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.

Effects of Different Delivery Modes on the Expression of Vesicle Transport-Related Genes in Female Pelvic Floor Muscle Repair After Injury.

A sudden rise in intra-abdominal pressure that causes the pressure in the bladder to rise during physical movement and/or activity, such as coughing, sneezing, laughing, running, or weightlifting, is known as stress urinary incontinence. This condition causes an uncontrollable overflow of urine. The study's goal was to determine whether effector molecules, specifically ADP ribosylation factor GTPase activated protein 3, might play a part in the female pelvic floor muscle's ability to heal after suffering damage during vaginal delivery. Pelvic floor muscle samples were taken from women who had at least one vaginal delivery and were enrolled in either the IU group (n = 45; issue of stress urinary incontinence) or the NL group (n = 85; no issue of stress urinary incontinence) depending on whether they had a problem with stress urinary incontinence. Vesicle transport-related genes in female pelvic floor muscle injury repair were discovered using Gene Expression Omnibus. For gene analysis and screening, RT-qPCR was employed. On the first day following injury, the expression level of ARFGAP3 mRNA increased by 2.8 times (p 0.05) and by 5 times (p 0.01) on the third day. On the first day following damage, STMN1 mRNA expression rose by 0.3 times (p 0.05). On the first day following injury, the expression level of THBS2 mRNA increased by 1.6 times (p 0.01). On the third day following the injury, the expression level of PLXNB2 mRNA increased by 1.2 times (p 0. 01), and on the fifth day following the injury, it increased by 2.5 times (p 0. 01). After pelvic floor muscle damage, the mRNA expression levels of the CSF1R, ANXA4, and EMR1 genes dropped. Between those with and without pelvic floor muscle damage, there was no statistically significant difference in the expression levels of LGARLS3, KDELR3, and KIF20A mRNA (p > 0. 05 for all). The differential expression of genes after pelvic floor muscle injury can identify the target in the process of pelvic floor muscle injury repair and regeneration.

A unified pelvic floor conceptual model for studying morphological changes with prolapse, age, and parity.

Several 2-dimensional and 3-dimensional measurements have been used to assess changes in pelvic floor structures and shape. These include assessment of urogenital and levator hiatus dimensions, levator injury grade, levator bowl volume, and levator plate shape. We argue that each assessment reflects underlying changes in an individual aspect of the overall changes in muscle and fascial structures. Vaginal delivery, aging, and interindividual variations in anatomy combine to affect pelvic floor structures and their connections in different ways. To date, there is no unifying conceptual model that permits the evaluation of how these many measures relate to one another or that reflects overall pelvic floor structure and function. Therefore, this study aimed to describe a unified pelvic floor conceptual model to better understand how the aforementioned changes to the pelvic floor structures and their biomechanical interactions affect pelvic organ support with vaginal birth, prolapse, and age. In this model, the pelvic floor is composed of 5 key anatomic structures: the (1) pubovisceral, (2) puborectal, and (3) iliococcygeal muscles with their superficial and inferior fascia; (4) the perineal membrane or body; and (5) the anal sphincter complex. Schematically, these structures are considered to originate from pelvic sidewall structures and meet medially at important connection points that include the anal sphincter complex, perineal body, and anococcygeal raphe. The pubovisceral muscle contributes primarily to urogenital hiatus closure, whereas the puborectal muscle is mainly related to levator hiatus closure, although each muscle contributes to the other. Dorsally and laterally, the iliococcygeal muscle forms a shelflike structure in women with normal support that spans the remaining area between these medial muscles and attachments to the pelvic sidewall. Other features include the levator plate, bowl volume, and anorectal angle. The pelvic floor conceptual model integrates existing observations and points out evident knowledge gaps in how parturition, injury, disease, and aging can contribute to changes associated with pelvic floor function caused by the detachment of one or more important connection points or pubovisceral muscle failure.