Comparison of Transvaginal sacrospinous Fixation with Interposition of Posterior PVDF (polyvinylidene fluoride) Mesh versus Levatorplasty for Entero-rectocele Repair: Mid-term Outcomes

Zargham M1, Kazemi R2, Shirchi M3, Tayebi S4, Gholipour F5, Saberi N1, Farajzadegan Z6, Hajebrahimi S7, Bahrami F8

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 638
Open Discussion ePosters
Scientific Open Discussion Session 107
Saturday 20th September 2025
10:50 - 10:55 (ePoster Station 4)
Exhibition
Female Pelvic Organ Prolapse Retrospective Study Surgery
1. Urology department, faculty of medicine, Isfahan university of medical sciences, Isfahan, Iran, 2. Isfahan kidney disease research center, Isfahan university of medical sciences, Ifsahan, Iran, 3. Isfahan kidney disease research center, Isfahan university of medical sciences, Isfahan, Iran, 4. Urology department, faculty of medicine, Iran university of medical sciences,Tehran, Iran, 5. Urology department, faculty of medicine, Isfahan university of medical sciences, Isfahan,Iran, 6. Department of community medicine, faculty of medicine, child growth and development center, Isfahan university of medical sciences, Isfahan, Iran, 7. Urology department, faculty of medicine, Tabriz university of medical sciences,Tabriz, Iran, 8. Faculty of medicine, Shiraz university of medical sciences, Shiraz, Iran
Presenter
Links

Abstract

Hypothesis / aims of study
In spite of FDA warnings regarding the use of mesh implants in transvaginal  pelvic organ prolapse repairs, FDA and UK national institute for health and care excellence recommended more research on risk/benefit profile of transvaginal mesh usage in POP surgeries [1]. This study aimed to compare the subjective and objective mid-term outcomes of using low-weighted monofilament PVDF mesh  to levatorplasty method for repairing high grade entero-rectocele via vaginal route and assess surgical outcome and mesh-associated adverse events.
Study design, materials and methods
In this retrospective cohort study, women with symptomatic stage ≥3 entero-rectocele prolapse, were assigned to transvaginal sacrospinous fixation with PVDF mesh implant (DynaMeshR-PR2 Soft kit) or classic levatorplasty between August 2012 and April 2023. All the surgeries were done by a single female urologist. The objective outcome was measured using the Pelvic Organ Prolapse Quantification (POP-Q) stage ≤1. Subjective outcomes evaluated by ICIQ-VS (International Consultation of Incontinence-Vaginal Symptoms) questionnaire. Patient satisfaction was quantified using the Patient Global Improvement Scale Inventory (PGI-I) at postoperative follow-up. All eligible women were followed up 3 and 12 months after surgery and then yearly.
Results
Seventy eight  women were enrolled in this study (21 females in PVDF mesh implant group and 57 females in levatorplasty group). Duration of the medical condition was longer in PVDF mesh implant group (6.8 ± 6.6 vs. 2.6 ± 1.8 years). The median time of follow-up was 5.5 ± 0.2 years and 6.9 ± 2.2 years for PVDF mesh implant group and Levatorplasty group, respectively (ranging from 1.5-11 years). At 12  months, both groups showed improvement in terms of POP-Q exam and ICIQ-VS score. Vaginal symptoms disappeared or improved but differed between the PVDF mesh implant group and the levatorplasty group: 86.2% (PVDF mesh implant) vs. 70.7% (levatorplasty), respectively (P value: 0.029). During follow up period, no recurrence was reported in both groups. Only one patient (5%) experienced vaginal mesh exposure 3 months post operation and underwent surgical intervention. She was the first patient who underwent mesh implant 11 years ago. Two cases (13.3%) in levatorplasty group, complicated with constipation and post-operative dysfunctional defecation and vaginal infection required re-hospitalization and intravenous antibiotics. In PVDF mesh implant group, two patients died 3 and 4 years after surgery. The causes of death were unrelated to urologic problems.
Interpretation of results
in our study, sacrospinous ligament fixation with PVDF mesh interposition was a combined approach to treat rectocele and enterocele as posterior and apical compartment prolapse simultaneously with acceptable outcomes and less morbidity and pain in comparison to levatorplasty. PVDF mesh implantation did not require levatorplasty and involved less dissection.
Concluding message
Overall, the posterior interposition of PVDF mesh for entero-rectocele repair offers good anatomical results without significant medium-term complications in concomitant high grade posterior and apical compartment prolapse.
Figure 1 Transvaginal PVDF mesh implantation. The mesh anchors the vaginal apex to sacrospinous ligament and the body of mesh reinforces rectovaginal septum to its position.
Figure 2 The base line demographic parameter of patient
References
  1. Urogynecologic surgical mesh implants. US Food and Drug Administration website. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm. Updated July 10, 2019. Accessed August 13, 2019.
Disclosures
Funding None Clinical Trial No Subjects Human Ethics Committee the Institutional Review Board of Isfahan University of Medical Sciences (IR.MUI.MED.REC.1401.077) Helsinki Yes Informed Consent Yes
03/07/2025 07:09:38