Self-Retaining Support Implant for the Treatment of Advanced Pelvic Organ Prolapse – Long term follow up

Levy G1, Padoa A2, Marcus N3, Beck A1, Fekete Z4, Cervigni M5

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 9
Urogynaecology 1 - Pelvic Organ Prolapse
Scientific Podium Short Oral Session 2
Wednesday 4th September 2019
09:15 - 09:22
Hall H2
Grafts: Synthetic Pelvic Organ Prolapse Prospective Study New Devices
1.Assuta University Hospital, Ashdod, Israel, 2.Assaf Harofeh Medical Center, Zrifin, Israel, 3.Ziv Medical Centerr, Tzfat, Israel, 4.Szeged University Hospital, Szeged, Hungary, 5.Gemelli University Medical Center, Rome, Italy
Presenter
G

Gil Levy

Links

Abstract

Hypothesis / aims of study
To evaluate the long-term safety and efficacy of a new trans-vaginal technique for the treatment of advanced anterior and apical POP, using an anchor-less implant.
Study design, materials and methods
This prospective, multi-center, international study involved 6 surgeons at 4 medical centers. Women with advanced, symptomatic POP were recruited. The surgical technique involved placement of an open trapezoid-shaped solid flexible frame which retains an ultra-light polypropylene mesh stretched within its parameter. (Fig. 1) No fixation techniques were used. (1) Demographic data and pre-operative validated quality of life (QoL) questionnaires (PFDI-20 and PISQ-12) were collected. Intra-operative and immediate post-operative data including length of the procedure, estimated blood loss and complications were documented. Patients were followed at 2, 6, 12, 24 and 36 months. Follow-up included repeated QoL questionnaires, Pelvic Organ Prolapse- Quantification (POP-Q) measurements and assessment for possible complications.
Results
Seventy women were recruited. Mean age was 63.1 (43-79) years, average parity was 4.6 (1-16) deliveries. Mean pre-operative POP-Q measurements were: Ba =3.1 (-2 to 6) cm and C=0.4 (-8 to 6) cm. Mean BMI was 26.3 kg/m2 (20.3-36.6). No intra-operative complications were observed. Surgical time averaged 24.7 min. Estimated blood loss averaged 155 cc. Mean follow up at last visit was 23.7 months (6 - 41). As for complications, two patients (2.8%) underwent ambulatory partial frame resection 8 and 12 months after implantation: one case secondary to frame erosion and one case due to voiding dysfunction. Two patients (2.8%) underwent a TVT-O procedure for de-novo stress urinary incontinence (SUI) 12 months following the procedure. At follow-up, the mean POP-Q measurements were as follows: Ba= -2.8 (-3 to -1) cm and C = -7 (-10 to 1) cm.(Fig. 2) Based on question number 3 in the PFDI-20 questionnaire, only two patients (2.8%) had recurrent symptomatic prolapse. No cases of mesh erosion or chronic pelvic pain were documented. PFDI scores showed significant improvement in prolapse and urinary domains and in total scores. Thirty-eight (54%) patients completed the PISQ12 questionnaire at their most recent FU visit. Available data showed a trend of improved sexual function, although this was not found to be significant. No chronic dyspareunia was documented.
Interpretation of results
The use of vaginal mesh in POP surgery has been shown to provide superior anatomical results when compared with native tissue repair, but has been accompanied by unique complications, such as organ perforation, bleeding, mesh erosion, mesh contraction and pain. (2) Data on complications of vaginal mesh surgery have originated in studies on mesh implants which require anchoring to pelvic myofascial structures. Clinical evidence supports the assumption that the anchoring process and not the mesh itself may be responsible for such complications. (3) Therefore, using an anchor-less implant should provide the anatomical benefits of vaginal meshes while minimizing the complications. This prospective, multi-center study on long-term outcome of the SRS implant shows a success rate of 97.2% subjective improvement upon QoL questionnaire analysis, along with minor and manageable complications. No severe graft-related adverse events or chronic pain conditions were observed. These findings allow us to conclude that the SRS implant is a safe and effective surgical option for patients with symptomatic anterior and apical vaginal prolapse. Vaginal POP repair using the SRS implant accurately imitates the physiologic support system: the SRS implant lateral arms are designed to imitate the attachments of the pubo-cervical fascia to the ATFP. The arms are connected ventrally by a bridge, designed to allow the passage of the urethra. The solid frame functions as the mesh-retaining system and allows the use of an ultra-light mesh (16 gr/m2). The device’s shape and size prevent its mobilization and therefore no anchoring or fixation is required. The results of this study show 95.8% anatomical success in a group of seventy patients at 24 months. A subgroup of twenty patients who completed 36 month-follow-up has experienced similar results. These long-term outcome data favorably compare with success rates of other trans-vaginal implants. At the same time, the low rate and severity of complications using the SRS implant technique found in this study indicates the procedure may be safer than previously studied vaginal mesh techniques.
Concluding message
On long term follow-up, the anchor-less SRS implant provides 97.2% subjective cure and 95.8% objective cure. The SRS technique is a safe and effective trans-vaginal surgical treatment for advanced pelvic organ prolapse.
Figure 1 Surgical insertion of the SRS
Figure 2 POP-Q measurements at baseline vs. last follow up visit [N=70]
References
  1. https://www.youtube.com/watch?v=WT0V-WCeYkU
  2. Altman MD PhD D, Väyrynen MD T, Engh MD PhD M, Axelsen MD PhD S, Falconer MD PhD C Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse. N Engl J Med 2011;364:1826-36.
  3. Gouri B. Diwadkar, MD, Matthew D. Barber, MD, MHS, Benjamin Feiner, MD, Christopher Maher, MD, and J. Eric Jelovsek, MD Complication and Reoperation Rates After Apical Vaginal Prolapse Surgical Repair A Systematic Review Obstet Gynecol. 2009 Feb;113(2 Pt 1):367-73.
Disclosures
Funding Lyra Medical Ltd. Clinical Trial Yes Registration Number ClinicalTrials.gov -NCT03195361 RCT No Subjects Human Ethics Committee Maynei HaYeshua Hospita, Assaf Harofeh M.C, Szeged University M.C. Helsinki Yes Informed Consent Yes