Matthew D Barber1, Linda Brubaker2, Ingrid Nygaard3, Clifford Y Wai4, Keisha Y Dyer5, David Ellington6, Amaanti Sridhar7, Marie G Gantz7. 1. Department of Obstetrics and Gynecology, Duke University Medical Center, Durham NC. Electronic address: matthew.barber@duke.edu. 2. Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California-San Diego, San Diego CA. 3. Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT. 4. Department of Obstetrics and Gynecology, University of Texas-Southwestern, Dallas TX. 5. Department of Obstetrics and Gynecology, Kaiser Permanente, San Diego, CA. 6. Department of Obstetrics and Gynecology, University of Alabama-Birmingham, Birmingham AL. 7. Department of Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, NC.
Abstract
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 receiveuterosacral (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.
RCT Entities:
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.
Authors: Marcella G Willis-Gray; Katherine E Husk; Taylor J Brueseke; Jennifer M Wu; Alexis A Dieter Journal: Female Pelvic Med Reconstr Surg Date: 2018 Nov/Dec Impact factor: 2.091
Authors: Carolyn W Swenson; Angela S Kelley; Dee E Fenner; Mitchell B Berger Journal: Female Pelvic Med Reconstr Surg Date: 2016 Sep-Oct Impact factor: 2.091
Authors: Matthew D Barber; Linda Brubaker; Kathryn L Burgio; Holly E Richter; Ingrid Nygaard; Alison C Weidner; Shawn A Menefee; Emily S Lukacz; Peggy Norton; Joseph Schaffer; John N Nguyen; Diane Borello-France; Patricia S Goode; Sharon Jakus-Waldman; Cathie Spino; Lauren Klein Warren; Marie G Gantz; Susan F Meikle Journal: JAMA Date: 2014-03-12 Impact factor: 56.272
Authors: Ingrid Nygaard; Victoria L Handa; Linda Brubaker; Diane Borello-France; John Wei; Ellen Wells; Patricia Goode Journal: Am J Obstet Gynecol Date: 2008-05 Impact factor: 8.661
Authors: Matthew D Barber; Cindy L Amundsen; Marie F R Paraiso; Alison C Weidner; Audrey Romero; Mark D Walters Journal: Int Urogynecol J Pelvic Floor Dysfunct Date: 2006-11-17