Effect of an Intrapartum Pelvic Dilator Device on Levator Ani Muscle Avulsion During Primiparous Vaginal Delivery: A Pilot Randomized Controlled Trial.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery. METHODS: A multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. During the first stage of labor, participants were randomized to receive the intravaginal device or standard-of-care labor management. The primary effectiveness endpoint was the presence of full LAM avulsion on transperineal pelvic-floor ultrasound at 3 months. Three urogynecologists performed blinded interpretation of ultrasound images. The primary safety endpoint was adverse events (AEs) through 3 months. RESULTS: A total of 214 women were randomized to Device (n = 113) or Control (n = 101) arms. Of 113 Device assignees, 82 had a device placed, of whom 68 delivered vaginally. Of 101 Control participants, 85 delivered vaginally. At 3 months, 110 participants, 46 Device subjects who received full device treatment, and 64 Controls underwent ultrasound for the per-protocol analysis. No full LAM avulsions (0.0%) occurred in the Device group versus 7 out of 64 (10.9%) in the Control group (p = 0.040; two-tailed Fisher's test). A single maternal serious AE (laceration) was device related; no neonate serious AEs were device related. CONCLUSIONS: The pelvic floor dilator device significantly reduced the incidence of complete LAM avulsion in nulliparous individuals undergoing first vaginal childbirth. The dilator demonstrated an acceptable safety profile and was well received by recipients. Use of the intrapartum electromechanical pelvic floor dilator in laboring nulliparous individuals may reduce the rate of LAM avulsion, an injury associated with serious sequelae including pelvic organ prolapse.

Pudendal Block at the Time of Transvaginal Prolapse Repair: A Randomized Controlled Trial.

IMPORTANCE: The utility of pudendal nerve blocks (PNBs) at the time of transvaginal surgery is mixed in the literature. No published study has evaluated the efficacy of PNB since the widespread adoption of Enhanced Recovery After Surgery (ERAS) pathways. OBJECTIVE: This study aimed to determine if PNB, in addition to ERAS measures, at the time of vaginal reconstructive surgery reduces opioid use in the immediate postoperative period. STUDY DESIGN: In this randomized, blinded, controlled trial, women scheduled for transvaginal multicompartment prolapse repair were randomized to bilateral PNB before incision with 20 mL of 0.5% bupivacaine versus usual care. Primary outcome was opioid use in morphine milligram equivalents (MME) for the first 24 hours. The study was powered to detect a 5.57-MME difference in opioid use in the first 24 hours between groups. RESULTS: Forty-four patients were randomized from January 2020 to April 2022. The PNB and control groups were well matched in demographic and surgical data. There was no difference in opioid use in first 24 hours between the control and PNB groups (8 [0-20] vs 6.7 [0-15]; P = 0.8). Median pain scores at 24 and 48 hours did not differ between groups (4 ± 2 vs 3 ± 3; P = 0.44) and 90% of participants were satisfied with pain control across both groups. Time to return to normal activities (median, 10 days) was also not different between the groups. CONCLUSIONS: Because pain satisfaction after transvaginal surgery in the era of ERAS is high, with overall low opioid requirements, PNB provides no additional benefit.

Enabling Technologies for Gynecologic Vaginal Surgery: A Systematic Review.

OBJECTIVE: To systematically review the literature to evaluate clinical and surgical outcomes for technologies that facilitate vaginal surgical procedures. DATA SOURCES: We systematically searched MEDLINE, EMBASE, and ClinicalTrials.gov from January 1990 to May 2022. METHODS OF STUDY SELECTION: Comparative and single-arm studies with data on contemporary tools or technologies facilitating intraoperative performance of vaginal gynecologic surgical procedures for benign indications were included. Citations were independently double screened, and eligible full-text articles were extracted by two reviewers. Data collected included study characteristics, technology, patient demographics, and intraoperative and postoperative outcomes. Risk of bias for comparative studies was assessed using established methods, and restricted maximum likelihood model meta-analyses were conducted as indicated. TABULATION, INTEGRATION, AND RESULTS: The search yielded 8,658 abstracts, with 116 eligible studies that evaluated pedicle sealing devices (n=32), nonrobotic and robotic vaginal natural orifice transluminal endoscopic surgery (n=64), suture capture devices (n=17), loop ligatures (n=2), and table-mounted telescopic cameras (n=1). Based on 19 comparative studies, pedicle sealing devices lowered vaginal hysterectomy operative time by 15.9 minutes (95% CI, -23.3 to -85), blood loss by 36.9 mL (95% CI, -56.9 to -17.0), hospital stay by 0.2 days (95% CI, -0.4 to -0.1), and visual analog scale pain scores by 1.4 points on a subjective 10-point scale (95% CI, -1.7 to -1.1). Three nonrandomized comparative studies and 53 single-arm studies supported the feasibility of nonrobotic vaginal natural orifice transluminal endoscopic surgery for hysterectomy, adnexal surgery, pelvic reconstruction, and myomectomy. Data were limited for robotic vaginal natural orifice transluminal endoscopic surgery, suture capture devices, loop ligatures, and table-mounted cameras due to few studies or study heterogeneity. CONCLUSION: Pedicle sealing devices lower operative time and blood loss for vaginal hysterectomy, with modest reductions in hospital stay and pain scores. Although other technologies identified in the literature may have potential to facilitate vaginal surgical procedures and improve outcomes, additional comparative effectiveness research is needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42022327490.