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

OBJECTIVE: To evaluate the safety and short term outcomes of a new, truly minimallyinvasive, 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.

Introducing a true minimally invasive meshless and dissectionless anchoring system for pelvic organ prolapse repair.

INTRODUCTION AND HYPOTHESIS: The objective was to demonstrate the biomechanical properties, feasibility, and potential advantages over conventional techniques of this new anchoring device, NeuGuide™. METHODS: We evaluated the pull-out forces required to pull the NeuGuide™ anchor elements from a uniform porcine ligament and a cadaver ligament. We also evaluated the function of the NeuGuide™ and the characteristics of the device for the establishment of verification evidence ensuring the reliability and feasibility of the device. We also evaluated the safety and performance of the NeuGuide™ procedure in female cadavers by palpating the sacro-spinous ligament in real time. We assessed the ability to deploy and fixate the anchor to the sacro-spinous ligament and to stitch the sutures from both sides of the vaginal apex to the cervix, without damaging the surrounding structures. RESULTS: All 12 anchors were inserted into the porcine ligament and the cadaver sacro-spinous ligaments successfully (mean pull-out force 34.13 ± 4.32 and 35.68 ± 9.28 respectively). None of the measured forces were below 20 N. No statistically significant difference was noted in the pull-out forces between the porcine and the cadavers (p = 0.60), between the two cadavers (p = 0.19) and between the right and left sacro-spinous ligaments. No abnormalities or malfunctions were noted in the functional performance of the device. Upon laparotomy, dissection of the cadavers revealed that the sacro-spinous ligaments were reached safely with no damage to the surrounding organs and tissues. CONCLUSIONS: This novel anchoring device (NeuGuide™) is aimed at facilitating a durable, easy, and short procedure for sacro-spinous ligament fixation with hypothetically fewer operative complications.

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.