Prospective study of an ultra-lightweight polypropylene Y mesh for robotic sacrocolpopexy

Abstract Introduction and hypothesis To prospectively evaluate the use of a particular polypropylene Y mesh for robotic sacrocolpopexy. Methods This was a prospective study of 120 patients who underwent robotic sacrocolpopexy. We compared preoperative and 12-month postoperative objective and subjective assessments via the Pelvic Organ Prolapse Quantification (POP-Q), the Pelvic Floor Distress Inventory, Short Form 20 (PFDI-20); the Pelvic Floor Impact Questionnaire, Short Form 7 (PFIQ-7); and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 (PISQ-12). Objective "anatomical success" was defined as POP-Q stage 0 or 1 at all postoperative intervals. We further defined "clinical cure" by simultaneously considering POP-Q points and subjective measures. To be considered a "clinical cure," a given patient had to have all POP-Q points ≤0, apical POP-Q point C ≤5, no reported pelvic organ prolapse symptoms on the PFDI-20, and no reoperation for prolapse at all postoperative intervals. Results Of the 120 patients, 118 patients completed the 1-year follow-up. The objective "anatomical success" rate was 89 % and the "clinical cure" rate was 94 %. The PFDI-20 mean score improved from 100.4 at baseline to 21.0 at 12 months (p<0.0001); PFIQ-7 scores improved from 61.6 to 8.0 (p<0.0001); and PISQ-12 scores improved from 35.7 to 38.6 (p <0.0009). No mesh erosions or mesh-related complications occurred. Conclusion The use of this ultra-lightweight Y mesh for sacrocolpopexy, eliminated the mesh-related complications in the first postoperative year, and provided significant improvement in subjective and objective outcomes

Porcine Dermis Compared with Polypropylene Mesh for Laparoscopic Sacrocolpopexy: A Randomized Controlled Trial

OBJECTIVE: To compare the surgical outcomes 12 months after laparoscopic sacrocolpopexy performed with porcine dermis and the current gold standard of polypropylene mesh.METHODS: Patients scheduled for laparoscopic sacrocolpopexy were eligible for this randomized controlled trial. Both our clinical research nurse and the patients were blinded as to which material was used. Our primary end point was objective anatomic cure defined as no pelvic organ prolapse quantification (POP-Q) points Stage 2 or greater at any postoperative interval. Our sample size calculation called for 57 patients in each group to achieve 90% power to detect a 23% difference in objective anatomic cure at 12 months ([alpha]=0.05). Our secondary end point was clinical cure. Any patient with a POP-Q point greater than zero, or Point C less than or equal to -5, or any complaints of prolapse symptoms whatsoever on Pelvic Floor Distress Inventory-20 or Pelvic Floor Impact Questionnaire, Short Form 7, or reoperation for prolapse were considered clinical failures ; the rest were clinical cures. Statistical comparisons were performed using the [chi]2 or independent samples t test as appropriate.RESULTS: As expected, there were no preoperative differences between the porcine (n=57) and mesh (n=58) groups. The 12-month objective anatomic cure rates for the porcine and mesh groups were 80.7% and 86.2%, respectively (P=.24), and the clinical cure rates for the porcine and mesh groups were 84.2% and 89.7%, respectively (P=.96). Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire, Short Form 7 score improvements were significant for both groups with no differences found between groups. There were no major operative complications.CONCLUSIONS: There were similar outcomes in subjective or objective results 12 months after laparoscopic sacrocolpopexy performed with either porcine dermis or polypropylene mesh

Sexual Function Before and 1 Year After Laparoscopic Sacrocolpopexy

Objective: This study aimed to compare sexual function before and 1 year after laparoscopic sacrocolpopexy using a porcine dermis or a polypropylene mesh material. Methods: This was a secondary analysis of sexual function measured before and 1 year after laparoscopic sacrocolpopexy in a group of 81 sexually active women participating in a randomized controlled trial comparing porcine dermis and polypropylene mesh. Sexual function was assessed using the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Responses to individual questions from the physical domain of the PISQ-12 were also analyzed. Additional information included the type of mesh material used and whether a concomitant suburethral sling or perineorrhaphy was performed. Results: There was a significant postoperative improvement in total PISQ-12 scores for the entire cohort (33.2 vs 38.3, P \u3c 0.01). Similarly, PISQ-12 scores were significantly improved in both groups (33.2 preoperative vs 37.4 one year postoperative in the porcine dermis, P \u3c 0.01 and 33.2 vs 39.2 in the polypropylene mesh, P \u3c 0.01). There were no differences between the 2 graft material groups. Preoperatively, 63.0% (48/76) of women reported avoiding sexual intercourse because of bulging in vagina (PISQ12-question #8), at 1 year postoperatively only 4% (3/76) had a positive response (P \u3c 0.01). We observed a significant decrease in the number of women who reported pain during intercourse at 12 months as evidenced by the responses to the PISQ12-question #5, 47.4% (36/76) versus 26.3% (20/76) (P \u3c 0.01). The addition of a suburethral sling or a perineorrhaphy did not negatively impact sexual function at 1 year. Conclusions: Laparoscopic sacrocolpopexy had a positive impact on sexual function at 1 year regardless of whether a porcine dermis or a polypropylene mesh material was used

Evaluation of a Transvaginal Mesh Delivery System for the Correction of Pelvic Organ Prolapse: Subjective and Objective Findings at least 1 Year after Surgery

Objective: We sought to track objective and subjective outcomes ≥1 year after transvaginal mesh system to correct prolapse. Study Design: This was a retrospective cohort study of 120 women who received a transvaginal mesh procedure (Avaulta Solo, CR Bard Inc, Covington, GA). Outcomes were pelvic organ prolapse quantification values; Pelvic Floor Distress Inventory, Short Form 20/Pelvic Floor Impact Questionnaire, Short Form 7 scores; and a surgical satisfaction survey. “Surgical failure” was defined as pelvic organ prolapse quantification point \u3e0, and/or any reports of vaginal bulge. Results: Of 120 patients, 116 (97%) were followed up for a mean of 14.4 months (range, 12–30). In all, 74 patients had only anterior mesh, 21 only posterior mesh, and 21 both meshes. Surgical cure rate was 81%. Surgical failure was more common if preoperative point C ≥+2 (35% vs 16%; P = .04). Mesh erosion and de novo pain occurred in 11.7% and 3.3%, respectively. Pelvic Floor Distress Inventory, Short Form 20/Pelvic Floor Impact Questionnaire, Short Form 7 scores improved (P \u3c .01). Conclusion: Objective and subjective improvements occurred at ≥1 year, yet failure rates were high when preoperative point C was ≥+2

Sexual Function Before and 1 Year After Laparoscopic Sacrocolpopexy

Objective: This study aimed to compare sexual function before and 1 year after laparoscopic sacrocolpopexy using a porcine dermis or a polypropylene mesh material. Methods: This was a secondary analysis of sexual function measured before and 1 year after laparoscopic sacrocolpopexy in a group of 81 sexually active women participating in a randomized controlled trial comparing porcine dermis and polypropylene mesh. Sexual function was assessed using the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Responses to individual questions from the physical domain of the PISQ-12 were also analyzed. Additional information included the type of mesh material used and whether a concomitant suburethral sling or perineorrhaphy was performed. Results: There was a significant postoperative improvement in total PISQ-12 scores for the entire cohort (33.2 vs 38.3, P G 0.01). Similarly, PISQ-12 scores were significantly improved in both groups (33.2 preoperative vs 37.4 one year postoperative in the porcine dermis, P G 0.01 and 33.2 vs 39.2 in the polypropylene mesh, P G 0.01). There were no differences between the 2 graft material groups. Preoperatively, 63.0% (48/76) of women reported avoiding sexual intercourse because of bulging in vagina (PISQ12-question #8), at 1 year postoperatively only 4% (3/76) had a positive response (P G 0.01). We observed a significant decrease in the number of women who reported pain during intercourse at 12 months as evidenced by the responses to the PISQ12-question #5, 47.4% (36/76) versus 26.3% (20/76) (P G 0.01). The addition of a suburethral sling or a perineorrhaphy did not negatively impact sexual function at 1 year. Conclusions: Laparoscopic sacrocolpopexy had a positive impact on sexual function at 1 year regardless of whether a porcine dermis or a polypropylene mesh material was used