Clinical evaluation of a next-generation absorbable ligature delivery system for reconstructive surgery in patients with POP

Shakhaliev R1, Shkarupa D1, Shulgin A1, Nikita K1

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 712
Open Discussion ePosters
Scientific Open Discussion Session 108
Saturday 20th September 2025
12:50 - 12:55 (ePoster Station 5)
Exhibition
Genital Reconstruction Grafts: Synthetic Pelvic Organ Prolapse Surgery New Devices
1. Saint-Petersburg State University Hopsital
Presenter
Links

Abstract

Hypothesis / aims of study
The conceptual idea behind this device was to preserve the familiar shape and structure of a mesh implant at the time of implantation (ensuring minimal tissue dissection and eliminating the need for additional fixation) while significantly reducing the amount of permanent synthetic material in the long-term postoperative period. Following the resorption process, separate, non-interwoven, non-resorbable filaments remain within the tissue (Fig. 1). 
The aim of this study is to evaluate the safety and efficacy of the novel implant in a clinical setting.
Study design, materials and methods
This prospective pilot study included 30 women with apical POP stages 2–4 according to the POP-Q classification. All participants underwent unilateral sacrospinal fixation using a partially resorbable ligature delivery system. Anatomical effectiveness was assessed using the POP-Q system 12 months postoperatively. Quality of life was evaluated with validated questionnaires (PFDI-20, ICIQ-SF), and patient satisfaction was assessed using IMPSS and PGI-I scales. In addition, pain levels in the lower abdomen and lower back were assessed using the VAS preoperatively and at follow-up. MRI scans with intravenous contrast were performed on two patients to evaluate tissue response to the implant. Statistical analyses were conducted using SPSS 27.0.
Results
At the 12-month follow-up, anatomical efficacy in apical compartment was achieved in 96.7% of patients. The recurrence rate of cystocele was 10%. No instances of implant erosion or chronic pelvic pain were observed. Significant improvement was demonstrated across all subscales of the PFDI-20 questionnaire (p<0.001). The ICIQ-SF scores improved but were not statistically significant (p=0.426). The Visual Analog Scale (VAS) scores for lower abdomen and lower back pain did not show significant differences postoperatively. Patient satisfaction was notably high, with IMPSS and PGI-I scores reflecting positive outcomes. Detailed anatomical and QoL outcomes presented in Figure 2. MRI examinations revealed scar formation around the implant threads with consistent and uniform contrast accumulation during the late venous phase, indicative of stable connective tissue integration (Figure 3).
Interpretation of results
The findings of this pilot study suggest that unilateral sacrospinal fixation  using a partially resorbable ligature delivery system may offer anatomical effectiveness comparable to that achieved with traditional polypropylene mesh implants. The absence of significant implant-related complications, such as erosion and chronic pelvic pain, potentially indicates improved biocompatibility due to partial material resorption. However, the modest sample size and limited follow-up duration necessitate cautious interpretation of these positive outcomes. The observed cystocele recurrence rate of 10% is consistent with data from existing literature [2]; importantly, these recurrences were clinically asymptomatic and did not markedly affect patient satisfaction or quality of life assessments. Preliminary MRI results provided encouraging indications of adequate tissue integration, supporting the hypothesis that partially resorbable implants may facilitate appropriate connective tissue formation without triggering chronic inflammatory responses. Nevertheless, further investigations involving larger populations and extended follow-up periods are needed to validate these initial observations.
Concluding message
The novel absorbable ligature delivery system demonstrated high efficacy and safety in sacrospinous fixation for apical prolapse correction and represents a promising alternative to traditional non-resorbable meshes. Further long-term studies are needed to confirm the durability of these results.
Figure 1 Macroscopic photo of the implant (1 - non-resorbable sutures, 2 - resorbable sutures)
Figure 2 Table 1. POP-Q points before and after surgery. Table 2. Pre- and postoperative quality of life and VAS data
Figure 3 Patient G, 72 years old. T1-VI with fat signal suppression after intravenous contrast - late venous phase. The scar at the level of the implant on the right side clearly uniformly accumulates contrast agent (arrows).
References
  1. Brown, B. N., Mani, D., Nolfi, A. L., Liang, R., Abramowitch, S. D., & Moalli, P. A. (2015). Characterization of the host inflammatory response following implantation of prolapse mesh in rhesus macaque. American Journal of Obstetrics and Gynecology, 213(5), 668.e1-668.e10. https://doi.org/10.1016/j.ajog.2015.08.002
  2. Yeung, E., Baessler, K., Christmann-Schmid, C., Haya, N., Chen, Z., Wallace, S. A., Mowat, A., & Maher, C. (2024). Transvaginal mesh or grafts or native tissue repair for vaginal prolapse. Cochrane Database of Systematic Reviews, 2024(3). https://doi.org/10.1002/14651858.CD012079.pub2
Disclosures
Funding The authors declare that no funding was received for conducting this study. Clinical Trial Yes Public Registry No RCT No Subjects Human Ethics Committee This study was approved by the Biomedical Ethics Committee of the St. Petersburg State University Hospital (protocol No. 06-1/23 dated 01.06.2023). Helsinki Yes Informed Consent Yes
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