Pelvic Organ Prolapse Reconstruction with the Chitosan-Based Novel Haemostatic Agent in Ovine Model-Preliminary Report.

This prospective study aimed to assess the feasibility of chitosan biomaterial and subcutaneous gel implantation in an ovine model, with implications for women with genital prolapse. Twenty-four ewes were divided into four groups (n = 6 per group): chitosan type B, chitosan type C, chitosan unmodified injections, and polypropylene mesh. Ovine models were chosen due to their morphological resemblance to human reproductive organs. Animals were sacrificed after 90 days for macroscopic, pathomorphological, and immunohistochemical analysis. In the chitosan type B group, IL-6 and IL-10 levels decreased after 28 days, while chitosan type C and injection groups exhibited higher IL-6 than IL-10 levels. The polypropylene group displayed the highest IL-6 and lowest IL-10 levels. Histological examination of the polypropylene group revealed no degenerative changes or inflammation, whereas chitosan injection induced local inflammation. Other groups exhibited no degenerative changes. Ewes implanted with chitosan displayed reduced inflammation compared to polypropylene-implanted ewes. Chitosan implantation facilitated vaginal tissue healing, in contrast to polypropylene mesh, which led to extrusion. While chitosan holds promise as an alternative to polypropylene mesh, further research is imperative for comprehensive evaluation. This study suggests the potential of a chitosan biomaterial in pelvic organ prolapse treatment, warranting additional investigation.

Patients' perspectives on quality and patient safety failures: lessons learned from an inquiry into transvaginal mesh in Australia.

BACKGROUND: Transvaginal mesh (TVM) surgeries emerged as an innovative treatment for stress urine incontinency and/or pelvic organ prolapse in 1996. Years after rapid adoption of these surgeries into practice, they are a key example of worldwide failure of healthcare quality and patient safety. The prevalence of TVM-associated harms eventually prompted action globally, including an Australian Commonwealth Government Senate Inquiry in 2017. METHOD: We analysed 425 submissions made by women (n = 417) and their advocates (n = 8) to the Australian Senate Inquiry, and documents from 5 public hearings, using deductive and inductive coding, categorisation and thematic analysis informed by three 'linked dilemmas' from healthcare quality and safety theory. We focused on women's accounts of: a) how harms arose from TVM procedures, and b) micro, meso and macro factors that contributed to their experience. Our aim was to explain, from a patient perspective, how these harms persisted in Australian healthcare, and to identify mechanisms at micro, meso and macro levels explaining quality and safety system failure. RESULTS: Our findings suggest three mechanisms explaining quality and safety failure: 1. Individual clinicians could ignore cases of TVM injury or define them as 'non-preventable'; 2. Women could not go beyond their treating clinicians to participate in defining and governing quality and safety; and. 3. Health services set thresholds for concern based on proportion of cases harmed, not absolute number or severity of harms. CONCLUSION: We argue that privileging clinical perspectives over patient perspectives in evaluating TVM outcomes allowed micro-level actors to dismiss women's lived experience, such that women's accounts of harms had insufficient or no weight at meso and macro levels. Establishing system-wide expectations regarding responsiveness to patients, and communication of patient reported outcomes in evaluation of healthcare delivery, may help prevent similar failures.

Exploring risk factors of pelvic organ prolapse at eastern of Democratic Republic of Congo: a case-control study.

BACKGROUND: Pelvic organ prolapse is a common debilitating condition worldwide. Despite surgical treatment, its recurrence can reach up to 30%. It has multiple risk factors, some of which are particular for a low-resource settings. The identification these factors would help to devise risk models allowing the development of prevention policies. The objective of this study was to explore risk factors for pelvic organ prolapse in a population in eastern Democratic Republic of Congo (DRC). METHODS: This was an unmatched case-control study conducted between January 2021 and January 2022. The sample size was estimated to be a total of 434 women (217 with prolapse as cases and 217 without prolapse as controls). Data comparisons were made using the Chi-Square and Student T tests. Binary and multivariate logistic regressions were used to determine associated factors. A p < 0.05 was considered significant. RESULTS: Variables identified as definitive predictors of pelvic organ prolapse included low BMI (aOR 2.991; CI 1.419-6.307; p = 0.004), home birth (aOR 6.102; CI 3.526-10.561; p < 0.001), family history of POP (aOR 2.085; CI 1.107-3.924; p = 0.023), history of birth without an episiotomy (aOR 3.504; CI 2.031-6.048; p = 0), height ≤ 150 cm (aOR 5.328; CI 2.942-9.648; p < 0.001) and history of giving birth to a macrosomic baby (aOR 1.929; IC 1.121-3.321; p = 0.018). CONCLUSIONS: This study identified that Body Mass Index and birth-related factors are definitive predictors of pelvic organ prolapse in a low-resource setting. These factors are potentially modifiable and should be targeted in any future pelvic organ prolapse prevention policy. Additionally, there seems to be a genetic predisposition for prolapse, which warrants further assessment in specifically designed large scale studies.

Postoperative complications and unanticipated healthcare encounters following mini-laparotomy vs. laparoscopic/robotic-assisted sacrocolpopexy: a comparative retrospective study.

BACKGROUND: Pelvic organ prolapse is a debilitating condition impacting lives of millions of women worldwide. Sacrocolpopexy (SCP) is considered an effective and durable surgical technique for treatment of apical prolapse. The aim of this study was to compare short-term outcomes including postoperative complications and unanticipated healthcare encounters between patients who underwent SCP with a mini-laparotomy approach compared to patients treated with laparoscopic and robotic-assisted laparoscopic SCP. METHODS: This was a retrospective cohort study including patients treated for apical prolapse at a university affiliated urogynecology practice. Patients over the age of 18 who underwent abdominal SCP between 2019 and 2023 were included. The cohort was formed into two groups: (1) Patients who underwent SCP through a mini-laparotomy incision (Mini-lap group); (2) Patients who underwent laparoscopic or robotic-assisted laparoscopic SCP (Lap/Robot group). RESULTS: A total of 116 patients were included in the final analysis. Ninety patients underwent either laparoscopic or robotic-assisted SCP, whereas 26 patients underwent SCP with a mini-laparotomy approach. Study participants exhibited a mean age of 63.1 ± 10.3 years, mean body mass index (BMI) of 25.8 ± 4.9 Kg/m2, and 77.6% of them identified as Caucasian. Upon comparison of demographic and past medical history between groups there were no statistically significant differences in age, BMI, menopausal status, race, parity or comorbid conditions. Patients in the Mini-lap group were less likely to have undergone previous abdominal surgery (11.5% vs. 50.6%, p < 0.001) and had more severe apical prolapse (stage 4 prolapse, 40% vs. 21.2%, p < 0.001) than their counterparts in the Lap/robot group. Regarding intraoperative parameters, length of surgery was significantly shorter in the Mini-lap group compared to the Lap/robot group (97.3 ± 35.0 min vs. 242.0 ± 52.6 min, p < 0.001). When focusing on the primary outcome, postoperative complications within the first 30 days after surgery, there were no differences noted between groups. Additionally, the number of unanticipated healthcare encounters, such as phone calls, clinic visits, emergency department visits, urgent care visits, readmissions and reoperations were similar between groups. CONCLUSIONS: Mini-laparotomy approach for SCP is safe with comparable intra- and postoperative complications, and unanticipated healthcare encounters compared to conventional minimally invasive methods.

Retrospective Cohort Study of Recovery From Sacrocolpopexy Versus Nonmesh Prolapse Repair.

IMPORTANCE: Providing recovery expectations for prolapse surgery is an important part of patient counseling and aids in patient-centered decision making. OBJECTIVES: The purpose of this study was to determine if postoperative recovery from minimally invasive sacrocolpopexy (MISCP) is noninferior to that of native tissue repair. STUDY DESIGN: Recovery at 2 and 6 weeks was quantified using the Postdischarge Surgical Recovery 13 scale, where higher scores indicate greater patient-perceived recovery. A 2:1 MISCP to native tissue repair ratio was used. The study population was created from 3 prior studies involving patients who underwent prolapse surgery between 2013 and 2021.Independent-samples t test was used for normally distributed data, Mann-Whitney U tests for nonnormally distributed data, and the χ2 test for population proportions. A parsimonious linear regression analysis was performed to determine if the surgical group independently predicted postdischarge surgical recovery at 2 and 6 weeks, after controlling for significant confounders identified during bivariate analysis. RESULTS: The study population included 476 patients: 352 underwent MISCP and 124 underwent native tissue repair.Postdischarge Surgical Recovery 13 scores for patients who underwent MISCP compared with native tissue repair were higher at 2 weeks (mean, 58.4 ± 18.2 vs 54.4 ± 18.7; P = 0.04) and at 6 weeks postoperatively (mean, 77.2 ± 15.6 vs 73.7 ± 18.7; P = 0.1). CONCLUSIONS: Our findings indicate that recovery after MISCP is noninferior to that of native tissue repair. This information is important for delivering patient-centered care during preoperative counseling.

The effect of advanced age on peri- and post-operative complications following pelvic floor repair surgeries.

OBJECTIVES: To assess whether advanced age is a risk factor for complications following pelvic organ prolapse (POP) repair surgeries using the Clavien-Dindo classification system. METHODS: In this retrospective cohort study, 260 women who had undergone POP repair surgery at the Soroka University Medical Center (SUMC) between the years 2014-2019 were included. A univariate analysis was conducted to compare the demographical, clinical, obstetrical and operative characteristics of patients by age group (younger or older than 70 years). We performed a similar analysis to assess for the possible association between several variables and post-operative complications. Variables that were found to be associated with post-operative complications (P < 0.2) were included in a multivariate analysis along with advanced age. RESULTS: During the 12 months follow-up period, more than half of the women had experienced at least one post-operative complication. Minor complications (grades 1-2 according to the Clavian-Dindo classification system) were the most common. One woman had died during the follow-up period, and none had experienced organ failure (grade 4). Hysterectomy, as part of POP surgery, was found to be significantly associated with post-operative complications. Additionally, grandmultiparity (> 5 births) showed a tendency towards an increased risk for post-operative complications, however this reached only borderline significance. We found no association between advanced age and post-operative complications. CONCLUSIONS: POP repair surgeries are safe for women of all ages. Major complications (grades 3-5) are rare in all age groups. Although advanced age was associated with a higher prevalence of comorbidity and a higher grade of prolapse, no significant difference in the post-operative complications was found between age groups. Concomitant hysterectomy at the time of POP repair surgery is a risk factor for post-operative complications.

Mesh-less laparoscopic extraperitoneal linear suspension treatment of vaginal vault prolapse.

OBJECTIVES: To report the results of a mesh-less laparoscopic extraperitoneal linear suspension technique for the treatment of post-hysterectomy vaginal vault prolapse (PHVP). STUDY DESIGN: A retrospective observational study was conducted collecting medical records of 41 patients with symptomatic PHVP treated between November 2017 to November 2019 in Gynecologic department of China-Japan Friendship Hospital. All patients had Pelvic Organ Prolapse Quantification (POP-Q) scores indicating stage 3-4 PHVP and underwent mesh-less laparoscopic extraperitoneal linear suspension.The primary outcome was the subjective satisfaction rate based on responses to validated questionnaires. The secondary outcomes were the objective anatomical cure rate based on POP-Q scores and complication rates. All listed parameters were determined before the surgery and at control examinations in 1 year and 3 years after the treatment. RESULTS: The operation was completed successfully without serious complications in all patients. Mean operation time was 53.8 mins. Comparison of the scores by the questionnaires revealed a significant improvement in the quality of life in the postoperative period.The subjective satisfaction rates were 100 % (41/41) and 95 % (38/40) at 1 year and 3 years after surgery. The objective cure rates were 100 % (41/41) and 97.5 % (39/40) at 1 year and 3 years after surgery, respectively. During the follow-up, none of the patients experienced suture exposure, infection, chronic pelvic pain, or other related complications. CONCLUSION: The mesh-less laparoscopic extraperitoneal linear suspension technique avoids the use of implantable synthetic mesh. It has been shown to lead to favorable postoperative outcomes, considerable patient contentment, and low complication rates. It offers a new, cost-effective treatment option for PHVP patients.

Colporrhaphies versus Colpocleisis Following Vaginal Hysterectomy for the Treatment of Advanced Pelvic Organ Prolapse: A Comparative Study.

BACKGROUND: Obliterative vaginal procedures may offer lower perioperative morbidity and equal success rates as reconstructive procedures for frail and elderly women who no longer desire future coital function. The combination of vaginal hysterectomy with either reconstructive or obliterative vaginal procedures has not yet been investigated. OBJECTIVES: To compare peri- and postoperative outcomes of vaginal hysterectomy with pelvic floor reconstruction (VHR) vs. vaginal hysterectomy with colpocleisis (VHC). METHODS: We conducted a retrospective study comparing medical and surgical data of patients undergoing either VHR or VHC between 2006 and 2015. Data were obtained from inpatient and outpatient medical records including peri- and postoperative course, as well as long-term (24 months) follow-up data. RESULTS: We identified 172 patients who underwent VHR and 44 who underwent VHC. Patients in the VHC group were significantly older (71.3 ± 4.5 vs. 68.6 ± 6.5 years, P = 0.01), and more likely to have medical co-morbidities (P = 0.001 and P = 0.029, respectively). Patients in the VHC group experienced shorter operative time (2.3 ± 0.58 vs. 2.7 ± 1.02 hours, P = 0.007), lower perioperative blood loss (P < 0.0001), shorter hospital stay (P < 0.0001), and lower rates of postoperative urinary retention. Long-term pelvic organ prolapse (POP) recurrence rates were significantly higher among the VHR group. Postoperative resolution of both stress urinary incontinence and overactive bladder were common in both groups. CONCLUSIONS: VHC is associated with lower perioperative blood loss, shorter operative time, shorter hospital stay, shorter time with an indwelling catheter, and lower long-term objective POP recurrence rates.

Two-Year Preclinical Evaluation of Long-Term Absorbable Poly-4-hydroxybutyrate Scaffold for Surgical Correction of Pelvic Organ Prolapse.

INTRODUCTION AND HYPOTHESIS: Fully absorbable implants may be an alternative to permanent meshes in the correction pf pelvic organ prolapse (POP) as they may reduce adverse events by promoting tissue regeneration and collagen metabolism. This study was aimed at evaluating the long-term host and biomechanical response to a fully absorbable poly-4-hydroxybutyrate (P4HB) scaffold in comparison with polypropylene (PP) mesh. METHODS: Poly-4-hydroxybutyrate scaffold (n = 16) and PP mesh (n = 16) were surgically implanted in the posterior vaginal wall of parous female Dohne Merino sheep. Vaginal explants were evaluated in terms of gross necropsy, host response (immune response, collagen deposition, tissue regeneration), biomechanics, and degradation of P4HB at 12 and 24 months post-implantation. RESULTS: Gross necropsy revealed no infection or fluid collection using P4HB or PP. At 12 months, exposures were observed with both P4HB (3 out of 8) and PP (4 out of 8), whereas at 24 months, exposures were observed only with PP (4 out of 8). The tensile stiffness of the P4HB explants was maintained over time despite complete absorption of P4HB. The collagen amount of the vaginal tissue after P4HB implantation increased over time and was significantly higher than PP at 24 months. P4HB scaffolds exhibited significantly lower myofibroblast differentiation than PP meshes at 24 months. CONCLUSIONS: The P4HB scaffold allowed for gradual load transfer to the vaginal wall and resulted in mechanically self-sufficient tissue. P4HB scaffold had a more favorable host response than PP mesh, with higher collagen content, lower myofibroblastic differentiation, and no exposures at 24 months. P4HB scaffolds have potential as an alternative to permanent implants in treating POP.

Transvaginal mesh or grafts or native tissue repair for vaginal prolapse.

BACKGROUND: Pelvic organ prolapse is the descent of one or more of the pelvic organs (uterus, vaginal apex, bladder, or bowel) into the vagina. In recent years, surgeons have increasingly used grafts in transvaginal repairs. Graft material can be synthetic or biological. The aim is to reduce prolapse recurrence and surpass the effectiveness of traditional native tissue repair (colporrhaphy) for vaginal prolapse. This is a review update; the previous version was published in 2016. OBJECTIVES: To determine the safety and effectiveness of transvaginal mesh or biological grafts compared to native tissue repair or other grafts in the surgical treatment of vaginal prolapse. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and two clinical trials registers (March 2022). SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing different types of vaginal repair (mesh, biological graft, or native tissue). DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed risk of bias, and extracted data. The primary outcomes were awareness of prolapse, repeat surgery, and recurrent prolapse on examination. MAIN RESULTS: We included 51 RCTs (7846 women). The certainty of the evidence was largely moderate (ranging from very low to moderate). Transvaginal permanent mesh versus native tissue repair Awareness of prolapse at six months to seven years was less likely after mesh repair (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.73 to 0.95; I2 = 34%; 17 studies, 2932 women; moderate-certainty evidence). This suggests that if 23% of women are aware of prolapse after native tissue repair, between 17% and 22% will be aware of prolapse after permanent mesh repair. Rates of repeat surgery for prolapse were lower in the mesh group (RR 0.71, 95% CI 0.53 to 0.95; I2 = 35%; 17 studies, 2485 women; moderate-certainty evidence). There was no evidence of a difference between the groups in rates of repeat surgery for incontinence (RR 1.03, 95% CI 0.67 to 1.59; I2 = 0%; 13 studies, 2206 women; moderate-certainty evidence). However, more women in the mesh group required repeat surgery for the combined outcome of prolapse, stress incontinence, or mesh exposure (RR 1.56, 95% CI 1.07 to 2.26; I2 = 54%; 27 studies, 3916 women; low-certainty evidence). This suggests that if 7.1% of women require repeat surgery after native tissue repair, between 7.6% and 16% will require repeat surgery after permanent mesh repair. The rate of mesh exposure was 11.8% and surgery for mesh exposure was 6.1% in women who had mesh repairs. Recurrent prolapse on examination was less likely after mesh repair (RR 0.42, 95% CI 0.32 to 0.55; I2 = 84%; 25 studies, 3680 women; very low-certainty evidence). Permanent transvaginal mesh was associated with higher rates of de novo stress incontinence (RR 1.50, 95% CI 1.19 to 1.88; I2 = 0%; 17 studies, 2001 women; moderate-certainty evidence) and bladder injury (RR 3.67, 95% CI 1.63 to 8.28; I2 = 0%; 14 studies, 1997 women; moderate-certainty evidence). There was no evidence of a difference between the groups in rates of de novo dyspareunia (RR 1.22, 95% CI 0.83 to 1.79; I2 = 27%; 16 studies, 1308 women; moderate-certainty evidence). There was no evidence of a difference in quality of life outcomes; however, there was substantial heterogeneity in the data. Transvaginal absorbable mesh versus native tissue repair There was no evidence of a difference between the two methods of repair at two years for the rate of awareness of prolapse (RR 1.05, 95% CI 0.77 to 1.44; 1 study, 54 women), rate of repeat surgery for prolapse (RR 0.47, 95% CI 0.09 to 2.40; 1 study, 66 women), or recurrent prolapse on examination (RR 0.53, 95% CI 0.10 to 2.70; 1 study, 66 women). The effect of either form of repair was uncertain for bladder-related outcomes, dyspareunia, and quality of life. Transvaginal biological graft versus native tissue repair There was no evidence of a difference between the groups at one to three years for the outcome awareness of prolapse (RR 1.06, 95% CI 0.73 to 1.56; I2 = 0%; 8 studies, 1374 women; moderate-certainty evidence), repeat surgery for prolapse (RR 1.15, 95% CI 0.75 to 1.77; I2 = 0%; 6 studies, 899 women; moderate-certainty evidence), and recurrent prolapse on examination (RR 0.96, 95% CI 0.71 to 1.29; I2 = 53%; 9 studies, 1278 women; low-certainty evidence). There was no evidence of a difference between the groups for dyspareunia or quality of life. Transvaginal permanent mesh versus any other permanent mesh or biological graft vaginal repair Sparse reporting of primary outcomes in both comparisons significantly limited any meaningful analysis. AUTHORS' CONCLUSIONS: While transvaginal permanent mesh is associated with lower rates of awareness of prolapse, repeat surgery for prolapse, and prolapse on examination than native tissue repair, it is also associated with higher rates of total repeat surgery (for prolapse, stress urinary incontinence, or mesh exposure), bladder injury, and de novo stress urinary incontinence. While the direction of effects and effect sizes are relatively unchanged from the 2016 version of this review, the certainty and precision of the findings have all improved with a larger sample size. In addition, the clinical relevance of these data has improved, with 10 trials reporting 3- to 10-year outcomes. The risk-benefit profile means that transvaginal mesh has limited utility in primary surgery. Data on the management of recurrent prolapse are of limited quality. Given the risk-benefit profile, we recommend that any use of permanent transvaginal mesh should be conducted under the oversight of the local ethics committee in compliance with local regulatory recommendations. Data are not supportive of absorbable meshes or biological grafts for the management of transvaginal prolapse.

[Comparison of Surgical Outcome of Laparoscopic Sacrocolpopexy between the Novice and Experienced Surgeon in Laparoscopic Surgery].

We retrospectively analyzed the safety and surgical outcomes of laparoscopic sacrocolpopexy (LSC) by the novice surgeon (performed ＜5 laparoscopic surgery). Between November 2017 and December 2020, there were 15 cases in which the novice surgeon performed part of LSC, 8 cases in which the novice performed all of LSC, and 50 cases in which the experienced surgeon (performed ＞100 laparoscopic surgery) performed all of LSC. We compared surgical outcome of the 50 cases operated by the experienced surgeon and 23 cases operated by the novice. The laparoscopic time was longer when performed by the novice than by the experienced surgeon (median 208 minutes vs 189 minutes, p＝0.039). Cases of pelvic organ prolapse quantification system (POP-Q) stage 4 were operated more often by the experienced surgeon than by the novice (28% vs 4.8%, p＝0.027). There were no significant differences in the complications and recurrence of pelvic organ prolapse (POP-Q≧2). The LSC process was divided into five steps. The laparoscopic time of all steps was longer when performed by the novice than by the experienced surgeon except the step of lifting up the sigmoid colon and hysterectomy. As the number of cases performed by the novice increased, the laparoscopic time of all steps decreased. The short-term surgical outcomes for cases operated by the novice and experienced surgeon were comparable when the novice avoided cases of POP-Q stage 4. LSC has been said to be difficult, but in this study, even novice surgeons in laparoscopic surgery may be able to perform LSC by accumulating cases. Although this study is not generalizable due to limitations, we believe it will inspire many young doctors to perform LSC.

Effect of two different surgical modalities for pelvic organ prolapse on postoperative wound infection in patients: A meta-analysis.

Sacrospinous ligament fixation (SSLF) is widely applied to the treatment of female pelvis organ prolapsed. Contradictory findings have already been reported in the comparison of sacrocolpopexy (SC) with SSLF. The objective of this study is to evaluate the efficacy of SC versus SSLF in treating pelvis organ prolapsed after operation. We conducted a meta-analysis of both operative approaches, including PubMed, Embase, and Cochrane Library. In this research, 822 articles were chosen from three databases, 201 were copied, and 10 were included. Among them, 7248 cases were operated on the prolapsed pelvis. It was found that SSLF surgery could significantly decrease the rate of postoperative wound infection after operation (odds ratio [OR], 0.59; 95% confidence interval [CI], 0.42-0.82; p = 0.001). No statistical significance was found among the SSLF and the SC surgery for the post-operation haemorrhage of the patient (OR, 0.81; 95% CI, 0.23-2.83; p = 0.75). No statistical significance was found among the SSLF and the SC surgery for the postoperative period of the patient's operation (mean difference, -15.46; 95% CI, -52.87 to 21.94; p = 0.42). Applying SSLF surgery to treat pelvic prolapse in women may benefit from a reduction in the number of post-operative wound infections. However, SSLF had no statistical significance with respect to the amount of haemorrhage after operation or operation time.

Mobility analysis of a posterior sacrospinous fixation using a finite element model of the pelvic system.

INTRODUCTION AND HYPOTHESIS: In order to improve the knowledge POP physiopathology and POP repair, a generic biomechanical model of the female pelvic system has been developed. In the literature, no study has currently evaluated apical prolapse repair by posterior sacrospinous ligament fixation using a generic model nor a patient-specific model that personalize the management of POP and predict surgical outcomes based on the patient's pre-operative Magnetic Resonance Imaging. The aim of our study was to analyze the influence of a right and/or left sacrospinous ligament fixation and the distance between the anchorage area and the ischial spine on the pelvic organ mobility using a generic and a patient-specific Finite Element model (FEM) of the female pelvic system during posterior sacrospinous ligament fixation (SSF). METHODS: Firstly, we used a generic 3D FEM of the female pelvic system previously made by our team that allowed us to simulate the mobility of the pelvic system. To create a patient-specific 3D FEM of the female pelvic system, we used a preoperative dynamic pelvic MRI of a 68 years old woman with a symptomatic stage III apical prolapse and cystocele. With these 2 models, a SSF was simulated. A right and/or left SSF and different distances between the anchorage area and the ischial spine (1 cm, 2 cm and 3 cm.) were compared. Outcomes measures were the pelvic organ displacement using the pubococcygeal line during maximal strain: Ba point for the most posterior and inferior aspect of the bladder base, C point the cervix's or the vaginal apex and Bp point for the anterior aspect of the anorectal junction. RESULTS: Overall, pelvic organ mobility decreased regardless of surgical technique and model. According to the generic model, C point was displaced by 14.1 mm and 11.5 mm, Ba point by 12.7 mm, and 12 mm and Bp point by 10.6 mm and 9.9 mm after left and bilateral posterior SSF, respectively. C point was displaced by 15.4 mm and 11.6 mm and Ba point by 12.5 mm and 13.1mm when the suture on the sacrospinous ligament was performed at 1 cm and 3 cm from the ischial spine respectively (bilateral posterior SSF configuration). According to the patient-specific model, the displacement of Ba point could not be analyzed because of a significative and asymmetric organ displacement of the bladder. C point was displaced by 4.74 mm and 2.12 mm, and Bp point by 5.30 mm and 3.24 mm after left and bilateral posterior SSF respectively. C point was displaced by 4.80 mm and 4.85 mm and Bp point by 5.35 mm and 5.38 mm when the suture on the left sacrospinous ligament was performed at 1 cm and 3 cm from the ischial spine, respectively. CONCLUSION: According to the generic model from our study, the apex appeared to be less mobile in bilateral SSF. The anchorage area on the sacrospinous ligament seems to have little effect on the pelvic organ mobilities. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04551859.

High Uterosacral Ligaments Suspension for Post-Hysterectomy Vaginal Vault Prolapse Repair.

Background and Objectives: Uterosacral ligaments (USLs) suspension is a well-studied, safe, and long-lasting technique for central compartment correction. Preliminary clinical experiences showed encouraging data for this technique, also for post-hysterectomy vaginal vault prolapse surgical treatment. However, up-to-date evidence for post-hysterectomy vaginal vault prolapse repair through high uterosacral ligaments suspension is limited. Consequently, with this study, we aimed to assess the efficiency, complications frequency, and functional results of native-tissue repair through USLs in vaginal vault prolapse. Materials and Methods: This was a retrospective study. Women with symptomatic vaginal vault prolapse (≥stage 2) who underwent surgery with transvaginal native-tissue repair by high uterosacral ligaments were included. Patient characteristics, preoperative assessment, operative data, postoperative follow-up visits, and re-interventions were collected from the hospital's record files. High uterosacral ligament suspension was performed according to the technique previously described by Shull. A transverse apical colpotomy at the level of the post-hysterectomy scar was performed in order to enter the peritoneal cavity. USLs were identified and transfixed from ventral to dorsal with three absorbable sutures. Sutures were then passed through the vaginal apex and tightened to close the transverse colpotomy and suspend the vaginal cuff. At the end of the surgical time, a diagnostic cystoscopy was performed in order to evaluate ureteral bilateral patency. Using the POP-Q classification system, we considered an objective recurrence as the descensus of at least one compartment ≥ II stage, or the need for a subsequent surgery for POP. The complaint of bulging symptoms was considered the item to define a subjective recurrence. We employed PGI-I scores to assess patients' satisfaction. Results: Forty-seven consecutive patients corresponding to the given period were analyzed. No intraoperative complications were observed. We observed one postoperative hematoma that required surgical evacuation. Thirty-three patients completed a minimum of one-year follow-up (mean follow-up 21.7 ± 14.6 months). Objective cure rate was observed in 25 patients (75.8%). No patients required reintervention. The most frequent site of recurrence was the anterior compartment (21.2%), while apical compartment prolapse relapsed only in 6% of patients. An improvement in all POP-Q parameters was recorded except TVL which resulted in a mean 0.5 cm shorter. Subjective recurrence was referred by 4 (12.1%) patients. The mean satisfaction assessed by PGI-I score was 1.6 ± 0.8. Conclusion: This analysis demonstrated that native-tissue repair through high USL suspension is an effective and safe procedure for the treatment of post-hysterectomy vaginal vault prolapse. Objective, subjective, functional, and quality of life outcomes were satisfactory, with minimal complications.

[Lower urinary tract injury in transvaginal reconstructive pelvic surgery].

Objective: To explore the characteristics, prevention and treatment strategies of lower urinary tract injury in transvaginal reconstructive pelvic surgery (vRPS). Methods: A retrospective analysis was conducted on 24 patients who suffered lower urinary tract injuries occuring in vRPS from January 2005 to June 2021, among which 4 cases were referred to our hospital from other hospitals. Results: (1) In our hospital, 1 952 patients underwent vRPS for anterior and (or) middle pelvic organ prolapse during that study period, with a 1.0% (20/1 952) incidence of lower urinary tract injuries occurring in 20 cases. (2) Ureteral injuries were observed in 14 cases who underwent transvaginal high uterosacral ligament suspension (1.4%, 14/966). The symptoms were relieved after the removal of sutures. (3) Bladder injuries occurred in 6 cases in our hospital, with 4 cases (0.7%, 4/576) in anterior transvaginal mesh surgery (aTVM), one (0.4%, 1/260) in colpocleisis, and one (0.7%, 1/150) in apical suspension for fornix prolapse. An additional 4 cases of bladder injury were referred to our hospital after aTVM. Among the 8 cases of bladder injury during aTVM, 2 cases were intraoperative incidents. Cystoscopy confirmed that the superficial branch or puncture rod of anterior vaginal mesh had penetrated into the bladder. Re-puncturing and placement of the mesh were successfully performed. No abnormalities were observed during a follow-up period of 4-5 years. Postoperative bladder injuries were identified in 6 cases, characterized by mesh erosion into the bladder and formation of calculi. These injuries were confirmed between 6 months to 2 years after vRPS. The exposed mesh and calculi in the bladder were removed through laparotomy or cystoscopy, followed up for 2-12 years. One case experienced slight re-erosion of mesh to the bladder. Conclusions: Lower urinary tract injuries are difficult to avoid in vRPS, particularly in transvaginal high uterosacral ligament suspension and aTVM. However, the incidence is low. Lower urinary tract injuries during vRPS could be easily detected and managed intraoperatively because of the use of cystoscopy. As long-term postoperative complications, erosion of transvaginal mesh to lower urinary tract postoperatively could be treated correctly, seldom with severe sequelae.

Effects of Obesity on Urogynecologic Prolapse Surgery Outcomes: A Systematic Review and Meta-analysis.

OBJECTIVE: To systematically review the literature on outcomes of pelvic organ prolapse (POP) surgery in patients from various body mass index (BMI) categories to determine the association between obesity and surgical outcomes. DATA SOURCES: PubMed, EMBASE, and Cochrane databases were searched from inception to April 12, 2022; ClinicalTrials.gov was searched in September 2022 (PROSPERO 2022 CRD42022326255). Randomized and nonrandomized studies of urogynecologic POP surgery outcomes were accepted in which categories of BMI or obesity were compared. METHODS OF STUDY SELECTION: In total, 9,037 abstracts were screened; 759 abstracts were identified for full-text screening, and 31 articles were accepted for inclusion and data were extracted. TABULATION, INTEGRATION, AND RESULTS: Studies were extracted for participant information, intervention, comparator, and outcomes, including subjective outcomes, objective outcomes, and complications. Outcomes were compared among obesity categories (eg, BMI 30-34.9, 35-40, higher than 40), and meta-analysis was performed among different surgical approaches. Individual studies reported varying results as to whether obesity affects surgical outcomes. By meta-analysis, obesity (BMI 30 or higher) is associated with an increased odds of objective prolapse recurrence after vaginal prolapse repair (odds ratio [OR] 1.38, 95% CI, 1.14-1.67) and after prolapse repair from any surgical approach (OR 1.31, 95% CI, 1.12-1.53) and with complications such as mesh exposure after both vaginal and laparoscopic POP repair (OR 2.10, 95% CI, 1.01-4.39). CONCLUSION: Obesity is associated with increased likelihood of prolapse recurrence and mesh complications after POP repair. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022326255.

Minimally invasive sacrocolpopexy: efficiency of robotic assistance compared to standard laparoscopy.

Minimally invasive abdominal sacrocolpopexy (SC) is the treatment of choice for symptomatic, high-grade, apical or multi-compartmental pelvic organ prolapse (POP), in terms of anatomical correction and treatment durability. Robot-assisted sacrocolpopexy (RASC) could be an attractive alternative to the gold standard laparoscopic sacrocolpopexy (LSC), for its ergonomic advantages in such a technically demanding procedure. However, it has not yet proven its superiority, consequently raising cost-effectiveness issues. Our primary objective was to assess if RASC can achieve better overall operative time (OOT) over LSC, with at least equivalent perioperative results. This was a single-center retrospective study including 100 patients (58 consecutive RASC cases and 42 LSC within the same time-period), with primary endpoint the OOT in both groups. Secondary results included complication rate, hospital stay, short-term anatomic results and OOT within and beyond the RASC learning curve. A multivariate linear regression was carried out for our primary outcome. The groups had comparable characteristics, except for BMI, which was lower in RASC group. The mean OOT was significantly lower in the RASC group (188 vs. 217 min, p ≤ 0.01), even after adjusting for possible confounders. Short-term anatomic results, complication rate, and blood loss were similar in the two groups. Mean hospital stay was significantly longer in the RASC group. Average RASC OOT was significantly shorter after the first 20 cases realized. This study demonstrated a significant reduction of OOT for RASC compared to LSC, with similar perioperative results, encouraging further use of the robotic technology for this indication.

Incidence and risk factors of stress urinary incontinence after laparoscopic hysterectomy.

OBJECTIVE: To observe the long-term effects of total hysterectomy on urinary function, evaluate the effects of preoperative nutritional status, urinary occult infection, and surgical factors on the induction of postoperative stress urinary incontinence (SUI), and explore the incidence and risk factors of SUI. STUDY DESIGN: From January 2017 to December 2017, 164 patients with benign non-prolapsing diseases who underwent a laparoscopic total hysterectomy in the First People's Hospital of Taicang were selected as the analysis objects. The International Incontinence Standard Questionnaire for Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) and Pelvic Floor Impact Questionnaire-short version 20 (PFDI-20) were used for telephone follow-up to subjectively assess the urinary function of patients, collect their medical records, and statistically analyze the number of postoperative SUI cases. Logistic multivariate analysis was used to analyze the influencing factors of postoperative female SUI, presented as adjusted odds ratios with 95% confidence intervals. RESULTS: Only 97 out of 164 patients completed the ICIQ-FLUTS and PFDI-20 questionnaires. Among these participants, 28 patients (28.86%) were diagnosed with SUI (study group), while 69 patients (71.13%) were classified as women without SUI (control group). The age, menopause, parity ≥ 2 times, Body mass index (BMI) ≥ 28 kg/m2, neonatal weight ≥ 4000 g, history of chronic cough, preoperative hemoglobin ≤ 100 g/L, preoperative urine bacteria ≥ 100u/L, preoperative uterine volume ≥ 90 cm3, intraoperative blood loss, and operation time of the study group were compared with those of the control group. The differences were statistically significant (P < 0.05). Further Logistic multivariate analysis showed that menopause, preoperative hemoglobin ≤ 100 g/L, preoperative urine bacteria ≥ 100u/L, uterine volume ≥ 90 cm3, history of chronic cough, BMI ≥ 28 kg/m2 were risk factors for postoperative SUI in patients undergoing hysterectomy (P < 0.05). CONCLUSIONS: Hysterectomy for benign non-prolapse diseases has a long-term potential impact on the urinary system of patients, and the risk of postoperative SUI increases. The main risk factors of SUI are parity, menopausal status, obesity, preoperative nutritional status, and occult infection of the urinary system.