Patrick J. Culligan

A Randomized Controlled Trial Comparing Fascia Lata and Synthetic Mesh for Sacral Colpopexy

Objective: To compare the objective anatomic outcomes after sacral colpopexy performed with cadaveric fascia lata and polypropylene mesh. Methods: Patients undergoing a sacral colpopexy were randomized to receive either fascia lata or polypropylene mesh in a double-blinded fashion. Data were collected at 6 weeks, 3 months, 6 months, and 1 year postoperatively. The main outcome measures were pelvic organ prolapse quantification (POP-Q) system stage and individual POP-Q points over time. Objective anatomic failure was defined as POP-Q stage 2 or more at any point during the follow-up period. Proportions of patients with objective anatomic failure at 1 year in each group were compared using the &khgr;2 test. Mean POP-Q points and stage at 1 year were compared by using the independent samples t test. Results: One hundred patients were randomized to receive either fascia (n = 46) or mesh (n = 54). Of the 89 patients returning for 1-year follow-up, 91% (41/45) of the mesh group and 68% (30/44) of the fascia group were classified as objectively cured (P = .007). We found significant differences between the mesh and fascia groups with respect to the 1-year postoperative comparisons of points Aa, C, and POP-Q stage. There were no differences between the 2 groups with respect to points TVL (total vaginal length), GH (genital hiatus), PB (perineal body), Ap or Bp (2 points along the posterior vaginal wall). Conclusions: Polypropylene mesh was superior to fascia lata in terms of POP-Q points, POP-Q stage, and objective anatomic failure rates. Level of Evidence: I

Predicting treatment choice for patients with pelvic organ prolapse

OBJECTIVE To evaluate which clinical factors were predictive of treatment choice for patients with pelvic organ prolapse. METHODS One hundred fifty-two patients were enrolled in this cross-sectional study to collect clinical data on potential predictors of treatment choice. Continuous parametric, continuous nonparametric (ordinal), and categoric data were compared with chosen management plan (expectant, pessary, surgery) using analysis of variance, the Kruskal–Wallis test, and the χ2 test for association, respectively. All significant predictors (P < .05) of treatment choice for pelvic organ prolapse identified during univariate analysis were entered into a backward elimination polytomous logistic regression analysis for predicting surgery versus pessary versus expectant management, with surgery as the reference group. RESULTS The probability of choosing expectant management rather than surgery 1) increases as the preoperative pelvic pain score increases (odds ratio [OR] 1.6; 95% confidence interval [CI] 1.07, 2.40; P = .024) and 2) decreases as the prolapse severity increases (OR 0.46; 95% CI 0.29, 0.72; P = .001). The probability of choosing pessary rather than surgery 1) increases as age increases (OR 1.1; 95% CI 1.05, 1.16; P < .001), 2) decreases as the prolapse severity increases (OR 0.77; 95% CI 0.60, 0.99; P = .042), and 3) is less if the participant had prior prolapse surgery (OR 0.23; 95% CI 0.07, 0.76; P = .017). CONCLUSION Age, prior prolapse surgery, preoperative pelvic pain scores, and pelvic organ prolapse severity were independently associated with treatment choices in a predictable way and provide physicians with medical evidence necessary to support a patients decision.

Anterior or posterior sacrospinous vaginal vault suspension: long-term anatomic and functional evaluation

OBJECTIVE To compare vaginal anatomy and sexual function after the conventional posterior and anterior sacrospinous vault suspension. METHODS A retrospective repeated measures cohort study included all 168 consecutive sacrospinous vault suspension procedures between July 1990 and February 1997. The posterior suspension (n = 92) used a posterior vaginal incision and pararectal dissection. Anterior suspension (n = 76) involved an anterior rather than posterior vaginal incision, retropubic perforation, and dissection of a paravaginal‐paravesical rather than pararectal space to accommodate the vaginal vault. Two polytetrafluoroethylene (00) sutures anchored the anterior vaginal cuff (for the anterior sacrospinous suspension) or the posterior vaginal cuff (for the posterior sacrospinous suspension) to the ligament. Postoperative evaluation included an examination using the pelvic organ prolapse quantitative system, assessment of vaginal width and axis, and symptom questionnaire. RESULTS Total vaginal length and apical suspension were slightly greater after the anterior suspension, and recurrent anterior vaginal relaxation was less likely. No differences were found in maximal dilator size or apical narrowing between the two groups. New onset dyspareunia was reported by two subjects in the anterior vault suspension group, and two in the posterior vault suspension group. Three of these four cases of de novo dyspareunia were attributable to either severe atrophy or recurrent prolapse, and none to vaginal narrowing or shortening. CONCLUSION After anterior sacrospinous vault suspension, vaginal length and apical suspension were slightly increased, and recurrent anterior vaginal prolapse decreased compared with the posterior sacrospinous suspension technique. Upper vaginal caliber and sexual function appear well preserved using either technique.

Is Pelvic Organ Prolapse a Cause of Pelvic or Low Back Pain

OBJECTIVE To test the null hypothesis that there is no association between pelvic organ prolapse and pelvic or low back pain. METHODS A total of 152 consecutive patients with pelvic organ prolapse completed a visual faces scale to quantify the amount of pelvic or low back pain present. Pelvic organ prolapse severity was graded by three techniques: 1) pelvic organ prolapse quantification staging; 2) descent of the leading edge of prolapse; and 3) dynamic cystoproctography. Linear and nonlinear associations of pelvic organ prolapse quantification staging, descent of the leading edge of prolapse, and dynamic cystoproctography findings with pelvic or low back pain were assessed. We also characterized the nature of any significant nonlinear associations. RESULTS Descent of the leading edge of prolapse was linearly associated with low back pain. Patients with greater descent of the leading edge of their prolapse reported less low back pain (r = −0.176, P = .034). Bladder descent during dynamic cystoproctography was nonlinearly associated with low back pain (P = .037). Neither of these associations was statistically significant after controlling for patient age and prior prolapse surgery. There were no linear or nonlinear associations between pelvic organ prolapse and pelvic pain. CONCLUSION Based on the data, pelvic organ prolapse is not a cause of pelvic or low back pain.

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

Introduction and hypothesisThe 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.MethodsAll 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.ResultsFifty-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).ConclusionsPolypropylene 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.

Rupture of the symphysis pubis during vaginal delivery followed by two subsequent uneventful pregnancies.

BACKGROUND Rupture of the symphysis pubis during vaginal delivery is a rare but debilitating complication. Factors contributing to rupture are poorly defined. CASE A healthy primigravida suffered a rupture of her symphysis pubis during an otherwise uncomplicated vaginal delivery. She experienced significant pain and difficulty walking for 6 months after the injury. Her 5-cm symphyseal separation was managed successfully with physical therapy and activity restriction. The patients two subsequent deliveries (one vaginal and one via cesarean delivery) were uneventful. CONCLUSION Severe symphyseal rupture during vaginal delivery can be managed without surgery. Risk factors for rupture are not well defined. Based on a literature review, there is a significant risk of repeat symphyseal rupture with subsequent vaginal delivery.

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 (&agr; = 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.

Nonsurgical Management of Pelvic Organ Prolapse

Although surgical management of symptomatic pelvic organ prolapse (POP) is common and often necessary, conservative treatments such as pessaries, pelvic floor muscle training, or both can usually result in symptomatic improvement. When treating patients with POP, health care practitioners should focus primarily on identification and alleviation of POP-related symptoms. It is appropriate to offer nonsurgical management to most people with POP. This article reviews the objective and subjective evaluation and nonsurgical management of POP, emphasizing a simple, practical approach to pessary fitting and management.

A randomized controlled trial comparing a modified Burch procedure and a suburethral sling: long-term follow-up

The aim of this study was to compare the long-term results of a modified Burch procedure with a sling procedure for the treatment of stress incontinence with a low-pressure urethra. Thirty-six women with urodynamic stress incontinence, low-pressure urethra, urethral hypermobility and no significant pelvic organ prolapse were randomly assigned to undergo either a modified Burch procedure (n=19) or a sling placement (n=17). Cure of the stress incontinence (defined as a negative stress test and negative pad-weight test) was the primary long-term endpoint. Secondary endpoints included subjective cure of stress incontinence (defined as no incontinence episodes on a 1-week voiding diary) and voiding function studies. Comparisons of group means were performed with the Mann–Whitney U-test, pooled variance t-tests and separate variance t-tests. Proportions were compared with Fishers exact test. A logistic regression analysis was performed to control for covariates that differed in our two groups despite randomization. Long-term follow-up (mean=72.6 months) was available for 82% (28/34) of the original study group. The objective cure rates for the Burch and sling groups were 84.6% and 100%, respectively (P=0.17). Mean uroflowmetry rates for the Burch and sling groups were 7.38 and 6.8 ml/s, respectively (P=0.58, 95%CI −2.5, 4.4). Mean postvoid residual volumes for both groups were 35 ml (P=0.97, 95% CI −23.8, 65.9). Two sling patients (12%) required partial resection of their slings because of erosion. Both patients remained continent. In terms of voiding function and stress incontinence cure, there were no differences between groups undergoing modified Burch or sling procedures for treatment of urodynamic stress incontinence with low-pressure urethra.

Bacterial Colony Counts During Vaginal Surgery

Objective: To describe the bacterial types and colony counts present before and during vaginal surgery. Methods: A descriptive study was undertaken of patients undergoing vaginal hysterectomy with or without reconstructive pelvic surgery. Aerobic and anaerobic bacterial cultures were obtained immediately before and throughout the surgical cases at preselected time intervals. Standard antimicrobial prophylaxis was administered in all cases. Mean total colony counts and mean anaerobic colony counts were determined by adding all colonies regardless of bacteria type. ‘Contamination’ was defined as ≥ 5000 colony-forming units/ml. Results: A total of 31 patients aged 26 to 82 years (mean age ± SD, 51 ± 15) were included. The highest total and anaerobic colony counts were found at the first intraoperative time interval. On the first set of cultures (30 minutes after the surgical scrub), 52% (16/31) of the surgical fields were contaminated, and at 90 minutes, 41% (12/29) were contaminated. A negligible number of subsequent cultures were contaminated. Conclusions: Any future interventions designed to minimize bacterial colony counts should focus on the first 30 to 90 minutes of surgery.