Long-term comparison of non-mesh anchoring vs mini mesh for apical suspension.

The EnPlace® device is a novel minimally invasive tool allowing transvaginal sacrospinous ligament (SSL) fixation of apical pelvic organ prolapse (POP). The study aimed to investigate the safety and short-term efficacy of the EnPlace® SSL fixation for significant apical POP repair. A retrospective cohort study of 123 consecutive patients (mean age 64.4 ± 11.1 years) with stage III or IV apical POP who underwent SSL fixation by the EnPlace® device. Safety and 6-month outcome results were analyzed and compared between 91 (74%) patients with uterine prolapse versus 32 (26%) patients with vaginal vault prolapse. There were no intraoperative or early postoperative complications. The mean (± standard deviation) duration of surgery was 30 ± 6.9 min and mean blood loss was 30.5 ± 18.5 mL. The average position of point C by POP-Quantification measurements before surgery and at 6 months postoperatively was 4.5 ± 2.8 cm and -3.1 ± 3.3 cm, respectively. Of 91 patients with preoperative uterine prolapse, eight (8.8%) patients developed a recurrent uterine prolapse within 6 months postoperatively. Of 32 patients with preoperative vault prolapse, two patients (6.3%) had recurrent vault prolapse. Short-term outcome results of EnPlace® SSL fixation suggest that it is a safe and effective minimally invasive transvaginal procedure for significant apical POP repair.

Background: Pelvic organ prolapse (POP) significantly impacts the quality of life, particularly in older women with a history of vaginal deliveries. Although conservative treatments provide some symptom relief, surgical interventions are more effective for managing POP. This study compares the outcomes and effectiveness of sacrospinous ligament fixation (SSLF) and laparoscopic lateral suspension (LLS) surgeries in the treatment of POP. Methods: This retrospective comparative cohort study included patients with symptomatic stage 2 or higher apical POP, treated at a tertiary hospital in Turkey between April 2021 and June 2022. Patients were treated with either SSLF or LLS surgeries and underwent preoperative and postoperative evaluations using the Prolapse Quality of Life (P-QoL) questionnaire and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Patients were divided into two groups: SSLF (n = 47) and LLS (n = 44). The primary outcome was the rate of anatomical failure, while secondary outcomes included improvements in functional capability and quality of life. Results: The study found that the rate of postoperative anterior compartment failure was significantly lower in the LLS group compared to the SSLF group (p = 0.005). The success rate of LLS for apical prolapse was 100%, compared to 93.6% for SSLF. In the posterior compartment, SSLF demonstrated a higher success rate (86.2%) than LLS (68.5%). Both procedures improved P-QoL scores and the PISQ-12 subscales; however, a significant improvement in total PISQ-12 scores was observed only in the LLS group (p = 0.009). Conclusions: Both SSLF and LLS are effective in treating POP and enhancing quality of life. However, LLS demonstrated higher success rates for anterior and apical prolapse, while SSLF was more effective in addressing in posterior compartment defects.

To estimate whether the urinary force of stream method is noninferior to a standard fill voiding trial for rate of catheterization within 6 weeks after apical prolapse surgery in those discharged without a catheter. A noninferiority randomized controlled trial was conducted in postoperative women comparing force of stream with standard fill voiding trials after vaginal, abdominal, or laparoscopic-robotic apical pelvic organ prolapse (POP) surgery. Before discharge, women in both groups were backfilled with 300 mL normal saline. Successful voiding criteria in the force of stream group was subjective force of stream of at least 50 using a visual analog scale; reporting less than 50 prompted a bladder scan. Successful voiding was defined as a postvoid residual volume of less than 500 mL. For the standard fill voiding trial group, voiding two thirds of the instilled amount indicated success. The primary outcome was the rate of catheterization within the 6-week postoperative period after surgical repair of apical prolapse among those discharged without a urinary catheter. Secondary endpoints included trial of void failure rates. A sample size of 59 patients per group who passed trial of void at discharge was needed to achieve 80% power using a noninferiority margin (delta of 10%). Total enrollment of 169 patients was necessary to account for an estimated 30% trial of void failure rate. From April 2016 and April 2017, 184 patients were enrolled (six enrolled before the trial registration date), with the first patient enrolled on April 1, 2016. One hundred seventy-four patients were randomized (86 in the force of stream group and 88 in the standard fill voiding trial group). No differences were observed in demographic or perioperative characteristics, except for stage 2 apical prolapse (52% in the force of stream group vs 36% in the standard fill voiding trial group). For the primary outcome, similar rates were found in those patients who passed their trial of void but subsequently needed catheterization for voiding dysfunction (force of stream 2.8% [2/71] vs standard fill voiding trial 3.1% [2/64]; difference -0.3%, 95% CI -8.69% to 8.08%). The incidence of trial of void failures at discharge was similar (force of stream 17.4% [15/86] vs standard fill voiding trial 26.4% [23/87]; risk ratio 0.65, 95% CI 0.37-1.18, P=nonsignificant). Force of stream was noninferior to standard fill voiding trial when comparing the rate of catheter insertion during the 6-week postoperative period after apical POP surgery in those discharged without a catheter. ClinicalTrials.gov, NCT02753920.

This study aimed to compare anterior sacrospinous ligament fixation (SSLF) with the standard posterior SSLF concerning complications and outcomes in patients with apical compartment pelvic organ prolapse (POP). This is an observational descriptive study using prospective data collected from two referral urogynecological centers. The study cohort represents all 135 women in our prospective study who underwent anterior approach bilateral anterior or unilateral posterior meshless SSLF from January 2018 to December 2020 using the PFDI-20 questionnaire and the POP quantification (POP-Q) system pre- and postoperatively. The objective success rate was assessed by the number of POP recurrence cases and total vaginal length (TVL) postoperatively. Patients were followed up for at least 6 months (range, 6 to 18 months). Data were analyzed using SPSS version 21. P < 0.05 was considered statistically significant. Sixty-seven (49.6%) patients underwent posterior SSLF, and 68 (50.4%) underwent anterior SSLF. The mean age of patients was 58.2 ± 9.7 and 64.9 ± 11.6, respectively (P < 0.001). Most patients who underwent the posterior approach had stage III apical prolapse (74.6%), while 65.5% of those who underwent anterior SSLF had stage II apical prolapse (P < 0.001). Following the treatment, no significant difference was detected between these two vaginal approaches in terms of women's satisfaction rate (P > 0.05). One case of postoperative recurrence was found in the posterior group, which ultimately led to surgical retreatment. There were no major intra- or postoperative complications in the groups. Postoperative TVL was higher in the anterior SSLF group (P < 0.001). The postoperative POPDI-6, CRADI-8, UDI-6, and PFDI-20 decreased significantly compared to preoperative status in both groups (P < 0.001). It appears that the anterior SSLF approach can be regarded as effective as the posterior approach in the management of apical POP. Therefore, the proper surgical technique can be chosen according to the surgeon's expertise and other compartment's prolapse status.

Objective: To evaluate the rates of serious complications and reoperation for recurrence following sacrospinous ligament fixation (SSLF) for apical pelvic organ prolapse. Methods: This was a national registry ancillary cohort comparative study. The VIGI-MESH registry includes data from 24 French health centers prospectively collected between May 2017 and September 2021. Time to occurrence of a serious complication or reoperation for genital prolapse recurrence was explored using the Kaplan–Meier curve and Log-rank test. The inverse probability of treatment weighting, based on propensity scores, was used to adjust for between-group differences. Results: A total of 1359 women were included and four surgical groups were analyzed: Anterior SSLF with mesh (n = 566), Anterior SSLF with native tissue (n = 331), Posterior SSLF with mesh (n = 57), and Posterior SSLF with native tissue (n = 405). Clavien–Dindo Grade III complications or higher were reported in 34 (2.5%) cases, with no statistically significant differences between the groups. Pelvic organ prolapse recurrence requiring re-operation was reported in 44 (3.2%) women, this was higher following posterior compared with anterior SSLF (p = 0.0034). Conclusions: According to this large database ancillary study, sacrospinous ligament fixation is an effective and safe surgical treatment for apical prolapse. The different surgical approaches (anterior/posterior and with/without mesh) have comparable safety profiles. However, the anterior approach and the use of mesh were associated with a lower risk of reoperation for recurrence compared with the posterior approach and the use of native tissue, respectively.

Same-day Discharge vs Planned Admission after Surgical Treatment for Apical Prolapse

The objective was to evaluate and compare the short-term postoperative complications of concomitant pelvic organ prolapse (POP) and rectal prolapse repair with isolated apical prolapse repair or rectopexy. This systematic review and meta-analysis were conducted in accordance with PRISMA guidelines. A comprehensive literature search was performed using Web of Science, PubMed, Embase, and Scopus for studies published up to April 2024. Studies included were retrospective case-control studies, clinical cohort studies, and randomized clinical trials comparing short-term complications between concomitant apical and rectal prolapse repairs versus isolated repairs. A total of seven studies, encompassing 16,471 patients, met the inclusion criteria. Of these, 843 patients underwent concomitant surgery, 7,808 underwent apical prolapse repair alone, and 7,820 underwent rectopexy alone. The meta-analysis revealed no significant increase in the overall complication rate for the concomitant group compared with the apical prolapse alone (OR 0.78; 95% CI 0.56, 1.09; p = 0.14; I2 = 0%) or rectopexy alone (OR 0.79; 95% CI 0.49, 1.25; p = 0.31; I2 = 48%). Furthermore, serious complication rates were not significantly higher in the concomitant group compared with isolated apical prolapse repair (OR 0.70; 95% CI 0.43, 1.16; p = 0.16; I2 = 0%) or rectopexy alone (OR 0.86; 95% CI 0.54, 1.35; p = 0.50; I2 = 39%). Concomitant apical and rectal prolapse repair does not significantly increase the risk of short-term postoperative complications compared with isolated repairs. This approach appears safe and feasible, suggesting that combined surgeries might offer a comprehensive treatment for patients with multicompartmental prolapse without elevating operative risks.

Definitions of apical vaginal support loss: a systematic review

OBJECTIVES: To determine the effect the Da Vinci robotic system made on our surgical approach to apical pelvic support defects during the first year of its institution at our medical center. MATERIALS AND METHODS: A retrospective review of our surgical database from June 2007 to June 2009 was conducted. The total number of uterosacral suspensions, sacrospinous ligament fixations, iliococcygeus fascia suspensions and abdominal sacrocolpopexy procedures during the year prior to the introduction of the robotic system (June 2007 to June 2008) was compared to the corresponding numbers in the following year after the robotic system was in use. The total number of robotic sacrocolpopexy procedures was also determined. Statistical analysis was performed using the chi-square statistical test with a P-value <0.05 was considered significant. RESULTS: During the two-year period, there were 135 total cases (39 in the first year, 96 in the second) performed for apical prolapse repair. In the first year, the primary surgery for apical prolapse was the uterosacral suspension with a rate of 72% (28/39). In the following year there was a notable decline in this procedure to only 27% (26/96) with a difference of 45% (P < 0.0001). Similarly, the rates of abdominal sacrocolpopexy declined from 17.9% (7/39) in the first year to 4.16% (4/96) in the year following the introduction of the robot with a difference of 13.7% (P < 0.004). There were no statistically significant changes in the rates of sacrospinous ligament fixation and iliococcygeus fascia suspensions in the two years with total rates less than 8%. During the second year, with the addition of the da Vinci system, the rates of robotic sacrocolpopexy were 57% (55/96), making this the primary method of apical prolapse repair during this year. In comparing vaginal to abdominal approaches there was a decline in the overall percentage of vaginal cases from 82% in the year prior to the robot to 38.5% the year following, which was a statistically significant change (P < 0.0001). CONCLUSION: At our institution, the surgical approach to apical prolapse repair significantly changed after the introduction of robotic technology. Evaluation of surgical outcomes following this paradigm shift are ongoing.

Objective. To evaluate the efficacy and safety of laparoscopic pectopexy without mesh implants (Mesh-less) in apical pelvic organ prolapse. Patients and methods. This study included 136 patients with symptomatic stage 2 apical prolapse (POP-Q) requiring surgical management. All patients were divided into two groups: the comparison group (n = 72) – patients with laparoscopic repair of pelvic organ prolapse (POP) using a mesh implant; the study group (n = 64) – patients with laparoscopic POP repair without mesh implants (Mesh-less). Results. The mean age of patients, mean duration of surgery, mean length of hospital stay, subjective treatment satisfaction, and frequency of postoperative POP recurrence did not differ significantly between groups. Conclusion. The surgical management of POP using laparoscopic pectopexy without mesh implants (Mesh-less) is a minimally invasive method of POP repair, comparable in efficacy to surgical treatment with mesh implants, but avoiding known Meshrelated complications. Key words: apical prolapse, genital prolapse repair, laparoscopy, pectopexy, Mesh-less pectopexy

Analysis of feasibility, efficacy and short-term results after six-arm transvaginal mesh OPUR implantation in women with apical prolapse. The same surgeon operated all of 39 women using mesh OPUR. Preoperatively patients had a standardized interview and clinical examination. Intraoperative and postoperative complications were analyzed. Postoperative evaluation included standardized interview, clinical examination and standardized pelvic floor ultrasound performed with 2D transvaginal probe and 4D abdominal probe. There was no complication that needed operative intervention. Hematomas in 3 patients resolved spontaneously. Transient voiding difficulties which lasted less than 7 days were observed in 5 patients. No erosion was observed. Comparison of pre- and postoperative results in 34 women revealed that in all 3 compartments improvement in POP-Q scale was statistically significant (p < 0.0000). One patient with malposition and rolled up mesh needed re-operation. During PFS-TV in 94.1% of patients urethra was normobile or hypermobile. In all of the patients urethral end of the mesh was positioned far enough from the middle part of the urethra (ultrasound) to implant suburethral sling without risk of collision. Sexually active women did not inform of any important discomfort or pain during intercourse. It seems that six-arm OPUR mesh, if implanted under strict surgical rules, gives low risk of complications and high chance to successfully reduce POP symptoms in short term after the operation. It seems that OPUR mesh should not have negative influence on the results after anti-incontinence suburethral sling.

Long-term reoperation risk after apical prolapse repair in female pelvic reconstructive surgery

ObjectivesThis prospective comparative cohort study aims to evaluate the safety and efficacy of transvaginal mesh compared to native tissue repair (NTR) in the surgical correction of anterior and apical compartment pelvic organ prolapse (POP) over a 36-month follow-up period. MethodsProspective comparative cohort study to prove superiority for efficacy and non-inferiority for serious adverse events (SAEs). The setting was 49 sites across the United States, Canada, Europe, and Australia. Women with bothersome POP symptoms indicated for vaginal surgery with pelvic organ prolapse quantification (POP-Q) scores of Ba ≥0 and C ≥ -1/2 total vaginal length were included. Interventions included vaginal NTR or single-incision transvaginal mesh based on shared decision-making. POP recurrence, the primary efficacy endpoint, was defined as anatomical prolapse beyond the hymenal ring, subjective perception of protrusion or bulge, or retreatment in the target compartment. The primary safety endpoint consisted of the proportion of device and/or procedure-related SAEs in the target compartment. Secondary endpoints included surgical parameters, quality of life, postoperative pain, and sexual function. ResultsPOP recurrence rate at 12 months was 13.1% in the Mesh-arm and 11.5% in the NTR-arm (P = 0.44). The primary safety endpoint was met, with the Mesh-arm demonstrating statistically non-inferior outcomes compared to the NTR-arm in the incidence of device and/or procedure-related SAEs in the target compartment through 12 months (P < 0.01). At 36 months, the surgical POP recurrence rate was 26.7% in the Mesh-arm and 27.0% in the NTR-arm. ConclusionsAt 12- and 36-month follow-up, transvaginal mesh was not superior, but non-inferior in terms of efficacy and safety when compared to NTR for patients with combined anterior and apical compartment prolapse.

Abdominal sacral colpopexy/hysteropexy is the gold standard for the treatment of vaginal apex support. However, dissection of the promontory may expose to potentially life-threatening complications. To avoid this risk, laparoscopic lateral suspension with mesh is an alternative. Robotic assistance may be helpful in both techniques. The objective of our study was to evaluate outcomes of robotically assisted laparoscopic lateral suspension (RALLS) with mesh for anterior and apical pelvic organ prolapse (POP). From March 2012 to January 2018, 59 consecutive patients underwent RALLS using titanized polypropylene mesh. Between August 2017 and September 2019, all patients were contacted to assess outcome. We performed a clinical exam and asked them to complete the patient global impression of improvement (PGI-I) questionnaire. Fifty-four patients (91.5%) were available for follow-up. Mean age was 58.5 years (28.8–79.8). There were no perioperative complications. The mean follow-up was 33.6 months (11.2–74.1).The objective cure rate (no prolapse beyond hymen) and the subjective cure rate (PGI-I ≤ 2) were 83.3% and 77.2%, respectively. Five women (9.3%) were reoperated for POP recurrence. There was no erosion. Of the 20 women complaining of stress urinary incontinence (SUI) preoperatively, 12 (60%) were cured without any additional SUI procedure. Only two women (10%) required TVT for persistent grade 2 SUI. Two women (5.9%) developed de novo SUI, but none of them required an operation. RALLS repair for POP with mesh is safe and effective and may represent an alternative to sacral colpopexy/hysteropexy.

Correlation of symptoms with location and severity of pelvic organ prolapse