Long-Term Outcomes of Restorelle® Direct Fix Anterior Mesh in the Treatment of Pelvic Organ Prolapse.

Objective The objective of this study was to evaluate the efficacy and long-term outcomes of the use of Restorelle® Direct Fix (Coloplast, Humlebæk, Denmark) anterior mesh for transvaginal surgical management of anterior compartment prolapse. Methods A retrospective case series review was conducted for 123 patients who underwent surgery for Baden-Walker Grade three and four anterior compartment prolapse with the Restorelle Direct Fix anterior mesh between July 1, 2017 and September 30, 2018 in a single center. Follow-up was conducted at one, six, 12, 24, and 36 months after treatment. A standardized questionnaire and pelvic examination were conducted at each visit to assess operative complications and subjective and objective cure rates. Results Sixty patients were included in the analysis with a three-year follow-up rate of 70.0%. At three years post-operatively, subjective and objective cure rates were 97.7% and 95.3% respectively. Seven (11.7%) patients complained of de novo stress urinary incontinence, four (6.7%) complained of de novo urge urinary incontinence and one (1.7%) complained of symptomatic recurrence. Significantly, six (10.0%) patients had transvaginal mesh exposure over the three-year follow-up, mostly presenting within the first year. One (2.4%) patient developed new asymptomatic mesh erosion at the 36-month visit and one patient required mesh loosening one month post-surgery. Conclusions Management of anterior compartment prolapse with transvaginal surgery using the Restorelle® Direct Fix anterior mesh was associated with good subjective and objective cure rates. However, significant rates of post-operative mesh exposure were noted within three years post-surgery, which hinders the recommendation of this device for augmentation of repair for anterior compartment prolapse.

Persistent ischiorectal fistula secondary to rectal extrusion of posterior vaginal mesh: Case report.

INTRODUCTION AND HYPOTHESIS: Vaginal mesh has been used for years to try to improve the results of pelvic organ prolapse surgery, but current evidence does not confirm this improvement and instead describes serious and frequent adverse events. CLINICAL CASE: 64-year-old patient with rectal extrusion of posterior vaginal mesh placed 8 years earlier, and persistent left ischiorectal fistula refractory to surgery. She required 5 surgeries, carried out jointly between gynecology and general surgery, to solve, firstly, the bilateral perianal abscess secondary to extrusion of the posterior vaginal mesh into the rectum and then the persistent left ischiorectal fistula, despite the removal of the material prosthetic. Finally, the fistula was solved by injection of platelet-rich plasma. CONCLUSIONS: Vaginal mesh complications often need a multidisciplinary approach, and treatment may require multiple approaches and more than one surgical procedure. In the case of a persistent fistula refractory to surgery, after removing the mesh, non-invasive regenerative therapies that promote vascular growth and tissue regeneration could be considered such as platelet-rich plasma.

Is transvaginal mesh surgery with polytetrafluoroethylene mesh ORIHIME® feasible for anterior pelvic organ prolapse?-Randomized comparative study between ORIHIME® and Polyform™.

OBJECTIVE: Transvaginal mesh surgery for pelvic organ prolapse has been widely performed in Japan, but polypropylene mesh has not been used in Japan since the ban on TVM using polypropylene mesh in the United States. Currently, polytetrafluoroethylene mesh ORIHIME® is the only mesh available for TVM in Japan. Although polytetrafluoroethylene is a safe material, its low coefficient of friction and insufficient adhesion to the surrounding tissue make it difficult to maintain the mesh position when it is used in the transvaginal mesh surgery. The aim of this study was to evaluate the feasibility of TVM-A2 using ORIHIME®. METHODS: One hundred cases of TVM-A2 were included in the study. The patients were randomly assigned to two groups: the ORIHIME® group (Group O) and the PolyformTM group (Group P). With 50 patients in each group, the complications and recurrences up to the fourth year were compared. Surgeries were performed using the TVM-A2 method. Statistical analysis was performed using EZR. RESULTS: There were no significant differences in baseline parameters between the two groups. We observed no perioperative complications, and saw one case of postoperative abscess formation in Group O, which resolved successfully after incision and drainage. The 4-year recurrence rate was significantly higher in Group O. CONCLUSION: As the recurrence rate was significantly higher in Group O, we conclude that TVM-A2 using ORIHIME® which is the same procedure as TVM-A2 using polypropylene mesh is not feasible in repairing the pelvic organ prolapse.

Novel technique of laparoscopic mid-urethral autologous rectus fascial sling for stress urinary incontinence.

Serious concerns have been raised over the safety of vaginal mesh tapes for stress urinary incontinence (SUI). Autologous rectus fascial sling and the more recent 'sling on a string' through a laparotomy are gaining popularity as native tissue options for SUI. We describe a novel technique of laparoscopic mid-urethral autologous rectus fascial sling for SUI. Ten patients underwent this new technique safely. At 12 months, all patients reported cure of SUI with normal voiding. The advantages of this technique include the minimal access approach, introduction of the sutures under laparoscopic guidance, and avoidance of over-tightening of the sling.

Comparison of perioperative adverse events following suburethral sling placement using synthetic mesh, autologous rectus fascia, and autologous fascia lata in a national surgical registry.

AIMS: To assess and compare 30-day perioperative adverse events following suburethral sling surgery using synthetic mesh, autologous rectus fascia, and autologous fascia lata in women. METHODS: This was a retrospective cohort study of patients who underwent fascial or synthetic sling placement for stress urinary incontinence between 2008 and 2021 using the American College of Surgeons' National Surgical Quality Improvement Program database. Current Procedural Terminology codes were used to identify patients undergoing each type of sling procedure. Multivariable regression analysis with stepwise regression was used to assess the odds of composite adverse events (e.g., urinary tract infection, surgical site infection, pulmonary embolism, and other reportable events) between cohorts. RESULTS: Of the 41 533 female patients who underwent isolated suburethral sling placement without concurrent procedures, 41 292 (99.4%) received a synthetic mesh sling, and 241 (0.6%) received an autologous facial sling. In the fascial sling cohort, 160 (66.4%) underwent rectus fascia harvest and 81 (33.6%) underwent fascia lata harvest. Sling surgeries involving autologous fascia were associated with increased odds of adverse events compared to those involving synthetic mesh, even after adjusting for confounders (adjusted odds ratio [aOR]: 3.63, 95% confidence interval [CI]: 2.56-5.15). Compared to fascial slings from rectus fascia, slings from fascia lata were associated with increased odds of composite adverse events (aOR: 2.11, 95% CI: 1.03-4.04). However, with the exclusion of urinary tract infections, the adverse event rate was similar between slings using the two fascial harvest techniques (aOR: 1.93, 95% CI: 0.81-4.63). CONCLUSIONS: In this retrospective database study, suburethral sling surgeries using autologous fascia were independently associated with a 3.6-fold increase in odds of 30-day perioperative adverse events compared to sling surgeries using synthetic mesh.

Diagnosis and management of complications following pelvic organ prolapse surgery using a synthetic mesh: French national guidelines for clinical practice.

Complications associated with pelvic organ prolapse (POP) surgery using a synthetic non-absorbable mesh are uncommon (<5%) but may be severe and may hugely diminish the quality of life of some women. In drawing up these multidisciplinary clinical practice recommendations, the French National Authority for Health (Haute Autorité de santé, HAS) conducted an exhaustive review of the literature concerning the diagnosis, prevention, and management of complications associated with POP surgery using a synthetic mesh. Each recommendation for practice was allocated a grade (A,B or C; or expert opinion (EO)), which depends on the level of evidence (clinical practice guidelines). PREOPERATIVE PATIENTS' INFORMATION: Each patient must be informed concerning the risks associated with POP surgery (EO). HEMORRHAGE, HEMATOMA: Vaginal infiltration using a vasoconstrictive solution is not recommended during POP surgery by the vaginal route (grade C). The placement of vaginal packing is not recommended following POP surgery by the vaginal route (grade C). During laparoscopic sacral colpopexy, when the promontory seems highly dangerous or when severe adhesions prevent access to the anterior vertebral ligament, alternative surgical techniques should be discussed per operatively, including colpopexy by lateral mesh laparoscopic suspension, uterosacral ligament suspension, open abdominal mesh surgery, or surgery by the vaginal route (EO). BLADDER INJURY: When a bladder injury is diagnosed, bladder repair by suturing is recommended, using a slow resorption suture thread, plus monitoring of the permeability of the ureters (before and after bladder repair) when the injury is located at the level of the trigone (EO). When a bladder injury is diagnosed, after bladder repair, a prosthetic mesh (polypropylene or polyester material) can be placed between the repaired bladder and the vagina, if the quality of the suturing is good. The recommended duration of bladder catheterization following bladder repair in this context of POP mesh surgery is from 5 to 10 days (EO). URETER INJURY: After ureteral repair, it is possible to continue sacral colpopexy and place the mesh if it is located away from the ureteral repair (EO). RECTAL INJURY: Regardless of the approach, when a rectal injury occurs, a posterior mesh should not be placed between the rectum and the vagina wall (EO). Concerning the anterior mesh, it is recommended to use a macroporous monofilament polypropylene mesh (EO). A polyester mesh is not recommended in this situation (EO). VAGINAL WALL INJURY: After vaginal wall repair, an anterior or a posterior microporous polypropylene mesh can be placed, if the quality of the repair is found to be satisfactory (EO). A polyester mesh should not be used after vaginal wall repair (EO). MESH INFECTION (ABSCESS, CELLULITIS, SPONDYLODISCITIS): Regardless of the surgical approach, intravenous antibiotic prophylaxis is recommended (aminopenicillin + beta-lactamase inhibitor: 30 min before skin incision +/- repeated after 2 h if surgery lasts longer) (EO). When spondylodiscitis is diagnosed following sacral colpopexy, treatment should be discussed by a multidisciplinary group, including especially spine specialists (rheumatologists, orthopedists, neurosurgeons) and infectious disease specialists (EO). When a pelvic abscess occurs following synthetic mesh sacral colpopexy, it is recommended to carry out complete mesh removal as soon as possible, combined with collection of intraoperative bacteriological samples, drainage of the collection and targeted antibiotic therapy (EO). Non-surgical conservative management with antibiotic therapy may be an option (EO) in certain conditions (absence of signs of sepsis, macroporous monofilament polypropylene type 1 mesh, prior microbiological documentation and multidisciplinary consultation for the choice of type and duration of antibiotic therapy), associated with close monitoring of the patient. BOWEL OCCLUSION RELATED TO NON-CLOSURE OF THE PERITONEUM: Peritoneal closure is recommended after placement of a synthetic mesh by the abdominal approach (EO). URINARY RETENTION: Preoperative urodynamics is recommended in women presenting with urinary symptoms (bladder outlet obstruction symptoms, overactive bladder syndrome or incontinence) (EO). It is recommended to remove the bladder catheter at the end of the procedure or within 48 h after POP surgery (grade B). Bladder emptying and post-void residual should be checked following POP surgery, before discharge (EO). When postoperative urine retention occurs after POP surgery, it is recommended to carry out indwelling catheterization and to prefer intermittent self-catheterization (EO). POSTOPERATIVE PAIN: Before POP surgery, the patient should be asked about risk factors for prolonged and chronic postoperative pain (pain sensitization, allodynia, chronic pelvic or non-pelvic pain) (EO). Concerning the prevention of postoperative pain, it is recommended to carry out a pre-, per- and postoperative multimodal pain treatment (grade B). The use of ketamine intraoperatively is recommended for the prevention of chronic postoperative pelvic pain, especially for patients with risk factors (preoperative painful sensitization, allodynia, chronic pelvic or non-pelvic pain) (EO). Postoperative prescription of opioids should be limited in quantity and duration (grade C). When acute neuropathic pain (sciatalgia or pudendal neuralgia) resistant to level I and II analgesics occurs following sacrospinous fixation, a reintervention is recommended for suspension suture removal (EO). When chronic postoperative pain occurs after POP surgery, it is recommended to systematically seek arguments in favor of neuropathic pain with the DN4 questionnaire (EO). When chronic postoperative pelvic pain occurs after POP surgery, central sensitization should be identified since it requires a consultation in a chronic pain department (EO). Concerning myofascial pain syndrome (clinical pain condition associated with increased muscle tension caused by myofascial trigger points), when chronic postoperative pain occurs after POP surgery, it is recommended to examine the levator ani, piriformis and obturator internus muscles, so as to identify trigger points on the pathway of the synthetic mesh (EO). Pelvic floor muscle training with muscle relaxation is recommended when myofascial pain syndrome is associated with chronic postoperative pain following POP surgery (EO). After failure of pelvic floor muscle training (3 months), it is recommended to discuss surgical removal of the synthetic mesh, during a multidisciplinary discussion group meeting (EO). Partial removal of synthetic mesh is indicated when a trigger point is located on the pathway of the mesh (EO). Total removal of synthetic mesh should be discussed during a multidisciplinary discussion group meeting when diffuse (no trigger point) chronic postoperative pain occurs following POP surgery, with or without central sensitization or neuropathic pain syndromes (EO). POSTOPERATIVE DYSPAREUNIA: When de novo postoperative dyspareunia occurs after POP surgery, surgical removal of the mesh should be discussed (EO). VAGINAL MESH EXPOSURE: To reduce the risk of vaginal mesh exposure, when hysterectomy is required during sacral colpopexy, subtotal hysterectomy is recommended (grade C). When asymptomatic vaginal macroporous monofilament polypropylene mesh exposure occurs, systematic imaging is not recommended. When vaginal polyester mesh exposure occurs, pelvic +/- lumbar MRI (EO) should be used to look for an abscess or spondylodiscitis, given the greater risk of infection associated with this type of material. When asymptomatic vaginal mesh exposure of less than 1 cm2 occurs in a woman with no sexual intercourse, the patient should be offered observation (no treatment) or local estrogen therapy (EO). However, if the patient wishes, partial excision of the mesh can be offered. When asymptomatic vaginal mesh exposure of more than 1 cm2 occurs or if the woman has sexual intercourse, or if it is a polyester prosthesis, partial mesh excision, either immediately or after local estrogen therapy, should be offered (EO). When symptomatic vaginal mesh exposure occurs, but without infectious complications, surgical removal of the exposed part of the mesh by the vaginal route is recommended (EO), and not systematic complete excision of the mesh. Following sacral colpopexy, complete removal of the mesh (by laparoscopy or laparotomy) is only required in the presence of an abscess or spondylodiscitis (EO). When vaginal mesh exposure recurs after a first reoperation, the patient should be treated by an experienced team specialized in this type of complication (EO). SUTURE THREAD VAGINAL EXPOSURE: For women presenting with vaginal exposure to non-absorbable suture thread following POP surgery with mesh reinforcement, the suture thread should be removed by the vaginal route (EO). Removal of the surrounding mesh is only recommended when vaginal mesh exposure or associated abscess is diagnosed. BLADDER AND URETERAL MESH EXPOSURE: When bladder mesh exposure occurs, removal of the exposed part of the mesh is recommended (grade B). Both alternatives (total or partial mesh removal) should be discussed with the patient and should be debated during a multidisciplinary discussion group meeting (EO).

Vaginal morphology and position associated with prolapse recurrence after vaginal surgery: A secondary analysis of the DEMAND study.

OBJECTIVE: To identify vaginal morphology and position factors associated with prolapse recurrence following vaginal surgery. DESIGN: Secondary analysis of magnetic resonance images (MRI) of the Defining Mechanisms of Anterior Vaginal Wall Descent cross-sectional study. SETTING: Eight clinical sites in the US Pelvic Floor Disorders Network. POPULATION OR SAMPLE: Women who underwent vaginal mesh hysteropexy (hysteropexy) with sacrospinous fixation or vaginal hysterectomy with uterosacral ligament suspension (hysterectomy) for uterovaginal prolapse between April 2013 and February 2015. METHODS: The MRI (rest, strain) obtained 30-42 months after surgery, or earlier for participants with recurrence who desired reoperation before 30 months, were analysed. MRI-based prolapse recurrence was defined as prolapse beyond the hymen at strain on MRI. Vaginal segmentations (at rest) were used to create three-dimensional models placed in a morphometry algorithm to quantify and compare vaginal morphology (angulation, dimensions) and position. MAIN OUTCOME MEASURES: Vaginal angulation (upper, lower and upper-lower vaginal angles in the sagittal and coronal plane), dimensions (length, maximum transverse width, surface area, volume) and position (apex, mid-vagina) at rest. RESULTS: Of the 82 women analysed, 12/41 (29%) in the hysteropexy group and 22/41 (54%) in the hysterectomy group had prolapse recurrence. After hysteropexy, women with recurrence had a more laterally deviated upper vagina (p = 0.02) at rest than women with successful surgery. After hysterectomy, women with recurrence had a more inferiorly (lower) positioned vaginal apex (p = 0.01) and mid-vagina (p = 0.01) at rest than women with successful surgery. CONCLUSIONS: Vaginal angulation and position were associated with prolapse recurrence and suggestive of vaginal support mechanisms related to surgical technique and potential unaddressed anatomical defects. Future prospective studies in women before and after prolapse surgery may distinguish these two factors.

Safety and Efficacy of Vaginal Implants in Pelvic Organ Prolapse Surgery: A Meta-analysis of 161 536 Patients.

CONTEXT: Among the many surgical treatments for pelvic organ prolapse (POP), better results can be achieved with the use of vaginal implants. However, owing to perceived complications, vaginal implant surgeries have been restricted or banned in many countries. OBJECTIVE: To assess the real value of vaginal implants in POP surgery and compare the safety and efficacy of operations with and without implants. EVIDENCE ACQUISITION: A systematic search was performed in three medical databases. Randomised controlled trials and observational studies comparing the safety and efficacy of vaginal POP surgery with implants versus native tissue were included. Safety outcomes were defined as different types of complications (functional and non-functional) and reoperations for complications. Efficacy outcomes were parameters of anatomical success and the rate of reoperations due to recurrence. A multivariate meta-analysis framework was used to estimate pooled odds ratios (ORs) with confidence intervals (CIs) with simultaneous control for study correlations and estimation of multiple correlated outcomes. EVIDENCE SYNTHESIS: We included 50 comparative studies in the analysis. Rates of reoperation for complications (OR 2.15, 95% CI 1.20-3.87), vaginal erosion (OR 14.05, 95% CI 9.07-21.77), vaginal bleeding (OR 1.67, 95% CI 1.25-2.23), and de novo stress urinary incontinence (OR 1.44, 95% CI 1.18-1.75) were significantly higher in the implant group. Rates of anatomical success (OR 3.22, 95% CI 2.06-5.0) and reoperation for recurrence (OR 0.55, 95% CI 0.36-0.85) were superior in the implant group. CONCLUSIONS: POP surgeries with vaginal implants are more effective than surgeries without implants, with acceptable complication rates. Therefore, the complete prohibition of implants for POP surgeries should be reconsidered. PATIENT SUMMARY: We compared vaginal surgery with and without implants for repair of pelvic organ prolapse. Despite higher complication rates, vaginal implants provide better long-term results overall than surgery without implants.

Comparison of laparoscopic sacrocolpopexy with vaginal reconstructive procedures and abdominal sacrocolpopexy for the surgical management of vaginal vault prolapse: a systematic review and meta-analysis.

Introduction: Vaginal vault prolapse, also known as apical prolapse, is a distressing condition that may affect women following hysterectomy, necessitating surgical intervention when conservative measures prove ineffective. The surgical management of apical compartment prolapse includes procedures such as laparoscopic sacrocolpopexy (LSCP), abdominal sacrocolpopexy (ASCP) or vaginal reconstructive procedures (VRP). This systematic review and meta-analysis aims to compare the outcomes of these interventions. Methods: A comprehensive search of electronic databases was conducted to identify eligible studies. Fourteen studies comprising a total of 1,289 women were included. The selected studies were analyzed to evaluate outcomes such as duration of surgery, length of hospital stay, blood loss, complication rates, and patient satisfaction. Results: LSCP did not demonstrate significant advantages over VRP in terms of perioperative or long-term outcomes. However, when compared to ASCP, LSCP showed shorter hospital stay, reduced blood loss, decreased postoperative pain, and lower rates of ileus. Discussion: This systematic review contributes to evidence-based decision-making for the surgical treatment of vaginal vault prolapse. While LSCP did not exhibit substantial benefits over VRP, it emerged as a preferable option compared to ASCP due to shorter hospital stays and reduced postoperative complications. The findings from this study provide valuable insights for clinicians and patients in selecting the most appropriate surgical approach for vaginal vault prolapse. However, future research should focus on long-term follow-ups, standardizing outcomes, and outcome measures, and evaluating cost-effectiveness to further enhance clinical practice.

The impact of vaginal surgical mesh devices on consultation rates by type and health care provider in UK primary care: A cohort study in the Clinical Practice Research Datalink.

OBJECTIVES: To examine consultation rates by type of consultation and health care provider in women with stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP), with and without surgical mesh implants. STUDY DESIGN: Longitudinal open cohort study from April 2006 to November 2018 in the Clinical Practice Research Datalink (CPRD). MAIN OUTCOME MEASURES: Rates of consultations with general practitioners (GPs), nurses, other clinicians and administrators by consultation type (face-to-face, telephone or administrative), and types of administrative consultations, estimated using negative binomial regression. RESULTS: Of 220,544 women eligible for inclusion, 74 % (n = 162,687) had SUI, 37 % (n = 82,123) had POP, and 11 % (n = 24,266) had both. Face-to-face consultation rates were stable over time, at about 9 per year. Administrative consultations with GPs and administrators increased between 2006 and 2018, but averaged 31 per year. After adjustment, for both SUI and POP mesh surgery, there were lower rates of face-to-face consultations with GPs, higher rates of face-to-face consultations with other clinicians, higher rates of telephone consultations with GPs and other clinicians, and higher rates of administrative consultations with GPs, nurses and administrators. The higher rate of consultations with GPs coded as administrative consisted of results recording and administrative codes, and the higher rates of consultations with administrators were coded as repeat issue, other, administration and third-party consultations. CONCLUSIONS: Caring for women with mesh places a higher administrative burden on GPs and administrators. There may be potential to reduce this workload through a more streamlined care pathway.

Pressure-Volume Loop Analysis of Voiding Workload: An Application in Trans-Vaginal Mesh-Repaired Pelvic Organ Prolapse Patients.

Although trans-vaginal mesh (TVM) offers a successful anatomical reconstruction and can subjectively relieve symptoms/signs in pelvic organ prolapse (POP) patients, its objective benefits to the voiding function of the bladder have not been well established. In this study, we investigated the therapeutic advantage of TVM on bladder function by focusing on the thermodynamic workload of voiding. The histories of 31 POP patients who underwent TVM repair were retrospectively reviewed. Cystometry and pressure volume analysis (PVA) of the patients performed before and after the operation were analyzed. TVM postoperatively decreased the mean voiding resistance (mRv, p < 0.05, N = 31), reduced the mean and peak voiding pressure (mPv, p < 0.05 and pPv, p < 0.01, both N = 31), and elevated the mean flow rate (mFv, p < 0.05, N = 31) of voiding. While displaying an insignificant effect on the voided volume (Vv, p < 0.05, N = 31), TVM significantly shortened the voiding time (Tv, p < 0.05, N = 31). TVM postoperatively decreased the loop-enclosed area (Apv, p < 0.05, N = 31) in the PVA, indicating that TVM lessened the workload of voiding. Moreover, in 21 patients who displayed postvoiding urine retention before the operation, TVM decreased the residual volume (Vr, p < 0.01, N = 21). Collectively, our results reveal that TVM postoperatively lessened the workload of bladder voiding by diminishing voiding resistance, which reduced the pressure gradient required for driving urine flow.

Long-Term Results after Bilateral Sacrospinous Colposuspension: A Prospective Study.

The loss of apical support is usually present in patients with pelvic organ prolapse. An effective correction for the vaginal apex may be an essential part of a durable repair for these women. Apical suspension of the sacrospinous ligament is likely one of the best treatments by the vaginal route. We proposed the evaluation of the functional and anatomical long-term results of an ultralight and macroporous sling. In this prospective study, bilateral sacrospinous colposuspension was performed in 32 patients with a specific mesh. Functional assessment with several validated quality of life questionnaires and pelvic examination was performed at 1, 6, 12, and 24 months after surgery. Pelvic examination using the POP-Q classification showed a very good efficacy of the BSC mesh with only three prolapse recurrences at 24 months after surgery. All the following QoL scores were significantly improved by two years: PFIQ-7 (p < 0.0001), PFDI-20 (p < 0.0001), and SF-12 (p < 0.0001). No improvement was achieved by the PISQ12 questionnaire. This vaginal minimally invasive procedure is effective, quick, reproducible, and easy. It may be a relevant option for a vaginal vault or cervical or uterine prolapse.

Anatomical and functional outcomes after bilateral sacrospinous colposuspension (BSC) for the treatment of female genital prolapse.

BACKGROUND: Pelvic organ prolapse is a bothersome condition affecting many women at advanced age, but also frequently observed in young women with certain risk factors. Various surgical techniques have been developed with the aim of providing effective surgical treatment for apical prolapse. The vaginal bilateral sacrospinous colposuspension surgery (BSC) with ultralight mesh and utilization of the i- stich is a relatively new minimal invasive technique with very promising outcomes. The technique offers apical suspension, in the presence or absence of the uterus. The objective of this study is to evaluate the anatomical and functional outcomes of bilateral sacrospinous colposuspension with ultralight mesh in 30 Patients treated with the vaginal single incision standardized technique. METHODS: In this retrospective study, 30 patients were treated by BSC for significant vaginal, uterovaginal or cervical prolapse. A simultaneous anterior colporrhaphy, posterior colporrhaphy or both were performed when indicated. Anatomical and functional outcomes were assessed 1 year postoperatively using the Pelvic Organ Prolapse Quantification system (POP-Q) and the standardised Prolapse Quality of Life (P-QOL) questionnair. RESULTS: The POP-Q parameters were significantly improved at twelve months after surgery compared to baseline. The total score and all four subdomains of the P-QOL-questionnaire showed positive trends and improvement at twelve months after surgery when compared to preoperative values. All patients were asymptomatic and expressed high satisfaction one year after surgery. No intraoperative adverse events were recorded for all patients. Only minimal postoperative complications were recorded and they all resolved completely with conservative management. CONCLUSION: This study highlights the functional and anatomical outcomes of the minimally invasive vaginal bilateral sacrospinal colposuspension with ultralight mesh for the management of apical prolapse. The one year postoperative results of the proposed procedure reflect excellent outcomes with minimal complications. The data published here are very promising and warrant further investigations and more studies to evaluate the long-term outcomes of BSC in the surgical management of apical defects. TRIAL REGISTRATION: The study protocol was approved by the Ethics Committee at the University Hospital of Cologne, Germany (Date of registration: 08.02.2022) (Registration number: 21-1494-retro) (retrospectively registered).

Anterior and Apical Prolapse: Comparison of Vaginal Mesh Surgery to Vaginal Surgery with No Mesh.

AIM OF THE STUDY: The aim of this study was to evaluate the anatomical results after an anterior sacrospinous ligament fixation (ASSLF) with native tissue repair (anterior colporraphy and apical suspension with prolene) compared to mesh repair for the correction of anterior prolapse at 12 months after surgery. MATERIALS AND METHODS: A monocentric prospective study comparing two similar cohorts who underwent ASSLF was conducted. The primary endpoint was the gain in the position of the Ba point relative to its position before surgery and twelve months after surgery. The secondary endpoints consisted of objective results, which were assessed using validated questionnaires. RESULTS: Fifty-three women were included in the native tissue repair group between June 2019 and March 2020. They were compared to 53 women operated on with anterior and apical mesh. There was no difference with respect to the Ba point after 1 year between the two groups (-2 [-3; 1.5]; -2 [-3; 1], p = 0.9789). The apex was significantly better corrected in the native tissue repair group (-7 vs. -6, p = 0.0007). There was also a better correction on the rectocele in the native tissue repair group (-3 vs. -2, p = 0.0178). The rate of Stage 2 anterior vaginal prolapse at one year was approximately 30% in both groups (no statistical difference). CONCLUSIONS: ASSFL without mesh does not increase the risk of cystocele recurrence at 1 year after surgery. A future prospective comparison of this native tissue repair technique with mesh suspension is necessary to explore these preliminary findings.

Subjective outcomes 12 years after transvaginal mesh versus native tissue repair in women with recurrent pelvic organ prolapse; a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The present study describes an extended follow-up study after 12 years and focusses on subjective outcomes of women who underwent surgery for recurrent pelvic organ prolapse in the randomized index study. METHODS: One hundred and ninety-four (194) women had been randomized in the original study and in the present study, 45 (47%) in the vaginal mesh repair versus 43 (43%) women with conventional vaginal native tissue repair completed the long-term questionnaires. The mesh used was a first-generation non-absorbable mesh kit. All types of conventional vaginal native tissue repairs were allowed, and additional vaginal native tissue repairs were allowed in the mesh group. The questionnaires as applied at baseline were used. The Patient Global Impression of Improvement questionnaire (PGI-I) was the primary outcome. RESULTS: At 12 years, 30 (71%) women in the mesh group versus 23 (59%) women in the native tissue repair group reported to be PGI-I (very) much improved (p=0.24). There were no differences found in any of the questionnaire domains. There was, however, a higher number of women who had had additional operations for recurrent pelvic organ prolapse, stress urinary incontinence, and/or exposure in the mesh group: 18 women (40%) in the mesh group versus 8 women (19%) in the native tissue repair group (p=0.03). CONCLUSIONS: There was no difference in subjective outcome between the groups, but there was a statistically significant higher number of women who had needed further operations. This study confirms that vaginal mesh should not be used in all women with recurrent pelvic organ prolapse.

When things go wrong: experiences of vaginal mesh complications.

INTRODUCTION: Previous research has suggested that complications stemming from vaginal mesh can lead to life-changing negative physical consequences including erosion and chronic pain. However, there has been little research on the experiences of women who have had complications. This study was aimed at exploring the individual experiences of women who have had vaginal mesh complications and how this has impacted them. METHODS: An explorative qualitative design was followed. Eighteen semi-structured interviews were conducted with women who had experienced complications with vaginal mesh due to stress urinary incontinence and pelvic organ prolapse. The mean age was 52 and the mean time since the mesh was fitted was 8 years (6 had since had it removed and a further 6 had had partial removal), and the mean time since first mesh-related symptom was 10 months. Data were analysed using thematic analysis. RESULTS: Four main themes were identified: perceived impact of mesh complications, attitudes of medical professionals, social support and positive growth. Results showed that participant experiences of their mesh complication were psychologically traumatic, including feelings of increased anxiety and fears relating to suicidal thoughts. Intimate relationships were also affected, with reduced sexual functioning and intimacy stemming from mesh complications. Negative experiences with medical professionals included feeling dismissed, a lack of recognition of their symptoms, and anger towards the profession. CONCLUSIONS: The impacts of vaginal mesh complications were found to be wide-reaching and life-changing, affecting numerous aspects of participants' lives. Greater awareness in this area is needed to provide further support for women experiencing vaginal mesh complications.

Reoperation for prolapse recurrence after sacrospinous mesh hysteropexy: characteristics of women choosing retreatment.

INTRODUCTION AND HYPOTHESIS: Factors that contribute to reoperation and surgical approaches for the management of recurrent uterovaginal prolapse after vaginal mesh hysteropexy (mesh hysteropexy) are unknown. We aimed to describe surgical management of pelvic organ prolapse recurrence after vaginal mesh hysteropexy, and patient characteristics in those who chose reoperation. METHODS: This is a descriptive analysis of women who experienced treatment failure within 5 years of mesh hysteropexy in a multi-site randomized trial. The composite definition of treatment failure included retreatment (pessary or reoperation), prolapse beyond the hymen, or bothersome prolapse symptoms. Characteristics of those pursuing and not pursuing repeat prolapse surgery, measures of prolapse, and symptom severity are described. RESULTS: Over 5-year follow up, 31/91 (34%) of the hysteropexy group met treatment failure criteria. All seven women who pursued reoperation reported bothersome prolapse symptoms; six were anatomic failures. Most seeking reoperation were early treatment failures; six (86%) by the 12-month visit and all by the 18-month visit. Compared to those electing expectant management, those pursuing reoperation had more apical prolapse, POP-Q point C median (IQR) -5.5 (-6.0, -4.0) cm versus +1.0 (-1.0, 3.0) cm respectively. Hysterectomy was performed in 6/7 reoperations (three vaginal, three endoscopic), with apical suspension in 5/6 hysterectomies. One participant with posterior compartment prolapse underwent transvaginal enterocele plication, uterosacral ligament suspension with posterior colpoperineorrhaphy. At a mean surgical follow-up of 34.3 (15.8) months, all women remained without anatomic or symptomatic failure. CONCLUSIONS: When recurrent prolapse after mesh hysteropexy occurred, most women did not choose reoperation. Those who pursued surgery experienced more significant apical prolapse and were universally symptomatic. CLINICAL TRIAL IDENTIFICATION NUMBER: NCT01802281.

Long term surgical outcomes of vaginal colposuspension using the Uphold Lite™ mesh system vs. vaginal vault uterosacral ligament suspension for treatment of apical prolapse.

OBJECTIVE: The aim of this study is to compare long-term outcomes (7-10 years) between vaginal hysterectomy with uterosacral ligament suspension (VHUSLS) and sacrospinous hysteropexy with the Uphold™ Lite mesh System (SHU) for management of apical prolapse. METHODS: Patients undergoing VHUSLS or SHU from 2008 to 2012 at a single tertiary referral center were included. Patients were contacted, asked to return for physical examination, and to complete the Pelvic Floor Distress Inventory (PFDI-20) questionnaire. Our primary outcome was anatomic failure defined as Stage 2 POP or higher of any compartment. The secondary outcome was subjective changes in symptoms based upon PFDI-20 responses. RESULTS: Two-hundred and two women were identified to have undergone the index surgeries from 2008 to 2012. Sixty-three agreed to return for follow up symptom evaluation and examination (30 VHUSLS and 33 SHU). Baseline characteristics were similar between groups. Clinical cure was high for both groups reaching 93.4 % and 94.0 % for the VHUSLS and SHU groups, respectively (p = 0.721). Anatomical success was lower with 44.7 % and 66.7 % of patients in the VHUSLS and SHU groups, respectively, meeting criteria for success (p = 0.138). There were no mesh complications among patients returning for exams. However, two patients who were contacted and were not interested in this study reported mesh complications and need for additional surgeries. Anterior vaginal wall support was noted to be significantly better supported for SHU (Ba -2.03 ± 0.75 vs -1.42 ± 0.92, p = 0.008). There were no differences between groups for overall PFDI-20 scores postoperatively. However, SHU patients reported higher rates of stress urinary incontinence compared to VHUSLS patients. CONCLUSION: In women with apical prolapse, VHUSLS and SHU afford similar long-term outcomes. SHU patients reported higher rates of stress urinary incontinence.

Mesh-Tissue Integration of Platelet-Rich Plasma-Decellularized Amnion Scaffold-Polypropylene Mesh Sandwiches Implanted in the Vesicovaginal Spaces of Hypoestrogenic Rabbit Models: Protocol for a Randomized Controlled Trial.

BACKGROUND: Mesh-augmented surgery with polypropylene meshes (PPMs) is often used in urogynecology and pelvic reconstructive surgery. However, the various complications that arise from its integration process have resulted in a decrease in the number of mesh-augmented surgeries performed worldwide. An approach to improving mesh-tissue integration is coating PPMs with anti-inflammatory and wound-healing molecules, such as platelet-rich plasma (PRP), which is a component of biotechnologies that are capable of accelerating wound healing. Estrogen is also known to have a beneficial effect on wound remodeling; therefore, a hypoestrogenic status may have negative implications for wound healing. The mechanism of how PRP plays a role in wound remodeling, especially among individuals in a hypoestrogenic state, has not been fully described until now. OBJECTIVE: Our aim is to investigate the impact of applying PRP to PPMs in hypoestrogenic rabbit models. METHODS: Our study will be a randomized controlled trial involving hypoestrogenic rabbit models. Samples were categorized into either the PRP group or the PPM group (1:1 ratio), with a minimum sample size of 16 in each arm, via simple random sampling. All samples were put into a hypoestrogenic state via bilateral oophorectomy. After confirming a decrease in estradiol level, the meshes were implanted in the vesicovaginal space. The samples were euthanized on the 14th, 28th, or 90th day of the surgery. The mesh-tissue integration process will be analyzed based on inflammatory parameters (inflammatory infiltrate, interleukin-17, and interleukin-1B expression); angiogenesis (CD31 expression); and collagen deposition, which will be assessed by using Masson trichrome staining. RESULTS: Our study is in the protocol development stage. A preliminary study regarding its feasibility, including the feasibility of the preparation of hypoestrogenic rabbit models, mesh implantation in the rabbits' vesicovaginal spaces, the PRP and amnion scaffold, started in February 2022. The results of our study are expected to be available by the end of 2022. CONCLUSIONS: Our randomized controlled trial is designed to provide high-quality evidence on the effect of applying a PRP-decellularized amnion scaffold to PPMs in the vesicovaginal spaces of hypoestrogenic rabbit models. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37942.

Application of Acellular Dermal Matrix in Gynaecology-A Current Review.

The aim of our study is to draw attention to the multitude of applications of acellular dermal matrix (ADM) in the surgical treatment of urogynaecological disorders, such as reduction in the reproductive organs, and in reconstructive gynaecology. Despite the existence of numerous operational methods and materials, the effectiveness of transvaginal operation is still insufficient. Native tissue operations are often not durable enough, while operations with synthetic materials have numerous side effects, such as infections, hematomas, vaginal erosion, or dyspareunia. Hence, the search continues for a different material with a better efficacy and safety profile than those previously mentioned. It seems that ADM can meet these requirements and be a useful material for urogynaecological surgery. Key words related to the usage of ADM in gynaecological reconstructive surgery were used to search relevant databases (NCBI MedLine, Clinical Key, Clinicaltrials.gov). This manuscript is based on 43 literature sources, 28 (65.11%) of which were released after 2016. Older sources are cited for the purpose of presenting basic science, or other important issues related to the manuscript. ADM seems to be an ideal material for urogynaecological and reconstructive surgery. It has high durability, and thus high effectiveness. Moreover, it does not have the side effects typical for synthetic materials. There are no reports of material rejection, erosion or dyspareunia directly related to the presence of the mesh. Due to the difficulties in obtaining ADM and the need to perform additional tests, this material is not common in routine clinical practice. Therefore, the number of cases and the size of the research groups are insufficient to clearly define the potential of mesh from biological tissue. However, the results are so promising that it is worth considering a wider introduction to the use of this material. Our hope is that increasing clinicians' awareness of this topic will lead to more studies comparing methods using native tissues or synthetic materials and those using ADM.