Minimally invasive sacrohysteropexy versus vaginal hysterectomy with uterosacral ligament suspension for pelvic organ prolapse: a prospective randomized non-inferiority trial
This study is prospective, randomized, controlled, non-inferiority trial to investigate whether minimally invasive Sacrohysteropexy (SH) is non-inferior to Vaginal hysterectomy (VH) with uterosacral ligament suspension (USLS) in women with symptomatic uterovaginal prolapse. We assigned patients to each study arm at a 1:1 ratio in the order of enrollment, based on a single sequence of randomization. The allocation sequence was disguised from all study personnel, including investigators, field staff, and participants, except for independent research personnel in order to prevent selection bias in the patients recruited. Due to two different surgeries, it was difficult to perform blinding. The primary outcome was prolapse recurrence 1 year after surgery. Prolapse recurrence was defined as the presence of prolapse ≥ stage 2 evaluated by the pelvic organ prolapse quantification (POP-Q) system, bothersome vaginal bulge symptoms defined as a response of ‘somewhat’, ‘moderately,’ or ‘quite a bit’ to Question 3 (a bulge or something falling out that can be seen or felt in the vaginal area) on the Pelvic Floor Distress Inventory-20 (PFDI-20), or retreatment for prolapse. The secondary outcomes included operating time, estimated blood loss, length of hospital stay, and operation-related complications. Pain intensity, quality of life (QOL), and activities of daily living (ADL) were evaluated using self-assessment questionnaires. The visual analog scale (VAS) was used to evaluate postoperative pain intensity at 1 d, 1 week, 1 month, 6 months, and 1 year after surgery. The VAS ranges from 0 to 10, with 0 representing the absence of pain and 10 representing the highest degree of pain . Pelvic floor dysfunction, representing quality of life, was measured using the Korean version of the PFDI-20 , comprising 20 questions divided into three subscales: Pelvic Organ Prolapse Distress Inventory-6, Colorectal-Anal Distress Inventory-8, and Urinary Distress Inventory-6. With these inventories, the respondents are asked whether they experience specific symptoms and, if so, the degree to which the symptoms are bothersome on a 4-point scale ranging from “not at all” to “quite a bit.” Each subscale is scored from to 0–100; with higher scores indicating a greater symptom burden. The PFDI-20 total score comprised the sum of these three subscale scores (0–300). The patients completed the PFDI-20 at baseline, 1 month, 6 months, and 1 year after surgery. To assess the activities that support daily life, such as telephone use, shopping, meal preparation, housework, laundry, driving or using public transportation, and financial and medication management, we evaluated the Instrumental Activities of Daily Living (IADL). The total IADL score ranged from 0 (low function) to 8 (high function, independent) .
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A total of 121 eligible participants were randomly assigned to receive either SH (n=60) or VH with USLS (n=61). The baseline characteristics and pelvic measurements did not differ between the two groups. One year after surgery, SH was non-inferior to VH with USLS for the primary outcome, prolapse recurrence (SH 15.8% vs. VH with USLS 16.4%, difference -0.6%, 95% CI -14.2% to 13.0% for LOCF analysis; SH 28.3% vs. VH with USLS 32.8%, difference -4.5%, 95% CI -20.9% to 11.8% for conservative imputation analysis). Most patients experienced anatomic recurrence of the anterior compartment. No patient exhibited anatomic recurrence of the apical compartment in either group. One patient in the SH group reported bothersome vaginal bulge symptoms and no patients in either group underwent retreatment for prolapse. In the VH with USLS group, there were significantly more patients who additionally received anterior (P<.001) and posterior vaginal repair (P=.017) than in the SH group. In both groups, more than half of the patients underwent additional TOT surgery. Operating time was significantly longer (P<.001) in the SH group, but there were no significant differences in the amount of estimated blood loss, length of hospital stay, and postoperative complication rates. Pain scores assessed using the VAS were higher at postoperative week 1, and month 1 in the SH group than in the VH with USLS group (week 1: SH, 3.0 [2.0–4.5], vs. VH with USLS, 2.0 [0.0–3.0]; P=.031, month 1: SH, 1.0 [0.0–3.0], vs. VH with USLS, 0.0 [0.0–1.0]; P=.038), but there were no between-group differences in pain scores thereafter. In addition, there were no significant differences between the two groups in PFDI-20 and IADL scores, with decreased values for PFDI-20 from baseline to 1-year follow-up.
Seoul National University Bundang Hospital