Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence

doi:10.1007/s00192-020-04271-y

Randomized Controlled Trial

. 2020 Oct;31(10):2155-2164.

doi: 10.1007/s00192-020-04271-y. Epub 2020 Mar 7.

Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence

Collaborators, Affiliations

Collaborators

NICHD Pelvic Floor Disorders Network and the National Institutes of Health Office of Research on Women’s Health:
Lauren Klein Warren, Daryl Matthews, Amanda Shaffer, Tamara T Terry, Jutta Thornberry, Dennis Wallace, Kevin A Wilson, Katherine Hartmann, Alicia Ballard, Julie Burge, Kathryn L Burgio, Kathy Carter, Patricia S Goode, Alayne D Markland, Lisa S Pair, Candace Parker-Autry, R Edward Varner, Tracey S Wilson, Cindy L Amundsen, Ingrid Harm-Ernandes, Mary Raynor, Nazema Y Siddiqui, Alison C Weidner, Jennifer M Wu, Michael E Albo, Cara Grimes, Charles W Nager, John N Nguyen, S Jakus-Waldman, Gouri Diwadkar, Keisha Y Dyer, Lynn M Hall, Linda M Mackinnon, Shawn A Menefee, Jasmine Tan-Kim, Gisselle Zazueta-Damian, Shanna Atnip, Elva Kelly Moore, David Rahn, Joseph Schaffer, D Borello-France, Susan F Meikle, Matthew D Barber, Anna Frick, John Eric Jelovsek, Betsy O'Dougherty, Marie F R Paraiso, Ly Pung, Beri M Ridgeway, Cheryl Williams, Linda Brubaker, Elizabeth Mueller, Mary Tulke, Yang Wang Casher, Yeh-Hsin Chen, Donna DiFranco, Bev Marchant, Cathie Spino, John T Wei, Jan Baker, Yvonne Hsu, Maria Masters, Amy Orr

Affiliations

¹ Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA. imeyer@uabmc.edu.
² RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.
³ Department of Reproductive Medicine, University of California-San Diego Health Systems, San Diego, CA, USA.
⁴ Department of Surgery, Division of Urology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
⁵ Division of Urogynecology and Reconstructive Pelvic Surgery, Alpert Medical School of Brown University, Providence, RI, USA.
⁶ Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.
⁷ Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA, USA.
⁸ Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
⁹ The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
¹⁰ Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA.

PMID: 32146521
PMCID: PMC7483223
DOI: 10.1007/s00192-020-04271-y

Randomized Controlled Trial

Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence

Isuzu Meyer et al. Int Urogynecol J. 2020 Oct.

. 2020 Oct;31(10):2155-2164.

doi: 10.1007/s00192-020-04271-y. Epub 2020 Mar 7.

Collaborators

NICHD Pelvic Floor Disorders Network and the National Institutes of Health Office of Research on Women’s Health:
Lauren Klein Warren, Daryl Matthews, Amanda Shaffer, Tamara T Terry, Jutta Thornberry, Dennis Wallace, Kevin A Wilson, Katherine Hartmann, Alicia Ballard, Julie Burge, Kathryn L Burgio, Kathy Carter, Patricia S Goode, Alayne D Markland, Lisa S Pair, Candace Parker-Autry, R Edward Varner, Tracey S Wilson, Cindy L Amundsen, Ingrid Harm-Ernandes, Mary Raynor, Nazema Y Siddiqui, Alison C Weidner, Jennifer M Wu, Michael E Albo, Cara Grimes, Charles W Nager, John N Nguyen, S Jakus-Waldman, Gouri Diwadkar, Keisha Y Dyer, Lynn M Hall, Linda M Mackinnon, Shawn A Menefee, Jasmine Tan-Kim, Gisselle Zazueta-Damian, Shanna Atnip, Elva Kelly Moore, David Rahn, Joseph Schaffer, D Borello-France, Susan F Meikle, Matthew D Barber, Anna Frick, John Eric Jelovsek, Betsy O'Dougherty, Marie F R Paraiso, Ly Pung, Beri M Ridgeway, Cheryl Williams, Linda Brubaker, Elizabeth Mueller, Mary Tulke, Yang Wang Casher, Yeh-Hsin Chen, Donna DiFranco, Bev Marchant, Cathie Spino, John T Wei, Jan Baker, Yvonne Hsu, Maria Masters, Amy Orr

Affiliations

¹ Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA. imeyer@uabmc.edu.
² RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.
³ Department of Reproductive Medicine, University of California-San Diego Health Systems, San Diego, CA, USA.
⁴ Department of Surgery, Division of Urology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
⁵ Division of Urogynecology and Reconstructive Pelvic Surgery, Alpert Medical School of Brown University, Providence, RI, USA.
⁶ Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.
⁷ Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA, USA.
⁸ Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
⁹ The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
¹⁰ Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA.

PMID: 32146521
PMCID: PMC7483223
DOI: 10.1007/s00192-020-04271-y

Abstract

Introduction and hypothesis: Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence.

Methods: This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse.

Results: Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II.

Conclusions: Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.

Keywords: Advanced prolapse; Pelvic organ prolapse; Prolapse repair; Sacrospinous ligament fixation; Uterosacral ligament suspension; Vaginal prolapse repair.

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References

1. FDA, Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal mesh placement for pelvic organ prolapse. US Food and Drug Administration, 2011: p. US Food and Drug Administration; 2011.
1. Boyles SH, Weber AM, and Meyn L, Procedures for pelvic organ prolapse in the United States, 1979–1997. Am J Obstet Gynecol, 2003. 188(1): p. 108–15. - PubMed
1. Montoya TI, Grande KB, and Rahn DD, Apical vaginal prolapse surgery: practice patterns and factors guiding route of repair. Female Pelvic Med Reconstr Surg, 2012. 18(6): p. 315–20. - PubMed
1. Wu JM, et al., Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol, 2014. 123(1): p. 141–8. - PMC - PubMed
1. Denman MA, et al., Reoperation 10 years after surgically managed pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol, 2008. 198(5): p. 555 e1–5. - PubMed

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[1] FDA, Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal mesh placement for pelvic organ prolapse. US Food and Drug Administration, 2011: p. US Food and Drug Administration; 2011.

[2] FDA, Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal mesh placement for pelvic organ prolapse. US Food and Drug Administration, 2011: p. US Food and Drug Administration; 2011.

[3] Boyles SH, Weber AM, and Meyn L, Procedures for pelvic organ prolapse in the United States, 1979–1997. Am J Obstet Gynecol, 2003. 188(1): p. 108–15. - PubMed

[4] Boyles SH, Weber AM, and Meyn L, Procedures for pelvic organ prolapse in the United States, 1979–1997. Am J Obstet Gynecol, 2003. 188(1): p. 108–15. - PubMed

[5] Montoya TI, Grande KB, and Rahn DD, Apical vaginal prolapse surgery: practice patterns and factors guiding route of repair. Female Pelvic Med Reconstr Surg, 2012. 18(6): p. 315–20. - PubMed

[6] Montoya TI, Grande KB, and Rahn DD, Apical vaginal prolapse surgery: practice patterns and factors guiding route of repair. Female Pelvic Med Reconstr Surg, 2012. 18(6): p. 315–20. - PubMed

[7] Wu JM, et al., Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol, 2014. 123(1): p. 141–8. - PMC - PubMed

[8] Wu JM, et al., Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol, 2014. 123(1): p. 141–8. - PMC - PubMed

[9] Denman MA, et al., Reoperation 10 years after surgically managed pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol, 2008. 198(5): p. 555 e1–5. - PubMed

[10] Denman MA, et al., Reoperation 10 years after surgically managed pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol, 2008. 198(5): p. 555 e1–5. - PubMed

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Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence

Collaborators

Affiliations

Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence

Authors

Collaborators

Affiliations

Abstract

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Abstract

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