The BioSynIRS trial: biologic versus synthetic mesh for multicompartment pelvic floor reconstruction

Selected patients with obstructed defecation syndrome (ODS) and concomitant pelvic organ prolapse (POP) may require laparoscopic resection rectopexy (L-RRP) with laparoscopic sacrocolpopexy (L-SCP). This trial compared the safety and efficacy of biologic versus synthetic mesh (BM or SM) in L-SCP.

In this single-center randomized pilot trial, 30 women with severe ODS underwent combined L-RRP and L-SCP using either a BM or SM. The primary endpoint was the severe adverse event rate. Secondary endpoints included functional and anatomical outcomes related to ODS and POP. Follow-up was complete at 12 months for all patients.

The 30 patients (15 per group) had similar baseline characteristics, comparable frequency of additional surgical procedures, longer operative time in the SM group, lower pain in the BM group, similar length of hospital stay, comparable adverse event rates, and no mesh-related complications. Severe adverse events were reported by two patients (13%) in the BM group versus five (33%) in the SM group. Functional outcomes and POP-Q scores significantly improved in both groups (p < 0.01), urinary incontinence was unchanged, and there were three cases of ODS recurrence at 12 months. The main limitation of this study is its pilot design with a limited sample size and short follow-up, precluding definitive conclusions regarding long-term durability and rare adverse events.

No significant differences in safety were detected between biologic and synthetic mesh; functional and anatomical outcomes improved similarly. Given the pilot design and limited sample size, these findings support the feasibility, but not equivalence or non-inferiority, of the biologic mesh. Adequately powered trials are required to confirm these findings and to evaluate the long-term durability of the biologic mesh.

Trial registration at ClinicalTrials.gov (NCT06245577) and at the German Clinical Trials Register (DRKS00033079).