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

Adi Y Weintraub,Alex Tsivian,Menahem Neuman,Yonatan Reuven,Joerg Neymeyer,David Yohay,Masha Ben Zvi

doi:10.1590/s1677-5538.ibju.2016.0356

Abstract

ABSTRACTObjective 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.

Highlights

Pelvic organ prolapse (POP) is a common problem in women and often requires surgical correction
Baseline preoperative clinical characteristics of the patients who underwent NeuGuideTM surgery are presented in Table-2
The NeuGuide device is mounted on the right index finger, and introduced into the vaginal cavity The right iscial spine and the sacrospinous ligament (SSL) are palpated through the vaginal wall The index finger is stabilized intimately to the mid SSL The anchor is deployed, and adequate pull-out force is proven

Summary

Introduction

Pelvic organ prolapse (POP) is a common problem in women and often requires surgical correction. In the USA, about 200,000 women undergo surgery for prolapse correction every year [1]. The lifetime risk of a woman to undergo a surgical procedure for the correction of pelvic floor dysfunctions (PFD) is 11%. Among these women, there is a close to 30% risk of re-operation due to failure or prolapse of another compartment [2]. Apical prolapse is defined as the descent of the apex of the vagina into the lower vagina, to or beyond the hymeneal ring. The apex can be either the uterus and cervix, cervix alone, or vaginal vault, depending upon whether the woman has undergone hysterectomy. The classification of prolapse according to the separate compartments is arbitrary, since the vagina is a continuum and prolapse of one compartment is often associated with prolapse of another [3]

Methods

Results

Conclusion