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.

Predictive Value of Biomechanical Mapping for Pelvic Organ Prolapse Surgery.

OBJECTIVE: This study examined biomechanical changes in pelvic floor after urogynecological surgery. METHODS: This multisite clinical study was designed to explore changes in tissue elasticity, pelvic support, and certain functions (contractive strength, muscle relaxation speed, muscle motility) after pelvic organ prolapse (POP) surgery. A biomechanical mapping of the pelvic floor was performed before and 4 to 6 months after the surgery. The biomechanical data for 52 parameters were acquired by vaginal tactile imaging for manually applied deflection pressures to vaginal walls and pelvic muscle contractions. The two-sample t-test (P < 0.05) was used to test the null hypothesis that presurgery data in group 1 (positive parameter change after surgery) and presurgery data in group 2 (negative parameter change after surgery) belonged to the same distribution. RESULTS: A total of 78 subjects with 255 surgical procedures were analyzed across 5 participating clinical sites. All 52 t-tests for group 1 versus group 2 had P value in the range from 4.0 × 10-10 to 4.3 × 10-2 associating all of the 52 parameter changes after surgery with the presurgical conditions. The P value of before and after surgery correlation ranged from 3.7 × 10-18 to 1.6 × 10-2 for 50 of 52 tests, with Pearson correlation coefficient ranging from -0.79 to -0.27. Thus, vaginal tactile imaging parameters strongly correlated weak pelvic floor presurgery with the positive POP surgery outcome of improved biomechanical properties. CONCLUSIONS: Pelvic organ prolapse surgery, in general, improves the biomechanical conditions and integrity of the weak pelvic floor. The proposed biomechanical parameters can predict changes resulting from POP surgery.

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.

Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse".

In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996-2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.

Vaginal tactile imaging.

Changes in the elasticity of the vaginal walls, connective support tissues, and muscles are thought to be significant factors in the development of pelvic organ prolapse, a highly prevalent condition affecting at least 50% of women in the United States during their lifetimes. It creates two predominant concerns specific to the biomechanical properties of pelvic support tissues: how does tissue elasticity affect the development of pelvic organ prolapse and how can functional elasticity be maintained through reconstructive surgery. We designed a prototype of vaginal tactile imager (VTI) for visualization and assessment of elastic properties of pelvic floor tissues. In this paper, we analyze applicability of tactile imaging for evaluation of reconstructive surgery results and characterization of normal and pelvic organ prolapse conditions. A pilot clinical study with 13 patients demonstrated that VTI allows imaging of vaginal walls with increased rigidity due to implanted mesh grafts following reconstructive pelvic surgery and VTI has the potential for prolapse characterization and detection.

Vaginal hysterectomy at the time of transvaginal mesh placement.

INTRODUCTION: : Previous investigations have shown an increased risk of mesh erosion when concomitant vaginal hysterectomy is performed at the time of transvaginal reconstruction with mesh. We hypothesize that vaginal hysterectomy can be performed without a high risk of erosion. METHODS: : This is a retrospective, repeated-measures study of women with uterovaginal prolapse who underwent vaginal hysterectomy and pelvic reconstruction with a transvaginal mesh technique using the Prolift system. Mesh was never placed behind the cuff closure and "T" incisions were not used. We compared preoperative quality-of-life and Pelvic Organ Prolapse Quantification values to postoperative values. RESULTS: : Forty women met the study criteria. The median length of follow-up was 12 months (range 4-43 months). Thirty-two (80%) of the women had at least 1 year of follow-up. Significant improvements were found in all quality-of-life measures. Except for genital hiatus and perineal body length, a significant change was seen in all Pelvic Organ Prolapse Quantification measures. The greatest mean change found was for point "C" going from +2.4 to -6.8 cm (P < 0.001). There was 1 (2.5%) mesh erosion. CONCLUSIONS: : When incisions for mesh placement are kept separate from the vaginal cuff, transvaginal mesh reconstruction can be safely performed at the time of hysterectomy.

Quality of life and surgical satisfaction after vaginal reconstructive vs obliterative surgery for the treatment of advanced pelvic organ prolapse.

OBJECTIVE: We sought to compare quality of life and patient satisfaction after obliterative vs reconstructive surgery. STUDY DESIGN: A retrospective cohort study of women who met the following inclusion criteria: age 65 years or older, leading edge of prolapse 4 cm or greater beyond the hymen, and vaginal reconstructive or obliterative surgery. Preoperative responses to the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) were collected retrospectively. We then mailed the same questionnaires, and the Surgical Satisfaction Questionnaire (SSQ-8), to these subjects postoperatively. RESULTS: Mode of surgery was evenly split (n = 45 per group) between the 90 patients meeting the inclusion criteria. Improvements from the preoperative to postoperative Incontinence Impact Questionnaire and Urogenital Distress Inventory were comparable as were postoperative Surgical Satisfaction Questionnaire scores. CONCLUSION: Improvements in condition-specific quality of life and postoperative patient satisfaction measures are comparable in women with prolapse who undergo either reconstructive or obliterative surgery.