A new surgical technique for the treatment of advanced pelvic floor prolapse

Levy G1, Marcus-Braun N2, Padoa A3, Fekete Z4, Bartfai G4, Pajor L4, Cervigni M5

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 674
Non Discussion Abstracts
Scientific Non Discussion Abstract Session 36
Pelvic Organ Prolapse New Devices Prospective Study
1. Assuta University Hospital, Ashdod, Israel, 2. Ziv Medical Center, Zefad, Israel, 3. Asaf Harofea Medical Center, Zrifin, Israel, 4. Szeged University Medical Center, Szeged, Hungary, 5. Gemeli Medical Center, Rome, Italy
Links

Abstract

Hypothesis / aims of study
To evaluate the safety and efficacy of a new transvaginal surgical technique for the treatment of third degree anterior and apical prolapse.
Study design, materials and methods
A prospective, multicentre, international study involving 6 surgeons at 4 centres. The study was approved by all relevant Ministries of Health and local ethical committees. Women with third degree symptomatic pelvic organ prolapse were recruited after approved and detailed informed consent was sighed. The technique involved placement of an open trapezoid-shaped solid flexible frame implant with an ultra-light polypropylene mesh. The device is inserted surgically between the bladder and the vaginal wall. When in place, the frame’s lateral arms positioned to follow the anatomy of the pelvic side walls and the distal part positioned behind the pubic bone. No fixation technique is needed. Demographic and pre-operative validated QoL questionnaires - PFDI and PISQ12 – were collected. Intra operative and immediate post-operative data including length of the procedure, estimated blood loss, pain level and complications documented. Patients were followed at 2, 6, 12, 24 and 36 months. Follow up included repeat QoL questioners, POP-Q evaluation and treatment of possible complications.
Results
Seventy women were recruited. Mean age was 63 (43-79) years-old, average parity was 4.5 (1-16) deliveries. Mean pre-operative POP-Q were Ba =2.9 (-2 to 6) cm and C=0.4 (-8 to 6) cm. No intra-operative complications were observed. Surgical time averaged 31.2 min. and estimated blood loss averaged 165 cc. Two patients (3%) had ambulatory partial frame resection: one case secondary to frame erosion and one case secondary to voiding dysfunction, 8 and 12 months after implantation, respectively. One patient (1.5%) underwent TVT-O procedure for De-novo SUI 12 months following the procedure. Mean follow-up was 24 (8-40) months. One patient lost to follow up. 19 patients (27%) completed 36 months. All patients completed at least 6 months follow-up. At follow-up, the mean POP-Q were: Ba= -2.8 (-3 to -1) cm and C = -7 (-10 to 1) cm. One patient (1.5%) had an asymptomatic apical descent with C at +1 cm. No cases of mesh erosion or chronic pelvic pain were documented. PFDI scores showed significant improvement of the prolapse, urinary domains and total scores. No chronic dyspareunia was documented among patients who completed the PISQ12.
Interpretation of results
The results confirm the safety and efficacy of the new surgical technique when compared to other currently used methods for the treatment of advanced pelvic organ prolapse. The new technique provides 100% subjective cure and 98.5% objective cure. This is the first time a solid material is used as a vaginal implant which provides safe and effective results. The frame retains the mesh at the desired location and provides a long-term mechanical support. The frame design allows the use of an ultra-light mesh preventing mesh erosions and reduction of intra and post-operative potential complications described with mesh fixation techniques.
Concluding message
Eliminating the need for anchoring techniques allows an efficient and safe transvaginal surgical treatment for advanced pelvic organ prolapse.
Disclosures
Funding Lyra Medical Ltd. Clinical Trial Yes Registration Number ClinicalTrials.gov No: NCT03195361 and NCT02209337 RCT No Subjects Human Ethics Committee Ministry of Health, Israel and Hungary Helsinki Yes Informed Consent Yes