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CO2 Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial

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Abstract

Introduction and hypothesis

Female stress urinary incontinence (SUI) is a prevalent condition, and conservative treatment options are needed. Were evaluated CO2 laser and radiofrequency as treatment for SUI.

Methods

One hundred thirty-nine women with SUI were eligible and randomized in a three-arm double-blind randomized controlled trial into radiofrequency (RF), laser (LS) and sham control (SCT) groups, with 3-monthly outpatient treatment sessions. One hundred fourteen women were included, 38 in each group, during a 12-month follow-up.

The primary outcomes were: subjective improvement of SUI, evaluated on a Likert scale, and objective cure, which was a composite outcome defined according to negative stress tests, voiding diary and pad test. Questionnaires were also applied. The sample size was calculated to provide 80% power to identify a 20% difference between groups, p < 0.05.

Results

Subjective improvement and objective cure of SUI were identified respectively in 72.6% and 45.2% in LS and in 61.7% and 44.7% in RF, both significantly higher than the 30.0% and 14.0% in SCT. Considering only mild cases (pad test < 10 g), objective cure was achieved in 66.7% in LS, 63.6% in RF and 22.2% in SCT. Significant reduction in the number of episodes of urinary incontinence was found according to voiding diaries (p = 0.029) and pad weight (p = 0.021). A significant reduction in urgency and urinary loss during sexual intercourse was observed only with LS and RF. Improvement in quality of life was also verified by the I-QoL and ICIQ-SF in favor of the energy-treated groups.

Conclusions

CO2 laser and radiofrequency are outpatient options for SUI treatment, with no major complications. They had similar results and presented better results than in the sham control group.

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Acknowledgments

This study received funding from CAPES (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, a Brazilian Federal Agency, linked to the Ministry of Education) and Process 2019/15802-1, FAPESP (Fundação de Amparo à Pesquisa do Estado de São Paulo, a public institution to promote academic research linked to the São Paulo State Government). Thanks to the Sector of Urogynecology and Vaginal Surgery, Federal University of São Paulo.

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Authors and Affiliations

  1. Department of Gynecology, Federal University of São Paulo, Alameda Jaú 759, SP, 01420-001, São Paulo, Brazil

    Ana Silvia Seki, Ana Maria H. M. Bianchi-Ferraro, Eliana S. M. Fonseca, Marair G. F. Sartori, Manoel J. B. C. Girão & Zsuzsanna I. K. Jarmy-Di Bella

Authors
  1. Ana Silvia Seki
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  2. Ana Maria H. M. Bianchi-Ferraro
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  3. Eliana S. M. Fonseca
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  4. Marair G. F. Sartori
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  5. Manoel J. B. C. Girão
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  6. Zsuzsanna I. K. Jarmy-Di Bella
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Contributions

AS Seki: Project development, Data collection, Data analysis, Manuscript writing.

AMHMB Ferraro: Project Development, Data analysis, Manuscript writing/editing.

ESM Fonseca: Data collection.

MGF Sartori: Project development, Manuscript editing.

MJBC Girão: Project development, Data analysis.

ZIKJD Bella: Project development, Data analysis, Manuscript writing/editing.

Corresponding author

Correspondence to Ana Maria H. M. Bianchi-Ferraro.

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Manoel J. B. C. Girão (in memoriam)

The preliminary results of this study were presented previously at the 58th Brazilian Congress of Gynecology and Obstetrics in Porto Alegre, Brazil (November 2019), and the paper received an awarded as an original study. It was also selected as an oral presentation at the 45th IUGA Annual Meeting (virtual), August/September 2020. In 2021, this study was presented and received first prize at the 26th Paulista Congress of Gynecology and Obstetrics in São Paulo (SOGESP).

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Seki, A.S., Bianchi-Ferraro, A.M.H.M., Fonseca, E.S.M. et al. CO2 Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial. Int Urogynecol J 33, 3535–3542 (2022). https://doi.org/10.1007/s00192-022-05091-y

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  • DOI: https://doi.org/10.1007/s00192-022-05091-y

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