Contemporary Use and Techniques of Laparoscopic Sacrocolpopexy With or Without Robotic Assistance for Pelvic Organ Prolapse.

The past 4 years have been consequential in the world of surgery to correct pelvic organ prolapse. In 2018, results of a large, multicenter randomized trial demonstrated very disappointing cure rates of traditional native tissue repairs at 5 years or more. In 2019, a vaginal mesh hysteropexy kit was removed from the market by the U.S. Food and Drug Administration only to subsequently demonstrate it provided better cure rates and similar risk profile to vaginal hysterectomy plus native tissue repair in its own 5-year study published in 2021. Meanwhile, the use and techniques of laparoscopic sacrocolpopexy with or without robotic assistance have evolved such that it is commonly adapted to treat all support defects for patients with uterovaginal or posthysterectomy prolapse. This article is intended to provide an overview of the contemporary use and techniques of laparoscopic sacrocolpopexy based on the evidence and our clinical experience.

Development and Validation of Urological and Appearance Domains of the Post-Affirming Surgery Form and Function Individual Reporting Measure (AFFIRM) for Transwomen following Genital Surgery.

PURPOSE: As feminizing gender-affirming surgery becomes increasingly accessible, functional outcomes are increasingly relevant. We aimed to develop and validate the first patient-reported outcome questionnaire focusing on postoperative symptomatology and quality of life. MATERIAL AND METHODS: Questions were developed from interviews with postoperative transwomen followed by face validation from a multispecialty clinician group. The measure was co-administered with established relevant questionnaires for concurrent validity testing. Participants were asked to complete the questionnaire at baseline and at a 2-week retest interval. RESULTS: The AFFIRM questionnaire is a 33-item patient-reported outcome measure comprising Appearance, Urological and Gynecologic domains, each scored to create a composite AFFIRM score. A total of 102 women participated, with 60% completing the test-retest. The overall Cronbach's α for AFFIRM was 0.79, and domain α for AFFIRM-A, AFFIRM-U and AFFIRM-G was 0.85, 0.87 and 0.42, respectively. Test-retest demonstrated score reliability (z values -1.862 to -0.005, p >0.05) with intraclass coefficients demonstrating moderate to good absolute correlation (0.54 to 0.88). The AFFIRM-A and AFFIRM-U correlated well with the Genital Appearance Satisfaction Measure and Urinary Distress Inventory-6, respectively (ρ 0.556 and 0.618, p <0.001); 89% of participants confirmed congruence between their external genitalia and gender identity, 87.8% reported clitoral sensation and 75.6% expressed satisfaction with vaginal caliber. Reported symptoms included a misdirected urinary stream (68.9%), nocturia (51.3%), urinary frequency (29.7%) and vaginal pain (46.7%). CONCLUSIONS: Transwomen have diverse symptoms not captured by unstructured questions or cisgender questionnaires. The AFFIRM questionnaire is the first tool available to reliably evaluate outcomes following feminizing gender-affirming surgery.

Long-Term Outcomes of Robotic-Assisted Laparoscopic Sacrocolpopexy Using Lightweight Y-Mesh.

OBJECTIVE: The objective of this study was to describe anatomic and symptomatic outcomes at 5 years or longer after robotic-assisted laparoscopic sacrocolpopexy using very lightweight polypropylene Y-mesh. METHODS: A prospective analysis of consecutive patients who underwent surgery at a single center between 2007 and 2011 was performed. Patients consented to objective and subjective assessment at 5 years or longer postoperatively. Surgical success was defined as meeting all of the following: (1) no retreatment for pelvic organ prolapse (POP) since surgery, (2) no prolapse beyond the introitus, (3) no apical descent below -5, and (4) no prolapse symptoms reported. Secondary outcome measures included Sandvik Incontinence Severity Index, the PFDI-20, the PFIQ-7, the PISQ-12, and the SSQ-8), rates of dyspareunia, mesh complications, and subjects' need for any surgical or nonsurgical prolapse treatment since their index surgery. RESULTS: Eighty percent of the potential study group (253/316) presented for examination and subjective assessment at 5 years or longer after their index surgeries.The surgical success rate was 226 (89.3%) of 253 with no apical failures. Only 4.4% (11/253) of the group met both objective and subjective failure criteria. Sixteen patients were classified as surgical failure owing to subjective criteria alone despite having no significant objective prolapse on examination. Ten patients (4%) elected to undergo subsequent POP repair. These operations consisted of 5 native tissue anterior repairs and 5 native tissue posterior repairs. In addition, 1 patient elected to use a pessary for recurrent anterior POP. The remaining 16 patients who experienced surgical failure elected no further prolapse treatment. CONCLUSIONS: Robotic-assisted laparoscopic sacrocolpopexy using very lightweight mesh provided excellent long-term results with no mesh-related complications.

A live porcine model for robotic sacrocolpopexy training.

INTRODUCTION AND HYPOTHESIS: Robotic sacrocolpopexy is an effective and durable technique for pelvic organ prolapse repair. However, the learning curve for this procedure has underscored the need for an effective surgical training module. Given the cost, infection risk, poor tissue compliance, and scarcity of human cadavers, the live porcine model represents a realistic, available, and cost-effective alternative. This article describes a live porcine model for teaching robotic sacrocolpopexy to determine whether it teaches key aspects of live human robotic sacrocolpopexy to the learner. METHODS: This robotic sacrocolpopexy model was created using the Da Vinci Xi or Si robotic system on domestic pigs under general anesthesia. The main steps of the model include: (1) creating the porcine "cervix" and (2) performing robotic sacrocolpopexy. The model was evaluated with a survey given to 18 board-certified surgeons who attended the training course between December 2016 and April 2018. RESULTS: All of the participants reported improvements in their economy of motion, tissue handling ability, suturing efficiency, and overall performance of robotic sacrocolpopexy. Furthermore, a majority of participants were likely to incorporate aspects of the model into their practice (88.8%) and recommend the model to colleagues (94.2%). CONCLUSIONS: The porcine model provides a feasible tool for teaching robotic sacrocolpopexy to physicians.

Understanding Your Online Ratings: A Methodological Analysis Using Urogynecologists in the United States.

OBJECTIVE: The influence of online physician ratings is growing, yet their interpretation remains difficult. Our aim was to analyze the online content of urogynecologists on 1 website to transform these ratings into practical tools for care improvement. METHODS: This cross-sectional analysis studied the ratings and reviews of every board-certified urogynecologist listed on Healthgrades.com. The ratio of 5:1 ratings was compared between various physician characteristics and practice qualities. Four investigators classified narrative reviews into one or more of the following themes: about the (1) physician, (2) clinical outcomes, (3) and/or staff. The content of the narrative reviews was analyzed, and word clouds were created to understand the primary motivators behind ratings. RESULTS: In February 2018, the Healthgrades pages for 689 urogynecologists were evaluated, and 523 physicians were included in the study. Higher 5:1 ratios were found among men versus women (4.0 vs 3.0; P < 0.01), and OB-GYN-trained versus urology-trained (4.0 vs 2.2; P < 0.01) physicians. A benchmarking rubric was developed to illustrate the 5:1 ratio distribution for all physicians stratified by number of ratings. A total of 3300 narrative reviews were assigned themes with strong inter- and intrarater reliability (Table 3). Physician qualities most influenced extreme scores (1 or 5 stars), whereas average reviews were more influenced by staff. Commonly discussed physician qualities included professionalism, time with patient, and counseling. CONCLUSIONS: Using the 5:1 rating ratio and simplified review themes as tools, physicians can understand what their ratings signify both as an indicator of their online reputation compared with their peers and as a means for improving the patient experience.

Sexual Satisfaction Changes Reported by Men After Their Partners' 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' 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 < 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.

Genetic Mutation that May Contribute to Failure of Prolapse Surgery in White Women: A Case-Control Study.

OBJECTIVE: To identify a potential genetic basis for early failure after prolapse surgery. DESIGN: Case-control study (Canadian Task Force classification II). SETTING: This study was carried out in 1 academic community medical center referral practice, and all patients had surgery at 1 of 2 hospitals. PATIENTS: Ten women with early, multicompartment prolapse recurrence after robotic sacrocolpopexy compared with 40 control subjects with known success after the same procedure. INTERVENTIONS: Patients were treated with robotic sacrocolpopexy. MEASUREMENTS AND MAIN RESULTS: DNA was isolated and initially genotyped on a single nucleotide polymorphism (SNP) array to direct more detailed exome analyses. Exome sequences were mapped to the Human Genome Reference Sequence (GRCh37), and variants were compared between groups and to participants in the 1000 Genomes Project. Statistical analyses were performed using a software package commonly used in genetics research. TaqMan assay was used for verification, and p values were adjusted using the false discovery rate. Demographics of groups were compared using χ(2), Mann-Whitney U, and t tests. A SNP [rs171821] located near the ZFYVE16 gene was associated with patients but not control subjects, and the false discovery rate-adjusted p value was .046 (odds ratio, 45.2; 95% confidence interval, 5.06-403). Exome analyses of this gene yielded another SNP [rs249038 (G/A)] in 6 of 10 patients and none of the control subjects (p = .02). This SNP causes a heterozygous missense mutation of glycine to serine predicted to be deleterious by the Protein Variation Effect Analyzer and was also very rare among participants in the 1000 Genomes Project (p < .001). CONCLUSIONS: Two SNPs located near the ZFYVE16 gene on chromosome 5 may have played a role in the early, multicompartment sacrocolpopexy failure experienced by our patients. (www.clinicaltrials.gov Identifier: NCT01614587).

Prevalence of Occult Malignancy Within Morcellated Specimens Removed During Laparoscopic Sacrocolpopexy.

OBJECTIVE: This study aimed to determine the prevalence of occult malignancy found in morcellated specimens removed in the context of pelvic organ prolapse repair operations. METHODS: A total of 786 cases were reviewed from a single health system between October 2006 and July 2015. Thorough chart reviews were performed to include pathological specimens. Demographic, perioperative, and postoperative data were collected. RESULTS: Four occult malignancies were identified including 3 endometrial adenocarcinomas of the uterus and 1 papillary serous carcinoma of the uterus. The overall prevalence of occult malignancy within morcellated specimens was 0.5% (4 of 786). On adopting universal screening with endometrial biopsy, 5 malignancies were identified (5 of 176) before morcellation and no postoperative malignancies in the remaining patients. CONCLUSIONS: Power morcellation is a low-risk procedure with laparoscopic supracervical hysterectomy and sacrocolpopexy. Universal screening is highly effective in detecting occult malignancy and in our small series eliminated the risk; studies in multiple institutions will be needed to determine its effectiveness in other hospital systems.

A posterior anal sling for fecal incontinence: results of a 152-patient prospective multicenter study.

BACKGROUND: The transobturator posterior anal sling (TOPAS) system is a posterior anal sling that is a minimally invasive, self-fixating polypropylene mesh intended to treat fecal incontinence (FI) in women who have failed conservative therapy. OBJECTIVE: We are reporting 1-year outcome in a prospective, multicenter study under investigational device exemption, evaluating this new treatment modality. STUDY DESIGN: A total of 152 women were implanted with the TOPAS system at 14 centers in the United States. FI was assessed preoperatively and at the 12-month follow up with a 14-day bowel diary, Cleveland Clinic Incontinence Scores, and FI Quality of Life questionnaires. Treatment success was defined as reduction in number of FI episodes of ≥50% compared to baseline. Missing bowel diary data were considered treatment failures. The Wilcoxon signed rank test was used to compare changes observed at 12 months vs baseline. RESULTS: Mean age was 59.6 years old (SD 9.7). The mean duration of FI was 110 mo (range 8-712) months. Mean length of the implant procedure was 33.4 (SD 11.6) minutes. Mean EBL was 12.9 (SD 10.5) mL. Average follow-up was 24.9 months. At 12 months, 69.1% of patients met the criteria for treatment success, and 19% of subjects reported complete continence. FI episodes/wk decreased from a median of 9.0 (range 2-40) at baseline to 2.5 (range 0-40) (P < .001). FI days decreased from a median of 5.0 (range 1.5-7) at baseline to 2.0 (range 0-7) (P < .001) over a 7-day period. FI associated with urgency decreased from a median at baseline of 2.0 (range 0-26) to 0 (range 0-14.5) (P < .001). The mean Cleveland Clinic Incontinence Scores decreased from 13.9 at baseline to 9.6 at 12 months (P < .001). FI Quality of Life scores for all 4 domains improved significantly from baseline to 12 months (P < .001). A total of 66 subjects experienced 104 procedure- and/or device-related adverse events (AEs). Most AEs were short in duration and 97% were managed without therapy or with nonsurgical interventions. No treatment-related deaths, erosions, extrusions, or device revisions were reported. The most common AE categories were pelvic pain (n = 47) and infection (n = 26). Those subjects experiencing pelvic pain had a mean pain score (0-10 scale, 0 = no pain) during the 12-month follow-up of 1.2 (SD 2.4). CONCLUSION: The TOPAS system provides significant improvements in FI symptoms and quality of life with an acceptable AE profile and may therefore be a viable minimally invasive treatment option for FI in women.

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'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.

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 < 0.0001). Mean CRAIQ-7 scores at baseline and 12 months were 11.1 (20) and 2.4 (9), respectively (P < 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.

Subjective and objective results 1 year after robotic sacrocolpopexy using a lightweight Y-mesh.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to assess outcomes following robotic sacrocolpopexy using a lightweight polypropylene Y-mesh. METHODS: During our study period, all patients who underwent robotic sacrocolpopexy were enrolled in this single-arm prospective trial. Endpoints included Pelvic Organ Prolapse Quantification (POP-Q) values; Pelvic Floor Distress Inventory, short form 20 (PFDI-20); Pelvic Floor Impact Questionnaire, short form 7 (PFIQ-7); Surgical Satisfaction scores; and the Sandvik Incontinence Severity Index. All surgeries were performed with a pre-configured monofilament type 1 polypropylene Y-mesh (Alyte©, C.R. Bard, Covington, GA, USA). Cure rates at 12 months were calculated using two separate definitions: (1) "clinical cure": no POP-Q points > 0, point C ≤ -5, no prolapse symptoms on the PFDI-20, and no reoperations for prolapse and (2) "objective anatomic cure": POP-Q stage 0 or 1, point C of ≤ -5, and no reoperations for prolapse. RESULTS: A total of 150 patients underwent robotic sacrocolpopexy and 143 (95 %) were available for 12-month follow-up. Mean age was 58.6 ± 9.8 and mean body mass index was 26.3 ± 4.5. Mean operative time and blood loss were 148 ± 27.6 min (range 75-250 min) and 51.2 ± 32, respectively. There were no mesh erosions or exposures, and mesh edges were not palpable in any patient. At 12 months the clinical cure rate was 95 %, and the objective anatomic cure rate was 84 %. The PFDI-20 mean score improved from 98 at baseline to 17 at 12 months (p < 0.0001); PFIQ-7 scores improved from 59 to 6.5 (p < 0.0001). CONCLUSIONS: Robotic sacrocolpopexy using this lightweight polypropylene Y-mesh offers excellent subjective and objective results at 1 year.

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 (α = 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 < 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.

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 < 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 < 0.01 and 33.2 vs 39.2 in the polypropylene mesh, P < 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 < 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 < 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.

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 "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 (α=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 χ 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00564083. LEVEL OF EVIDENCE: I.

Subjective and objective outcomes 1 year after robotic-assisted laparoscopic sacrocolpopexy.

We aimed to assess the subjective and objective outcomes 1 year after robotic sacrocolpopexy using a type I polypropylene mesh. This was a case series of 64 patients who underwent a robotic-assisted laparoscopic sacrocolpopexy using a type I monofilament polypropylene mesh coated with hydrophilic porcine collagen. Objective and subjective outcomes were assessed using the pelvic organ prolapse quantification (POP-Q), the short forms of the Pelvic Floor Impact Questionnaire (PFIQ 7) and the Pelvic Floor Distress Inventory (PFDI-20). Outcome measures were collected pre-operatively and 1 year post-operatively on all but one patient, who was lost to follow-up. Paired comparisons between pre- and post-operative outcomes were performed using the Wilcoxon signed rank test. At 1 year, POP-Q stage II or greater and loss of follow-up were considered to be surgical failure. The "surgical cure" rate was 89%. We observed three distal anterior failures, two distal posterior failures and one apical failure, and one patient was lost to follow-up. We found significant differences between pre- and post-operative POP-Q measurements (p < 0.001) and PFDI-20/PFIQ-7 total scores (p < 0.001). Robotic sacrocolpopexy using this polypropylene mesh resulted in significant improvements in subjective and objective outcome measures at 1 year.

Sacrohysteropexy followed by successful pregnancy and eventual reoperation for prolapse.

A multitude of uterine-sparing prolapse repairs exist in the literature, but little is published on subsequent pregnancy and long-term success following a repair. A 35-year-old gravida 2 para 2 underwent laparoscopic sacrohysteropexy and suburethral sling for stage III prolapse and stress urinary incontinence. She conceived 6 months postprocedure. Her antepartum course was complicated by third trimester pelvic pressure--successfully managed with a pessary. She delivered via cesarean section at term. At 12 months postpartum she had no signs of prolapse. Two years postpartum, she reprolapsed and underwent robotic assisted laparoscopic supracervical hysterectomy, sacrocolpopexy, and perineorrhaphy. Two years postoperatively she remained without any prolapse symptoms. Laparoscopic sacrohysteropexy is a reasonable surgical option for patients with pelvic organ prolapse considering future pregnancies.

Randomized trial of fascia lata and polypropylene mesh for abdominal sacrocolpopexy: 5-year follow-up.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to evaluate the 5-year surgical outcomes of abdominal sacrocolpopexy among subjects randomized to receive polypropylene mesh or cadaveric fascia lata. METHODS: All 100 subjects from the original randomized clinical trial were eligible. Primary outcome was objective anatomic failure: any pelvic organ prolapse quantification (POP-Q) point ≥ - 1. Secondary outcome was clinical failure-presence of bulge or prolapse symptoms and either a POP-Q point C ≥ ½ TVL or any POP-Q point >0-and interim surgical re-treatment. Wilcoxon tests and Fisher's exact test were performed. RESULTS: Fifty-eight subjects returned for 5-year follow-up-29 mesh and 29 fascia. Objective anatomic success rates were: mesh, 93% (27/29) and fascia, 62% (18/29) (p = 0.02). Clinical success rates were: mesh, 97% (28/29) and fascia, 90% (26/29) (p = 0.61). CONCLUSIONS: Polypropylene mesh was superior to cadaveric fascia lata using objective anatomic outcomes. Success rates of mesh and fascia were comparable using a clinical definition that combined symptoms with anatomic measures.

Uncomplicated vaginal delivery following midurethral sling.

BACKGROUND: : Delivery mode following midurethral sling remains controversial. There are no formal guidelines as to the preferred mode of delivery following midurethral sling. CASE: : A 33-year-old gravida 2 para 2 underwent midurethral sling placement 16 months after the delivery of her first child for severe stress urinary incontinence (SUI). She conceived 2 months postprocedure and had an uneventful antepartum course. She remained without any SUI and delivered via uncomplicated spontaneous vaginal delivery at 38 weeks' gestation. One year after her delivery, she was still free of SUI symptoms. CONCLUSIONS: : Midurethral sling placement may be a valid treatment option for patients with stress incontinence even if they are contemplating future pregnancies and subsequent vaginal delivery.