Long-term Data on Graft-Related Complications After Sacrocolpopexy With Lightweight Compared With Heavier-Weight Mesh.

OBJECTIVE: To estimate the long-term incidence and characteristics of graft-related complications, rate of reintervention for graft-related complications and prolapse, and subjective and anatomical outcomes after laparoscopic sacrocolpopexy with heavier-weight (more than 44 g/m2) compared with lightweight (28 g/m2) polypropylene mesh, the latter with resorbable poliglecaprone component. METHODS: We conducted a single-center study that compared two consecutive prospective cohorts of patients who were undergoing laparoscopic sacrocolpopexy for symptomatic stage 2 or greater cervical or vault prolapse, by using either heavier-weight polypropylene mesh or lightweight polypropylene mesh at a similar duration of follow-up. The primary outcome was the occurrence of graft-related complications and their nature. Secondary outcomes included reinterventions for graft-related complications, recurrent apical prolapse, a subjective outcome (PGIC [Patient Global Impression of Change] score 4 or higher), and an anatomical outcome (point C -1 cm or greater). RESULTS: We identified consecutive patients: 101 were implanted with heavier-weight polypropylene, and 238 were implanted with lightweight polypropylene; all were audited at comparable follow-up times (heavier-weight mesh: 97 months [interquartile range 16 months]; lightweight mesh: 92.5 months [interquartile range 58 months]). Graft-related complications were more frequent in patients with heavier-weight than lightweight mesh (22.8% [23/101] vs 7.3% [13/178]; hazard ratio [HR] 3.3, 95% CI 1.6-7.1), more frequently symptomatic (heavier-weight mesh: 16.8% [17/101] vs lightweight mesh: 2.8% [5/178]; HR 6.0, 95% CI 2.5-14.3), and more frequently lead to reintervention for graft-related complications (heavier-weight mesh: 18.8% [19/101] vs lightweight mesh: 2.1% [5/238]; HR 4.6, 95% CI 1.9-11.2). The vast majority of patients improved (PGIC score 4 or higher), without difference between groups (heavier-weight mesh: 71/84 [84.9%]; lightweight mesh: 154/178 [86.5%]; HR 0.8, 95% CI 0.6-1.1); neither was there a difference in anatomical failure rate (heavier-weight mesh: 1/60 [1.7%] vs lightweight mesh: 8/131 [6.1%]; HR 0.3, 95% CI 0.1-1.4). Reoperations for recurrent vault prolapse were scarce (0.0% in heavier-weight mesh, vs 0.4% in lightweight mesh). CONCLUSION: In two consecutive cohorts, the number of graft-related complications, symptomatic graft-related complications, and reinterventions for graft-related complications were higher in patients implanted with heavier-weight polypropylene than when lightweight polypropylene was used. There were no differences in subjective, objective outcomes, and reoperation rates for prolapse. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04378400. FUNDING: To assist in this audit, the University Hospitals Leuven received support from Ethicon Endosurgery.

Validation of a high-fidelity training model for fetoscopic spina bifida surgery.

Open fetal surgery for spina bifida (SB) is safe and effective yet invasive. The growing interest in fetoscopic SB repair (fSB-repair) prompts the need for appropriate training. We aimed to develop and validate a high-fidelity training model for fSB-repair. fSB-repair was simulated in the abdominal cavity and on the stomach of adult rabbits. Laparoscopic fetal surgeons served either as novices (n = 2) or experts (n = 3) based on their experience. Technical performance was evaluated using competency Cumulative Sum (CUSUM) analysis and the group splitting method. Main outcome measure for CUSUM competency was a composite binary outcome for surgical success, i.e. watertight repair, operation time ≤ 180 min and Objective-Structured-Assessment-of-Technical-Skills (OSATS) score ≥ 18/25. Construct validity was first confirmed since competency levels of novices and experts during their six first cases using both methods were significantly different. Criterion validity was also established as 33 consecutive procedures were needed for novices to reach competency using learning curve CUSUM, which is a number comparable to that of clinical fSB-repair. Finally, we surveyed expert fetal surgeons worldwide to assess face and content validity. Respondents (26/49; 53%) confirmed it with ≥ 71% of scores for overall realism ≥ 4/7 and usefulness ≥ 3/5. We propose to use our high-fidelity model to determine and shorten the learning curve of laparoscopic fetal surgeons and retain operative skills.

Stress urinary incontinence after transvaginal mesh surgery for anterior and apical prolapse: preoperative risk factors.

INTRODUCTION AND HYPOTHESIS: Debate persists over whether surgery to correct pelvic organ prolapse (POP) should be combined with midurethral sling (MUS) insertion. The aim of this study was to evaluate the incidence of stress urinary incontinence (SUI) up to 12 months after transvaginal mesh surgery, with or without MUS, and to identify risk factors for postoperative SUI. METHODS: This retrospective single-center study included patients who underwent transvaginal mesh surgery with Uphold™ between October 2010 and December 2017. The primary outcome was the prevalence of SUI at 12 months postoperatively. Univariate and multivariate logistic regression was used to identify risks factors for postoperative SUI. RESULTS: Of the 308 women included, 123 (40%) were continent (no SUI), 108 (35%) had SUI, and 76 (25%) had occult SUI. Forty-nine patients (15.9%) had a concomitant MUS procedure. At 12 months after surgery, 35.9% of patients without concomitant MUS had SUI vs 14.3% with (p = 0.003). Thirty-five patients (29%) developed de novo SUI. Postoperative complications were more common in patients with concomitant MUS (30.6% vs 17%; p = 0.003). The best predictor of postoperative SUI was the presence of preoperative SUI (OR 2.52 (1.25-5.09). Concomitant MUS (p < 0.001), and prior POP surgery (p = 0.034) were protective factors for postoperative SUI. CONCLUSION: Preoperative SUI is the most important risk factor for postoperative SUI. However, given the higher risk of postoperative complications with concomitant MUS and the acceptable rate of de novo SUI rate without it, two-stage surgery seems preferable for patients with preoperative SUI.

Prospective ultrasonographic follow-up of transvaginal lightweight meshes: a 1-year multicenter study.

INTRODUCTION AND HYPOTHESIS: The use of new lightweight meshes in pelvic organ prolapse (POP) surgery may reduce complications related to mesh retraction (chronic pain, dyspareunia, and mesh exposure). The aim of this study was to investigate changes in the area and position of Uphold Lite™ mesh 6 weeks and 12 months after anterior and/or apical prolapse repair. METHODS: This observational prospective multicenter study included patients who had undergone transvaginal surgery for symptomatic POP-Q stage ≥ II anterior and/or apical compartment prolapse with placement of Uphold Lite mesh. The dimensions and position of the mesh were evaluated at 6 weeks and 12 months by ultrasonography. Correlations between ultrasonographic mesh characteristics and POP recurrence were analyzed. RESULTS: Fifty evaluable women with an average age of 66.8 years were included. No statistically significant difference in mesh area was found between week 6 and month 12 postoperatively, either at rest (1746.92 vs. 1574.48 mm2; p = 0.15) or on Valsalva (1568.81 vs. 1542.98 mm2; p = 0.65). The ROC-AUC of the distance between the mesh and the bladder neck (M-BN) at 6 weeks for predicting cystocele recurrence at 12 months was 0.764 (95% CI 0.573-0.955) at rest and 0.724 (95% CI 0.533-0.916) on Valsalva. An M-BN distance > 12.5 mm could predict cystocele recurrence at month 12 with a sensitivity of 80% and a specificity of 69%. CONCLUSIONS: Ultrasonographic measurements of the Uphold Lite™ mesh appear to remain stable between 6 weeks and 12 months postoperatively. M-BN distance correlates with cystocele recurrence. These results appear to confirm the value of ultrasound in mesh evaluation.

Simulated vaginal delivery causes transients vaginal smooth muscle hypersensitivity and urethral sphincter dysfunction.

BACKGROUND: Although pelvic floor dysfunction (PFD) has a multifactorial etiology, pregnancy and childbirth are considered crucial events predisposing to urinary incontinence as well as pelvic organ prolapse, which are highly prevalent. Rats are the most frequently used animal model and pudendal nerve crush (PNC) and vaginal distension (VD) are often used to mimic vaginal delivery. OBJECTIVE: To document the time course of events after simulated vaginal delivery (SVD) on the urethral sphincter and the vaginal smooth muscle layer. MATERIALS AND METHODS: Virgin female Sprague-Dawley rats were subjected to SVD (PNC + VD) or sham surgery and evaluated at 7, 14, 21, and 42 days after the injury. Urethral function was determined in vivo by microultrasound during cystometry and vaginal smooth muscle layer was harvested for in vitro pharmacologic investigation by isometric tension recording. Furthermore, vaginal and urethral samples were investigated by immunohistochemistry and real-time quantitative polymerase chain reaction. RESULTS: Microultrasound showed no bursting of the urethral sphincter in the SVD group at 7 days with a functional recovery starting at 14 days, and normal bursting at 21 and 42 days. Vaginal smooth muscle showed higher sensitivity to carbachol at 14 and 21 days after injury; however, at 42 days, its sensitivity decreased when compared with sham. CONCLUSION: SVD induces urethral dysfunction and a shift in vaginal smooth muscle contractile responses to carbachol.

Long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh (TVM) or native tissue repair. METHODS: Prospective, randomized, multicenter study conducted between April 2005 and December 2009 comparing anterior colporrhaphy with trans-obturator vaginal mesh (Pelvitex/Ugytex®, Sofradim, Trevoux, France) for the treatment of anterior vaginal wall prolapse. The primary endpoint was functional recurrence rate 5-8 years after surgery. Secondary endpoints consisted of anatomical results, mesh-related morbidity and patient satisfaction measured through validated questionnaires. RESULTS: Of the 147 women originally included, 75 (51%) were successfully re-contacted a median of 7 years after the initial surgery. The primary outcome, subjective recurrence of prolapse, was similar between the TVM and the anterior colporrhaphy groups (31 vs 34% respectively). Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004). Mesh exposure occurred in 4 of the 39 patients (13%) during follow-up, 2 of which had a surgical reintervention. Reintervention for prolapse took place in 7 patients (9%). CONCLUSION: Seven-year follow-up showed similar functional outcomes for mesh and native tissue repair in anterior vaginal wall prolapse. TVM did not reduce repeat surgery in the long term; it did, however, reduce anatomical recurrence. Mesh exposure rates were relatively high, but no difference in outcome of pain or dyspareunia was noted.

Assessment of Electrospun and Ultra-lightweight Polypropylene Meshes in the Sheep Model for Vaginal Surgery.

BACKGROUND: There is an urgent need to develop better materials to provide anatomical support to the pelvic floor without compromising its function. OBJECTIVE: Our aim was to assess outcomes after simulated vaginal prolapse repair in a sheep model using three different materials: (1) ultra-lightweight polypropylene (PP) non-degradable textile (Restorelle) mesh, (2) electrospun biodegradable ureidopyrimidinone-polycarbonate (UPy-PC), and (3) electrospun non-degradable polyurethane (PU) mesh in comparison with simulated native tissue repair (NTR). These implants may reduce implant-related complications and avoid vaginal function loss. DESIGN, SETTING, AND PARTICIPANTS: A controlled trial was performed involving 48 ewes that underwent NTR or mesh repair with PP, UPy-PC, or PU meshes (n=12/group). Explants were examined 60 and 180 d (six per group) post-implantation. INTERVENTION: Posterior rectovaginal dissection, NTR, or mesh repair. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Implant-related complications, vaginal contractility, compliance, and host response were assessed. Power calculation and analysis of variance testing were used to enable comparison between the four groups. RESULTS: There were no visible implant-related complications. None of the implants compromised vaginal wall contractility, and passive biomechanical properties were similar to those after NTR. Shrinkage over the surgery area was around 35% for NTR and all mesh-augmented repairs. All materials were integrated well with similar connective tissue composition, vascularization, and innervation. The inflammatory response was mild with electrospun implants, inducing both more macrophages yet with relatively more type 2 macrophages present at an early stage than the PP mesh. CONCLUSIONS: Three very different materials were all well tolerated in the sheep vagina. Biomechanical findings were similar for all mesh-augmented repair and NTR. Constructs induced slightly different mid-term inflammatory profiles. PATIENT SUMMARY: Product innovation is needed to reduce implant-related complications. We tested two novel implants, electrospun and an ultra-lightweight polypropylene textile mesh, in a physiologically relevant model for vaginal surgery. All gave encouraging outcomes.

Exo-anal imaging of the anal sphincter: a comparison between introital and transperineal image acquisition.

INTRODUCTION AND HYPOTHESIS: Three-dimensional exoanal ultrasound imaging of the anal sphincter may be obtained transperineally with a convex probe, or at the introitus with a transvaginal probe. We hypothesised that introital acquisition would yield better quality and more reproducible evaluation. METHODS: We acquired three 3D volumes of the anal sphincter (one transperineal transverse with a 4- to 8-MHz convex probe and two introital with a 5- to 9-MHz probe in transverse and mid-sagittal view) in 20 representative women attending the gynaecology clinic. Each 3D dataset was anonymised and hence blinded for clinical data and for acquisition method. Images were analysed off-line by two expert specifically trained ultrasonographers in a random order to assess image quality, sphincter integrity and sphincteric measurements. We assessed the intra- and interrater agreement by the Cohen's kappa (κ) and by the intraclass correlation coefficient for categorical and continuous variables respectively. RESULTS: The mid-sagittal introital acquisition had most inconclusive images owing to unsatisfactory quality, on which raters agreed (К = 0.80). Subsequently, agreement in the anal sphincter evaluation between transverse introital and transperineal acquisitions was compared. Agreement on internal anal sphincter gap was excellent for both transverse introital (К = 0.87) and transperineal acquisition (К = 0.93). Agreement on external anal sphincter discontinuity was excellent for the transperineal acquisition (К = 0.87) and good for the transverse introital acquisition (К = 0.73). Intra- and interrater agreement of external and internal anal sphincteric measurements were best for transperineal acquisitions. CONCLUSIONS: In our hands, transperineal acquisition with a 4- to 8-MHz probe performed better than introital acquisition with a 5- to 9-MHz probe in the assessment of the anal sphincter complex.

Medium-term outcome of laparoscopic sacrocolpopexy using polivinylidene fluoride as compared to a hybrid polyglecaprone and polypropylene mesh: A matched control study.

AIM: To compare 2-year outcomes of laparoscopic sacrocolpopexy (LSCP) either with polyvinylidene fluoride (PVDF) or hybrid polypropylene containing a resorbable polyglecaprone (PP+ PG) mesh. MATERIALS AND METHODS: Retrospective audit on 105 consecutive patients undergoing LSCP a with PVDF-mesh (DynaMesh, FEG Textiltechniken), matched by prolapse stage and cervicopexy or vault suspension to 105 controls undergoing LSCP with a hybrid PP + PG-mesh (Ultrapro, Ethicon). Patients are part of an ongoing prospective study. The primary outcome measure was the Patient Global Impression of Change score (PGIC), the coprimary variable was failure rate at the vault (≤1 cm). Other outcomes were intraoperative and postoperative complications within 3 months categorized by the Clavien-Dindo classification, reinterventions, graft-related complications (GRCs) and functional outcomes. All assessments were performed by an independent assessor. Data are reported as median (interquartile range) number and percent as appropriate, the Mann-Whitney U, χ2 , or Fisher exact were used for comparison. RESULTS: Patient satisfaction in the PVDF group, as measured with the PGIC, was high (90.9% PGIC, ≥4) as well as was the anatomical success (97.3%) at a follow-up of 26 months. These outcomes were comparable to those of PP + PG-patients (84.8% PGIC, ≥4; 94.9% anatomical success). There were five patients (2.4%) with Dindo-III or higher complications and three patients had GRCs (1.5%), without differences between mesh type. Level-II posterior defects (Bp ≥ -1) were less likely in PVDF patients (34.1% vs 50% for PP + PG-patients; P = .003). Women in the PVDF group also were less bothered by prolapse (7.5% vs 26.4%; P = .001), yet they complained more of constipation (15.0% vs 9.0%; P = .01). CONCLUSION: There were no differences in patient satisfaction and anatomical outcomes after LSCP either with PVDF or PP + PG mesh.

First delivery and ovariectomy affect biomechanical and structural properties of the vagina in the ovine model.

INTRODUCTION AND HYPOTHESIS: Animal models are useful for investigating the genesis of pelvic floor dysfunction and for developing novel therapies for its treatment. There is a need for an alternative large-animal model to the nonhuman primate. Therefore we studied the effects of the first vaginal delivery, ovariectomy and systemic hormonal replacement therapy (HRT) on the biomechanical and structural properties of the ovine vagina. METHODS: We examined the gross anatomical properties of nulliparous, primiparous, ovariectomized multiparous, and ovariectomized hormone-replaced multiparous sheep (six animals per group). We also harvested mid-vaginal and distal vaginal tissue to determine smooth muscle contractility and passive biomechanical properties, for morphometric assessment of the vaginal wall layers, to determine collagen and elastin content, and for immunostaining for α-smooth muscle actin and estrogen receptor-α. RESULTS: There were no regional differences in the nulliparous vagina. One year after the first vaginal delivery, stiffness and contractility of the distal vagina were decreased, whereas the elastin content increased. The mid-vagina of ovariectomized sheep was stiff, and its epithelium was thin and lacked glycogen. HRT decreased the stiffness of the mid-vagina by 45% but had no measurable effect on contractility or elastin content, and increased epithelial thickness and glycogen content. HRT also increased the epithelial thickness and glycogen content of the distal vagina. At this location, there were no changes in morphology or stiffness. CONCLUSION: In sheep, life events including delivery and ovariectomy affect the biomechanical properties of the vagina in a region-specific way. Vaginal delivery mainly affects the distal region by decreasing stiffness and contractility. HRT can reverse the increase in stiffness of the mid-vagina observed after surgical induction of menopause. These observations are in line with scanty biomechanical measurements in comparable clinical specimens.

Ultrasound visualization of sacrocolpopexy polyvinylidene fluoride meshes containing paramagnetic Fe particles compared with polypropylene mesh.

INTRODUCTION AND HYPOTHESIS: Paramagnetic Fe particles can be added during synthetic mesh production to allow visibility on magnetic resonance imaging. Our aim was to evaluate whether transperineal ultrasound (TPUS) allows visualization, measurement, and characterization of polyvinylidene fluoride (PVDF mesh) containing Fe particles compared with regular polypropylene (PP) meshes used for sacrocolpopexy. METHODS: Women up to 1.5 years after laparoscopic sacrocolpopexy who were implanted with a PP or PVDF mesh underwent clinical examination and 2D, 3D, and 4D TPUS. Acquired volumes were analyzed offline for mesh position at rest and maximal Valsalva and for mesh dimensions and characteristics, with the operator blinded to group assignment. The two groups were compared. RESULTS: There were 17 women in the PP and 25 in the PVDF mesh group, without differences in baseline demographics. None had significant prolapse, recurrence, symptoms, or complications. On TPUS, mesh was visible in all patients both caudally (perineal) and cranially but was more echogenic in the PVDF mesh group. Mesh length from distal to proximal that was visible on TPUS was longer for PVDF mesh, for both anterior and posterior vaginal arms (all P < 0.05), and for mesh above the vaginal apex (P = 0.002). The inferior aspects of the mesh showed areas of double mesh layers, suggesting folding in 80% of women in both groups, without symptoms. CONCLUSIONS: PVDF mesh permits clearer visualization and is seen over a longer stretch on TPUS, with longer visible mesh arms. The latter can be due to differences in operative technique, presence of microparticles, implant textile structure, or patient characteristics.

Fate of mesoangioblasts in a vaginal birth injury model: influence of the route of administration.

Currently cell therapy is considered as an experimental strategy to assist the healing process following simulated vaginal birth injury in rats, boosting the functional and morphologic recovery of pelvic floor muscles and nerves. However, the optimal administration route and dose still need to be determined. Mesangioblasts theoretically have the advantage that they can differentiate in skeletal and smooth muscle. We investigated the fate of mesoangioblasts transduced with luciferase and green fluorescent protein reporter genes (rMABseGFP/fLUC) using bioluminescence, immunofluorescence and RT-PCR in rats undergoing simulated birth injury. rMABseGFP/fLUC were injected locally, intravenously and intra-arterially (common iliacs and aorta). Intra-arterial delivery resulted in the highest amount of rMABseGFP/fLUC in the pelvic organs region and in a more homogeneous distribution over all relevant pelvic organs. Sham controls showed that the presence of the injury is important for recruitment of intra-arterially injected rMABseGFP/fLUC. Injection through the aorta or bilaterally in the common iliac arteries resulted in comparable numbers of rMABseGFP/fLUC in the pelvic organs, yet aortic injection was faster and gave less complications.

Short term post-operative morphing of sacrocolpopexy mesh measured by magnetic resonance imaging.

BACKGROUND: Sacrocolpopexy (SC) involves suspension of the vaginal vault or cervix to the sacrum using a mesh. Following insertion, the meshes have been observed to have undergone dimensional changes. OBJECTIVE: To quantify dimensional changes of meshes following implantation and characterize their morphology in-vivo. DESIGN SETTING AND PARTICIPANTS: 24 patients underwent SC using PolyVinyliDeneFluoride mesh loaded with Fe3O4 particles. Tailored anterior and posterior mesh flaps were sutured to the respective vaginal walls, uniting at the apex. The posterior flap continued to the sacrum and was attached there. Meshes were visualized on magnetic resonance (MR) imaging at 12 [3-12] (median [range]) months postoperatively and 3D models of the mesh were generated. Dynamic MR sequences were acquired during valsalva to record mesh mobility. OUTCOME MEASURES: The area of the vagina effectively supported by the mesh (Effective Support Area (ESA)) was calculated. The 3D models' wall thickness map was analyzed to identify the locations of mesh folding. Intraclass correlation (ICC) was calculated to test the reliability of the methods. To measure the laxity and flatness of the mesh, the curvature and the ellipticity of the sacral flap were calculated. RESULTS: The ESA calculation methodology had ICC = 0.97. A reduction of 75.49 [61.55-78.67] % (median [IQR]) in area, 47.64 [38.07-59.81] % in anterior flap, and of 23.95 [10.96-27.21] % in the posterior flap was measured. The mesh appeared thicker near its attachment at the sacral promontory (n = 19) and near the vaginal apex (n = 22). The laxity of the mesh was 1.13 [1.10-1.16] and 60.55 [49.76-76.25] % of the sacral flap was flat. We could not reliably measure mesh mobility (ICC = 0.16). CONCLUSION: A methodology for complete 3D characterization of SC meshes using MR images was presented. After implantation, the supported area is much lower than what is prepared prior to implantation. We propose this happened during the surgery itself.

Transvaginal Mesh Insertion in the Ovine Model.

This protocol describes mesh insertion into the rectovaginal septum in sheep using a single vaginal incision technique, with and without the trocar-guided insertion of anchoring arms. Parous sheep underwent the dissection of the rectovaginal septum, followed by the insertion of an implant with or without four anchoring arms, both designed to fit the ovine anatomy. The anchoring arms were put in place using a trocar and an "outside-in" technique. The cranial arms were passed through the obturator, gracilis, and adductor magnus muscles. The caudal arms were fixed near the sacrotuberous ligament, through the coccygeus muscles. This technique allows for the mimicking of surgical procedures performed in women suffering from pelvic organ prolapse. The anatomical spaces and elements are easily identified. The most critical part of the procedure is the insertion of the cranial trocar, which can easily penetrate the peritoneal cavity or the surrounding pelvic organs. This can be avoided by a more extensive retroperitoneal dissection and by guiding the trocar more laterally. This approach is designed only for experimental testing of novel implants in large animal models, as trocar-guided insertion is currently not used clinically.

Physiologic musculofascial compliance following reinforcement with electrospun polycaprolactone-ureidopyrimidinone mesh in a rat model.

PURPOSE: Electrospun meshes may be considered as substitutes to textile polypropylene implants. We compared the host response and biomechanical properties of the rat abdominal wall following reinforcement with either polycaprolactone (PCL) modified with ureidopyrimidinone-motifs (UPy) or polypropylene mesh. METHODS: First we measured the response to cyclic uniaxial load within the physiological range both dry (room temperature) and wet (body temperature). 36 rats underwent primary repair of a full-thickness abdominal wall defect with a polypropylene suture (native tissue repair), or reinforced with either UPy-PCL or ultra-light weight polypropylene mesh (n = 12/group). Sacrifice was at 7 and 42 days. Outcomes were compliance of explants, mesh dimensions, graft related complications and semi-quantitative assessment of inflammatory cell (sub) types, neovascularization and remodeling. RESULTS: Dry UPy-PCL implants are less stiff than polypropylene, both are more compliant in wet conditions. Polypropylene loses stiffness on cyclic loading. Both implant types were well incorporated without clinically obvious degradation or herniation. Exposure rates were similar (n = 2/12) as well as mesh contraction. There was no reinforcement at low loads, while, at higher tension, polypropylene explants were much stiffer than UPy-PCL. The latter was initially weaker yet by 42 days it had a compliance similar to native abdominal wall. There were eventually more foreign body giant cells around UPy-PCL fibers yet the amount of M1 subtype macrophages was higher than in polypropylene explants. There were less neovascularization and collagen deposition. CONCLUSION: Abdominal wall reconstruction with electrospun UPy-PCL mesh does not compromise physiologic tissue biomechanical properties, yet provokes a vivid inflammatory reaction.

Cell-based secondary prevention of childbirth-induced pelvic floor trauma.

With advancing population age, pelvic-floor dysfunction (PFD) will affect an increasing number of women. Many of these women wish to maintain active lifestyles, indicating an urgent need for effective strategies to treat or, preferably, prevent the occurrence of PFD. Childbirth and pregnancy have both long been recognized as crucial contributing factors in the pathophysiology of PFD. Vaginal delivery of a child is a serious traumatic event, causing anatomical and functional changes in the pelvic floor. Similar changes to those experienced during childbirth can be found in symptomatic women, often many years after delivery. Thus, women with such PFD symptoms might have incompletely recovered from the trauma caused by vaginal delivery. This hypothesis creates the possibility that preventive measures can be initiated around the time of delivery. Secondary prevention has been shown to be beneficial in patients with many other chronic conditions. The current general consensus is that clinicians should aim to minimize the extent of damage during delivery, and aim to optimize healing processes after delivery, therefore preventing later dysfunction. A substantial amount of research investigating the potential of stem-cell injections as a therapeutic strategy for achieving this purpose is currently ongoing. Data from small animal models have demonstrated positive effects of mesenchymal stem-cell injections on the healing process following simulated vaginal birth injury.

In vivo evidence of significant levator ani muscle stretch on MR images of a live childbirth.

OBJECTIVE: Vaginal childbirth is believed to be a significant risk factor for the development of pelvic floor dysfunction later in life. Previous studies have explored the use of medical imaging and simulations of childbirth to determine the stretch in the levator ani muscle. A report in 2012 has recorded magnetic resonance images of a live childbirth of a 24 year old woman giving birth vaginally for the second time, using a 1.0 Tesla open, high-field scanner. Our objective was to determine the stretch ratios in the levator muscle using these magnetic resonance images of live childbirth. STUDY DESIGN: Three-dimensional magnetic resonance image sequences were obtained to visualize coronal and axial planes before and after the childbirth. These images were obtained before the expulsion phase without pushing and were used to reconstruct the levator muscle and the fetal head in 3 dimensions. The fetal head was approximated to be an ellipsoid, and it is assumed that its middle section is visible in dynamic magnetic resonance images. Assuming incompressibility, the full deformation field of the fetal head is then calculated. Real-time cine magnetic resonance images were acquired for the during the expulsion phase, occurring over 2 contractions in the midsagittal plane. The levator muscle stretch is estimated using a custom program. The program calculates points of contact between the fetal head ellipsoid and the levator ani muscle model as the head descends down the birth canal and moves them orthogonal to its surface. Circumferential stretch was calculated to represent the extension needed to allow the passage of the fetal head. RESULTS: Starting from a position in the preexpulsion phase, the levator muscle experiences a maximum circumferential stretch of 248% on the posterior-medial portion of the levator ani muscle, as shown in previously published finite element simulations. However, the maximal stretch was notably less than that predicted by finite element models. This is because our baseline 3-dimensional model of the levator muscle is created from images taken shortly before expulsion and thus is already in a stretched state. Furthermore, the finite element models are created from images of a healthy nulliparous woman, while this study uses images from a para 2 woman. CONCLUSION: This study is the first attempt to estimate the stretch in levator ani muscle using magnetic resonance images of a live childbirth. The stretch was significant and the locations corroborate with previous findings of finite element models.

Laparoscopic versus robotic-assisted sacrocolpopexy for pelvic organ prolapse: a systematic review.

The use of robot-assisted surgery (RAS) has gained popularity in the field of gynaecology, including pelvic floor surgery. To assess the benefits of RAS, we conducted a systematic review of randomized controlled trials comparing laparoscopic and robotic-assisted sacrocolpopexy. The Cochrane Library (1970-January 2015), MEDLINE (1966 to January 2015), and EMBASE (1974 to January 2015) were searched, as well as ClinicalTrials.gov and the International Clinical Trials Registry Platform. We identified two randomized trials (n = 78) comparing laparoscopic with robotic sacrocolpopexy. The Paraiso 2011 study showed that laparoscopic was faster than robotic sacrocolpopexy (199 ± 46 vs. 265 ± 50 min; p < .001), yet in the ACCESS trial, no difference was present (225 ± 62.3 vs. 246.5 ± 51.3 min; p = .110). Costs for using the robot were significantly higher in both studies, however, in the ACCESS trial, only when purchase and maintenance of the robot was included (LSC US$11,573 ± 3191 vs. RASC US$19,616 ± 3135; p < .001). In the Paraiso study, RASC was more expensive even without considering those costs (LSC US$ 14,342 ± 2941 vs. RASC 16,278 ± 3326; p = 0.008). Pain was reportedly higher after RASC, although at different time points after the operation. There were no differences in anatomical outcomes, pelvic floor function, and quality of life. The experience with RASC was tenfold lower than that with LSC in both studies. The heterogeneity between the two studies precluded a meta-analysis. Based on small randomized studies, with surgeons less experienced in RAS than in laparoscopic surgery, robotic surgery significantly increases the cost of a laparoscopic sacrocolpopexy. RASC would be more sustainable if its costs would be lower. Though RASC may have other benefits, such as reduction of the learning curve and increased ergonomics or dexterity, these remain to be demonstrated.

Evaluating Alternative Materials for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse: A Comparison of the In Vivo Response to Meshes Implanted in Rabbits.

PURPOSE: Serious complications can develop with the mesh implants used for stress urinary incontinence and pelvic organ prolapse surgery. We evaluated 2 materials currently in clinical use and 2 alternative materials using a rabbit abdominal model to assess host response and biomechanical properties of the materials before and after implantation. MATERIALS AND METHODS: Poly-L-lactic acid and polyurethane meshes were electrospun to be compared to commercially available polypropylene and polyvinylidene fluoride meshes. A total of 40 immunocompetent full-thickness abdominal wall defect rabbit models were used, including 8 in each of the poly-L-lactic acid, polyurethane, polyvinylidene fluoride and polypropylene experimental groups, and sham controls. Two 20 mm defects were created per animal and primarily repaired. The experimental groups then underwent onlay of each repair material while sham controls did not. Four rabbits per group were sacrificed at days 30 and 90. Abdominal wall specimens containing the defect with or without repair material were explanted to be assessed by histology (hematoxylin and eosin staining, and immunohistochemistry) and biomechanical testing at 30 and 90 days. RESULTS: At 90 days of implantation tissues repaired with all 4 materials showed biomechanical properties without significant differences. However, polypropylene and polyvinylidene fluoride meshes demonstrated a sustained chronic inflammatory response profile by 90 days. In contrast, poly-L-lactic acid and polyurethane meshes integrated well into host tissues with a decreased inflammatory response, indicative of constructive remodeling. CONCLUSIONS: Poly-L-lactic acid and polyurethane alternative materials achieved better host integration in rabbit models than current synthetic repair materials.

Three-dimensional analysis of implanted magnetic-resonance-visible meshes.

OBJECTIVE: Our primary objective was to develop relevant algorithms for quantification of mesh position and 3D shape in magnetic resonance (MR) images. METHODS: In this proof-of-principle study, one patient with severe anterior vaginal wall prolapse was implanted with an MR-visible mesh. High-resolution MR images of the pelvis were acquired 6 weeks and 8 months postsurgery. 3D models were created using semiautomatic segmentation techniques. Conformational changes were recorded quantitatively using part-comparison analysis. An ellipticity measure is proposed to record longitudinal conformational changes in the mesh arms. The surface that is the effective reinforcement provided by the mesh is calculated using a novel methodology. The area of this surface is the effective support area (ESA). RESULTS: MR-visible mesh was clearly outlined in the images, which allowed us to longitudinally quantify mesh configuration between 6 weeks and 8 months after implantation. No significant changes were found in mesh position, effective support area, conformation of the mesh's main body, and arm length during the period of observation. Ellipticity profiles show longitudinal conformational changes in posterior arms. CONCLUSIONS: This paper proposes novel methodologies for a systematic 3D assessment of the position and morphology of MR-visible meshes. A novel semiautomatic tool was developed to calculate the effective area of support provided by the mesh, a potentially clinically important parameter.