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To assess whether COSingle-centre, sham-controlled, double-blind, randomised trial.A tertiary centre in Belgium.Sixty women with moderate to severe GSM symptoms.All participants eventually received three consecutive laser and three consecutive sham applications, either first laser followed by sham, or conversely.The primary outcome was the participant-reported change in severity of the MBS at 12 weeks. Secondary outcomes included subjective (patient satisfaction, sexual function, urinary function) and objective (pH, Vaginal Health Index Score, in vivo microscopy) measurements assessing the short-term effect and the longevity of treatment effects at 18 months after start of the therapy. Adverse events were reported at every visit.The MBS severity score decreased from 2.86 ± 0.35 to 2.17 ± 0.93 (-23.60%; 95% CI -36.10% to -11.10%) in women treated with laser compared with 2.90 ± 0.31 to 2.52 ± 0.78 (-13.20%; 95% CI -22.70% to -3.73%) in those receiving sham applications (p = 0.13). There were no serious adverse events reported up to 18 months.In women with GSM, the treatment response 12 weeks after laser application was comparable to that of sham applications. There were no obvious differences for secondary outcomes and no serious adverse events were reported.

Vaginal natural orifice transluminal endoscopic surgery (NOTES) is a novel technique for minimally invasive gynecological surgery. Adequate training and standardization are key elements to patient safety and quality of care. Based on consensus statements and expert opinion; we report a step-by-step guidance for hysterectomy via natural orifice transluminal endoscopy. A detailed description is presented of pre- and postoperative care, and the instruments and equipment used, and surgical steps are illustrated by photographic images. This report can guide surgeons in their training to perform a hysterectomy via NOTES. ispartof: ACTA OBSTETRICIA ET GYNECOLOGICA SCANDINAVICA vol:101 issue:6 pages:649-656 ispartof: location:United States status: published

INTRODUCTION: Concerns about vaginal mesh have reduced the use of mid-urethral slings (MUS) in some countries. In view of their potential withdrawal in Belgium and The Netherlands, we polled urogynaecologists on their practice for treating stress urinary incontinence (SUI) and what their experience is with alternative procedures, and we asked them how their patients perceive the risk and success rates. METHODS: A survey among members of the pelvic floor special interest group of the Flemish Society for Obstetrics and Gynaecology, Belgian Association of Urology and Dutch Society of Obstetrics and Gynaecology. RESULTS: Their primary procedure of choice is the MUS (99%). Sixty-five per cent performs at least 25 MUS yearly; they report high success (90%; IQR [85-92]) and low adverse outcome rates. Physicians anticipate complications as reported in the literature: 5% (IQR [410]) overactive bladder, 5% (IQR [2-10]) voiding problems, 2% (IQR [15]) exposures, 2% (IQR [1-5]) dyspareunia and 1% (IQR [1-3]) chronic pain. Eighty-five per cent of physicians report their patients express fears about having a MUS though usually they cannot precisely tell why. Reportedly they tell their physicians of concerns about pain (54%), exposure (45%), dyspareunia (25%), voiding problems (15%) or overactive bladder (8%). Only half of respondents had ever performed a colposuspension. The majority of these were older and performed colposuspension via laparotomy. Only six (4%) had performed > 20 colposuspensions yearly. CONCLUSION: Dutch and Belgian urogynaecologists estimate success and adverse effect rates of MUS in line with the literature. Their patients most cited worries were fear of chronic pain and exposure. Only half of respondents had ever performed a colposuspension. They were older and performed the procedure via laparotomy.

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.

Background To compare surgical outcomes of patients with leiomyomas after robotic-assisted laparoscopic myomectomy (RALM), laparoscopic myomectomy (LsM), or laparotomic myomectomy (LtM) and to construct a useful algorithm for the best modus operandi for uterine leiomyomas. Methods Design: A retrospective chart review. Data included patient (age and BMI) and fibroid characteristics (number, measurements of the primary fibroid, type, and location), operating time, blood loss, hospitalization length, complications during and after surgery, and complications during posttreatment pregnancies. Comparisons were based on chi-square and two-sample t tests. Setting: University teaching hospital. Patients: Between 1 January 2009 and 31 December 2016, 51 RALMs, 84 LsMs, and 52 LtMs were performed at our institution. Interventions: Three different approaches of myomectomy were performed: robotic-assisted laparoscopy (RALM), laparoscopy (LsM), and laparotomy (LtM). Results There was no significant difference in the distribution of the location and the type of myoma between the three groups. The mean size of the largest myoma removed by LsM, RALM, and LtM was 60.9, 70.8, and 92.6 mm (p Conclusion RALM should replace open surgery if feasible and should not replace traditional laparoscopy unless other benefits are proven.

Study Objective: Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a novel minimal invasive surgical technique allowing a variety of gynecological procedures. The current literature describes improved patient comfort, improved better cosmetic results, and reduced operation time. This is a first study to assess pregnancy outcome after fertility-preserving vNOTES procedures. Design/Participants/Materials/Setting/Methods: We performed a retrospective observational cohort study including 125 patients under 43 years that underwent fertility-preserving vNOTES over a 5-year period (2014–2019). The gynecological surgical procedures included were vNOTES myomectomy, vNOTES salpingectomy for ectopic pregnancy, vNOTES unilateral adnexectomy, and vNOTES cystectomy. A total of 26 pregnancies in 21 cases were observed, with deliveries between 2015 and 2020. Results: Retrospective analysis in this patient group showed that 18 pregnancies were diagnosed within 1 year after vNOTES (85.7%). Mean interval between surgery and pregnancy was 6 months. Fertility treatment was performed in 28.6%. In the 26 observed pregnancies, no vNOTES-related complications were observed and delivery was at term in all cases. Mode of delivery was a vaginal delivery in twenty cases (76.9% of total) of which 2 cases vacuum assisted (7.7%) and a Caesarean section in 6 cases (23.1% of total). Two cases of trial of labor after Caesarean are described after vNOTES surgery, both ended in an uncomplicated vaginal delivery. In case of vaginal delivery, the perineum was intact in 15%, a mediolateral episiotomy was performed in 50 and 35% a grade 1–2 perineal rupture was described. No grade 3–4 perineal ruptures are described. Limitations: A limitation of this study is the retrospective design which does not correct for confounding factors. Further larger multicenter studies are needed to validate these data. Conclusions: This is the first study describing pregnancy outcome after fertility-preserving vNOTES procedures. vNOTES did not affect the mode of delivery or cause pregnancy-related complications. vNOTES did not increase the risk of extensive perineal tears during vaginal delivery. These preliminary data show no adverse events when vNOTES is performed in women of reproductive age. Posterior colpotomy as performed in all vNOTES procedures is by itself not an indication for an elective Caesarean section.

Laparoscopy offers better exposure and surgical detail, avoids the need for excessive abdominal packing and bowel manipulation, next to reduced blood loss and lesser morbidity. It is therefore the ideal approach for pelvic floor procedures to treat urinary incontinence, pelvic organ, and rectal prolapse. The most commonly performed procedures are sacrocolpopexy, rectopexy, and colposuspension, which evolved from the stage of technical experimentation (1990s) and uncontrolled studies (early twenty-first century) to procedures for which today level I evidence is available that they provide equally good outcomes as their open counterparts. Offering a combination of incontinence, vaginal prolapse, and rectal surgery requires a multidisciplinary surgical team. The generic limitations of laparoscopy are its steep learning curve and long operation times, the limited number of degrees of freedom and its two-dimensional vision. Those limitations may in part or completely be overcome by a robotic approach, though there are no studies demonstrating a clinical benefit. Robotic surgery may shorten the learning curve for surgeons not familiar with “straight stick” laparoscopy, but remains expensive. This may change in the near future as more competitors will be on the market. Likewise, colposuspension may rekindle because of the negative advertisement for synthetic materials making patients ask for alternatives for mid-urethral slings.

Background Laparoscopic sacrocolpopexy is the preferred procedure for restoring vaginal vault prolapse. An assistant uses a vaginal manipulator to position and tension the vault such that the surgeon can dissect the bladder, rectum and vault to eventually suture a synthetic mesh used to suspend the vagina to the longitudinal anterior vertebral ligament. Vaginal vault manipulation requires application of high forces for long periods of time. Methods This work quantifies the task by measuring and analyzing the interaction forces and the workspace during vaginal vault manipulation. From the measurements we developed a uniaxial model, expressing the increase in interaction force and stiffness of the vagina. By adapting the model parameters, the difference in interaction force and stiffness between moderate and severe prolapse is predicted. Findings For moderate prolapse the average interaction force and stiffness start at 2.56 N and 0.11 N mm−1 in the tensionfree state, and go up to 20.14 N and 0.53 N mm−1 after complete insertion of the instrument. For severe degrees of prolapse, tissue interaction is much lower starting at 1.68 N and 0.06 N mm−1 while staying limited to 12.20 N and 0.30 N mm−1 at full extension. Interpretation Population data shows that the stage of prolapse and total vaginal length increase with age and parity. The interaction force and stiffness of the vagina are correlated with this degree of prolapse. By adapting the model parameters a good estimation of the tissue interaction is found for patients with mild and severe prolapse.

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. 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. 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

Background Data concerning laparoscopic sacrocolpopexy (LSCP) in elder women are scarce. We compared intra-operative and early-postoperative complications associated with laparoscopic colpo-, cervico-, or hysteropexy in women under and above 70 years. Methods Retrospective assessment by an independent investigator of a prospective cohort of 571 consecutive women undergoing LSCP in a tertiary unit over an 18-year period. Data included were patient demographics, operative variables, intra-operative, and early (≤ 3 months) postoperative complications. Complications were graded according to the Clavien-Dindo classification and mesh complications categorized using the International Urogynaecological Association (IUGA)-classification. Findings Median age was 66 (IQR 15, range 27-91) and 204 (35.7%) patients were older than 70 years. There were no deaths. Strategic conversion rate was 2.3% (13/571), the majority because of extensive adhesions yet early in our experience. Reactive conversion rate was 0.7% (4/571). Among 554 patients who had a completed LSCP, there were 20 intra-operative complications (3.6%), mostly bladder (1.3%) and vaginal (1.1%) injuries. Eighty-four patients had a total of 95 early-postoperative Dindo ≥ II complications (15.1%). Most common complications were infectious and treated medically (Dindo II). Clinically major complications are rare (III = 3.1% and IV = 0.2%). Reoperation for suspected bleeding (IIIb = 0.7%) was the most common reintervention, typically without demonstrable cause. Most mesh complications were vaginal exposures. Septuagenarians were not more likely to have an intra-operative (4.0 vs 3.3% p = 0.686) or early-postoperative complication (13.6 vs 16.0% p = 0.455) than younger patients. Mesh complications were also equally uncommon. Conclusions LSCP is as well-tolerated by women above 70 years as by younger women.

Study Objective We aimed to report an update of the systematic review and meta-analysis published in 2016, comparing hysterectomy by vaginal natural orifice transluminal endoscopic surgery (vNOTES) to the laparoscopic approach for benign indications. Design This was a systematic review and meta-analysis. We searched MEDLINE, EMBASE, CENTRAL and additional sources and aimed to retrieve randomised controlled trials (RCTs), controlled clinical trials (CCTs) and prospective/retrospective cohort studies in human subjects that allowed direct comparison of vNOTES to laparoscopy. Primary outcome was the proportion of women successfully treated with the intended approach to perform hysterectomy without conversion to any other technique. Setting N/A. Patients or Participants We included studies in the adult female population, undergoing removal of the uterus for benign gynecological disease. Studies on interventions for genital prolapse or gynecological malignancy were excluded. Interventions N/A. Measurements and Main Results Our search yielded one RCT and five retrospective cohort trials. Pooled analysis of two subgroups showed that, compared to conventional laparoscopy, vNOTES is equally effective to successfully remove the uterus in individuals meeting the inclusion criteria. vNOTES had significantly lower values for operation time, length of stay and estimated blood loss. There was no significant difference in intra-operative and post-operative complications, readmission, pain scores at 24 hours post-operative and change in haemoglobin on day 1 post-operative. Conclusion The available randomised and observational data show that vNOTES hysterectomy is an effective and safe novel technique for women eligible for endoscopic surgery.

BACKGROUND: Possible transtubal spillage of malignant cells is a major concern in fluid instillation sonography, as it is in hysteroscopy. This study aims to compare the transtubal flow of gel and saline and validate the clinical hypothesis that application of fluids with higher viscosity causes less spillage. METHODS: Randomized controlled in vitro trial comparing gel and saline infusion on 15 tissue specimens after hysterectomy with bilateral salpingectomy. Instillations are performed with saline and gel dyed with a 1% ink solution. Qualitative assessment of tubal spill is investigated as primary outcome. Secondary outcomes are instillation-volume and -pressure, assessed by measuring endometrial cavity dilation at in vitro ultrasound examination and subjective numeric 10-point scoring of the instillation pressure by a dedicated examiner. RESULTS: Tubal flow was more often observed during saline instillation (odds ratio 4.88, P = 0.008). Median subjectively assessed instillation pressures were nine arbitrary units for gel and three for saline (P < 0.001). Tubal flow occurred from 2 cc onward in the saline group versus five cc in the gel instillation group. Cavitary dilation did not differ between both groups. CONCLUSION: Gel instillation sonography is in vitro associated with less tubal flow and therefore could be a safer diagnostic test compared to saline infusion sonography or hysteroscopy. In vivo studies are necessary to confirm these results. ispartof: JOURNAL OF MEDICAL ULTRASOUND vol:28 issue:1 pages:35-40 ispartof: location:India status: published

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. ispartof: INTERNATIONAL UROGYNECOLOGY JOURNAL vol:31 issue:6 pages:1107-1113 ispartof: location:England status: published

Background: Possible transtubal spillage of malignant cells is a major concern in fluid instillation sonography, as it is in hysteroscopy. This study aims to compare the transtubal flow of gel and saline and validate the clinical hypothesis that application of fluids with higher viscosity causes less spillage. Methods: Randomized controlled in vitro trial comparing gel and saline infusion on 15 tissue specimens after hysterectomy with bilateral salpingectomy. Instillations are performed with saline and gel dyed with a 1% ink solution. Qualitative assessment of tubal spill is investigated as primary outcome. Secondary outcomes are instillation-volume and -pressure, assessed by measuring endometrial cavity dilation at in vitro ultrasound examination and subjective numeric 10-point scoring of the instillation pressure by a dedicated examiner. Results: Tubal flow was more often observed during saline instillation (odds ratio 4.88, P = 0.008). Median subjectively assessed instillation pressures were nine arbitrary units for gel and three for saline (P < 0.001). Tubal flow occurred from 2 cc onward in the saline group versus five cc in the gel instillation group. Cavitary dilation did not differ between both groups. Conclusion: Gel instillation sonography is in vitro associated with less tubal flow and therefore could be a safer diagnostic test compared to saline infusion sonography or hysteroscopy. In vivo studies are necessary to confirm these results.

(1) Objective: We aimed to report an update of the systematic review and meta-analysis by Baekelandt et al. (2016). (2) Method: We followed PRISMA guidelines to perform this systematic review. We searched MEDLINE, EMBASE, CENTRAL and additional sources and aimed to retrieve randomised controlled trials (RCTs), controlled clinical trials (CCTs) and prospective/retrospective cohort studies in human subjects that allowed direct comparison of vNOTES to laparoscopy. (3) Results: Our search yielded one RCT and five retrospective cohort trials. Pooled analysis of two subgroups showed that, compared to conventional laparoscopy, vNOTES is equally effective to successfully remove the uterus in individuals meeting the inclusion criteria. vNOTES had significantly lower values for operation time, length of stay and estimated blood loss. There was no significant difference in intra- and postoperative complications, readmission, pain scores at 24 h postoperative and change in hemoglobin (Hb) on day 1 postoperative. ispartof: JOURNAL OF CLINICAL MEDICINE vol:9 issue:12 ispartof: location:Switzerland status: published

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.

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 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 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.