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

A prospective study of a single-incision sling at the time of robotic sacrocolpopexy

Abstract Introduction and hypothesis The objective of this study was to evaluate the efficacy and safety of the Miniarc Precise® single-incision sling (American Medical Systems, Minnetonka, MN, USA) placed at the time of a robotic sacrocolpopexy. Methods This was a prospective study of a single-incision suburethral sling placed at the time of robotic sacrocolpopexy in women with stress urinary incontinence (SUI) and pelvic organ prolapse. Primary outcome measure was cure at 1 year, defined objectively by a negative cough stress test (CST) and subjectively by a score of "0 or 1" on question 17 of the Pelvic Floor Distress Inventory (PFDI-20): "Do you experience urine leakage related to coughing/sneezing/laughing?" Secondary outcome measures included the change in Urinary Distress Inventory (UDI-6) and Urinary Impact Questionnaire (UIQ-7) scores at 1 year. All sling-related complications were reported. Paired Student's t test and the Wilcoxon signed-rank test were used for statistical analysis. Results One hundred and one patients were included between August 2010 and July 2012. One-year follow-up was available for 97 out of 101 patients (96 %). Objective cure was 90 % and subjective cure was 87 %. Baseline UDI-6 scores improved from 34.8±25.1 to 6.7±11.2 at 1 year (p<0.001). Similarly, UIQ-7 scores improved from 21.1±22.8 to 2.4± 8.2 at 1 year (p < 0.001). There were no intraoperative cystotomies, no mesh erosions, no sling revisions, and no cases of urinary retention. The retreatment rate for persistent SUI was 8 % (8 out of 97). Conclusions The addition of a single-incision suburethral sling at the time of robotic sacrocolpopexy in women with SUI resulted in an 87 % cure rate at 1 year

A prospective study of a single-incision sling at the time of robotic sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to evaluate the efficacy and safety of the Miniarc Precise® single-incision sling (American Medical Systems, Minnetonka, MN, USA) placed at the time of a robotic sacrocolpopexy. METHODS: This was a prospective study of a single-incision suburethral sling placed at the time of robotic sacrocolpopexy in women with stress urinary incontinence (SUI) and pelvic organ prolapse. Primary outcome measure was cure at 1 year, defined objectively by a negative cough stress test (CST) and subjectively by a score of 0 or 1 on question 17 of the Pelvic Floor Distress Inventory (PFDI-20): Do you experience urine leakage related to coughing/sneezing/laughing? Secondary outcome measures included the change in Urinary Distress Inventory (UDI-6) and Urinary Impact Questionnaire (UIQ-7) scores at 1 year. All sling-related complications were reported. Paired Student\u27s t test and the Wilcoxon signed-rank test were used for statistical analysis. RESULTS: One hundred and one patients were included between August 2010 and July 2012. One-year follow-up was available for 97 out of 101 patients (96 %). Objective cure was 90 % and subjective cure was 87 %. Baseline UDI-6 scores improved from 34.8 ± 25.1 to 6.7 ± 11.2 at 1 year (p \u3c 0.001). Similarly, UIQ-7 scores improved from 21.1 ± 22.8 to 2.4 ± 8.2 at 1 year (p \u3c 0.001). There were no intraoperative cystotomies, no mesh erosions, no sling revisions, and no cases of urinary retention. The retreatment rate for persistent SUI was 8 % (8 out of 97). CONCLUSIONS: The addition of a single-incision suburethral sling at the time of robotic sacrocolpopexy in women with SUI resulted in an 87 % cure rate at 1 year

Sexual Satisfaction Changes Reported by Men After Their Partnersʼ Robotic-Assisted Laparoscopic Sacrocolpopexies

OBJECTIVES: This study aimed to compare the preoperative and postoperative sexual satisfaction reported by male sexual partners of women undergoing surgical correction of pelvic organ prolapse. METHODS: This was a single-center prospective cohort study. Heterosexual, sexually active English-speaking couples in which the women were planning to undergo robotic-assisted laparoscopic sacrocolpopexy for correction of pelvic organ prolapse were eligible for enrollment in the study. Validated sexual function questionnaires-the Sexual Experience Questionnaire (SEX-Q; Mulhall et al. J Sex Med. 2008) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (Rogers, et al. Int Urogynecol J Pelvic Floor Dysfunct. 2003)-were used to evaluate preoperative and postoperative male and female sexual experience, respectively. These preoperative scores were compared using paired t tests. The Student t and the Mann-Whitney tests were used to compare study-eligible couples with noneligible couples and to compare study participants with nonparticipants. RESULTS: During the study enrollment period, 92 couples met the inclusion criteria and 45 of those were enrolled. Complete data sets of preoperative and postoperative questionnaires were obtained for 36 couples. After their partners\u27 successful reconstructive surgery, male study subjects reported improved total SEX-Q scores (mean ± SD, 71 ± 16.7 vs 76.5 ± 17.8; P = 0.025). Within the subscales of the SEX-Q, there was significant improvement between preoperative and postoperative individual satisfaction scores (mean ± SD, 65.7 ± 16.8 vs 78.9 ± 17.5; P \u3c 0.0001), but not within the erectile dysfunction or couple satisfaction subscales. Female partners reported improved Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 scores after surgery (mean ± SD, 36.6 ± 5.5 vs 40.0 ± 4.6; P = 0.003). CONCLUSIONS: Sexually active heterosexual men and women reported improved sexual experience after successful prolapse repair

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

Prospective Study of an Ultra-lightweight Polypropylene Y Mesh for Robotic Sacrocolpopexy

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 \u27anatomical success\u27 was defined as POP-Q stage 0 or 1 at all postoperative intervals. We further defined \u27clinical cure\u27 by simultaneously considering POP-Q points and subjective measures. To be considered a \u27clinical cure,\u27 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 \u27anatomical success\u27 rate was 89 % and the \u27clinical cure\u27 rate was 94 %. The PFDI-20 mean score improved from 100.4 at baseline to 21.0 at 12 months ( p \u3c 0.0001); PFIQ-7 scores improved from 61.6 to 8.0 ( p \u3c 0.0001); and PISQ-12 scores improved from 35.7 to 38.6 ( p \u3c 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

Prospective Cohort Study of Bowel Function After Robotic Sacrocolpopexy

Objective: This study aimed to determine bowel function changes 12 months after robotic sacrocolpopexy. Methods: We performed a single-center prospective cohort study evaluating bowel function 12 months after robotic sacrocolpopexy between 2007 and 2011. Bowel function symptoms were measured by the Colorectal-Anal Distress Inventory, Short Form 8 (CRADI-8). Specific impacts on quality of life with regard to bowel function were evaluated using the Colorectal-Anal Impact Questionnaire, Short Form 7 (CRAIQ-7). Splinting to defecate was defined as any positive response to question 4 of the Pelvic Floor Distress Inventory-20 which reads, do you ever have to push on the vagina or around the rectum to have or complete a bowel movement?. Lastly, patients were grouped according to perineorrhaphy versus no perineorrhaphy and bowel function scores were examined. Results: Of 423 consecutive patients who underwent robotic sacrocolpopexy at our institution, 393 (93%) completed a 12-month follow-up. Mean CRADI-8 scores at baseline and 12 months were 21.1 (20) and 7.3 (11), respectively (P \u3c 0.0001). Mean CRAIQ-7 scores at baseline and 12 months were 11.1 (20) and 2.4 (9), respectively (P \u3c 0.0001). Preoperatively, 152 patients reported a need to splint the vagina or perineum to complete a bowel movement. At 12 months, 70% reported complete resolution of splinting. Con comitant perineorrhaphy was performed on 87 patients and there were no differences in 12-month CRADI-8 or CRAIQ-7 scores between groups. Conclusions: Robotic sacrocolpopexy was associated with significant improvements in bowel function as measured by CRADI-8 as well as improvements in impact on quality of life as measured by CRAIQ-7

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

Predictive Validity of a Training Protocol Using a Robotic Surgery Simulator

Background: Robotic surgery simulation may provide a way for surgeons to acquire specific robotic surgical skills without practicing on live patients. Methods: Five robotic surgery experts performed 10 simulator skills to the best of their ability, and thus, established expert benchmarks for all parameters of these skills. A group of credentialed gynecologic surgeons naive to robotics practiced the simulator skills until they were able to perform each one as well as our experts. Within a week of doing so, they completed robotic pig laboratory training, after which they performed supracervical hysterectomies as their first-ever live human robotic surgery. Time, blood loss, and blinded assessments of surgical skill were compared among the experts, novices, and a group of control surgeons who had robotic privileges but no simulator exposure. Sample size estimates called for 11 robotic novices to achieve 90% power to detect a 1 SD difference between operative times of experts and novices ([alpha] = 0.05). Results: Fourteen novice surgeons completed the study-spending an average of 20 hours (range, 9.7-38.2 hours) in the simulation laboratory to pass the expert protocol. The mean operative times for the expert and novices were 20.2 (2.3) and 21.7 (3.3) minutes, respectively (P = 0.12; 95% confidence interval, -1.7 to 4.7), whereas the mean time for control surgeons was 30.9 (0.6) minutes (P \u3c 0.0001; 95% confidence interval, 6.3-12.3). Comparisons of estimated blood loss (EBL) and blinded video assessment of skill yielded similar differences between groups. Conclusions: Completing this protocol of robotic simulator skills translated to expert-level surgical times during live human surgery. As such, we have established predictive validity of this protocol