A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial
Studies about the clinical utility of fillers on penile augmentation (PA) are lacking. Furthermore, no randomized study has compared the utilities of fillers. To compare the efficacy and safety between hyaluronic acid (HA) and polylactic acid (PLA) filler injection for PA. This prospective, randomiz...
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| Veröffentlicht in: | Journal of sexual medicine 2019-04, Vol.16 (4), p.577-585 |
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| creator | Yang, Dae Yul Ko, Kyungtae Lee, Seong Ho Lee, Won Ki |
| description | Studies about the clinical utility of fillers on penile augmentation (PA) are lacking. Furthermore, no randomized study has compared the utilities of fillers.
To compare the efficacy and safety between hyaluronic acid (HA) and polylactic acid (PLA) filler injection for PA.
This prospective, randomized patient/evaluator-blind, comparative multicenter study consisted of an initial 2-week baseline period and 48-week patient/evaluator-blind post-injection period. 72 patients with small penis syndrome were enrolled from 3 institutions between March–July 2016. Patients were divided into 2 groups: the HA group, comprising 36 patients injected with HA, and the PLA group, comprising 36 patients injected with PLA.
Penile girth and satisfaction were assessed at baseline and at 4, 12, 24, and 48 weeks after injection.
Penile girth increases adequately lasted ≤48 weeks in both groups (16.95 ± 10.53 and 13.49 ± 9.98 mm of mean increase in the HA and PLA groups, respectively; P < .001). The mean penile girth increase in the HA group was significantly greater than that in the PLA group at 4 weeks (P < .001). Subsequently, it gradually decreased and was no longer significantly different at 48 weeks (P = .075). Satisfaction levels increased after injection and were maintained ≤48 weeks. No significant differences were observed in the overall satisfaction level between the groups (P > .05). Filler injection–related adverse events were mild and transient and occurred in 1 and 3 patients in the HA and PLA groups, respectively.
This study provides an overview of the efficacy and safety of HA and PLA fillers, which are the most commonly used soft tissue fillers for PA.
This study, to our knowledge, is the first to compare the efficacy and safety between different filler injections for human PA. However, it was impossible to perform a researcher-blinded trial because of the unique properties of fillers, and 31 patients (43.1%) were dropped during the study period.
Both HA and PLA filler injections for PA led to a significant augmentative effect without serious adverse events and had clinically comparable efficacy and safety.
Yang DY, Ko K, Lee SH, et al. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med 2019;16:577–585. |
| doi_str_mv | 10.1016/j.jsxm.2019.01.310 |
| format | Article |
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To compare the efficacy and safety between hyaluronic acid (HA) and polylactic acid (PLA) filler injection for PA.
This prospective, randomized patient/evaluator-blind, comparative multicenter study consisted of an initial 2-week baseline period and 48-week patient/evaluator-blind post-injection period. 72 patients with small penis syndrome were enrolled from 3 institutions between March–July 2016. Patients were divided into 2 groups: the HA group, comprising 36 patients injected with HA, and the PLA group, comprising 36 patients injected with PLA.
Penile girth and satisfaction were assessed at baseline and at 4, 12, 24, and 48 weeks after injection.
Penile girth increases adequately lasted ≤48 weeks in both groups (16.95 ± 10.53 and 13.49 ± 9.98 mm of mean increase in the HA and PLA groups, respectively; P < .001). The mean penile girth increase in the HA group was significantly greater than that in the PLA group at 4 weeks (P < .001). Subsequently, it gradually decreased and was no longer significantly different at 48 weeks (P = .075). Satisfaction levels increased after injection and were maintained ≤48 weeks. No significant differences were observed in the overall satisfaction level between the groups (P > .05). Filler injection–related adverse events were mild and transient and occurred in 1 and 3 patients in the HA and PLA groups, respectively.
This study provides an overview of the efficacy and safety of HA and PLA fillers, which are the most commonly used soft tissue fillers for PA.
This study, to our knowledge, is the first to compare the efficacy and safety between different filler injections for human PA. However, it was impossible to perform a researcher-blinded trial because of the unique properties of fillers, and 31 patients (43.1%) were dropped during the study period.
Both HA and PLA filler injections for PA led to a significant augmentative effect without serious adverse events and had clinically comparable efficacy and safety.
Yang DY, Ko K, Lee SH, et al. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med 2019;16:577–585.</description><identifier>ISSN: 1743-6095</identifier><identifier>EISSN: 1743-6109</identifier><identifier>DOI: 10.1016/j.jsxm.2019.01.310</identifier><identifier>PMID: 30833149</identifier><language>eng</language><publisher>Netherlands: Elsevier Inc</publisher><subject>Adult ; Augmentation ; Cosmetic Techniques ; Double-Blind Method ; Filler ; Humans ; Hyaluronic Acid ; Hyaluronic Acid - administration & dosage ; Injections ; Male ; Middle Aged ; Penis ; Penis - drug effects ; Polyesters - administration & dosage ; Polylactic Acid ; Prospective Studies ; Treatment Outcome</subject><ispartof>Journal of sexual medicine, 2019-04, Vol.16 (4), p.577-585</ispartof><rights>2019 International Society for Sexual Medicine</rights><rights>Copyright © 2019 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-4ec23c2c816eb515292872cd06e15e63ba7ed42647ea5431740e70ba89c63cf43</citedby><cites>FETCH-LOGICAL-c356t-4ec23c2c816eb515292872cd06e15e63ba7ed42647ea5431740e70ba89c63cf43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30833149$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yang, Dae Yul</creatorcontrib><creatorcontrib>Ko, Kyungtae</creatorcontrib><creatorcontrib>Lee, Seong Ho</creatorcontrib><creatorcontrib>Lee, Won Ki</creatorcontrib><title>A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial</title><title>Journal of sexual medicine</title><addtitle>J Sex Med</addtitle><description>Studies about the clinical utility of fillers on penile augmentation (PA) are lacking. Furthermore, no randomized study has compared the utilities of fillers.
To compare the efficacy and safety between hyaluronic acid (HA) and polylactic acid (PLA) filler injection for PA.
This prospective, randomized patient/evaluator-blind, comparative multicenter study consisted of an initial 2-week baseline period and 48-week patient/evaluator-blind post-injection period. 72 patients with small penis syndrome were enrolled from 3 institutions between March–July 2016. Patients were divided into 2 groups: the HA group, comprising 36 patients injected with HA, and the PLA group, comprising 36 patients injected with PLA.
Penile girth and satisfaction were assessed at baseline and at 4, 12, 24, and 48 weeks after injection.
Penile girth increases adequately lasted ≤48 weeks in both groups (16.95 ± 10.53 and 13.49 ± 9.98 mm of mean increase in the HA and PLA groups, respectively; P < .001). The mean penile girth increase in the HA group was significantly greater than that in the PLA group at 4 weeks (P < .001). Subsequently, it gradually decreased and was no longer significantly different at 48 weeks (P = .075). Satisfaction levels increased after injection and were maintained ≤48 weeks. No significant differences were observed in the overall satisfaction level between the groups (P > .05). Filler injection–related adverse events were mild and transient and occurred in 1 and 3 patients in the HA and PLA groups, respectively.
This study provides an overview of the efficacy and safety of HA and PLA fillers, which are the most commonly used soft tissue fillers for PA.
This study, to our knowledge, is the first to compare the efficacy and safety between different filler injections for human PA. However, it was impossible to perform a researcher-blinded trial because of the unique properties of fillers, and 31 patients (43.1%) were dropped during the study period.
Both HA and PLA filler injections for PA led to a significant augmentative effect without serious adverse events and had clinically comparable efficacy and safety.
Yang DY, Ko K, Lee SH, et al. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med 2019;16:577–585.</description><subject>Adult</subject><subject>Augmentation</subject><subject>Cosmetic Techniques</subject><subject>Double-Blind Method</subject><subject>Filler</subject><subject>Humans</subject><subject>Hyaluronic Acid</subject><subject>Hyaluronic Acid - administration & dosage</subject><subject>Injections</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Penis</subject><subject>Penis - drug effects</subject><subject>Polyesters - administration & dosage</subject><subject>Polylactic Acid</subject><subject>Prospective Studies</subject><subject>Treatment Outcome</subject><issn>1743-6095</issn><issn>1743-6109</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UU1v1DAUtBCIlsIf4IB85NCk_sgn4pKutrRSESsoZ8trv4Ajx97aSSH8Mf4eXrbLEV_8NJqZpzeD0GtKckpodTHkQ_w55ozQNic055Q8Qae0LnhWUdI-Pc6kLU_QixgHQnh67Dk64aThnBbtKfrd4ZUfdzKY6B32PZ6-A173vVFSLVg6jb_IHqYFX8L0A8Dh60XaOXhnFO6U0X8pG28XK9V0xK6MtRDwjRsggcnXOLwBZyzgbv42gpvkHn6HO_xxtkmWEAjneJPgNF6sH9IOOfmQXVrjNOhz_Dnt8aP5BRrfBSPtS_SslzbCq8f_DH29Wt-trrPbTx9uVt1tpnhZTVkBinHFVEMr2Ja0ZC1raqY0qYCWUPGtrEEXrCpqkGXBU2AEarKVTasqrvqCn6G3B99d8PczxEmMJiqwVjrwcxSMNg0jNStIorIDVQUfY4Be7IIZZVgEJWJfmBjEvjCxL0wQKlJhSfTm0X_ejqD_SY4NJcL7AwHSlQ8GgogqhaRAm5DSFdqb__n_AZ7JqQI</recordid><startdate>201904</startdate><enddate>201904</enddate><creator>Yang, Dae Yul</creator><creator>Ko, Kyungtae</creator><creator>Lee, Seong Ho</creator><creator>Lee, Won Ki</creator><general>Elsevier Inc</general><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>201904</creationdate><title>A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial</title><author>Yang, Dae Yul ; Ko, Kyungtae ; Lee, Seong Ho ; Lee, Won Ki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-4ec23c2c816eb515292872cd06e15e63ba7ed42647ea5431740e70ba89c63cf43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Augmentation</topic><topic>Cosmetic Techniques</topic><topic>Double-Blind Method</topic><topic>Filler</topic><topic>Humans</topic><topic>Hyaluronic Acid</topic><topic>Hyaluronic Acid - administration & dosage</topic><topic>Injections</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Penis</topic><topic>Penis - drug effects</topic><topic>Polyesters - administration & dosage</topic><topic>Polylactic Acid</topic><topic>Prospective Studies</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yang, Dae Yul</creatorcontrib><creatorcontrib>Ko, Kyungtae</creatorcontrib><creatorcontrib>Lee, Seong Ho</creatorcontrib><creatorcontrib>Lee, Won Ki</creatorcontrib><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>Journal of sexual medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yang, Dae Yul</au><au>Ko, Kyungtae</au><au>Lee, Seong Ho</au><au>Lee, Won Ki</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial</atitle><jtitle>Journal of sexual medicine</jtitle><addtitle>J Sex Med</addtitle><date>2019-04</date><risdate>2019</risdate><volume>16</volume><issue>4</issue><spage>577</spage><epage>585</epage><pages>577-585</pages><issn>1743-6095</issn><eissn>1743-6109</eissn><abstract>Studies about the clinical utility of fillers on penile augmentation (PA) are lacking. Furthermore, no randomized study has compared the utilities of fillers.
To compare the efficacy and safety between hyaluronic acid (HA) and polylactic acid (PLA) filler injection for PA.
This prospective, randomized patient/evaluator-blind, comparative multicenter study consisted of an initial 2-week baseline period and 48-week patient/evaluator-blind post-injection period. 72 patients with small penis syndrome were enrolled from 3 institutions between March–July 2016. Patients were divided into 2 groups: the HA group, comprising 36 patients injected with HA, and the PLA group, comprising 36 patients injected with PLA.
Penile girth and satisfaction were assessed at baseline and at 4, 12, 24, and 48 weeks after injection.
Penile girth increases adequately lasted ≤48 weeks in both groups (16.95 ± 10.53 and 13.49 ± 9.98 mm of mean increase in the HA and PLA groups, respectively; P < .001). The mean penile girth increase in the HA group was significantly greater than that in the PLA group at 4 weeks (P < .001). Subsequently, it gradually decreased and was no longer significantly different at 48 weeks (P = .075). Satisfaction levels increased after injection and were maintained ≤48 weeks. No significant differences were observed in the overall satisfaction level between the groups (P > .05). Filler injection–related adverse events were mild and transient and occurred in 1 and 3 patients in the HA and PLA groups, respectively.
This study provides an overview of the efficacy and safety of HA and PLA fillers, which are the most commonly used soft tissue fillers for PA.
This study, to our knowledge, is the first to compare the efficacy and safety between different filler injections for human PA. However, it was impossible to perform a researcher-blinded trial because of the unique properties of fillers, and 31 patients (43.1%) were dropped during the study period.
Both HA and PLA filler injections for PA led to a significant augmentative effect without serious adverse events and had clinically comparable efficacy and safety.
Yang DY, Ko K, Lee SH, et al. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med 2019;16:577–585.</abstract><cop>Netherlands</cop><pub>Elsevier Inc</pub><pmid>30833149</pmid><doi>10.1016/j.jsxm.2019.01.310</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1743-6095 |
| ispartof | Journal of sexual medicine, 2019-04, Vol.16 (4), p.577-585 |
| issn | 1743-6095 1743-6109 |
| language | eng |
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| source | MEDLINE; Oxford Journals |
| subjects | Adult Augmentation Cosmetic Techniques Double-Blind Method Filler Humans Hyaluronic Acid Hyaluronic Acid - administration & dosage Injections Male Middle Aged Penis Penis - drug effects Polyesters - administration & dosage Polylactic Acid Prospective Studies Treatment Outcome |
| title | A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial |
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