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Pain and activity after vaginal reconstructive surgery for pelvic organ prolapse and stress urinary incontinence [with consumer summary] |
Barber MD, Brubaker L, Nygaard I, Wai CY, Dyer KY, Ellington D, Sridhar A, Gantz MG, for the NICHD Pelvic Floor Disorders Network |
American Journal of Obstetrics and Gynecology 2019 Sep;221(3):233.e231-233.e216 |
clinical trial |
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Little is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse. OBJECTIVE: 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 two common transvaginal prolapse repairs, uterosacral ligament and sacrospinous ligament vaginal vault suspension. STUDY DESIGN: This planned secondary analysis of a 2x2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2 to 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 to 10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0 to 100; higher score = higher activity) prior to surgery and at 2 weeks, 4 to 6 weeks, and 3 months postoperatively. The SF-36 was completed at baseline, 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 +/- standard error) 2.24 + 0.23 and 2.76 + 0.25; both increased slightly from baseline at 2 weeks (+0.65, p < 0.001 and +0.74, p = 0.007 respectively) then decreased below baseline at 3 months (-0.87 and -1.14 respectively, p < 0.001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4 to 6 weeks (-1.26, p = 0.014 and -0.95, p = 0.002) and 3 months (-1.97 and -1.50, p < 0.001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4 to 6 weeks (+9.24, p < 0.001) and 3 months (+13.79, p < 0.001). SF-36 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 < 0.001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery, 53.7% at 2 and 26.1% at 4 to 6 weeks post-operatively; thereafter, use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of non-narcotic 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 to 6 weeks postoperatively (4.6% versus 10.5%, p = 0.043) 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 stage 2 to 4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4 to 6 weeks.
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