Objectives The purpose of this study was to explore the utility of an injectable purified exosome product derived from human apheresis blood to (1) augment surgical closure of vaginal mesh exposures, and (2) serve as a stand-alone therapy for vaginal mesh exposure. Methods Sixteen polypropylene meshes (1×1–3×3 cm) were implanted in the vaginas of 7 Yorkshire-crossed pigs by urogynecologic surgeons (day 0). On day 7, group 1 underwent surgical intervention via vaginal tissue suture reclosure with (n=2 pigs, n=4 meshes) or without (n=2 pigs, n=4 meshes) exosome injection; group 2 underwent medical intervention with an exosome injection (n=3, n=8 meshes). One animal in group 2 was given oral 2′-deoxy-5-ethynyluridine to track cellular regeneration. Euthansia occurred at 5 weeks. Results Mesh exposures treated with surgical closure alone experienced reexposure of the mesh. Exosome treatment with or without surgical closure resulted in partial to full mesh exposure resolution up to 3×3 cm. Exosome-treated tissues had significantly thicker regenerated epithelial tissue (208 μm exosomes-only and 217 μm surgery+exosomes, versus 80 μm for surgery-only; P < 0.05); evaluation of 2′-deoxy-5-ethynyluridine confirmed de novo regeneration throughout the epithelium and underlying tissues. Capillary density was significantly higher in the surgery+exosomes group ( P = 0.03). Surgery-only tissues had a higher inflammatory and fibrosis response as compared with exosome-treated tissues. Conclusions In this pilot study, exosome treatment augmented healing in the setting of vaginal mesh exposure, reducing the incidence of mesh reexposure after suture closure and decreasing the area of mesh exposure through de novo tissue regeneration after exosome injection only. Further study of varied local tissue conditions and mesh configurations is warranted.
Antimullerian Hormone as a Serum Biomarker for Risk of Chemotherapy-Induced Amenorrhea
Abstract Antimullerian hormone (AMH) is a promising biomarker for ovarian reserve. In this study, we assessed AMH before and 1 year after initiation of adjuvant chemotherapy on National Surgical Adjuvant Breast and Bowel Project (NSABP)/NRG Oncology B-47 in female participants aged 42 years and younger (median age = 39 years). At baseline, median AMH was 1.2 ng/mL; 13 (4.7%) values were less than 0.1 ng/mL (the threshold for detectable levels, in the perimenopause and menopause range), and 57 values (20.6%) were less than 0.5 ng/mL. At 1 year, 215 (77.6%) were less than 0.1 ng/mL, and 264 (95.3%) were less than 0.5 ng/mL. Postchemotherapy menses were reported by 46.2% of participants. Multivariable logistic regression found that the odds of having postchemotherapy menses increased with younger age, higher body mass index, and higher prechemotherapy AMH, but not by trastuzumab administration or by the choice of chemotherapy (doxorubicin-cyclophosphamide followed by paclitaxel vs docetaxel-cyclophosphamide). We conclude that higher prechemotherapy AMH predicts a lower risk of chemotherapy-induced amenorrhea and that AMH 1 year after chemotherapy initiation is not informative in this setting because it is likely to be very low.
Can Urodynamic Parameters Predict Sling Revision for Voiding Dysfunction in Women Undergoing Synthetic Midurethral Sling Placement?
Objective The objective of the study was to evaluate the utility of urodynamic studies performed before primary midurethral sling placement for stress urinary incontinence in predicting the need for subsequent sling release for voiding dysfunction. Methods The health records of women managed with primary synthetic midurethral sling placement at Mayo Clinic (Rochester, MN) from January 1, 2002, to December 31, 2012, were reviewed. The primary outcome was surgical sling release for postoperative voiding dysfunction (ie, prolonged retention, elevated postvoid residual volumes with new voiding symptoms, or de novo onset or worsening of overactive bladder symptoms). Logistic regression models were used to evaluate associations between potential clinical risk factors and the primary outcome. Results Overall, 1629 women underwent primary synthetic midurethral sling placement during the study time frame, including 1081 patients (66%) who underwent a preoperative multichannel urodynamic evaluation. A sling release for voiding dysfunction was performed for 51 patients (3.1%) at a median of 1.9 months postoperatively (interquartile range, 1.3–9.3 months). Patients undergoing sling release were significantly more likely to have had retropubic sling placement (P = 0.003) and concomitant prolapse surgery (P = 0.005). On univariate analysis, no urodynamic parameters were associated with the risk of sling release; evaluated parameters included peak flow rate (P = 0.20), postvoid residual volume (P = 0.37), voiding without detrusor contraction (P = 0.96), and detrusor pressure at maximal flow (P = 0.23). Conclusions Sling release for voiding dysfunction was rare in our cohort. No urodynamic parameters were associated with the risk of sling release.
Symptom Relief and Retreatment After Vaginal, Open, or Robotic Surgery for Apical Vaginal Prolapse
Objectives The aim of this work was to determine the degree of symptom relief and survival free of retreatment after Mayo-McCall culdoplasty (MMC), open abdominal sacrocolpopexy (ASC), and robotic sacrocolpopexy (RSC) for posthysterectomy vaginal vault prolapse. Methods We retrospectively studied patients who had undergone surgery for posthysterectomy apical vaginal prolapse from January 1, 2000, through June 30, 2012, at our institution. Baseline characteristics and perioperative outcomes were abstracted from electronic health records. Cross-sectional data for current pelvic floor symptoms were collected by using validated questionnaires. Survival free of retreatment was estimated with the Kaplan-Meier method. To account for selection bias, adjusted analyses using inverse probability weighting (IPW) were performed to compare outcomes for MMC versus ASC, MMC versus RSC, and ASC versus RSC. Results Of 512 patients, 337 completed at least a validated or abbreviated questionnaire. Among MMC, ASC, and RSC groups, overall Pelvic Floor Distress Inventory 20, Pelvic Floor Impact Questionnaire Short Form 7, and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 summary scores were not significantly different. There was no significant difference in 5-year survival free of retreatment for MMC (94.0%) versus RSC (95.5%) and ASC (94.8%) versus RSC (92.1%). However, patients who had MMC were more likely to have retreatment than patients who had ASC during the first 10 years (10-year survival free of retreatment: 81.1% vs 95.4%; hazard ratio, 3.68 [95% confidence interval, 1.51–8.98]); the 10-year data were not available for RSC comparisons, given the later initiation of RSC. Conclusions Symptom relief was comparable after MMC, ASC, and RSC. Among all groups, most patients were free of retreatment for prolapse at 5 years. Between the MMC and ASC groups, survival free of retreatment (%) within 10 years was still favorable, but ASC had greater durability, particularly after accounting for selection bias.
An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction
Introduction and hypothesis There has been an increasing need for the terminology on the conservative management of female pelvic floor dysfunction to be collated in a clinically based consensus report. Methods This Report combines the input of members and elected nominees of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS), assisted at intervals by many external referees. An extensive process of nine rounds of internal and external review was developed to exhaustively examine each definition, with decision‐making by collective opinion (consensus). Before opening up for comments on the webpages of ICS and IUGA, five experts from physiotherapy, neurology, urology, urogynecology, and nursing were invited to comment on the paper. Results A Terminology Report on the conservative management of female pelvic floor dysfunction, encompassing over 200 separate definitions, has been developed. It is clinically based, with the most common symptoms, signs, assessments, diagnoses, and treatments defined. Clarity and ease of use have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in female pelvic floor dysfunction. Ongoing review is not only anticipated, but will be required to keep the document updated and as widely acceptable as possible. Conclusion A consensus‐based terminology report for the conservative management of female pelvic floor dysfunction has been produced, aimed at being a significant aid to clinical practice and a stimulus for research.
Outcomes of Robotic Sacrocolpopexy Using Only Absorbable Suture for Mesh Fixation
Objective The optimal suture selection for mesh attachment during robotic sacrocolpopexy (RSC) is currently unknown. Here, we sought to evaluate the outcomes of RSC using absorbable sutures for vaginal and sacral mesh attachment. Methods We retrospectively reviewed 132 RSC surgeries that were performed for vaginal vault prolapse in the Division of Gynecologic Surgery at our institution from February 2007 to December 2013. All cases were performed with absorbable suture (polyglactin) for vaginal and sacral mesh fixation. Sacrocolpopexy failure was defined as patients undergoing either repeat prolapse surgery or pessary use for recurrent prolapse. The durability of RSC was assessed via Kaplan-Meier method. Results The median age at surgery was 61.1 years (interquartile range [IQR], 55.6–68.2) and the median length of postoperative follow-up was 33 months (IQR, 15.7–57). The median body mass index was 26.5 kg/m2 (IQR, 24.3–29.7). During follow-up, 10 patients underwent prolapse retreatment. There were 2 apical recurrences, 4 distal anterior recurrences, 2 posterior recurrences, and, in 2 cases, the location was unknown. One apical recurrence was confirmed to be secondary to detachment of the mesh from the sacral promontory. Among those with recurrence, the median time to recurrence was 15.5 months (IQR, 4.22–35.9). Overall, the 1-year and 3-year freedom from repeat surgery rates were 96% and 93%, respectively. Conclusions With a median follow-up of 33 months, the use of absorbable suture for both vaginal and sacral attachments during RSC is effective. Further studies evaluating suture selection and mesh attachment techniques for RSC are needed.