Female Sexual Function following Sling Surgery: A Prospective Parallel Cohort, Multi-Center Study of the Solyx™ Single Incision Sling System versus the Obtryx™ II Sling System

No AccessJournal of UrologyAdult Urology1 Sep 2021Female Sexual Function following Sling Surgery: A Prospective Parallel Cohort, Multi-Center Study of the Solyx™ Single Incision Sling System versus the Obtryx™ II Sling SystemThis article is commented on by the following:Editorial Comment Amanda B. White, Jennifer T. Anger, Karyn Eilber, Bruce S. Kahn, Ricardo R. Gonzalez, and Anna Rosamilia Amanda B. WhiteAmanda B. White *Correspondence: Department of Women's Health, University of Texas at Austin, Dell Medical School, 1301 W. 38th Street, Suite 705, Austin, Texas 78705 telephone: 512-324-7036; FAX: 512-324-7036; E-mail Address: [email protected] Department of Women's Health, University of Texas at Austin, Dell Medical School, Austin, Texas Investigator (522 Solyx) and consultant for Boston Scientific. More articles by this author , Jennifer T. AngerJennifer T. Anger Department of Surgery, Division of Urology, Cedars-Sinai Health System, Los Angeles, California Investigator (522 Solyx) and expert witness for Boston Scientific. More articles by this author , Karyn EilberKaryn Eilber Department of Surgery, Division of Urology, Cedars-Sinai Health System, Los Angeles, California Investigator (522 Solyx), expert witness and advisory board for Boston Scientific; consultant and speaker for Allergan; and expert witness for Ethicon. More articles by this author , Bruce S. KahnBruce S. Kahn Department of Obstetrics and Gynecology, Scripps Clinic, San Diego, California Investigator (522 Solyx) for Boston Scientific and expert witness for Johnson & Johnson. More articles by this author , Ricardo R. GonzalezRicardo R. Gonzalez Department of Urology, Houston Methodist Hospital, Houston, Texas Investigator (522 Solyx), consultant, advisory board member and speaker’s bureau for Boston Scientific. More articles by this author , and Anna RosamiliaAnna Rosamilia Department of Women's Health, Monash Medical Centre and Cabrini Hospital, Melbourne, Australia Investigator (522 Solyx), investigator-initiated research for Boston Scentific; investigator for Coloplast; speaker for Allergan; and expert witness for Ethicon. More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001830AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Limited data exist regarding sexual function after single incision sling (SIS) surgery. We compared sexual function 36 months postoperatively between patients undergoing SIS and transobturator sling (TMUS) for treatment of stress urinary incontinence. Materials and Methods: Assessment of sexual function was a planned secondary objective of this prospective, multi-center study that enrolled women to Solyx SIS or Obtryx II TMUS. The primary study aim was to compare efficacy and safety using non-inferiority design at 36 months. Patient-reported outcomes of sexual function were assessed at baseline and 6, 12, 18, 24 and 36 months using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Changes in sexual function were analyzed within and between groups. Outcomes for patients requiring surgical retreatment were determined. Results: Baseline characteristics were balanced using propensity score stratification (N=141 SIS, N=140 TMUS). Groups were similar in age, body mass index and concomitant surgery performed. Average length of followup was 30 months. Baseline sexual activity was similar (123/141 SIS, 114/140 TMUS, p=0.18). Severity of urinary incontinence did not correlate with baseline sexual activity. Mean PISQ-12 scores increased significantly from baseline to 36 months for both groups, indicating better sexual function at each visit. There were no significant differences in PISQ-12 scores between groups except at 36 months, where the difference was small (−2.5, 95% CI [−4.7, 0.2]). Among patients undergoing surgical retreatment (9/281, 3%), improvement in sexual function was maintained. De novo dyspareunia was rare following both treatments (SIS 1/141, TMUS 0/140, p=1.00). Conclusions: Patients have significant improvement in sexual function after SIS and TMUS. De novo sexual pain is low after sling surgery. References 1. : Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999; 281: 537. Google Scholar 2. : Sexual activity and function in women with and without pelvic floor disorders. Int Urogynecol J 2013; 24: 91. Google Scholar 3. : Female sexual function and pelvic floor disorders. Obstet Gynecol 2008; 111: 1045. Google Scholar 4. : Sexual function in women with pelvic floor disorders. Can Urol Assoc J, suppl., 2013; 7: S199. 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Google Scholar This study was sponsored by Boston Scientific; the sponsor assembled a team of collaborators to design this study in accordance with the FDA 522 mandate and provided statistical analysis of data. Authors independently completed the writing of the report and submitted article for publication. Clinical Trial Identification Number: NCT01784588. Presented at the second Joint Scientific Meeting of the American Urogynecologic Society and International Urogynecological Association, September 24–29, 2019, Nashville, Tennessee. © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited BySmith J (2021) This Month in Adult UrologyJournal of Urology, VOL. 206, NO. 3, (495-497), Online publication date: 1-Sep-2021.Related articlesJournal of UrologyJun 7, 2021, 12:00:00 AMEditorial Comment Volume 206Issue 3September 2021Page: 696-705 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.Keywordsdyspareuniaurinary incontinence, stresssuburethral slingMetricsAuthor Information Amanda B. White Department of Women's Health, University of Texas at Austin, Dell Medical School, Austin, Texas *Correspondence: Department of Women's Health, University of Texas at Austin, Dell Medical School, 1301 W. 38th Street, Suite 705, Austin, Texas 78705 telephone: 512-324-7036; FAX: 512-324-7036; E-mail Address: [email protected] Investigator (522 Solyx) and consultant for Boston Scientific. More articles by this author Jennifer T. Anger Department of Surgery, Division of Urology, Cedars-Sinai Health System, Los Angeles, California Investigator (522 Solyx) and expert witness for Boston Scientific. More articles by this author Karyn Eilber Department of Surgery, Division of Urology, Cedars-Sinai Health System, Los Angeles, California Investigator (522 Solyx), expert witness and advisory board for Boston Scientific; consultant and speaker for Allergan; and expert witness for Ethicon. More articles by this author Bruce S. Kahn Department of Obstetrics and Gynecology, Scripps Clinic, San Diego, California Investigator (522 Solyx) for Boston Scientific and expert witness for Johnson & Johnson. More articles by this author Ricardo R. Gonzalez Department of Urology, Houston Methodist Hospital, Houston, Texas Investigator (522 Solyx), consultant, advisory board member and speaker’s bureau for Boston Scientific. More articles by this author Anna Rosamilia Department of Women's Health, Monash Medical Centre and Cabrini Hospital, Melbourne, Australia Investigator (522 Solyx), investigator-initiated research for Boston Scentific; investigator for Coloplast; speaker for Allergan; and expert witness for Ethicon. More articles by this author Expand All This study was sponsored by Boston Scientific; the sponsor assembled a team of collaborators to design this study in accordance with the FDA 522 mandate and provided statistical analysis of data. Authors independently completed the writing of the report and submitted article for publication. Clinical Trial Identification Number: NCT01784588. Presented at the second Joint Scientific Meeting of the American Urogynecologic Society and International Urogynecological Association, September 24–29, 2019, Nashville, Tennessee. Advertisement PDF DownloadLoading ...