Carol A. Graham

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.

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.

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.

Predicting Treatment Choice for Patients With Pelvic Organ Prolapse

This study was conducted to identify clinical factors that are predictive of treatment choice for pelvic organ prolapse. One hundred forty-six women diagnosed with pelvic organ prolapse were educated about their conditionand possible treatments before being offered one of three different treatment choices: expectant management (any choice other than pessary or surgery, including pelvic muscle exercises), pessary, or surgery. Data were recorded for all factors that might be predictors of treatment choice, including age (mean, 62 years); weight (mean body mass index, 26.5); vaginal parity (mean, 3.23); history of incontinence and prolapse surgery; pelvic and lower back pain scores; pelvic organ prolapse severity; pain medication use; prior hysterectomy; presence of cystocele, rectocele, enterocele, or uterovaginal-vaginal vault prolapse on examination; and presence of ovaries. Prior surgery included hysterectomy 68.5%, prolapse surgery 32.9%, and incontinence procedures 43.2%. The ovaries were intact in 71% of patients. Approximately 40% of participants reported no lower back or pelvic pain. Lower back and pelvic pain scores, as measured on a scale of 1 to 5 based on facial expressions, were at level 1 for 15% and 18% of participants, and at level 2 for 30% and 21% of participants, respectively. Ten percent of patients reported level 3 pain in both lower back and pelvic area, and lower back and pelvic pain were reported by approximately 5% each in both level 4 and level 5. Cystoceles were diagnosed in 65% of the women, rectoceles in 41%, enteroceles in 55%, and uterovaginal-vaginal vault in 88% of women. Nearly two thirds of the women (65%) were diagnosed with cystocele, 41% and 55% had rectocele and enterocele, respectively, and most (88%) had uterovaginal-vaginal vault prolapse with the leading edge descending a mean 2.2 cm beyond the introitus. Pelvic organ prolapse quantification (POP-Q) system scores were stage I in 4.8% of patients, stage II in 29.7%, stage III in 53%, and stage IV in 2.1% of patients. Overall, expectant management was the treatment choice for 11% of the participants, 19.4% chose pessary, and 69.4% elected to be treated with surgery. Factors that attained a significant influence in the choice of treatment were age (P <0.001), enterocele (P = 0.004), lower back pain (P = 0.040), pelvic pain (P = 0.022), descent of leading edge of prolapse (P = 0.002), and POP-Q stage (P <0.001). These factors were used for logistic regression analysis comparing expectant management and pessary with surgery. The chance of a patient choosing expectant management over surgery improved as the pelvic pain score increased (odds ratio [OR], 1.6; P = 0.024), but decreased with greater descension of the leading edge of prolapse (OR, 0.46; P = 0.001). The likelihood of choosing pessary over surgery increased with age (OR, 1.1; P <0.001) but decreased with increased length of prolapse descension (OR, 0.77; P = 0.0420), and decreased with prior prolapse surgery (OR, 0.23; P = 0.017). A regression model was developed for predicting management choice: expectant management versus surgery; y = 0.47 (pelvic pain score) - 0.78 (descent of leading edge of prolapse) - 2.04: pessary versus surgery; y = 0.096 (age) - 0.26 (descent of leading edge of prolapse) - 1.48 (prior prolapse surgery) - 6.381.

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.