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.

Vaginal pessary: a culprit for intraperitoneal bladder perforation.

Vaginal pessaries are widely considered to be a safe and effective non-surgical management option for women with pelvic organ prolapse. Complications may occur, and are more frequent with improper care and certain device designs and materials. It is imperative to provide information to patients about potential complications. We present the case of a woman in her 70s who presented to the Emergency Department with increasing groin and abdominal pain following a vaginal pessary insertion 2 days prior for grade 3 vaginal vault prolapse. On presentation, her abdomen was markedly distended with guarding. Laboratory investigations showed a significant acute kidney injury with a metabolic acidosis. An initial non-contrast CT showed fluid and inflammatory changes surrounding the bladder, and bladder perforation was suspected. A subsequent CT cystogram showed extravasation of contrast from the bladder into the peritoneal cavity, in keeping with an intraperitoneal bladder rupture. The patient underwent an emergency bladder repair in theatre.

Pelvic organ prolapse: a cross-sectional study during mass campaign in two hospitals in the city of Kananga in the Democratic Republic of Congo.

Introduction: pelvic organ prolapse is a dynamic pathology that can worsen or regress especially postpartum and is the basis of several disorders that bother the patient and alter her quality of life. This study aims to determine the epidemiological, clinical, and therapeutic profile of pelvic organ prolapse in the town of Kananga. Methods: this is a cross-sectional study of cases of pelvic organ prolapse recorded during the mass campaign organized in the Bon-Berger Hospital of Tshikaji and Saint Georges Hospital of Katoka in the town of Kananga, from January 1 to July 31, 2023. Non-probability convenience sampling was used to select cases. Results: we recorded 138 cases of prolapse out of 572 patients. The prevalence of pelvic organ prolapse is 24.12% with an average monthly incidence of 19.71 (SD: 4.23) cases per month. The prevalence of recurrence of pelvic organ prolapse is 8.69%. The average age of patients is 54.86 (SD: 11.36) years with an average parity of 7.62 (SD: 1.8) deliveries. Its preoperative symptomatology consists of the intravaginal mass associated with digestive and urinary disorders in 97.00% (n=130), stage III hysterocele predominates in 68.70% (n=92), surgical treatment is the most practiced in 91.79% (n=123) and hysterectomy associated with the treatment of cystocele and rectocele by vaginal surgical access is the most practiced in 80.60% (n=108). Conclusion: pelvic organ prolapse is a real public health problem in the city of Kananga, its symptoms are classic and its treatment is surgical via the vaginal route.

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.

Short-Term Outcomes After Hysterectomy for Endometrial Cancer/EIN With Concomitant Pelvic Floor Disorder Surgery.

IMPORTANCE: Endometrial cancer and precancer are common gynecologic problems for many women. A majority of these patients require surgery as the mainstay of treatment. Many of these patients often have concurrent pelvic floor disorders. Despite the prevalence and shared risk, fewer than 3% of women undergo concomitant surgery for PFDs at the time of surgery for endometrial cancer or endometrial intraepithelial neoplasia/hyperplasia. OBJECTIVE: This study aimed to evaluate postoperative morbidity of concomitant pelvic organ prolapse (POP) and/or urinary incontinence (UI) procedures at the time of hysterectomy for endometrial cancer (EC) or endometrial intraepithelial neoplasia/endometrial hyperplasia (EIN/EH). METHODS: This retrospective analysis of women undergoing hysterectomy for EC or EIN/EH between 2017 and 2022 used the American College of Surgeons National Surgical Quality Improvement Program database. The primary outcome was any major complication within 30 days of surgery. Comparisons were made between 2 cohorts: hysterectomy with concomitant pelvic organ prolapse/urinary incontinence procedures (POPUI) versus hysterectomy without concomitant POP or UI procedures (HYSTAlone). A subgroup analysis was performed in patients with EC. A propensity score matching cohort was also created. RESULTS: A total of 23,144 patients underwent hysterectomy for EC or EIN/EH: 1.9% (n = 432) had POP and/or UI procedures. Patients with POPUI were older, were predominantly White, had higher parity, and had lower body mass index with lower American Society of Anesthesiologists class. Patients with POPUI were less likely to have EC (65.7% vs 78.3%, P < 0.0001) and more likely to have their hysterectomy performed by a general obstetrician- gynecologists or urogynecologists. Major complications were low and not significantly different between POPUI and HYSTAlone (3.7% vs 3.6%, P = 0.094). A subgroup analysis of EC alone found that the HYSTAlone subset did not have more advanced cancers, yet the surgeon was more likely a gynecologic oncologist (87.1% vs 68.0%, P < 0.0001). There were no statistically significant differences between the 2 cohorts for the primary and secondary outcomes using propensity score matching analysis. CONCLUSIONS: Concomitant prolapse and/or incontinence procedures were uncommon and did not increase the rate of 30-day major complications for women undergoing hysterectomy for EC/EH.

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.

Treatment of Cervical Cancer Complicated by Advanced Pelvic Organ Prolapse: A Case Report.

ABSTRACT: Concurrent cervical cancer with advanced pelvic organ prolapse is rare: there are no well-established treatment recommendations. It is hypothesized that chronic irritation, as with long-standing pelvic organ prolapse, may lead to dysplasia and human papillomavirus-independent carcinoma, which represents only 5% of cervical cancers. Two patients with complete uterine procidentia were referred to gynecologic oncology with cervical squamous cell carcinoma; both were clinically staged as International Federation of Gynaecology and Obstetrics IB3. Treatment planning was complicated by procidentia in both cases. Standard definitive treatment of locally advanced cervical cancer is radiation therapy and concurrent chemotherapy; however, the mobility and externalization of the target lesion raised concerns regarding anatomic reproducibility during radiation treatment. After multidisciplinary team discussion (gynecologic oncology, urogynecology, radiation oncology), surgical resection and co-management with gynecologic oncology and urogynecology were successfully performed for definitive management for both patients. Although rare, this case study demonstrates the importance of multidisciplinary coordination in these complex clinical scenarios.

Association of Neighborhood-Level Socioeconomic Status With Prolapse Management Decision.

IMPORTANCE: This study identifies how neighborhood-level socioeconomic status (SES) may affect patients' treatment decisions for pelvic organ prolapse (POP). OBJECTIVE: This study aimed to evaluate the association of neighborhood-level SES with the decision of surgical versus conservative POP management. STUDY DESIGN: This was a retrospective cohort study of patients newly diagnosed with POP at a tertiary medical center between 2015 and 2021. Patients lost to follow-up or poor surgical candidates were excluded. Patient characteristics, demographics, and treatment selection were abstracted from the electronic health record. Conservative management was defined as expectant, pessary, and/or pelvic floor physical therapy. Five-digit zip codes were linked to the Area Deprivation Index and used as a surrogate for neighborhood-level SES. Area Deprivation Indices were dichotomized at or below the sample median (less disadvantaged area) and above the sample median (more disadvantaged area). Logistic regression models estimated the odds of choosing surgical versus conservative management as a function of the Area Deprivation Index. RESULTS: A total of 459 patients met the eligibility criteria (non-Hispanic White, 88.2%). The median age was 63 years (interquartile range, 52-70 years), and the majority had stage 2 POP (65.7%). Of all patients, 59.3% had Medicare/Medicaid, 39.9% were privately insured, and 0.9% were uninsured. Furthermore, 74.7% selected surgical management, and 25.3% chose conservative management. Increasing age and higher Pelvic Organ Prolapse Quantification System stage were significantly associated with selecting surgery (P = 0.01). Women residing in a more disadvantaged area had a 67% increased odds of choosing surgical over conservative management (adjusted odds ratio, 1.67; 95% confidence interval, 1.06-2.64) after adjusting for age, race/ethnicity, body mass index, and Pelvic Organ Prolapse Quantification System stage. CONCLUSIONS: Residing in a more disadvantaged zip code was associated with 67% increased odds of choosing surgical versus conservative POP management.

Impact of the Duration of the Second Stage of Labor on Postpartum Pelvic Floor Symptoms.

IMPORTANCE: The associated effect of duration of the second stage of labor (SSL) on pelvic floor symptoms development is not well studied. OBJECTIVE: This study aimed to examine the association between duration of SSL and pelvic floor symptoms at 6 months postpartum among primiparous women. STUDY DESIGN: A planned secondary analysis of a multicenter randomized trial evaluating the impact of immediate versus delayed pushing on vaginal delivery rates, maternal morbidity, and neonatal outcomes was conducted between 2014 and 2018. For pelvic floor arm participants, demographic, pelvic examination, and validated questionnaire data were collected postpartum. Primary outcome was change in Pelvic Floor Distress Inventory 20 (PFDI-20) score from immediate to 6 months postpartum. Secondary outcomes included changes in the Pelvic Floor Impact Questionnaire, Fecal Incontinence Severity Index, Modified Manchester Health Questionnaire scores, and Pelvic Organ Prolapse Quantification measurements at 6 months postpartum. Participants were analyzed by SSL duration ≤60 minutes or >60 minutes. RESULTS: Of the 2,414 trial participants, 767 (32%) completed pelvic floor assessments at 6 months. Pelvic Floor Distress Inventory 20 scores significantly improved at 6 months in the ≤60 minutes SSL group compared with >60 minutes SSL (-14.3 ± 48.0 and -3.2 ± 45.3, respectively; P = 0.04). Changes from immediate postpartum in total and subscale scores for other questionnaires at 6 months did not differ between groups. Prolapse stage did not differ between groups. Perineal body was significantly shorter in the >60 minutes SSL group (3.7 ± 0.7, 3.5 ± 0.8; P = 0.03). CONCLUSIONS: Women with SSL >60 minutes experience less improvement in PFDI-20 scores at 6 months. Greater tissue and innervation trauma in those with SSL >60 minutes may explain persistently less improvement in PFDI-20 scores.

Defecatory dysfunction and anal incontinence symptoms among women with pelvic organ prolapse: 5-year retrospective study in a tertiary center.

OBJECTIVE: To investigate the prevalence of DD and AI with POP symptoms in females attending a urogynecology clinic, and to identify factors associated with DD and AI in POP symptoms patients. METHODS: Computer-based medical records of women with POP symptoms attending a urogynecology clinic in a referral tertiary center between January 2016 and December 2020 were reviewed. Demographic data were collected. Selected defecatory dysfunction (DD) and anal incontinence (AI) were recorded. The associations between patient characteristics, site and severity of prolapse, and DD and AI symptoms in POP patients were investigated for identified associated factors. RESULTS: The mean age of the 754 participants was 65.77 ± 9.44 years. Seven hundred and fifteen (94.83%) were menopause. The prevalence of DD and AI in patients with POP symptoms was 44.03% (332/754) and 42.04% (317/754) according to the PFBQ and medical history records, respectively. Advanced posterior wall prolapse (OR 1.59, 95% CI 1.10-2.30) and wider GH (OR1.23, 95% CI 1.05-1.43) were identified as risk factors for DD by multivariate analysis. Additionally, single-compartment prolapse (OR 0.4, 95% CI 0.21-0.76) and a stronger pelvic floor muscle assessed with brink score (OR 0.94, 95% CI 0.88-0.98) are protective factors for AI. CONCLUSION: DD and AI are prevalent among women with POP symptoms who visit a urogynecology clinic. DD should be evaluated in women with POP symptoms especially in women with increased genital hiatus and point Ap beyond the hymen. To prevent AI, women with POP should be encouraged to perform pelvic floor muscle training in order to increase pelvic floor muscle strength.

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.

A randomized clinical trial comparing internal and external pessaries in the treatment of pelvic organ prolapse in postmenopausal women: A pilot study.

INTRODUCTION AND HYPOTHESIS: Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently developed as an alternative. The study's objective was to compare the efficacy of external and internal pessaries in treating POP in postmenopausal women. METHODS: This parallel randomized (1:1 ratio) open-blind study included 40 symptomatic women with stage 2 or 3 POP. They were randomized into two groups: group 1 (internal pessary) and group 2 (external pessary) (n = 20 in each); and evaluated at the start of and 3 months after the treatment. Statistical analysis was performed to compare the results within and between the groups before and after the 3-month treatment. RESULTS: The groups were homogeneous, except for the variables previous pregnancies (p = 0.030) and POP-Q score of apical prolapse (p = 0.023) whose values were higher in group 2. A significant improvement in quality of life was observed in both groups after 3 months of follow-up; however, internal pessaries were found to be more effective (p < 0.001). In group 1 there were differences between the initial and final POP-Q scores of anterior (0.004) and apical prolapse (p = 0.005). The complication rate associated with internal pessary use was high (p = 0.044). CONCLUSIONS: The present data suggested that external pessaries have a similar effect to internal ones for the treatment of POP and improvement of the quality of life of postmenopausal women.

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.