Safety and short term outcomes of a new truly minimally-invasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair

Abstract

Objective To evaluate the safety and short term outcomes of a new, truly minimally-invasive, mesh-less and dissection-less anchoring system for pelvic floor apical repair.Methods A prospective study was conducted using the NeuGuide™ device system for pelvic floor apical repair. The primary effectiveness outcome was centro-apical pelvic floor prolapse by POP-Q after six months. The primary safety outcome was intra-operative, immediate (first 48 h) post-operative complications and adverse effects after six months. A standardized questionnaire (UDI-6) to assess quality of life at entry and during follow-up visits was used. Patients’ six months-follow-up and evaluation are reported.Results The mean age of the study population (n=10) was 63.8±12.0 years. All patients had a previous prolapse surgery. Five had a previous hysterectomy and two had stress urinary incontinence symptoms. During surgery six patients had a concurrent colporrhaphy. There was no injury to the bladder, rectum, pudendal nerves, or major pelvic vessels and no febrile morbidity was recorded. At six months, no cases of centro-apical recurrence were noted. Patients were satisfied with the procedure and had favorable quality of life scores. Using the UDI-6 questionnaire an improvement, in all domains was seen. Moreover, although the sample size was small, the improvement in urge and overflow incontinence related domains were demonstrated to be statistically significant.Conclusions This new NeuGuide™ device allows rapid and safe introduction of a suspending suture through the sacrospinous ligament and makes sacrospinous ligament fixation easy to perform, while avoiding dissection and mesh complications.

The Utility of Endovaginal Ultrasound in the Design of a Sacrospinous Ligament Anchoring Device in Patients with and without Pelvic Organ Prolapse

“…Phase I: Four fresh-frozen female pelves were selected randomly following Open Journal of Obstetrics and Gynecology Firstly, we performed a NeuGuide™ sacrospinous anchoring for all of the four cadaveric pelves as described previously [34]. In summary, The NeuGuide™ is designed to enable centro-apical pelvic floor support for the uterine cervix without need of either vaginal dissection or mesh implants in patients with a central compartment defect that need suspension.…”

“…Once the button is pressed, the inner shaft pushes the anchor distally and allows the wings to deploy. The applicator is equipped with a safety latch that protects the button, to avoid undesired deployment [34]. During the procedure, The NeuGuide device is mounted on the right index finger, and introduced into the vaginal cavity.…”

“…The previous steps are repeated on the left side and the suture is tied appropriately. The small cervical incision is closed [34].…”

“…Patients were satisfied with the procedure and had favorable quality of life scores. The NeuGuide™ device allowed rapid and safe introduction of a suspending suture through the sacrospinous ligament and made sacrospinous ligament fixation easy to perform, while avoiding dissection and mesh complications [34].…”

“…The cadavers were defrosted for 36 hours and brought to room temperature in an external bath. Then we performed a NeuGuide™ SSL anchor according to the device instructions [34] (Figure 1). Afterwards, 2D/3D endovaginal ultrasound (US) (BK…”