EnPlace device effective for pelvic organ prolapse repair

EnPlace device effective for pelvic organ prolapse repair | Image Credit: © Khunatorn - © Khunatorn - stock.adobe.com.

According to a recent study published in the International Journal of Gynecology & Obstetrics, the EnPlace (FEMSelect, Tel Aviv, Israel) sacrospinous ligament (SSL) fixation device is safe and effective for minimally invasive transvaginal procedure for significant apicalpelvic organ prolapse (POP) repair.

POP has a significant negative impact on quality of life, affecting the anterior compartment, apical compartment, and posterior compartment. Eleven percent to 19% of women will experience surgery for POP in their lifetime.

The apical compartment is the main compartment affected in 20% of POP cases, presenting a surgical challenge. Apical POP repair is often accomplished through transabdominal sacrocolpopexy, but this method requires specialized skills, is costly, will not work for every patient, and may cause abdominal and mesh issues.

Transvaginal apical repair is an alternative method of treating POP. Multiple tools for fixating the SSL have been developed, but none have been proven superior over the others. The FDA has also issued warnings related to vaginal mesh for POP surgery, leading this method to be mostly abandoned.

The EnPlace device allows for SSL fixation without extensive dissection or mesh. To determine the safety and short-term efficacy of this novel device, investigators conducted a retrospective cohort study across 2 university-affiliated medical centers between May 2019 and May 2022.

There were 123 patients who were treated for significant apical POP with the EnPlace device. Investigators collected the medical charts of these patients and evaluated demographic, clinical, inoperative, and postoperative data. Stage 3 and stage 4 apical POP were considered significant.

Patients with previous pelvic radiation therapy, malignancy, reproductive tract anomalies, previous pelvic inflammatory disease, or a nickel or nitinol allergy were excluded. The POP-Quantification (POP-Q) measurements, comprised of 6 vaginal locations and 3 anatomical markers, was used to evaluate POP severity.

The EnPlace device contains a finger guide built-in working channel, allowing transvaginal insertion and anchor deployment in the SSL. Patients with concomitant anterior and posterior POP and stress urinary incontinence underwent a native-tissue prolapse repair and mid-urethral sling.

Participants were divided into a uterine prolapse group and vault prolapse group, comprised of 74% and 26% of patients respectively. Outcomes were compared between both groups. Postoperative follow-up occurred at 6 weeks, 3 months, and 6 months. Surgical success was determined by a lack of POP symptoms, no apical POP beyond stage 1, and no need for recurrent apical POP surgery.

Of patients, 98.4% received concomitant colporrhaphies for cystocele and rectocele repair, with an average surgery duration of 25 to 50 minutes. About 11% of these patients also received mid-urethral sling. The average blood loss among these patients was 30.5 ± 18.5 mL. No intraoperative or postoperative complications were observed.

Before surgery, the average point C by POP-Q measurements was +4.5 ± 2.8 cm. This changed to −5.4 ± 0.7 cm at the end of surgery and −3.1 ± 3.3 cm at 6 months postoperatively. Recurrent uterine prolapse during follow-up was reported in 8.8% of patients with preoperative uterine prolapse. Of patients with preoperative vault prolapse, 6.3% had recurrent vault prolapse.

Recurrent stage 2 cystocele or rectocele during follow-up was seen in 5.7% of patients. There were no significant risk factors for procedure failure observed. No significant lower urinary tract symptoms, bowel symptoms, or dyspareunia were observed postoperatively. 

Removal of the EnPlace device because of pain was seen in 1 patient. The median score of pain improvement from 1 to 100 was 87.3.

These results indicated safety and short-term efficacy from the EnPlace device. Investigators recommended future studies to evaluate the long-term efficacy.

Reference

Gold RS, Baruch Y, Neuman M, Sumerov N, Groutz A. The EnPlace® sacrospinous ligament fixation—A novel minimally invasive transvaginal procedure for apical pelvic organ prolapse repair: Safety and short-term outcome results. International Journal of Gynecology & Obstetrics. 2023. doi:10.1002/ijgo.14927