The BioSynIRS trial: biologic versus synthetic mesh for multicompartment pelvic floor reconstruction.
Severe adverse events trended lower with biologic mesh than synthetic mesh, pilot trial found.
The BioSynIRS trial: biologic versus synthetic mesh for multicompartment pelvic floor reconstruction.
Selected patients with obstructed defecation syndrome (obstructed defecation syndrome) and concomitant pelvic organ prolapse (prolapse) may require laparoscopic resection rectopexy (laparoscopic resection rectopexy) with laparoscopic sacrocolpopexy (laparoscopic sacrocolpopexy).
This trial compared the safety and efficacy of biologic versus synthetic mesh (BM or SM) in laparoscopic sacrocolpopexy.
In this single-center randomized pilot trial, 30 women with severe obstructed defecation syndrome underwent combined laparoscopic resection rectopexy and laparoscopic sacrocolpopexy using either a BM or SM.
biologic mesh trended toward fewer severe adverse events than synthetic mesh
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.
Functional outcomes and POP-Q scores significantly improved in both groups (p < 0.01), urinary incontinence was unchanged, and there were three cases of obstructed defecation syndrome recurrence at 12 months.
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.