CO2 Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial
Introduction and hypothesis Female stress urinary incontinence (SUI) is a prevalent condition, and conservative treatment options are needed. Were evaluated CO 2 laser and radiofrequency as treatment for SUI. Methods One hundred thirty-nine women with SUI were eligible and randomized in a three-arm...
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| Veröffentlicht in: | International Urogynecology Journal 2022-12, Vol.33 (12), p.3535-3542 |
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| creator | Seki, Ana Silvia Bianchi-Ferraro, Ana Maria H. M. Fonseca, Eliana S. M. Sartori, Marair G. F. Girão, Manoel J. B. C. Jarmy-Di Bella, Zsuzsanna I. K. |
| description | Introduction and hypothesis
Female stress urinary incontinence (SUI) is a prevalent condition, and conservative treatment options are needed. Were evaluated CO
2
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
|
| doi_str_mv | 10.1007/s00192-022-05091-y |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2636870754</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2636870754</sourcerecordid><originalsourceid>FETCH-LOGICAL-c352t-51c6733f1b383ec239db030895071ed659591aa19507011217cba7fb12b28fcd3</originalsourceid><addsrcrecordid>eNp9kcFu1DAQhi0EEkvhBTiNxKUcUsaeJE6OqxUFpJUqIThbjuOUVIm9jJNDeBVetl62EhIHDpY142_-3_YvxFuJNxJRf0iIslUFqrwqbGWxPRM7WRIVhIqeix22pAsqa_VSvErpARHLDO7E78OdgqNNnsGGHtj2YxzY_1x9cBu4OJ8s-x6WCBbSDzvnVlg4TnDPcT3BGGBhb5fZhwXiAClXKcHKY7C85eMzPoYs5uH6uP96m4m138DyDPT-BvbZMfRxHn9lkyfp6ezHo51eixeDnZJ_87Rfie-3H78dPhfHu09fDvtj4ahSS1FJV2uiQXbUkHeK2r5DwqatUEvf11VbtdJaea5RSiW166weOqk61QyupytxfdE9ccwPT4uZx-T8NNng45qMqqluNOqqzOi7f9CHuHLItzNKU102lWybTKkL5TimxH4wJx7n_CFGojnnZS55mZyX-ZOX2fIQXYZShsO957_S_5l6BOU7mR0</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2736485198</pqid></control><display><type>article</type><title>CO2 Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial</title><source>SpringerNature Journals</source><creator>Seki, Ana Silvia ; Bianchi-Ferraro, Ana Maria H. M. ; Fonseca, Eliana S. M. ; Sartori, Marair G. F. ; Girão, Manoel J. B. C. ; Jarmy-Di Bella, Zsuzsanna I. K.</creator><creatorcontrib>Seki, Ana Silvia ; Bianchi-Ferraro, Ana Maria H. M. ; Fonseca, Eliana S. M. ; Sartori, Marair G. F. ; Girão, Manoel J. B. C. ; Jarmy-Di Bella, Zsuzsanna I. K.</creatorcontrib><description>Introduction and hypothesis
Female stress urinary incontinence (SUI) is a prevalent condition, and conservative treatment options are needed. Were evaluated CO
2
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
CO
2
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.</description><identifier>ISSN: 0937-3462</identifier><identifier>EISSN: 1433-3023</identifier><identifier>DOI: 10.1007/s00192-022-05091-y</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Clinical trials ; Gynecology ; Lasers ; Medicine ; Medicine & Public Health ; Original Article ; Urinary incontinence ; Urology</subject><ispartof>International Urogynecology Journal, 2022-12, Vol.33 (12), p.3535-3542</ispartof><rights>The International Urogynecological Association 2022</rights><rights>The International Urogynecological Association 2022.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c352t-51c6733f1b383ec239db030895071ed659591aa19507011217cba7fb12b28fcd3</citedby><cites>FETCH-LOGICAL-c352t-51c6733f1b383ec239db030895071ed659591aa19507011217cba7fb12b28fcd3</cites><orcidid>0000-0003-3235-8915</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00192-022-05091-y$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00192-022-05091-y$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>315,782,786,27931,27932,41495,42564,51326</link.rule.ids></links><search><creatorcontrib>Seki, Ana Silvia</creatorcontrib><creatorcontrib>Bianchi-Ferraro, Ana Maria H. M.</creatorcontrib><creatorcontrib>Fonseca, Eliana S. M.</creatorcontrib><creatorcontrib>Sartori, Marair G. F.</creatorcontrib><creatorcontrib>Girão, Manoel J. B. C.</creatorcontrib><creatorcontrib>Jarmy-Di Bella, Zsuzsanna I. K.</creatorcontrib><title>CO2 Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial</title><title>International Urogynecology Journal</title><addtitle>Int Urogynecol J</addtitle><description>Introduction and hypothesis
Female stress urinary incontinence (SUI) is a prevalent condition, and conservative treatment options are needed. Were evaluated CO
2
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
CO
2
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.</description><subject>Clinical trials</subject><subject>Gynecology</subject><subject>Lasers</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Article</subject><subject>Urinary incontinence</subject><subject>Urology</subject><issn>0937-3462</issn><issn>1433-3023</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kcFu1DAQhi0EEkvhBTiNxKUcUsaeJE6OqxUFpJUqIThbjuOUVIm9jJNDeBVetl62EhIHDpY142_-3_YvxFuJNxJRf0iIslUFqrwqbGWxPRM7WRIVhIqeix22pAsqa_VSvErpARHLDO7E78OdgqNNnsGGHtj2YxzY_1x9cBu4OJ8s-x6WCBbSDzvnVlg4TnDPcT3BGGBhb5fZhwXiAClXKcHKY7C85eMzPoYs5uH6uP96m4m138DyDPT-BvbZMfRxHn9lkyfp6ezHo51eixeDnZJ_87Rfie-3H78dPhfHu09fDvtj4ahSS1FJV2uiQXbUkHeK2r5DwqatUEvf11VbtdJaea5RSiW166weOqk61QyupytxfdE9ccwPT4uZx-T8NNng45qMqqluNOqqzOi7f9CHuHLItzNKU102lWybTKkL5TimxH4wJx7n_CFGojnnZS55mZyX-ZOX2fIQXYZShsO957_S_5l6BOU7mR0</recordid><startdate>20221201</startdate><enddate>20221201</enddate><creator>Seki, Ana Silvia</creator><creator>Bianchi-Ferraro, Ana Maria H. M.</creator><creator>Fonseca, Eliana S. M.</creator><creator>Sartori, Marair G. F.</creator><creator>Girão, Manoel J. B. C.</creator><creator>Jarmy-Di Bella, Zsuzsanna I. K.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-3235-8915</orcidid></search><sort><creationdate>20221201</creationdate><title>CO2 Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial</title><author>Seki, Ana Silvia ; Bianchi-Ferraro, Ana Maria H. M. ; Fonseca, Eliana S. M. ; Sartori, Marair G. F. ; Girão, Manoel J. B. C. ; Jarmy-Di Bella, Zsuzsanna I. K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c352t-51c6733f1b383ec239db030895071ed659591aa19507011217cba7fb12b28fcd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Clinical trials</topic><topic>Gynecology</topic><topic>Lasers</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Article</topic><topic>Urinary incontinence</topic><topic>Urology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Seki, Ana Silvia</creatorcontrib><creatorcontrib>Bianchi-Ferraro, Ana Maria H. M.</creatorcontrib><creatorcontrib>Fonseca, Eliana S. M.</creatorcontrib><creatorcontrib>Sartori, Marair G. F.</creatorcontrib><creatorcontrib>Girão, Manoel J. B. C.</creatorcontrib><creatorcontrib>Jarmy-Di Bella, Zsuzsanna I. K.</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>International Urogynecology Journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Seki, Ana Silvia</au><au>Bianchi-Ferraro, Ana Maria H. M.</au><au>Fonseca, Eliana S. M.</au><au>Sartori, Marair G. F.</au><au>Girão, Manoel J. B. C.</au><au>Jarmy-Di Bella, Zsuzsanna I. K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>CO2 Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial</atitle><jtitle>International Urogynecology Journal</jtitle><stitle>Int Urogynecol J</stitle><date>2022-12-01</date><risdate>2022</risdate><volume>33</volume><issue>12</issue><spage>3535</spage><epage>3542</epage><pages>3535-3542</pages><issn>0937-3462</issn><eissn>1433-3023</eissn><abstract>Introduction and hypothesis
Female stress urinary incontinence (SUI) is a prevalent condition, and conservative treatment options are needed. Were evaluated CO
2
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
CO
2
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.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><doi>10.1007/s00192-022-05091-y</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-3235-8915</orcidid></addata></record> |
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| source | SpringerNature Journals |
| subjects | Clinical trials Gynecology Lasers Medicine Medicine & Public Health Original Article Urinary incontinence Urology |
| title | 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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