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Transurethral delivery of radiofrequency energy for tissue micro-remodeling in the treatment of stress urinary incontinence

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Abstract

This initial human study was performed to determine the safety and quality of life impact of transurethral radiofrequency energy (RFe) tissue micro-remodeling of the proximal urethra and bladder outlet in patients with stress urinary incontinence (SUI). Forty-one patients with SUI were sequentially enrolled into four treatment groups and then underwent rapid outpatient treatment under conscious sedation using an investigational RFe delivery device. The device is passed through the urethra and palpably positioned by the anchoring of a balloon within the bladder outlet. Four small needle electrodes are deployed into the proximal urethra and/or bladder outlet submucosa, and RFe is delivered. No patient has suffered a serious adverse event in 6 months of follow-up. At 6 months, 75%–80% of patients in all four groups have demonstrated an improvement in quality of life. Two groups demonstrated statistical significance in both mean quality of life improvement and incontinence frequency reduction at 6 months.

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Abbreviations

MCE:

Minor clinical event

SAE:

Serious adverse events

SUI:

Stress urinary incontinence

VAS:

Visual analog scale

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Acknowledgements

This study was sponsored by Novasys Medical Inc., Newark, California. None of the authors have equity positions in the sponsoring company.

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Author notes

  1. Mariano Sotomayor

    Present address: , c/o Dr Peter S. Edelstein, 39684 Eureka Drive, Newark, California, 94560, USA

Authors and Affiliations

  1. Department of Urology, Salvador Zubirán National Nutrition Institute, Mexico City, Mexico

    Mariano Sotomayor & Guillermo Feria Bernal

Authors
  1. Mariano Sotomayor
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  2. Guillermo Feria Bernal
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Corresponding author

Correspondence to Mariano Sotomayor.

Additional information

Editorial Comment: Treatment of stress urinary incontinence via transurethral delivery of radiofrequency energy appears to be effective and safe in this small study with 6 months' follow-up. Treatment resulted in significantly improved quality of life scores and up to 75% of patients were cured 3–6 months after treatment. Although the simplicity of this minimally invasive procedure is appealing, the long-term efficacy and safety of transurethral delivery of radiofrequency energy for the treatment of stress urinary incontinence should be carefully evaluated in larger prospective studies.

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Sotomayor, M., Bernal, G.F. Transurethral delivery of radiofrequency energy for tissue micro-remodeling in the treatment of stress urinary incontinence. Int Urogynecol J 14, 373–379 (2003). https://doi.org/10.1007/s00192-003-1083-y

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  • DOI: https://doi.org/10.1007/s00192-003-1083-y

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