urinary tract location of micro-remodeling sites. No serious and only limited minor adverse events were associated with the treatment. Incidence of quality of life score improvement at 12 months ranged from 75 to 78%, and statistically significant incontinence episode frequency reduction was demonstrated by three of four treatment groups. RF micro-remodeling demonstrated 12-month safety, quality of life improvement, and incontinence episode frequency reduction. No one treatment group demonstrated clear superiority in efficacy outcomes.
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Acknowledgement
This study was sponsored by Novasys Medical, Inc., Newark, California, USA.
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The institution received financial support for the performance of the study from the sponsor. Neither author has an equity position in the sponsoring company nor received direct financial support
A limited portion of these study results was presented in poster (abstract) form at the International Continence Society Meeting, Florence, Italy, 2003
Editorial Comment: This is an interesting 1-year follow-up on a study involving a minimally invasive radiofrequency technique for shrinking periurethral collagen and providing relief of stress urinary incontinence. The first publication of these patients appeared in volume 14 of this journal, but only had 6-month data. It is encouraging to see that the data at 12 months remain positive. Except for the group II patients, all of the I-QOL scores remain essentially unchanged. While it appears there is an increase in the incontinence episode frequency from 6 months to 12 months, particularly in group IV, overall there is a good reduction in incontinent episode frequency. This in combination with no change in I-QOL scores is encouraging that the treatment remains effective at 1 year. These data are interesting and we wish the authors success in their phase III study
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Sotomayor, M., Bernal, G.F. Twelve-month results of nonsurgical radiofrequency energy micro-remodeling for stress incontinence. Int Urogynecol J 16, 192–196 (2005). https://doi.org/10.1007/s00192-004-1223-z
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DOI: https://doi.org/10.1007/s00192-004-1223-z