Linda Blackwell

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

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.

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.

Effect of anesthesia on voiding function after tension-free vaginal tape procedure.

OBJECTIVE To determine whether the mode of anesthesia used during the tension-free vaginal tape procedure affects postoperative voiding function. METHODS A retrospective cohort study was performed using cases in which tension-free vaginal tape placement was the sole procedure performed. Of the 173 cases reviewed, we were able to use the data from 163. Hierarchal linear regression was used to identify independent predictors of our dependent variable: days to complete voiding. In the first block, established predictors of postoperative voiding dysfunction were entered into the model. In the second block, potential confounders of the relationship between anesthesia type and days to complete voiding identified during univariate analysis (P < .15) were entered into the model. In the third block, anesthesia type was entered into the model to determine whether it added any unique variance after controlling for previously established predictors of postoperative voiding dysfunction. RESULTS The mean days to complete voiding was similar in our local or regional anesthesia (n = 90) and general anesthesia groups (n = 73) (2.3 [0–21] versus 2.3 [0–14], P = 95). Our final regression model (F = 2.74, P = .011) included age, prior pelvic organ prolapse surgery, and preoperative urge symptoms and explained 22.2% of the variance in days to complete voiding. Anesthesia type did not add any predictive improvement after controlling for these variables. CONCLUSION General anesthesia, and therefore lack of a cough-stress test, does not increase the chance of postoperative voiding dysfunction associated with tension-free vaginal tape.

Proteomic techniques identify urine proteins that differentiate patients with interstitial cystitis from asymptomatic control subjects

OBJECTIVE The purpose of this study was to identify differences in urine proteins between patients with interstitial cystitis (IC) and asymptomatic control (AC) subjects with the use of proteomic techniques. STUDY DESIGN Nine patients with IC and their age-, race-, and sex-matched AC subjects volunteered a urine specimen. Urine proteins were separated with the use of 2-dimensional polyacrylamide gels. Differing proteins underwent digestion and matrix-assisted laser desorption ionization-time of flight mass spectrometry. Computer-assisted data analysis was used to identify the corresponding protein. Differences in urine protein responses between patients with IC and AC subjects were evaluated by the Mann-Whitney U test to account for the nonnormal frequency distribution of the parameter estimate or chi-square when data were bimodal. RESULTS Four proteins differed significantly between patients with IC and AC subjects. The AC subjects had a greater concentration of a uromodulin (P = .019) and two kininogens (P = .023, .046). The patients with IC had a greater concentration of inter-alpha-trypsin inhibitor heavy chain H4 (P = .019). CONCLUSION These urine protein isoforms may be biomarkers for IC.

Prevalence and severity of urinary incontinence in kidney transplant recipients.

OBJECTIVE: To estimate the prevalence and severity of urinary incontinence and its impact on activities of daily living in kidney transplant recipients. METHODS: The continence status, severity, and impact of urinary incontinence on activities of daily living in female kidney transplant recipients was studied by using Sandviks Incontinence Severity Index and the Incontinence Impact Questionnaire. Clinical and sociodemographic data from post-transplant incontinent and continent participants were compared by using χ2, Student t, and Mann-Whitney U tests. RESULTS: One hundred of 123 female kidney transplant recipients completed the survey for a response rate of 81.3%. The prevalence of urinary incontinence in female kidney transplant recipients was 28%. The mean Sandviks Incontinence Severity Index score was 5.1 (median 3.5; 95% confidence interval 3.6, 6.6). The mean Incontinence Impact Questionnaire score was 12.9 (median 4.8; 95% confidence interval 6.7, 18.9). Incontinent kidney transplant recipients recorded a greater daily fluid intake on their 3-day diaries than continent kidney transplant recipients (2,951.9 ± 1,228.6 mL compared with 1,854.6 ± 614.8 mL, P = .04). CONCLUSIONS: The prevalence rate of urinary incontinence from interviewed kidney transplant recipients was 28%, which had minimal impact on activities of daily living and may not be predicted by a history of incontinence before kidney failure. LEVEL OF EVIDENCE: II-3

Comorbidities affect the impact of urinary incontinence as measured by disease-specific quality of life instruments.

The aim of this study was to determine if the impact of urinary incontinence on activities of daily living, as measured by a disease-specific quality of life instrument, is dependent on comorbid conditions. Incontinent kidney transplant recipients participated in a survey to determine the impact of urinary incontinence on activities of daily living using the Incontinence Impact Questionnaire (IIQ-7). Similar information was collected from the charts of nontransplant incontinent women. Participants were matched for age, incontinence severity, pads per day, and leaks per day noted in a 3-day 24-h bladder diary. IIQ-7 scores from participants were compared using Mann-Whitney U tests. Nontransplant incontinent women reported a 200% greater affect of incontinence on activities of daily living than incontinent renal transplant recipients (35.5±26.5 vs 12.9±15.4, p<0.0001) despite similarities in incontinence severity measures. Urinary incontinence has less of an impact on activities of daily living for renal transplant recipients than nontransplant incontinent women with similar incontinence severity measures because the disease-specific quality of life instrument used in this study was sensitive to their comorbid condition (transplant status).

Measuring the utility of incontinence care seeking

The purpose of this study was to establish the structure and factor validity of an expectation questionnaire and estimate its reliability in an ethnically heterogeneous incontinent female population. CATIs were conducted on a nonprobability sample of 275 incontinent women to assess the likelihood of a specific outcome of incontinence care seeking. Principal component and confirmatory factor analysis were performed to estimate factor loadings and establish the fit of the expectation questionnaire. Cronbach’s alpha coefficients were estimated to establish the reliability of the final expectation questionnaire. Six items loaded on a control factor (factor loadings 0.502–0.806). The control item with the highest loading was “I would be able to resume my normal activities” (r = 0.806). Four items loaded on an internalized fear/anxiety factor (factor loadings 0.449–0.497). The internalized fear/anxiety item with the highest loading was “I would be told it was caused by something I had done in my past” (r = 0.485). Two items loaded on an externalized fear/anxiety factor (factor loadings 0.553–0.726). The externalized fear/anxiety item with the highest loading was “I would be referred to a specialist” (r = 0.553). A χ2/df value of 1.70, goodness-of-fit index of 0.95, comparative fit index of 0.95, and a root mean square error of approximation of 0.050 (probability of close fit of 0.463) established the fit of our final expectation questionnaire. Cronbach’s alpha coefficient for the final 12-item expectation questionnaire was 0.56. The 12-item expectation questionnaire is a valid and reliable tool for measuring utility of incontinence care seeking in an ethnically heterogeneous incontinent female population.

A randomized, controlled trial comparing fascia lata and synthetic mesh for sacral colpopexy

One hundred women with posthysterectomy vaginal vault prolapse who were scheduled for sacral colpopexy at the University of Louisville Health Sciences Center participated in this double-blind, randomized trial comparing the use of cadaveric fascia lata and polypropylene mesh. The Pelvic Organ Prolapse Quantification system (POP-Q) was used for patient evaluation preoperatively and at 3 months, 6 months, and 1 year postoperatively. Fascial lata was used in 46 patients and polypropylene mesh was used in 54. Eighty-nine women, 44 in the fascia group and 45 in the mesh group, completed the 1-year study period. The 2 groups were similar in social demographics, clinical characteristics, and operative data. Adverse events possibly related to the graft were experienced by 26% of women who received mesh and 15% of women who received fascia (P = .19). Other surgical procedures, in tension-free tape procedures, posterior repairs, and paravaginal repairs were performed frequently and at similar rates in the 2 groups. At the 1-year examination, the rate of objective anatomic failure, as defined by Weber et al, was greater in the women who received fascia (14 of 44; 32%) compared with those who received mesh (4 of 45; 9%) (P = .007). There were 15 instances of POP-Q point Aa (point along the distal anterior vaginal wall) and 3 of POP-Q point Ap (posterior vaginal wall) reaching at least the -1 position. There were no point C (vaginal cuff) failures. The results of the POP-Q evaluations changed over the year of observation. At the end of 12 months, significant differences in between the 2 groups were seen for the mean values of point Aa (P = .02), point C (P = .04), and prolapse stage (P = .03). No differences were seen in total vaginal length, genital hiatus, perineal body, or points Ap or Bp (points along the posterior vaginal wall). When risk factors for surgical failure of sacral colpopexy, other than graft material (age, body mass index, prior prolapse or continence surgery), were subjected to univariate analysis, no significant predictors of failure were seen.

Effect of anesthesia on voiding function after a tension-free vaginal tape procedure

This study was conducted to determine the difference in outcome of tension-free vaginal tape placement under local or regional anesthesia, which enables the surgeon to perform the cough-stress test while placing the vaginal tape, versus general anesthesia, which permits only an approximate placement of the tape. The authors reviewed the medical records of 173 women with urodynamically proven genuine stress incontinence who underwent tension-free vaginal tape placement alone with no other procedures performed. The data from these records was used to develop a statistical model using hierarchical linear regression. The first block included known risk factors for postoperative voiding dysfunction. The second added potential confounding variables, including surgeon, prior surgery, preoperative irritative bladder symptoms, blood loss, and urodynamic evaluation results. The third block incorporated anesthesia type into the model. Information was sufficient for analysis in 163 patients, of whom 90 had regional or local anesthesia and 73 had general anesthesia. The 2 groups were similar in age and clinical characteristics. Eight women in the local or regional anesthesia group and 6 in the general anesthesia group experienced introa- or postoperative complications, which included 1 retropubic hematoma, 1 instance of postoperative pseudomembranous colitis, 1 erosion, and 11 bladder perforations. All perforations healed with 3 days of Foley catheterization. Both groups had achieved complete voiding in an average of 2.3 days, but the range for the local or regional anesthesia was 0-21 days and the range for general anesthesia was 0-14 days. Univariate analysis of all possible confounding factors found surgeon, prior surgery, preoperative irritative symptoms. maximum cotton swab deflection, Valsalva void, and maximum flow rate to be significant at P <.15. Analysis of these variables accounted for 22.2% of the difference in days to complete voiding. Analysis, including the type of anesthesia, found no influence on postoperative voiding or any interaction of anesthesia type with other variables. The final model found predictive significance only for age, prior pelvic reconstructive surgery for pelvic organ prolapse, and preoperative irritative symptoms, all factors which had been previously identified as having predictive value for postoperative voiding dysfunction.