Andrew I. Sokol

Vaginal Mesh for Prolapse A Randomized Controlled Trial

OBJECTIVE: To present 3-month outcomes of a double-blind, multicenter randomized controlled trial comparing traditional vaginal prolapse surgery without mesh with vaginal surgery with mesh. METHODS: Women with pelvic organ prolapse quantification prolapse stages 2–4 were randomized to vaginal colpopexy repair with mesh or traditional vaginal colpopexy without mesh. The primary outcome measure was objective treatment success (pelvic organ prolapse quantification stage 1 or lower) at 3 months. Secondary outcome measures included quality-of-life variables and complication rates. RESULTS: Sixty-five women were recruited from January 2007 to August 2009, when the study was halted due to predetermined stopping criteria for vaginal mesh erosion at a median follow-up of 9.7 months (range, 2.4–26.7 months). Thirty-two women underwent mesh colpopexy (24 anterior mesh, eight total mesh), and 33 women had vaginal colpopexies without mesh (primarily uterosacral ligament suspension) and concurrent colporrhaphy. There were no statistically significant baseline differences between the mesh and no-mesh groups with respect to demographics, menopausal status, and race. Analysis of the mesh and no-mesh women found no difference with respect to overall recurrence (mesh: 19 [59.4%] compared with no mesh: 24 [70.4%], P=.28). There were five (15.6%) vaginal mesh erosions. Two cystotomies and one blood transfusion occurred in the mesh group only. Subjective cure of bulge symptoms was noted in 93.3% of mesh patients and 100% of no-mesh patients. Furthermore, subjective quality-of-life measurements did not differ between the two groups at baseline or 3 months postoperatively. CONCLUSION: At 3 months, there is a high vaginal mesh erosion rate (15.6%) with no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540. LEVEL OF EVIDENCE: I

One-year objective and functional outcomes of a randomized clinical trial of vaginal mesh for prolapse

OBJECTIVE The purpose of this study was to show 12-month outcomes of a randomized trial that compared vaginal prolapse repair with and without mesh. STUDY DESIGN Women with stage ≥2 prolapse were assigned randomly to vaginal repair with or without mesh. The primary outcome was prolapse stage ≤1 at 12 months. Secondary outcomes included quality of life and complications. RESULTS All 65 evaluable participants were followed for 12 months after trial stoppage for mesh exposures. Thirty-two women had mesh repair; 33 women had traditional repair. At 12 months, both groups had improvement of pelvic organ prolapse-quantification test points to similar recurrence rates. The quality of life improved and did not differ between groups: 96.2% mesh vs 90.9% no-mesh subjects reported a cure of bulge symptoms; 15.6% had mesh exposures, and reoperation rates were higher with mesh. CONCLUSION Objective and subjective improvement is seen after vaginal prolapse repair with or without mesh. However, mesh resulted in a higher reoperation rate and did not improve 1-year cure.

Single-Incision Mini-Sling Compared With Tension-Free Vaginal Tape for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial.

OBJECTIVE: To compare the efficacy of a single-incision mini-sling, placed in the “U” position, with tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence. METHODS: Women with urodynamic stress incontinence with or without genital prolapse were randomized to receive a mini-sling or TVT (N=263). Those randomized to the mini-sling received two “sham” suprapubic incisions to facilitate blinding. The primary outcome was subjective cure (absence of any urinary incontinence or retreatment) as assessed at 1 year. This trial was a noninferiority study design. RESULTS: Participants receiving the mini-sling were less likely to have a bladder injury (0.8% compared with 4.8%; P=.0.46), more likely to be discharged without a catheter (78.5% compared with 63%; P=.008), and had less pain for postoperative days 1–3. One year after surgery, the rate of cure was similar between treatment groups (mini-sling 55.8% compared with TVT 60.6%; mean difference, 4.8%; 95% confidence interval, −16.7 to +7.2); however, this did not meet our predefined noninferiority criteria of −12%. Incontinence severity at 1 year was greater with the mini-sling than with TVT (mean severity score ± SD: 2.2±2.7 compared with 1.5±1.9; P=.015), resulting predominantly from a higher proportion of participants with “severe” incontinence postoperatively (16% compared with 5%; P=.025). CONCLUSION: The mini-sling placed in the “U” position results in similar subjective cure rates to TVT 1 year after surgery but postoperative incontinence severity is greater with the mini-sling than with TVT. LEVEL OF EVIDENCE: I

Risk factors for conversion to laparotomy during gynecologic laparoscopy.

STUDY OBJECTIVE To identify risk factors and short-term outcomes associated with conversion from laparoscopic surgery to laparotomy. DESIGN Case control study (Canadian Task Force classification II-2). SETTING Large urban, academic medical center. SUBJECTS All 2530 gynecologic laparoscopies, including those converted to laparotomy. INTERVENTION Laparoscopic surgery. MEASUREMENTS AND MAIN RESULTS Statistical analysis was performed to compare risk factors in converted versus non-converted cases. Multiple logistic regression analysis was performed using variables found to be significant on univariate analysis. Of 2530 laparoscopies identified, 159 (6.3%) were converted to laparotomy; 323 were selected by random number assignment from the remaining cases for the control group. The following factors were significantly associated with unintended laparotomy (OR; 95% CI): surgeon inexperience (2.43; 1.38, 4.17), level of laparoscopic complexity (3.19; 1.20, 5.10), body mass index greater than 30 kg/m(2) (2.45; 1.40, 4.41), suspicion of malignancy (17.45; 7.32, 43.57), history of laparotomy (1.34; 1.02, 1.78), presence of adhesions (2.30; 1.37, 3.76), and intraoperative technical difficulty (17.86; 7.32, 43.57). When stratified by level of complexity, experience in laparoscopy does not appear to confer protection during level 1 laparoscopic procedures (0.42; 0.12, 1.37) but does significantly reduce the frequency of conversion during level 2 procedures (0.39; 0.72, 0.93). Age, parity, bowel injury, vascular injury, and history of pelvic inflammatory disease and endometriosis did not increase the risk of conversion. Compared with controls, patients who were converted experienced significantly greater blood loss (p < 0.001), longer operating room time (p < 0.001), and longer hospital stay (p < 0.001). CONCLUSION All women undergoing laparoscopy should be counseled that unintended laparotomy is a known risk and has additional morbidity over laparoscopy alone. Less-experienced surgeons attempting complicated procedures significantly increase the risk of conversion.

Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study

BACKGROUND: There is growing interest in uterine conservation at the time of surgery for uterovaginal prolapse, but limited data compare different types of hysteropexy. OBJECTIVE: We sought to compare 1‐year efficacy and safety of laparoscopic sacral hysteropexy and vaginal mesh hysteropexy. STUDY DESIGN: This multicenter, prospective parallel cohort study compared laparoscopic sacral hysteropexy to vaginal mesh hysteropexy at 8 institutions. We included women ages 35–80 years who desired uterine conservation, were done with childbearing, and were undergoing 1 of the above procedures for stage 2–4 symptomatic anterior/apical uterovaginal prolapse (anterior descent at or beyond the hymen [Aa or Ba ≥ 0] and apical descent at or below the midvagina [C ≥ –TVL/2]). We excluded women with cervical elongation, prior mesh prolapse repair, cervical dysplasia, chronic pelvic pain, uterine abnormalities, and abnormal bleeding. Cure was defined as no prolapse beyond the hymen and cervix above midvagina (anatomic), no vaginal bulge sensation (symptomatic), and no reoperations. Pelvic Organ Prolapse Quantification examination and validated questionnaires were collected at baseline and 12 months including the Pelvic Floor Distress Inventory Short Form, Female Sexual Function Index, and Patient Global Impression of Improvement. In all, 72 subjects/group were required to detect 94% vs 75% cure (80% power, 15% dropout). Intention‐to‐treat analysis was used with logistic regression adjusting for baseline differences. RESULTS: We performed 74 laparoscopic sacral hysteropexy and 76 vaginal mesh hysteropexy procedures from July 2011 through May 2014. Laparoscopic patients were younger (P < .001), had lower parity (P = .006), were more likely premenopausal (P = .008), and had more severe prolapse (P = .02). Laparoscopic procedure (174 vs 64 minutes, P < .0001) and total operating time (239 vs 112 minutes, P < .0001) were longer. There were no differences in blood loss, complications, and hospital stay. One‐year outcomes for the available 83% laparoscopic and 80% vaginal hysteropexy patients revealed no differences in anatomic (77% vs 80%; adjusted odds ratio, 0.48; P = .20), symptomatic (90% vs 95%; adjusted odds ratio, 0.40; P = .22), or composite (72% vs 74%; adjusted odds ratio, 0.58; P = .27) cure. Mesh exposures occurred in 2.7% laparoscopic vs 6.6% vaginal hysteropexy (P = .44). A total of 95% of each group were very much better or much better. Pelvic floor symptom and sexual function scores improved for both groups with no difference between groups. CONCLUSION: Laparoscopic sacral hysteropexy and vaginal mesh hysteropexy had similar 1‐year cure rates and high satisfaction.

Short-term outcomes of robotic versus conventional laparoscopic sacral colpopexy.

Objective This study aimed to compare operative times and short-term outcomes between robotic and laparoscopic sacral colpopexy. Methods A retrospective cohort study using a convenience sample was performed comparing patients who underwent robotic and laparoscopic sacral colpopexy during a 4-year period. Operative time, blood loss, perioperative complications, and objective cure of prolapse at 3 months were compared. Results Robotic procedures in 65 women and laparoscopic sacral colpopexy procedures in 23 women were performed. Median preoperative prolapse was stage 3 for both groups. There was no statistically significant difference in the median operative time between the robotic and laparoscopic groups, although this did not include robot setup time and did include concurrent procedures that differed significantly between groups (334 vs 325 minutes, P = 0.30). Estimated blood loss was lower in the robotic group (50 vs 100 mL, P = 0.003). Median hospital stay was 1 day in both groups (P = 0.23). There were no differences in overall objective cure rates between robotic and laparoscopic groups at 3 months of follow-up (87.1% vs 91.3%, P = 0.72). Perioperative complications, including visceral injury and mesh erosion, did not differ significantly between these groups. Conclusions Robotic and laparoscopic sacral colpopexy had similar operative times, short-term anatomic cure rates, perioperative complications, and length of hospital stay.

Risk factors for prolapse development in white, black, and hispanic women

Objectives: This study aimed to examine the risk factors for prevalence and incidence of pelvic organ prolapse (POP) in whites, Hispanics, and blacks. Methods: This is a secondary analysis of the Womens Health Initiative (WHI) Estrogen plus Progestin Clinical Trial (E + P). Of the original E + P trial population of 16,608, 12,667 women (78.3%; 11,194 whites, 804 blacks, and 669 Hispanics) were included in the final study sample and evaluated during the 5-year period. The outcomes evaluated were any prolapse (WHI prolapse grades 1-3) and WHI prolapse grade 2 or 3. Descriptive analyses, logistic regression, and proportional hazard modeling were performed. Results: Increasing parity correlates with increasing WHI prolapse grades (0-3) in whites and blacks but not Hispanics. The incidence of grade 2 or 3 POP increased by 250% in white women with 1 child (hazard ratio [HR], 2.50; 95% confidence interval [CI], 1.68-3.71) in comparison to nulliparous women and grew with higher parity. For blacks, a weak association between the parity and grade 2 or 3 POP was noted only in women who had 5 or more kids (HR, 10.41; 95% CI, 1.38-78.77). Blacks were less likely (HR, 0.53; 95% CI, 0.40-0.71) to develop grade 2 or 3 POP compared with whites. For grade 2 or 3 POP, age was found to be a risk factor in whites (odds ratio [OR], 1.03; 95% CI, 1.02-1.04) only and body mass index (≥25 kg/m2, <30 kg/m2) in whites (OR, 1.64; 95% CI, 1.34-2.02) and Hispanics (OR, 2.87; 95% CI, 1.03-2.02). Conclusions: White women are at a much greater risk for developing grade 2 or 3 POP compared with blacks. Parity correlates most strongly with the risk of prolapse development in whites and possibly in grand multiparous blacks.

Resident opinions on vaginal hysterectomy training.

Objectives: The purpose of this study was to explore resident opinions about vaginal hysterectomy training and to evaluate future practice patterns and impediments to continuing vaginal hysterectomies after graduation. Methods: An anonymous survey was e-mailed to fourth-year gynecology residents before graduation. The survey assessed opinions on vaginal hysterectomy training and future practice plans. Results: One hundred eighty-three residents responded from 41 states. Most residents (75%) think vaginal hysterectomy training has been adequate to prepare them for future practice. Residents were more likely to respond that their training was adequate if they had performed more than 20 vaginal hysterectomies and if they had learned morcellation techniques. Only 42% of residents report vaginal route as their preferred route for hysterectomy. Conclusions: Most residents feel that training in vaginal hysterectomy has been adequate to prepare them for their future practice, although they are more likely to feel prepared if they have performed more than 20 vaginal hysterectomies.

Age-specific variation in aneuploidy incidence among biochemical screening programs

OBJECTIVE Our purpose was to compare the observed age-related incidence of Down syndrome in two large screening programs with the commonly quoted incidences used in biochemical screening programs. STUDY DESIGN Data from two large prenatal screening programs were stratified in 5-year age groups. The age-related incidence of Down syndrome was compared with the commonly used incidence as reported by Cuckle. RESULTS No significant differences were found in age-related incidences of Down syndrome in any age group between the screening groups or among women ages 15 through 29 in any of the three groups. However, for women 30 to 34 and > or = 40 years old, a trend was noted toward a higher incidence in the screening groups. For women ages 35 to 39, the observed incidence was significantly greater in the screening groups compared with the data of Cuckle. CONCLUSION Our data suggest an underascertainment in Down syndrome risk built into the Cuckle model, particularly in high-risk patients.

Transvaginal Versus Transabdominal Placement of Synthetic Mesh at Time of Sacrocolpopexy

Objectives Our primary aim was to compare mesh-related complications at the time of total vaginal hysterectomy with laparoscopic sacrocolpopexy (TVH-LSC) versus laparoscopic placement of sacrocolpopexy mesh at time of laparoscopic supracervical hysterectomy (LSH-LSC). Our secondary aim was to compare operative time, intraoperative and postoperative complications, as well as subjective and objective success between these groups. Methods We performed a retrospective cohort study with prospective follow-up for patients with uterovaginal prolapse who underwent TVH-LSC or LSH-LSC from June 2008 to July 2012. We collected baseline demographics, mesh-related complications, intraoperative and postoperative complications, and pelvic organ prolapse quantification data. We contacted patients postoperatively for telephone interviews and to request a return to the office for repeat examination. Results One hundred eighty-two patients were included: 123 TVH-LSC and 59 LSH-LSC. There was no difference in the rate of mesh-related complications (1.6% [2/123]; 95% confidence interval, 0–3.86% vs 1.7% [1/59]; 95% confidence interval, 0–4.99%; P = 1.0). Median examination follow-up was similar between groups (9 (2–17) months TVH-LSC vs 9 (2–17) months LSH-LSC, P = 1.0). The TVH-LSC was associated with a significantly shorter operative time (256 ± 53 vs 344 ± 81 minutes; P < 0.01). There were no differences in intraoperative or postoperative complications or subjective and objective success between groups. Conclusions There was no difference in mesh-related complications between groups (1.6% TVH-LSC vs 1.7% LSH-LSC; P = 1.0). Vaginal mesh attachment during TVH-LSC decreased operative time by over 1 hour with no differences in intraoperative complications, reoperation for recurrent prolapse, and subjective or objective outcomes compared to LSH-LSC.