Shifts in Vaginal Bacterial Community Composition Are Associated With Vaginal Mesh Exposure.

OBJECTIVE: The objective of this study was to evaluate the relationship between vaginal mesh exposure and vaginal bacterial community composition. METHODS: Vaginal swab samples were collected from 13 women undergoing excision of vaginal mesh with vaginal mesh exposure. Samples were collected at the midvagina, site of exposure, and underneath the vaginal epithelium at the exposure. Control samples were collected vaginally during 15 new patient examinations. For all samples, we extracted genomic DNA and polymerase chain reaction amplified and sequenced the 16S rRNA gene V4 region. We tested for differences in the microbiota among control and exposure samples with PERMANOVA tests of beta diversity measures (Morisita-Horn dissimilarity) and Wilcoxon rank sum tests of Lactobacillus distribution. RESULTS: Vaginal bacterial communities in both control and case groups were divided into 2 primary community types, one characterized by Lactobacillus dominance (>50% of community) and the other by low Lactobacillus and a high diversity of vaginal anaerobes. In 10 of 13 case women, bacterial communities were highly similar between the 3 vaginal sites (adonis R2 = 0.86, P = 0.0099). In the 3 women with community divergence, all 3 were characterized by decreased Lactobacillus abundance at the exposure site. Overall, Lactobacillus abundance was lower at the site of mesh exposure and under the epithelium than in the experimental control (W = 137, P = 0.072, r = 0.41; W = 146, P = 0.025, r = 0.50). Common putative pathogenic mesh colonizing bacteria were common (in 51 of 54 samples), but generally not abundant (median relative abundance = 0.014%). CONCLUSIONS: In vaginal mesh exposure cases, a woman is more likely to have a diverse, non-Lactobacillus-dominant community.

Comparative analyses of attitude, knowledge, and recollection of preoperative counseling regarding pelvic mesh among women with or without a mesh-related complication.

PURPOSE: Our objective was to compare the recollection of preoperative counseling regarding mesh for pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI) among women with or without a mesh-related complication (MRC). We hypothesized that the patients who had MRC would better recollect counseling regarding complications associated with mesh. METHODS: We conducted a retrospective cohort study among women who had prior implantation of synthetic, non-absorbable mesh for POP and/or SUI at least 3 months prior who presented with or without a MRC. The primary outcome was the proportion of women who recalled being counseled preoperatively about the risk of mesh exposure. RESULTS: Ninety-six women were included in the final analysis (50 MRC; 46 no MRC). MRC women presented further in time from the index surgery [median 69 months [IQR 26-115] vs 12 months (IQR 6-64), p < 0.01]. After adjustment for time since surgery and age, MRC women were significantly less likely to recall being counseled about the possibility of any MRC [19/50 (38%) vs 32/44 (73%), aOR 0.29, 95% CI 0.11-0.79, p = 0.01]. They were also less likely to report they would undergo the same surgery again 5-point Likert scale [median 3 (IQR 1-4) vs 5 (IQR 3-5), 5-point Likert scale, p < 0.01], less satisfied with their mesh surgery [median 1 (IQR 1-3) vs 5 (IQR 3-5), 5-point Likert scale, p < 0.01] and recommended improved preoperative counseling [27/50 (54%) vs 6/46 (13%), p < 0.01]. CONCLUSION: Women who experienced MRC were less likely to recall being counseled about the possibility of MRC and report more unmet needs regarding perioperative counseling than women without MRC.

Return to Baseline Functional Status in Older Women Undergoing Surgery for Pelvic Organ Prolapse.

OBJECTIVE: The aim of the study was to determine the rate of return to baseline functional status 3 months after surgery for pelvic organ prolapse (POP) in women 65 years or older. METHODS: This is a multicenter prospective cohort study of women older than 65 years undergoing POP surgery. Functional status was determined by the Activities Assessment Scale at the preoperative visit and 3 months after surgery. We compared a variety of clinical variables and preoperative functional status scores for women who worsened, improved, or returned to baseline functional status after surgery using univariable and multivariable analysis. RESULTS: A total of 192 women were enrolled in the study. Of 176 women who completed both sets of questionnaires, 59% improved, 35% returned, and 6% worsened from their baseline functional status. Variables significantly associated with postoperative functional status score were depression (P < 0.002) and preoperative functional status score (P < 0.001). The group that improved from baseline had the lowest (worst) preoperative functional status score (78.7 ± 16.4), whereas the group that worsened after surgery had the highest (best) preoperative functional status score (98.6 ± 2.2). After adjusting for age and depression, higher preoperative functional status score was predictive of failure to return to baseline functional status. CONCLUSIONS: Most older women undergoing surgery for POP, including those with low preoperative functional status, return to or improve from their baseline functional status within 3 months of surgery. Women with higher functional status before surgery are less likely to report improvement in physical functioning after surgery.

The Impact of Fluoroscopy During Percutaneous Nerve Evaluation on Subsequent Implantation of a Sacral Neuromodulator Among Women With Pelvic Floor Disorders: A Randomized, Noninferiority Trial.

OBJECTIVES: To evaluate whether percutaneous nerve evaluation (PNE) without fluoroscopy is inferior to fluoroscopy use in women undergoing trials of sacral neuromodulation (SNM) for pelvic floor disorders (PFDs). MATERIALS AND METHODS: In an unblinded noninferiority trial, women undergoing PNE were randomized to fluoroscopy or no fluoroscopy. The primary outcome was "success" and defined as implantation of the permanent SNM device within three months of PNE. At an expected 40% success and a 30% noninferiority threshold, 33 participants in each group were needed for 80% power (α = 0.05). Univariate analyses and a logistic regression model adjusting for univariate variables associated with the primary outcome were performed. RESULTS: From April 2016 to December 2018, 74 participants underwent PNE of which 36 underwent PNE with fluoroscopy and 38 without. The fluoroscopy group had less baseline mean daily voids compared to the no fluoroscopy group (10.79 ± 6.48 vs. 16.21 ± 10.05, p = 0.01). PNE performed without fluoroscopy had similar success (18/38, 47.4%) compared to fluoroscopy (21/36, 58.3%), meeting our noninferiority definition (difference 10.9%, 90% CI -8% to 30%, p = 0.049). In a logistic regression model adjusting for age, Charlson comorbidity index, stage of prolapse, and number of baseline voids per day, trial success was still similar between the two groups (adjOR 1.82, 95% CI 0.52 to 6.94, p = 0.36). CONCLUSIONS: PNE performed without fluoroscopy is noninferior to PNE with fluoroscopy use for the outcome of SNM device implantation within three months among women undergoing therapy for PFDs.

The Accuracy of Portable Ultrasound Bladder Scanner Measurements of Postvoid Residual Volume in Women With Pelvic Organ Prolapse.

OBJECTIVES: The purpose of this study was to evaluate the accuracy of portable bladder scanner postvoid residual (PVR) volume measurements in patients with pelvic organ prolapse. A secondary goal was to determine whether covariates such as bladder volume and stage of prolapse affect bladder scanner accuracy. STUDY DESIGN: Complex urodynamic studies were performed on 70 patients with stage II or greater prolapse. Complex urodynamic studies included measurement of maximum bladder capacity (MBC) as well as measurement of PVR by urethral catheterization before, and following, complex filling cystometry. For each catheterized PVR, a corresponding bladder scanner measurement was obtained; the primary outcome was the difference between these measurements. In addition, bladder scanner measurements of MBC were compared with MBC by urodynamic pump. Measurements were compared by paired t test. Linear regression was used to assess association between covariates and bladder scanner error. RESULTS: There was no significant difference between catheter and bladder scanner PVR at the initial (mean difference, 5.94 mL; 95% confidence interval [CI], -3.8 to 15.7) or final (mean difference, 1.37 mL; 95% CI, -10.9 to 13.6) measurements. Maximum bladder capacity measurements by bladder scanner were significantly smaller than catheterized measurements (mean difference, -21.3 mL; 95% CI, -40.3 to -2.3). Stage III/IV prolapse was associated with increased bladder scanner error (P = 0.03). CONCLUSIONS: The portable bladder scanner accurately measures PVR in patients with pelvic organ prolapse and could be considered as an alternative to catheterized assessment. However, stage III/IV prolapse is associated with increased bladder scanner error, which should be considered when determining appropriate candidates for bladder scanner PVR assessment.

Sentiment Analysis of Web Sites Related to Vaginal Mesh Use in Pelvic Reconstructive Surgery.

OBJECTIVES: The purpose of this study was to utilize sentiment analysis to describe online opinions toward vaginal mesh. We hypothesized that sentiment in legal Web sites would be more negative than that in medical and reference Web sites. METHODS: We generated a list of relevant key words related to vaginal mesh and searched Web sites using the Google search engine. Each unique uniform resource locator (URL) was sorted into 1 of 6 categories: "medical", "legal", "news/media", "patient generated", "reference", or "unrelated". Sentiment of relevant Web sites, the primary outcome, was scored on a scale of -1 to +1, and mean sentiment was compared across all categories using 1-way analysis of variance. Tukey test evaluated differences between category pairs. RESULT: Google searches of 464 unique key words resulted in 11,405 URLs. Sentiment analysis was performed on 8029 relevant URLs (3472 legal, 1625 "medical", 1774 "reference", 666 "news media", 492 "patient generated"). The mean sentiment for all relevant Web sites was +0.01 ± 0.16; analysis of variance revealed significant differences between categories (P < 0.001). Web sites categorized as "legal" and "news/media" had a slightly negative mean sentiment, whereas those categorized as "medical," "reference," and "patient generated" had slightly positive mean sentiments. Tukey test showed differences between all category pairs except the "medical" versus "reference" in comparison with the largest mean difference (-0.13) seen in the "legal" versus "reference" comparison. CONCLUSIONS: Web sites related to vaginal mesh have an overall mean neutral sentiment, and Web sites categorized as "medical," "reference," and "patient generated" have significantly higher sentiment scores than related Web sites in "legal" and "news/media" categories.

Changes in the Vaginal Microenvironment as Related to Frequency of Pessary Removal.

OBJECTIVE: The aim of the study was to describe the effect of frequency of pessary removal on the vaginal microenvironment. METHODS: We performed a secondary analysis of a multicenter randomized trial of hydroxyquinoline gel in women presenting for pessary fitting. Patients had vaginal secretions analyzed at baseline, 2 weeks, and 3 months. Patients were stratified by frequency of pessary removal at least once daily, at least once weekly, and less often than once weekly. These groups were compared for prevalence of Lactobacillus predominance (primary outcome), anaerobic predominance, Mobiluncus prominence, vaginal symptoms, and bacterial vaginosis by Nugent criteria, and correction for confounding variables was performed. RESULTS: One hundred thirty-seven women were included in this analysis: 34 (25%) removed the pessary daily, 54 (39%) at least weekly, and 49 (36%) less often than once weekly. Women who removed the pessary less often than weekly were older (P < 0.01), using more hormone therapy (P = 0.03), and more likely to have bacterial vaginosis at baseline (P < 0.01). At 2 weeks, the predominance of Lactobacillus in the group removing pessary daily was higher (41% daily vs 24% weekly vs 9% longer, P = 0.03) and this persisted after confounder correction (P < 0.01). Women who removed their pessary less than weekly were more likely to have anaerobic predominance at 3 months (P = 0.04). CONCLUSIONS: Women who remove their pessaries less often than once weekly have an increased prevalence of anaerobes at 3 months, but no difference in vaginal symptoms or pessary satisfaction.

Use of an iPad™ application in preoperative counseling for pelvic reconstructive surgery: a randomized trial.

INTRODUCTION AND HYPOTHESIS: The goal of this study was to evaluate whether the addition of an iPad™ application to the informed consent process for pelvic organ prolapse (POP) surgery improves patient understanding and retention of information compared with standard verbal counseling (SVC) alone. METHODS: Patients scheduled for POP surgery were randomized to SVC alone or SVC augmented with an iPad™ application. Prior to counseling, immediately following counseling, and 6 weeks after surgery, patients completed a written quiz testing their understanding of POP and surgical repair (worst score 0; best score 20). Primary outcome was score change from pre- to immediately postcounseling. Secondary outcomes were patient satisfaction and score change from postcounseling to 6 weeks after surgery. Twenty-six patients per group were needed to detect a 2.8-point difference in score change between groups (80% power; α = 0.05). RESULTS: Sixty patients were randomized, and 57 patients (29 SVC; 28 iPad) were included in the final analysis. There was no significant difference in score change between groups immediately postcounseling. Six weeks after surgery, patients in the iPad group had more deterioration of score (iPad -4.0 ± 2.8 vs. SVC -0.6 ± 2.3 points; p = 0.02). Both groups reported similar satisfaction with counseling. CONCLUSIONS: The addition of a POP-based iPad™ application to the informed consent process for POP surgery did not improve patient comprehension immediately postcounseling and resulted in poorer retention of information 6 weeks after surgery compared with SVC alone.

Current practice patterns and knowledge among gynecologic surgeons of InterStim® programming after implantation.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to describe surgeons' current practices in InterStim® programming after initial implantation and their knowledge of programming parameters. We hypothesized that surgeons performing their own reprogramming would have increased knowledge. METHODS: We administered a written survey to attendees at the Society of Gynecologic Surgeons Scientific Meeting and analyzed those on which surgeons indicated they offer InterStim® care. The survey queried surgeon characteristics, experience with InterStim® implantation and programming, and clinical opinions regarding reprogramming and tested six knowledge-based questions about programming parameters. Correct response to all six questions was the primary outcome. RESULTS: One hundred and thirty-five of 407 (33%) attendees returned the survey, of which 99 met inclusion criteria. Most respondents (88 of 99; 89%) were between 36 and 60 years, 27 (73%) were women, 76 (77%) practiced in a university setting, and 76 (77%) were trained in Female Pelvic Medicine and Reconstructive Surgery (FPMRS). Surgeons who had InterStim® programming training were more likely to perform their own programming [15/46 (32%) vs 6/47 (13%), p = 0.03]. Most answered all knowledge-based questions correctly (62/90, 69%); no surgeon characteristics were significantly associated with this outcome. Most surgeons cited patient comfort (71/80, 89%) and symptom relief (64/80, 80%) as important factors when reprogramming, but no prevalent themes emerged on how and why surgeons change certain programming parameters. CONCLUSIONS: Surgeons who had formal InterStim® programming training are more likely to perform programming themselves. No surgeon characteristic was associated with improved programming knowledge. We found that surgeons prioritize patient comfort and symptoms when deciding to reprogram.

Retroperitoneal Hemorrhage After Sacral Neurostimulator Placement for Urgency Urinary Incontinence.

Sacral neuromodulation (SNM) is an effective therapy for patients who experience urinary incontinence, idiopathic urinary retention, and fecal incontinence. Although typically a low-risk procedure, rarely, it can be associated with significant hemorrhage. A 61-year-old woman on chronic anticoagulation underwent uncomplicated implantation of SNM for refractory urgency urinary incontinence. Anticoagulation was held on the day of surgery and resumed on postoperative day 1. On postoperative day 2, the patient developed an extensive retroperitoneal hemorrhage. This was successfully treated by angioembolization of the left lateral sacral artery with the InterStim device left in situ. At 6-month follow-up, the device was functioning properly, and the patient's urinary symptoms were well controlled. Retroperitoneal hemorrhage is a rare complication after SNM placement. Conservative management with angioembolization should be considered as a first-line approach.

The Effect of Lithotomy Position on Nerve Stretch: A Cadaveric Study.

OBJECTIVE: The objective of our study was to design a method to measure nerve stretch in cadaveric subjects and then use the method to assess femoral nerve stretch in the lithotomy position with varying degrees of flexion and extension. METHODS: A university-based, cadaveric observational study of femoral nerve stretch was conducted. In 6 cadaveric subjects, femoral nerve near the inguinal ligament was dissected in each cadaveric subject. The nerve was marked, and digital images of the nerve were obtained in the supine position and lithotomy position in both flexion and extension. Distances were calculated using the ratio of pixels to millimeter specific for each image. The average distance for each set of images was then used to calculate the percent change from supine for each position. RESULTS: We were able to assess nerve stretch using photo-editing software. For extended position, all nerves showed some degree of stretch with the mean percent change in nerve length being 10.35%. For all other positions, most showed a decrease of nerve length. There was not a significant relation between degree of extension and stretch (Pearson r, P < 0.05). CONCLUSIONS: Hip extension between 10 and 20 degrees consistently stretches the femoral nerve greater than 5%. The potential for femoral nerve stretch and avoiding hip extension should be considered when positioning a patient in lithotomy for surgical procedures.

Anatomical Relationships of Burch Colposuspension Sutures.

OBJECTIVES: The prevalent use of minimally invasive midurethral slings for the treatment of stress urinary incontinence in the last several decades has resulted in fewer Burch procedures being performed and diminished surgical experience in performing the Burch colposuspension. However, recent antimesh media has resulted in more patients requesting nonmesh anti-incontinence procedures and a subsequent need for surgeons to refamiliarize themselves with the Burch procedure and its relevant anatomy. The objective of this study was to evaluate the relationships of Burch sutures to surrounding neurovascular anatomic structures in the human cadaver. METHODS: The retropubic space of 11 unembalmed female cadavers was dissected, and a Burch procedure performed. The distance from the Burch sutures' location through both Cooper's ligament and the vagina to the obturator neurovascular bundle and external iliac vessels was measured. RESULTS: The mean distance from the most lateral stitch in Cooper's ligament to the obturator bundle was 25.9 ± 7.6 mm and to the external iliac vessels was 28.9 ± 9.3 mm, and in some instances, these structures were less than 1.5 cm away. CONCLUSIONS: The obturator bundle and external iliac lie, on average, within 3 cm of sutures placed during a Burch colposuspension. Knowledge of these anatomical relationships is valuable when dissecting the space of Retzius and placing sutures for a Burch to avoid injury.

The relationship between age and pelvic organ prolapse bother.

INTRODUCTION AND HYPOTHESIS: A variety of factors affect the amount of bother experienced by different women with equivalent pelvic organ prolapse (POP). The goal of this study was to describe the relationship between age and bother experienced from objectively equivalent stages of POP. METHODS: Records of all patients presenting to a pelvic floor subspecialty clinic between January 2014 and March 2015 were reviewed. Women with POP stage ≥ 2 were included. The level of bother experienced from prolapse symptoms was defined as the score on the validated Pelvic Organ Prolapse Distress Inventory (POPDI). Multiple linear regression was performed to examine the relationship between age and the POPDI score. A sample size of 150 patients was determined to have 80 % power to detect an effect of age equivalent to an increase in R2 of 0.05. RESULTS: A total of 229 charts were reviewed and 165 patients were included in the final analysis. The effect of age on prolapse bother in the entire population was quadratic (p = 0.0497). Women at both ends of the spectrum were less bothered by prolapse, whereas women in the 6th and 7th decades of life demonstrated the highest level of bother, irrespective of stage. This same quadratic relationship remained in women with stage 2 prolapse (p = 0.019). CONCLUSIONS: Women in the 6th and 7th decades of life experience higher levels of bother from POP than older or younger women with the same stage of prolapse. This suggests that women in these decades of life might be at a higher risk for impairment of quality of life from POP.