A novel anchoring system for pelvic organ prolapse repair: an observational study.

INTRODUCTION AND HYPOTHESIS: Sacrospinous ligament (SSL) fixation is an effective and widely used vaginal procedure for correcting apical prolapse. The Saffron Fixation System (Coloplast Corp., Minneapolis, MN, USA) is a new anchoring device aimed at facilitating a durable, easy, and short procedure for SSL fixation with the goal of minimizing operative complications. The objective was to demonstrate the efficacy and safety of anchor deployment and suture fixation for pelvic organ prolapse repair using the Saffron Fixation System. METHODS: An observational human cadaver study was conducted to measure the distance between anchor location and anatomical landmarks in the pelvis, and the holding force of the fixated anchors. Anchors were placed in four human cadavers by different implanters. The pull-out force of these anchors was measured to assess efficacy (three cadavers by three implanters) and the distance between anchors and primal vessels and nerves was measured to assess safety (one cadaver by one implanter). RESULTS: Nineteen out of 20 anchors (95%) were correctly placed as judged by independent assessment performed by non-implanting surgeons. Distance between anchors and surrounding nerves and vessels exceeded 10 mm. Mean (SD) pull out-force was 17.9 (5.6) N. CONCLUSION: The innovative anchoring device that was developed appeared to enable precise and solid anchor placement in the SSL. Future clinical studies are needed to explore if the theoretical advantages of this device translate to improved clinical outcomes in comparison with available suturing and anchoring devices.

Quantitative Assessment and Interpretation of Vaginal Conditions.

INTRODUCTION: Few means exist to provide quantitative and reproducible assessment of vaginal conditions from biomechanical and functional standpoints. AIM: To develop a new approach for quantitative biomechanical characterization of the vagina. METHODS: Vaginal tactile imaging (VTI) allows biomechanical assessment of soft tissue and function along the entire length of the anterior, posterior, and lateral vaginal walls. This can be done at rest, with applied vaginal deformation, and with pelvic muscle contraction. RESULTS: Data were analyzed for 42 subjects with normal pelvic floor support from an observational case-controlled clinical study. The average age was 52 years (range = 26-90 years). We introduced 8 VTI parameters to characterize vaginal conditions: (i) maximum resistance force to insertion (newtons), (ii) insertion work (millijoules), (iii) maximum stress-to-strain ratio (elasticity; kilopascals per millimeter), (iv) maximum pressure at rest (kilopascals), (v) anterior-posterior force at rest (newtons), (vi) left-right force at rest (newtons), (vii) maximum pressure at muscle contraction (kilopascals), and (viii) muscle contraction force (newtons). We observed low to moderate correlation of these parameters with subject age and no correlation with subject weight. 6 of 8 parameters demonstrated a P value less than .05 for 2 subject subsamples divided by age (≤52 vs >52 years), which means 6 VTI parameters change with age. CONCLUSIONS: VTI allows biomechanical and functional characterization of the vaginal conditions that can be used for (i) understanding "normal" vaginal conditions, (ii) quantification of the deviation from normality, (iii) personalized treatment (radiofrequency, laser, or plastic surgery), and (iv) assessment of the applied treatment outcome. Egorov V, Murphy M, Lucente V, et al. Quantitative Assessment and Interpretation of Vaginal Conditions. Sex Med 2018;6:39-48.

Risk factors for lower urinary tract injury at the time of hysterectomy for benign reasons.

OBJECTIVES: To identify risk factors associated with lower urinary tract injury at the time of performing hysterectomy for benign indications. METHODS: We conducted a multi-center case-control study of women undergoing hysterectomy for benign disease. Cases were identified via ICD-9 codes for lower urinary tract injury at the time of hysterectomy from 2007 to 2011: controls were two subsequent hysterectomies following the index case in the same institution that did not have lower urinary tract injury. Logistic regression was used to perform univariate and multivariate comparisons between groups. RESULTS: At 7 centers, 135 cases and 270 controls were identified. Cases comprised 118 bladder injuries and 25 ureteral injuries; 8 women had both bladder and ureteral injury. Bladder injury was associated with a history of prior cesarean section OR 2.9 (95% CI 1.7-5), surgery by a general obstetrician and gynecologist OR 2.4 (95% CI 1.2-5.2), and total abdominal hysterectomy OR1.9 (95%CI 1.06-3.4). Ureteral injury was more likely among women who underwent laparoscopic-assisted vaginal hysterectomy (LAVH) OR 10.4 (95%CI 2.3-46.6) and total abdominal hysterectomy (TAH) OR 4.7 (95% CI 1.4-15.6). CONCLUSION: Bladder injury at the time of benign hysterectomy is associated with a prior history of Cesarean section and TAH as well as surgery by generalist OB-GYN; ureteral injury is associated with LAVH and TAH.