TY - JOUR
T1 - Pain and activity after vaginal reconstructive surgery for pelvic organ prolapse and stress urinary incontinence
AU - NICHD Pelvic Floor Disorders Network
AU - Barber, Matthew D.
AU - Brubaker, Linda
AU - Nygaard, Ingrid
AU - Wai, Clifford Y.
AU - Dyer, Keisha Y.
AU - Ellington, David
AU - Sridhar, Amaanti
AU - Gantz, Marie G.
AU - Dickersin, Kay
AU - Jiang, Luohua
AU - Lavender, Missy
AU - O'Dell, Kate
AU - Ryan, Kate
AU - Tulikangas, Paul
AU - Kong, Lan
AU - McClish, Donna
AU - Rickey, Leslie
AU - Shade, David
AU - Tuteja, Ashok
AU - Yount, Susan
N1 - Funding Information:
This study was supported by grants from the Eunice Kennedy Schriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health (2 UG1 HD041261-16, 2 UG1 HD054214, 2 UG1 HD041267-17, 2 UG1 HD054241, 2 U24 HD069031, U01 HD041249, U10 HD041250, U10 HD041261, U10 HD041267, U10 HD054136, U10 HD054214, U10 HD054215, U01 HD069031, and U10 HD054241).Dr Barber received royalties from Elsevier and UpToDate; Dr Brubaker received editorial stipends from the Journal of the American Medical Association, the Female Pelvic Medicine and Reconstructive Surgery journal, and UpToDate, and honorarium from the American Board of Obstetrics and Gynecology; Dr Dyer received research funding from Pelvalon, Sunnyvale, CA; Dr Nygaard received an editorial stipend from Elsevier; Dr Gantz received research funding from Boston Scientific on behalf of the Eunice Kennedy Schriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network; the other authors report no conflict of interest. This trial is registered at clinicaltrials.gov under Registration number NCT00597935. Investigators include the following: Cleveland Clinic, Cleveland OH, Anna Frick, MD, John Eric Jelovsek, MD, Betsy O'Dougherty, Marie F. R. Paraiso, MD, Ly Pung, RN, Beri M. Ridgeway, MD, and Cheryl Williams; Duke University, Durham NC, Cindy L. Amundsen, MD, Ingrid Harm-Ernandes, Mary Raynor, Nazema Y Siddiqui, MD, Anthony G. Visco, MD, Alison C. Weidner, MD, and Jennifer M. Wu, MD; Kaiser Permanente–Downey, John Nguyen, MD; Kaiser Permanente – Bellflower, Sharon Jakus-Waldman, MD; Kaiser Permanente–San Diego, Gouri Diwadkar, MD, Lynn M. Hall, Linda M, Mackinnon, Shawn A. Menefee, MD, Jasmine Tan-Kim, MD, and Gisselle Zazueta-Damian; Loyola University, Chicago, IL, Elizabeth Mueller, MD, and Mary Tulke; University of Pittsburgh, Magee-Womens Research Institute, Diane Borello-France; RTI International, Research Triangle Park, NC, Lauren Klein Warren, Daryl Matthews, Amanda Shaffer, Tamara T. Terry, Jutta Thornberry, Dennis Wallace, Ryan E. Whitworth, and Kevin A Wilson; Vanderbilt University, Nashville, TN, Katherine Hartmann, MD; University of Alabama at Birmingham, Alicia Ballard, Julie Burge, Kathryn L. Burgio, PhD, Kathy Carter, Patricia S. Goode, MD, Alayne D. Markland, MD, Lisa S. Pair, Candace Parker-Autry, MD, Holly E. Richter, PhD, MD, R. Edward Varner, MD, and Tracey S. Wilson; University of California, San Diego, Michael E. Albo, MD, Cara Grimes, MD, Emily.S Lukacz, MD, and Charles W. Nager, MD; University of Michigan, Ann Arbor, MI, Yang Wang Casher, Yeh-Hsin Chen, Donna DiFranco, Bev Marchant, Cathie Spino, and John T. Wei, MD; University of Utah Medical Center, Salt Lake City, UT, Jan Baker, Yvonne Hsu, Maria Masters, and Amy Orr; University of Texas–Southwestern, Dallas TX, Shanna Atnip, Elva Kelly Moore, David Rahn, MD, and Joseph Schaffer, MD; Northwest Texas Physician Group, Amarillo, TX, Susan F. Meikle, MD. The Pelvic Floor Disorders Network Data Safety and Monitoring Board members are as follows: Kay Dickersin, Johns Hopkins Bloomberg School of Public Health; Luohua Jiang, Texas A&M Health Science University; Missy Lavender, Women's Health Foundation; Kate O'Dell, UMass Memorial Medical Center; Kate Ryan, National Women's Health Network; Paul Tulikangas, University of Connecticut Hartford Hospital; Lan Kong, Penn State University College of Medicine; Donna McClish, Virginia Commonwealth University; Leslie Rickey, Yale New Haven Hospital; David Shade, Johns Hopkins University; Ashok Tuteja, University of Utah; and Susan Yount, Frontier Nursing University, Lexington KY.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2019/9
Y1 - 2019/9
N2 - Background: Little is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse. Objective: The objectives of the study were to describe postoperative pain and functional activity after transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling and to compare these outcomes between patients receiving 2 common transvaginal prolapse repairs, uterosacral ligament, and sacrospinous ligament vaginal vault suspension. Study Design: This planned secondary analysis of a 2 × 2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2–4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers. Participants were also randomized to receive perioperative pelvic muscle therapy or usual care. All patients received transvaginal native tissue repairs and a midurethral sling. Participants completed the Surgical Pain Scales (0–10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0–100; higher score = higher activity) prior to surgery and at 2 weeks, 4–6 weeks, and 3 months postoperatively. The MOS 36-item Short-Form Health Survey was completed at baseline and 6, 12, and 24 months after surgery; the bodily pain, physical functioning, and role–physical subscales were used for this analysis (higher scores = less disability). Self-reported pain medication use was also collected. RESULTS: Before surgery, average pain at rest and during normal activity were (adjusted mean ± SE) 2.24 ± 0.23 and 2.76 ± 0.25; both increased slightly from baseline at 2 weeks (+0.65, P =.004, and +0.74, P =.007, respectively) and then decreased below baseline at 3 months (–0.87 and –1.14, respectively, P <.001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4–6 weeks (–1.26, P =.014, and –0.95, P =.002) and 3 months (–1.97 and –1.50, P <.001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4–6 weeks (+9.24, P <.001) and 3 months (+13.79, P <.001). The MOS 36-item Short-Form Health Survey Bodily Pain, Physical Functioning, and Role–Physical Scales demonstrated significant improvements from baseline at 6, 12, and 24 months (24 months: +5.62, +5.79, and +4.72, respectively, P <.001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery and 53.7% at 2 and 26.1% at 4–6 weeks postoperatively; thereafter use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of nonnarcotic pain medication was reported by 48.1% of participants prior to surgery, 68.7% at 2 weeks, and similar to baseline at 3 months; thereafter use dropped steadily to 26.6% at 2 years. Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4–6 weeks postoperatively (4.6% vs 10.5%, P =.043) but no difference in groin or thigh pain. Conclusion: Pain and functional activity improve for up to 2 years after native tissue reconstructive surgery with uterosacral or sacrospinous vaginal vault suspension and midurethral sling for stages 2–4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4–6 weeks.
AB - Background: Little is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse. Objective: The objectives of the study were to describe postoperative pain and functional activity after transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling and to compare these outcomes between patients receiving 2 common transvaginal prolapse repairs, uterosacral ligament, and sacrospinous ligament vaginal vault suspension. Study Design: This planned secondary analysis of a 2 × 2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2–4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers. Participants were also randomized to receive perioperative pelvic muscle therapy or usual care. All patients received transvaginal native tissue repairs and a midurethral sling. Participants completed the Surgical Pain Scales (0–10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0–100; higher score = higher activity) prior to surgery and at 2 weeks, 4–6 weeks, and 3 months postoperatively. The MOS 36-item Short-Form Health Survey was completed at baseline and 6, 12, and 24 months after surgery; the bodily pain, physical functioning, and role–physical subscales were used for this analysis (higher scores = less disability). Self-reported pain medication use was also collected. RESULTS: Before surgery, average pain at rest and during normal activity were (adjusted mean ± SE) 2.24 ± 0.23 and 2.76 ± 0.25; both increased slightly from baseline at 2 weeks (+0.65, P =.004, and +0.74, P =.007, respectively) and then decreased below baseline at 3 months (–0.87 and –1.14, respectively, P <.001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4–6 weeks (–1.26, P =.014, and –0.95, P =.002) and 3 months (–1.97 and –1.50, P <.001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4–6 weeks (+9.24, P <.001) and 3 months (+13.79, P <.001). The MOS 36-item Short-Form Health Survey Bodily Pain, Physical Functioning, and Role–Physical Scales demonstrated significant improvements from baseline at 6, 12, and 24 months (24 months: +5.62, +5.79, and +4.72, respectively, P <.001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery and 53.7% at 2 and 26.1% at 4–6 weeks postoperatively; thereafter use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of nonnarcotic pain medication was reported by 48.1% of participants prior to surgery, 68.7% at 2 weeks, and similar to baseline at 3 months; thereafter use dropped steadily to 26.6% at 2 years. Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4–6 weeks postoperatively (4.6% vs 10.5%, P =.043) but no difference in groin or thigh pain. Conclusion: Pain and functional activity improve for up to 2 years after native tissue reconstructive surgery with uterosacral or sacrospinous vaginal vault suspension and midurethral sling for stages 2–4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4–6 weeks.
KW - functional activity
KW - pelvic floor disorders
KW - pelvic organ prolapse
KW - postoperative pain
KW - sacrospinous ligament fixation
KW - stress urinary incontinence
KW - uterosacral ligament suspension
KW - vaginal reconstructive surgery
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U2 - 10.1016/j.ajog.2019.06.004
DO - 10.1016/j.ajog.2019.06.004
M3 - Article
C2 - 31201809
AN - SCOPUS:85071639396
SN - 0002-9378
VL - 221
SP - 233.e1-233.e16
JO - American Journal of Obstetrics and Gynecology
JF - American Journal of Obstetrics and Gynecology
IS - 3
ER -