Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence
Objective The purpose of this study was to evaluate the efficacy and safety of a novel disposable intravaginal device for treatment of stress urinary incontinence (SUI) in women. Study Design Sixty women with severe SUI were recruited from 2 sites in Israel to wear preweighed pads during a 7-day con...
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| Veröffentlicht in: | American journal of obstetrics and gynecology 2008-05, Vol.198 (5), p.594.e1-594.e7 |
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| container_end_page | 594.e7 |
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| container_issue | 5 |
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| container_title | American journal of obstetrics and gynecology |
| container_volume | 198 |
| creator | Ziv, Elan, MD Stanton, Stuart L., FRCS, FRCOG Abarbanel, Joseph, MD |
| description | Objective The purpose of this study was to evaluate the efficacy and safety of a novel disposable intravaginal device for treatment of stress urinary incontinence (SUI) in women. Study Design Sixty women with severe SUI were recruited from 2 sites in Israel to wear preweighed pads during a 7-day control period followed by a 28-day device usage period in which the device and preweighed pads were worn daily for 8 hours. The primary endpoint was the percentage of women who achieved a ≥ 70% reduction in pad weight gain (PWG) from the control period to the last 14 days of device usage. Results Sixty women who enrolled into the study and used the device for any period of time were included in the intent to treat (ITT) population. Eighty-five percent of them achieved a ≥ 70% reduction in PWG ( P = .01). Improvements in overall quality of life, subjective perception of incontinence, and satisfaction with the device were observed. Conclusion The intravaginal device is easy to use, well-tolerated, and effective in reducing SUI. |
| doi_str_mv | 10.1016/j.ajog.2008.01.061 |
| format | Article |
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Study Design Sixty women with severe SUI were recruited from 2 sites in Israel to wear preweighed pads during a 7-day control period followed by a 28-day device usage period in which the device and preweighed pads were worn daily for 8 hours. The primary endpoint was the percentage of women who achieved a ≥ 70% reduction in pad weight gain (PWG) from the control period to the last 14 days of device usage. Results Sixty women who enrolled into the study and used the device for any period of time were included in the intent to treat (ITT) population. Eighty-five percent of them achieved a ≥ 70% reduction in PWG ( P = .01). Improvements in overall quality of life, subjective perception of incontinence, and satisfaction with the device were observed. Conclusion The intravaginal device is easy to use, well-tolerated, and effective in reducing SUI.</description><identifier>ISSN: 0002-9378</identifier><identifier>EISSN: 1097-6868</identifier><identifier>DOI: 10.1016/j.ajog.2008.01.061</identifier><identifier>PMID: 18377862</identifier><identifier>CODEN: AJOGAH</identifier><language>eng</language><publisher>Philadelphia, PA: Mosby, Inc</publisher><subject>Adolescent ; Adult ; Aged ; Biological and medical sciences ; Disposable Equipment ; Equipment Design ; Female ; Gynecology. Andrology. Obstetrics ; Humans ; Incontinence Pads ; intravaginal device ; Medical sciences ; Middle Aged ; Nephrology. Urinary tract diseases ; Obstetrics and Gynecology ; pad weight gain ; Pain - epidemiology ; Patient Satisfaction ; Pessaries ; Prostheses and Implants ; Quality of Life ; stress urinary incontinence (SUI) ; Treatment Outcome ; Urinary Incontinence, Stress - therapy ; Urinary system involvement in other diseases. Miscellaneous ; Urinary tract. Prostate gland</subject><ispartof>American journal of obstetrics and gynecology, 2008-05, Vol.198 (5), p.594.e1-594.e7</ispartof><rights>Mosby, Inc.</rights><rights>2008 Mosby, Inc.</rights><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c439t-c6eb883bbef0811dfbf418de789a6fafc36e9367d5d5d0b5ee7813c9b948589e3</citedby><cites>FETCH-LOGICAL-c439t-c6eb883bbef0811dfbf418de789a6fafc36e9367d5d5d0b5ee7813c9b948589e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ajog.2008.01.061$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>309,310,314,780,784,789,790,3550,23930,23931,25140,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20320685$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18377862$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ziv, Elan, MD</creatorcontrib><creatorcontrib>Stanton, Stuart L., FRCS, FRCOG</creatorcontrib><creatorcontrib>Abarbanel, Joseph, MD</creatorcontrib><title>Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence</title><title>American journal of obstetrics and gynecology</title><addtitle>Am J Obstet Gynecol</addtitle><description>Objective The purpose of this study was to evaluate the efficacy and safety of a novel disposable intravaginal device for treatment of stress urinary incontinence (SUI) in women. Study Design Sixty women with severe SUI were recruited from 2 sites in Israel to wear preweighed pads during a 7-day control period followed by a 28-day device usage period in which the device and preweighed pads were worn daily for 8 hours. The primary endpoint was the percentage of women who achieved a ≥ 70% reduction in pad weight gain (PWG) from the control period to the last 14 days of device usage. Results Sixty women who enrolled into the study and used the device for any period of time were included in the intent to treat (ITT) population. Eighty-five percent of them achieved a ≥ 70% reduction in PWG ( P = .01). Improvements in overall quality of life, subjective perception of incontinence, and satisfaction with the device were observed. Conclusion The intravaginal device is easy to use, well-tolerated, and effective in reducing SUI.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Disposable Equipment</subject><subject>Equipment Design</subject><subject>Female</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Incontinence Pads</subject><subject>intravaginal device</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Obstetrics and Gynecology</subject><subject>pad weight gain</subject><subject>Pain - epidemiology</subject><subject>Patient Satisfaction</subject><subject>Pessaries</subject><subject>Prostheses and Implants</subject><subject>Quality of Life</subject><subject>stress urinary incontinence (SUI)</subject><subject>Treatment Outcome</subject><subject>Urinary Incontinence, Stress - therapy</subject><subject>Urinary system involvement in other diseases. Miscellaneous</subject><subject>Urinary tract. Prostate gland</subject><issn>0002-9378</issn><issn>1097-6868</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kk2LFDEQQIMo7rj6BzxILnrrtpJMpxMQYVnWVVjwoIK3kE5XhrQ9nTHpHph_b5oZFPYgOeSjXhXFqxDymkHNgMn3Q22HuKs5gKqB1SDZE7JhoNtKKqmekg0A8EqLVl2RFzkP65Vr_pxcMSXaVkm-If7O--CsO1E79TRbj_OJRk8tneIRR9qHfIjZdiPSMM3JHu0uTLa84zE4pD4mOie0c5h2NJdTznRJhUinwrs4lQBODl-SZ96OGV9d9mvy49Pd99vP1cPX-y-3Nw-V2wo9V05ip5ToOvSgGOt957dM9dgqbaW33gmJWsi2b8qCrsESYcLpTm9VozSKa_LuXPeQ4u8F82z2ITscRzthXLKRmkmluSggP4MuxZwTenNIYV_aNgzMatcMZrVrVrsGmCl2S9KbS_Wl22P_L-WiswBvL4DNzo4-2cmF_JfjIDhI1RTuw5nD4uIYMJnswuqpDwndbPoY_t_Hx0fpbgxTGeP4C0-Yh7ikMqNsmMncgPm2Dn79BqAAmGh-ij8pHa-F</recordid><startdate>20080501</startdate><enddate>20080501</enddate><creator>Ziv, Elan, MD</creator><creator>Stanton, Stuart L., FRCS, FRCOG</creator><creator>Abarbanel, Joseph, MD</creator><general>Mosby, Inc</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20080501</creationdate><title>Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence</title><author>Ziv, Elan, MD ; Stanton, Stuart L., FRCS, FRCOG ; Abarbanel, Joseph, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c439t-c6eb883bbef0811dfbf418de789a6fafc36e9367d5d5d0b5ee7813c9b948589e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Disposable Equipment</topic><topic>Equipment Design</topic><topic>Female</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>Incontinence Pads</topic><topic>intravaginal device</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Obstetrics and Gynecology</topic><topic>pad weight gain</topic><topic>Pain - epidemiology</topic><topic>Patient Satisfaction</topic><topic>Pessaries</topic><topic>Prostheses and Implants</topic><topic>Quality of Life</topic><topic>stress urinary incontinence (SUI)</topic><topic>Treatment Outcome</topic><topic>Urinary Incontinence, Stress - therapy</topic><topic>Urinary system involvement in other diseases. Miscellaneous</topic><topic>Urinary tract. Prostate gland</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ziv, Elan, MD</creatorcontrib><creatorcontrib>Stanton, Stuart L., FRCS, FRCOG</creatorcontrib><creatorcontrib>Abarbanel, Joseph, MD</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>American journal of obstetrics and gynecology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ziv, Elan, MD</au><au>Stanton, Stuart L., FRCS, FRCOG</au><au>Abarbanel, Joseph, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence</atitle><jtitle>American journal of obstetrics and gynecology</jtitle><addtitle>Am J Obstet Gynecol</addtitle><date>2008-05-01</date><risdate>2008</risdate><volume>198</volume><issue>5</issue><spage>594.e1</spage><epage>594.e7</epage><pages>594.e1-594.e7</pages><issn>0002-9378</issn><eissn>1097-6868</eissn><coden>AJOGAH</coden><abstract>Objective The purpose of this study was to evaluate the efficacy and safety of a novel disposable intravaginal device for treatment of stress urinary incontinence (SUI) in women. Study Design Sixty women with severe SUI were recruited from 2 sites in Israel to wear preweighed pads during a 7-day control period followed by a 28-day device usage period in which the device and preweighed pads were worn daily for 8 hours. The primary endpoint was the percentage of women who achieved a ≥ 70% reduction in pad weight gain (PWG) from the control period to the last 14 days of device usage. Results Sixty women who enrolled into the study and used the device for any period of time were included in the intent to treat (ITT) population. Eighty-five percent of them achieved a ≥ 70% reduction in PWG ( P = .01). Improvements in overall quality of life, subjective perception of incontinence, and satisfaction with the device were observed. Conclusion The intravaginal device is easy to use, well-tolerated, and effective in reducing SUI.</abstract><cop>Philadelphia, PA</cop><pub>Mosby, Inc</pub><pmid>18377862</pmid><doi>10.1016/j.ajog.2008.01.061</doi><tpages>3</tpages></addata></record> |
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| ispartof | American journal of obstetrics and gynecology, 2008-05, Vol.198 (5), p.594.e1-594.e7 |
| issn | 0002-9378 1097-6868 |
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| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Adolescent Adult Aged Biological and medical sciences Disposable Equipment Equipment Design Female Gynecology. Andrology. Obstetrics Humans Incontinence Pads intravaginal device Medical sciences Middle Aged Nephrology. Urinary tract diseases Obstetrics and Gynecology pad weight gain Pain - epidemiology Patient Satisfaction Pessaries Prostheses and Implants Quality of Life stress urinary incontinence (SUI) Treatment Outcome Urinary Incontinence, Stress - therapy Urinary system involvement in other diseases. Miscellaneous Urinary tract. Prostate gland |
| title | Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence |
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