Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial
STUDY QUESTIONIs a mechanical hand-held device for removing a single-rod subdermal contraceptive implant safe for implant users? SUMMARY ANSWERIn terms of safety, the device is non-inferior to the standard technique for implant removal. WHAT IS KNOWN ALREADYAn easy-to-use device for removing a subde...
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| creator | Hubacher, David Byamugisha, Josaphat Kakaire, Othman Nalubwama, Hadija Emtell Iwarsson, Karin Bratlie, Marte Chen, Pai-Lien Gemzell-Danielsson, Kristina |
| description | STUDY QUESTIONIs a mechanical hand-held device for removing a single-rod subdermal contraceptive implant safe for implant users? SUMMARY ANSWERIn terms of safety, the device is non-inferior to the standard technique for implant removal. WHAT IS KNOWN ALREADYAn easy-to-use device for removing a subdermal contraceptive implant may be helpful in settings where skilled providers are in short supply. Prior to this study, the only report on the world's first hand-held, mechanical device with build-in incisor was a Swedish study using earlier versions of the product. STUDY DESIGN, SIZE, DURATIONFrom December 2019 to November 2020, we conducted a three-arm, open-label non-inferiority randomized trial involving 225 Ugandan women to assess safety (primary outcome) and measure implant removal efficacy (secondary outcomes) of a newly developed, hand-held device, compared to the standard removal technique. PARTICIPANTS/MATERIALS, SETTING, METHODSWe randomized participants desiring removal of their one-rod contraceptive implant in a 1:1:1 ratio: standard technique/lidocaine injection, new device/lidocaine patch or new device/lidocaine injection. For primary safety endpoints, we examined removal complications and grouped them according to severity. For secondary endpoints on efficacy, we defined three device outcomes: intact implant removed without additional tools (primary), implant removed allowing implant breakage, but without tools (secondary) and implant removed allowing implant breakage and non-scalpel tools (tertiary). We assessed provider feedback on the device and used chi-square tests for all comparisons. MAIN RESULTS AND THE ROLE OF CHANCEWe recruited 225 participants and randomly assigned (n = 75) to each group. For safety, no primary complications occurred in any treatment group, while only one secondary complication occurred in each treatment group (1%). Primary efficacy was 100% (standard technique), 85% (new device/lidocaine patch) and 73% (new device/lidocaine injection) (P |
| doi_str_mv | 10.1093/humrep/deac179 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_swepu</sourceid><recordid>TN_cdi_swepub_primary_oai_swepub_ki_se_451550</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2702182243</sourcerecordid><originalsourceid>FETCH-LOGICAL-c360t-e958665db09c7e124bf73b808441b157588666c65a7dd783075952a031bef80f3</originalsourceid><addsrcrecordid>eNpVUktrFTEUDqLYa3XrOksXTZtMJsmMC0GKLygIouuQSc70RjPJmGRuqb_JH2nKvQhd5fC9Dpx8CL1m9JLRkV_ttyXDeuXAWKbGJ2jHeklJxwV9ina0kwNhTLIz9KKUn5S2cZDP0RkXo6RM9Tv09xss6WACTjM2-A5CIKsJq5kC4BSB5ORw2SYHeWkim2LNxsJa_QGwX9ZgYsVb8fG2uR04b00Fh_cmOrKH4Bp28LZFZVxqA012uILdR_97g7fNkxuYFv8H3AVOK0QSzAThAscUiY8zZJ-yr_e4Zm_CS_RsNqHAq9N7jn58_PD9-jO5-frpy_X7G2K5pJXAKAYphZvoaBWwrp9mxaeBDn3PJiaUGBotrRRGOacGTpUYRWcoZxPMA535OSLH3HIH6zbpNfvF5HudjNcn6FebQPeCCUGb_t1R35gFnIWHK4VHtsdM9Ht9mw66rVW96FvAm1NATu0wperFF9s-w0RIW9Gdoh0buq7nTXp5lNqcSskw_1_DqH6ohD5WQp8qwf8B9QWvhw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2702182243</pqid></control><display><type>article</type><title>Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><source>SWEPUB Freely available online</source><creator>Hubacher, David ; Byamugisha, Josaphat ; Kakaire, Othman ; Nalubwama, Hadija ; Emtell Iwarsson, Karin ; Bratlie, Marte ; Chen, Pai-Lien ; Gemzell-Danielsson, Kristina</creator><creatorcontrib>Hubacher, David ; Byamugisha, Josaphat ; Kakaire, Othman ; Nalubwama, Hadija ; Emtell Iwarsson, Karin ; Bratlie, Marte ; Chen, Pai-Lien ; Gemzell-Danielsson, Kristina</creatorcontrib><description>STUDY QUESTIONIs a mechanical hand-held device for removing a single-rod subdermal contraceptive implant safe for implant users? SUMMARY ANSWERIn terms of safety, the device is non-inferior to the standard technique for implant removal. WHAT IS KNOWN ALREADYAn easy-to-use device for removing a subdermal contraceptive implant may be helpful in settings where skilled providers are in short supply. Prior to this study, the only report on the world's first hand-held, mechanical device with build-in incisor was a Swedish study using earlier versions of the product. STUDY DESIGN, SIZE, DURATIONFrom December 2019 to November 2020, we conducted a three-arm, open-label non-inferiority randomized trial involving 225 Ugandan women to assess safety (primary outcome) and measure implant removal efficacy (secondary outcomes) of a newly developed, hand-held device, compared to the standard removal technique. PARTICIPANTS/MATERIALS, SETTING, METHODSWe randomized participants desiring removal of their one-rod contraceptive implant in a 1:1:1 ratio: standard technique/lidocaine injection, new device/lidocaine patch or new device/lidocaine injection. For primary safety endpoints, we examined removal complications and grouped them according to severity. For secondary endpoints on efficacy, we defined three device outcomes: intact implant removed without additional tools (primary), implant removed allowing implant breakage, but without tools (secondary) and implant removed allowing implant breakage and non-scalpel tools (tertiary). We assessed provider feedback on the device and used chi-square tests for all comparisons. MAIN RESULTS AND THE ROLE OF CHANCEWe recruited 225 participants and randomly assigned (n = 75) to each group. For safety, no primary complications occurred in any treatment group, while only one secondary complication occurred in each treatment group (1%). Primary efficacy was 100% (standard technique), 85% (new device/lidocaine patch) and 73% (new device/lidocaine injection) (P < 0.0001). Secondary efficacy was 100% (standard technique), 92% (new device/lidocaine patch) and 79% (new device/lidocaine injection) (P < 0.0001). Tertiary efficacy was 100% (standard technique), 96% (new device/lidocaine patch) and 91% (new device/lidocaine injection) (P = 0.017). Unsuccessful removals with the new device did not hinder subsequent implant extractions with standard back-up tools. In over 90% of the 150 device procedures, providers agreed or strongly agreed that the product is an acceptable alternative to standard removal technique. LIMITATIONS, REASONS FOR CAUTIONWe tested a new removal device in the hands of Ugandan nurses who were adept at standard removal techniques; our estimates of removal efficacy may not apply to lower-level providers who arguably may be the prime beneficiaries of this technology. WIDER IMPLICATIONS OF THE FINDINGSThe study was conducted in a region of the world where the new device could be used to expand access to implant removal services. Intended beneficiaries of the new product are implant users who cannot easily find skilled providers for traditional scalpel-dependent removals and/or users who are intimidated by scalpel procedures, and lower-level providers who can be trained to help deliver services to meet a growing demand. The new device is a safe, acceptable alternative; efficacy was high, but not on par with standard technique. STUDY FUNDING/COMPETING INTEREST(S)Funding for this study was provided by the RemovAid AS of Norway with grants from Research Council of Norway (GLOBVAC number 228319), Bill & Melinda Gates Foundation (grant INV-007571) and SkatteFUNN. M.B. is founder and former CEO of RemovAid AS, Norway. M.B. holds contraceptive rod remover patents (2012 1307156.8 and 2015), pre-removal test (filed) and shares in RemovAid AS. All of the remaining authors' institutions received payments in the form of contracts to help conduct the study; the funds for these contracts emanated from RemovAid AS. TRIAL REGISTRATION NUMBERNCT04120337. TRIAL REGISTRATION DATE9 October 2019. DATE OF FIRST PATIENT’S ENROLMENT23 December 2019.</description><identifier>ISSN: 0268-1161</identifier><identifier>EISSN: 1460-2350</identifier><identifier>DOI: 10.1093/humrep/deac179</identifier><identifier>PMID: 35960174</identifier><language>eng</language><publisher>Oxford University Press</publisher><subject>Original</subject><ispartof>Human reproduction (Oxford), 2022-09, Vol.37 (10), p.2320-2333</ispartof><rights>The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c360t-e958665db09c7e124bf73b808441b157588666c65a7dd783075952a031bef80f3</cites><orcidid>0000-0001-6516-1444 ; 0000-0002-5757-9741</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,550,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:150436936$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Hubacher, David</creatorcontrib><creatorcontrib>Byamugisha, Josaphat</creatorcontrib><creatorcontrib>Kakaire, Othman</creatorcontrib><creatorcontrib>Nalubwama, Hadija</creatorcontrib><creatorcontrib>Emtell Iwarsson, Karin</creatorcontrib><creatorcontrib>Bratlie, Marte</creatorcontrib><creatorcontrib>Chen, Pai-Lien</creatorcontrib><creatorcontrib>Gemzell-Danielsson, Kristina</creatorcontrib><title>Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial</title><title>Human reproduction (Oxford)</title><description>STUDY QUESTIONIs a mechanical hand-held device for removing a single-rod subdermal contraceptive implant safe for implant users? SUMMARY ANSWERIn terms of safety, the device is non-inferior to the standard technique for implant removal. WHAT IS KNOWN ALREADYAn easy-to-use device for removing a subdermal contraceptive implant may be helpful in settings where skilled providers are in short supply. Prior to this study, the only report on the world's first hand-held, mechanical device with build-in incisor was a Swedish study using earlier versions of the product. STUDY DESIGN, SIZE, DURATIONFrom December 2019 to November 2020, we conducted a three-arm, open-label non-inferiority randomized trial involving 225 Ugandan women to assess safety (primary outcome) and measure implant removal efficacy (secondary outcomes) of a newly developed, hand-held device, compared to the standard removal technique. PARTICIPANTS/MATERIALS, SETTING, METHODSWe randomized participants desiring removal of their one-rod contraceptive implant in a 1:1:1 ratio: standard technique/lidocaine injection, new device/lidocaine patch or new device/lidocaine injection. For primary safety endpoints, we examined removal complications and grouped them according to severity. For secondary endpoints on efficacy, we defined three device outcomes: intact implant removed without additional tools (primary), implant removed allowing implant breakage, but without tools (secondary) and implant removed allowing implant breakage and non-scalpel tools (tertiary). We assessed provider feedback on the device and used chi-square tests for all comparisons. MAIN RESULTS AND THE ROLE OF CHANCEWe recruited 225 participants and randomly assigned (n = 75) to each group. For safety, no primary complications occurred in any treatment group, while only one secondary complication occurred in each treatment group (1%). Primary efficacy was 100% (standard technique), 85% (new device/lidocaine patch) and 73% (new device/lidocaine injection) (P < 0.0001). Secondary efficacy was 100% (standard technique), 92% (new device/lidocaine patch) and 79% (new device/lidocaine injection) (P < 0.0001). Tertiary efficacy was 100% (standard technique), 96% (new device/lidocaine patch) and 91% (new device/lidocaine injection) (P = 0.017). Unsuccessful removals with the new device did not hinder subsequent implant extractions with standard back-up tools. In over 90% of the 150 device procedures, providers agreed or strongly agreed that the product is an acceptable alternative to standard removal technique. LIMITATIONS, REASONS FOR CAUTIONWe tested a new removal device in the hands of Ugandan nurses who were adept at standard removal techniques; our estimates of removal efficacy may not apply to lower-level providers who arguably may be the prime beneficiaries of this technology. WIDER IMPLICATIONS OF THE FINDINGSThe study was conducted in a region of the world where the new device could be used to expand access to implant removal services. Intended beneficiaries of the new product are implant users who cannot easily find skilled providers for traditional scalpel-dependent removals and/or users who are intimidated by scalpel procedures, and lower-level providers who can be trained to help deliver services to meet a growing demand. The new device is a safe, acceptable alternative; efficacy was high, but not on par with standard technique. STUDY FUNDING/COMPETING INTEREST(S)Funding for this study was provided by the RemovAid AS of Norway with grants from Research Council of Norway (GLOBVAC number 228319), Bill & Melinda Gates Foundation (grant INV-007571) and SkatteFUNN. M.B. is founder and former CEO of RemovAid AS, Norway. M.B. holds contraceptive rod remover patents (2012 1307156.8 and 2015), pre-removal test (filed) and shares in RemovAid AS. All of the remaining authors' institutions received payments in the form of contracts to help conduct the study; the funds for these contracts emanated from RemovAid AS. TRIAL REGISTRATION NUMBERNCT04120337. TRIAL REGISTRATION DATE9 October 2019. DATE OF FIRST PATIENT’S ENROLMENT23 December 2019.</description><subject>Original</subject><issn>0268-1161</issn><issn>1460-2350</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>D8T</sourceid><recordid>eNpVUktrFTEUDqLYa3XrOksXTZtMJsmMC0GKLygIouuQSc70RjPJmGRuqb_JH2nKvQhd5fC9Dpx8CL1m9JLRkV_ttyXDeuXAWKbGJ2jHeklJxwV9ina0kwNhTLIz9KKUn5S2cZDP0RkXo6RM9Tv09xss6WACTjM2-A5CIKsJq5kC4BSB5ORw2SYHeWkim2LNxsJa_QGwX9ZgYsVb8fG2uR04b00Fh_cmOrKH4Bp28LZFZVxqA012uILdR_97g7fNkxuYFv8H3AVOK0QSzAThAscUiY8zZJ-yr_e4Zm_CS_RsNqHAq9N7jn58_PD9-jO5-frpy_X7G2K5pJXAKAYphZvoaBWwrp9mxaeBDn3PJiaUGBotrRRGOacGTpUYRWcoZxPMA535OSLH3HIH6zbpNfvF5HudjNcn6FebQPeCCUGb_t1R35gFnIWHK4VHtsdM9Ht9mw66rVW96FvAm1NATu0wperFF9s-w0RIW9Gdoh0buq7nTXp5lNqcSskw_1_DqH6ohD5WQp8qwf8B9QWvhw</recordid><startdate>20220930</startdate><enddate>20220930</enddate><creator>Hubacher, David</creator><creator>Byamugisha, Josaphat</creator><creator>Kakaire, Othman</creator><creator>Nalubwama, Hadija</creator><creator>Emtell Iwarsson, Karin</creator><creator>Bratlie, Marte</creator><creator>Chen, Pai-Lien</creator><creator>Gemzell-Danielsson, Kristina</creator><general>Oxford University Press</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>D8T</scope><scope>ZZAVC</scope><orcidid>https://orcid.org/0000-0001-6516-1444</orcidid><orcidid>https://orcid.org/0000-0002-5757-9741</orcidid></search><sort><creationdate>20220930</creationdate><title>Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial</title><author>Hubacher, David ; Byamugisha, Josaphat ; Kakaire, Othman ; Nalubwama, Hadija ; Emtell Iwarsson, Karin ; Bratlie, Marte ; Chen, Pai-Lien ; Gemzell-Danielsson, Kristina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c360t-e958665db09c7e124bf73b808441b157588666c65a7dd783075952a031bef80f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Original</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hubacher, David</creatorcontrib><creatorcontrib>Byamugisha, Josaphat</creatorcontrib><creatorcontrib>Kakaire, Othman</creatorcontrib><creatorcontrib>Nalubwama, Hadija</creatorcontrib><creatorcontrib>Emtell Iwarsson, Karin</creatorcontrib><creatorcontrib>Bratlie, Marte</creatorcontrib><creatorcontrib>Chen, Pai-Lien</creatorcontrib><creatorcontrib>Gemzell-Danielsson, Kristina</creatorcontrib><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Freely available online</collection><collection>SwePub Articles full text</collection><jtitle>Human reproduction (Oxford)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hubacher, David</au><au>Byamugisha, Josaphat</au><au>Kakaire, Othman</au><au>Nalubwama, Hadija</au><au>Emtell Iwarsson, Karin</au><au>Bratlie, Marte</au><au>Chen, Pai-Lien</au><au>Gemzell-Danielsson, Kristina</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial</atitle><jtitle>Human reproduction (Oxford)</jtitle><date>2022-09-30</date><risdate>2022</risdate><volume>37</volume><issue>10</issue><spage>2320</spage><epage>2333</epage><pages>2320-2333</pages><issn>0268-1161</issn><eissn>1460-2350</eissn><abstract>STUDY QUESTIONIs a mechanical hand-held device for removing a single-rod subdermal contraceptive implant safe for implant users? SUMMARY ANSWERIn terms of safety, the device is non-inferior to the standard technique for implant removal. WHAT IS KNOWN ALREADYAn easy-to-use device for removing a subdermal contraceptive implant may be helpful in settings where skilled providers are in short supply. Prior to this study, the only report on the world's first hand-held, mechanical device with build-in incisor was a Swedish study using earlier versions of the product. STUDY DESIGN, SIZE, DURATIONFrom December 2019 to November 2020, we conducted a three-arm, open-label non-inferiority randomized trial involving 225 Ugandan women to assess safety (primary outcome) and measure implant removal efficacy (secondary outcomes) of a newly developed, hand-held device, compared to the standard removal technique. PARTICIPANTS/MATERIALS, SETTING, METHODSWe randomized participants desiring removal of their one-rod contraceptive implant in a 1:1:1 ratio: standard technique/lidocaine injection, new device/lidocaine patch or new device/lidocaine injection. For primary safety endpoints, we examined removal complications and grouped them according to severity. For secondary endpoints on efficacy, we defined three device outcomes: intact implant removed without additional tools (primary), implant removed allowing implant breakage, but without tools (secondary) and implant removed allowing implant breakage and non-scalpel tools (tertiary). We assessed provider feedback on the device and used chi-square tests for all comparisons. MAIN RESULTS AND THE ROLE OF CHANCEWe recruited 225 participants and randomly assigned (n = 75) to each group. For safety, no primary complications occurred in any treatment group, while only one secondary complication occurred in each treatment group (1%). Primary efficacy was 100% (standard technique), 85% (new device/lidocaine patch) and 73% (new device/lidocaine injection) (P < 0.0001). Secondary efficacy was 100% (standard technique), 92% (new device/lidocaine patch) and 79% (new device/lidocaine injection) (P < 0.0001). Tertiary efficacy was 100% (standard technique), 96% (new device/lidocaine patch) and 91% (new device/lidocaine injection) (P = 0.017). Unsuccessful removals with the new device did not hinder subsequent implant extractions with standard back-up tools. In over 90% of the 150 device procedures, providers agreed or strongly agreed that the product is an acceptable alternative to standard removal technique. LIMITATIONS, REASONS FOR CAUTIONWe tested a new removal device in the hands of Ugandan nurses who were adept at standard removal techniques; our estimates of removal efficacy may not apply to lower-level providers who arguably may be the prime beneficiaries of this technology. WIDER IMPLICATIONS OF THE FINDINGSThe study was conducted in a region of the world where the new device could be used to expand access to implant removal services. Intended beneficiaries of the new product are implant users who cannot easily find skilled providers for traditional scalpel-dependent removals and/or users who are intimidated by scalpel procedures, and lower-level providers who can be trained to help deliver services to meet a growing demand. The new device is a safe, acceptable alternative; efficacy was high, but not on par with standard technique. STUDY FUNDING/COMPETING INTEREST(S)Funding for this study was provided by the RemovAid AS of Norway with grants from Research Council of Norway (GLOBVAC number 228319), Bill & Melinda Gates Foundation (grant INV-007571) and SkatteFUNN. M.B. is founder and former CEO of RemovAid AS, Norway. M.B. holds contraceptive rod remover patents (2012 1307156.8 and 2015), pre-removal test (filed) and shares in RemovAid AS. All of the remaining authors' institutions received payments in the form of contracts to help conduct the study; the funds for these contracts emanated from RemovAid AS. TRIAL REGISTRATION NUMBERNCT04120337. TRIAL REGISTRATION DATE9 October 2019. DATE OF FIRST PATIENT’S ENROLMENT23 December 2019.</abstract><pub>Oxford University Press</pub><pmid>35960174</pmid><doi>10.1093/humrep/deac179</doi><tpages>14</tpages><orcidid>https://orcid.org/0000-0001-6516-1444</orcidid><orcidid>https://orcid.org/0000-0002-5757-9741</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Original |
| title | Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial |
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