Apical Support Research Articles

Regional Performance of Apical Support Procedures at Time of Hysterectomy for Benign Indications: What Is the Role of Surgeon Training?

The objective of this study was to determine factors associated with performance of concomitant apical support procedures (ASPs) with benign hysterectomy at a regional medical system. Benign hysterectomies performed within 1 regional medical system from January 2011 to November 2017 were identified using International Classification of Diseases, Ninth and 10th Revision, and Current Procedural Terminology codes. Primary outcome was performance of concomitant ASP. χ2 Tests compared categorical variables. Multivariable logistic regression analysis was performed to determine factors associated with performance of concomitant ASP. A total of 12,345 benign hysterectomies were performed during the study period. Uterovaginal prolapse was the primary diagnosis in 924 (7.48%) hysterectomies and an associated diagnosis in 1180 (9.56%) hysterectomies. A total of 686 patients (5.56%) had concurrent ASPs: 119 (17.3%) in patients without a diagnosis of prolapse and 567 (82.7%) with prolapse. Using multivariable logistic regression, controlling for age, race, insurance type, hospital type, procedure year, hysterectomy route, and surgeon training in patients with a diagnosis of prolapse, older age, supracervical hysterectomy, and surgeon training were associated with performance of ASPs. Even in patients with a preoperative diagnosis of uterovaginal prolapse, ASPs are not routinely performed at time of hysterectomy. Fellowship-trained surgeons were more likely to perform ASPs. Ongoing educational efforts during training and postgraduate at the national and regional level on the importance of reestablishing apical vaginal support at time of hysterectomy is needed to prevent incident and recurrent post-hysterectomy vaginal vault prolapse.

Anterior Bilateral Sacrospinous Ligament Fixation: A Safe Route for Apical Repair

Traditionally, sacrospinous ligament fixation is performed unilaterally with a posterior dissection for correction of apical vaginal prolapse. There is limited information on alternative techniques including bilateral application and use of anterior vaginal dissection for this procedure. The objective of this study is to evaluate the anatomic and perioperative outcomes in women who have undergone bilateral sacrospinous ligament fixation through an anterior approach. This cohort represents women in our prospective repository who underwent anterior approach bilateral sacrospinous ligament fixation between September 2011 and June 2014. Concomitant procedures were performed as indicated. Pelvic organ prolapse quantification points were measured preoperatively and at 6 weeks and 6 months postoperatively and were compared. Perioperative outcome measures and adverse events were also analyzed. In this cohort, 144 women underwent anterior approach to bilateral sacrospinous ligament fixation. The patients' mean age was 57.8 ± 10.9 years, and the average body mass index was 29.6 ± 5.8 kg/m. In patients who underwent anterior approach bilateral sacrospinous ligament fixation, points Aa, Ba, C, Gh, Ap, and Bp remained at stage I or less when compared with pelvic organ prolapse quantification measurements at the baseline. Perioperative and postoperative complications were minimal, with 1 (0.7%) patient requiring a blood transfusion and 3 (2%) patients suffered from intraoperative lower urinary tract injuries, none of which were attributable to the sacrospinous fixation part of the procedure. Anterior approach bilateral sacrospinous ligament fixation is a safe and effective procedure for reestablishing apical support in a patient with apical vaginal prolapse.

Uterus-Sparing Surgery: Outcomes of Transvaginal Uterosacral Ligament Hysteropexy

Recently, there has been a paradigm shift toward uterine conservation during the surgical management of pelvic organ prolapse (POP), specifically uterine prolapse. There are few reports on transvaginal uterosacral ligament hysteropexy (TULH). This study aimed to describe our surgical technique and outcomes. Retrospective review and description of surgical technique. Anatomic outcome has been reported using the POP quantification system. Complications were segregated. A comparison of parametric continuous variables was performed using paired t test. Categoric variables were evaluated using the Pearson χ2 test and the Fisher exact test. A p-value <.05 was considered significant. Teaching hospital. Forty patients who underwent TULH from 2009 to 2017. TULH. A total of 40 patients met the inclusion criteria. Of these, 56.1% had preoperative stage 3 prolapse. The median operative time was 116 minutes. The mean estimated blood loss was 158.5 mL. Transient ureteral obstruction occurred in 2 patients. The mean follow-up time was 17.2 months, and all patients had significant improvement of prolapse (p <.001). There was also an improvement in urinary incontinence and bladder storage symptoms (p <.001). None of the patients were reoperated on for recurrent POP. TULH is an effective uterus-preserving surgical alternative for the treatment of uterovaginal prolapse and provides good apical support. It is also associated with a low short-term recurrence and incidence of reoperation. TULH is a viable option for suitable patients with uterovaginal prolapse who desire uterine conservation.

Video of uterovaginal procidentia repair incorporating a high extraperitoneal uterosacral vault suspension.

Women with high-grade uterovaginal prolapse have a higher incidence of levator injury, larger levator hiatal defects, and are at a greater risk of recurrent prolapse after pelvic organ prolapse (POP) surgery. RCOG guidelines have recommended prophylactic sacrospinous suspension at the time of vaginal hysterectomy, whenever there is a marked uterovaginal prolapse. The aim of the video is to describe our surgical approach at the time of surgery for advanced POP, and describe the technique for modified McCall high extraperitoneal vault suspension. We have modified the McCall culdoplasty by extending the dissection of the middle portion of the uterosacral/cardinal ligaments so that the sutures can be placed higher and more laterally extraperitoneally to re-support the vaginal cuff at the time of a vaginal hysterectomy. The video highlights the surgical technique used for apical support at the time of surgery for advanced POP. This video demonstrates our modified McCall technique for vault suspension at the time of vaginal surgery for advanced POP. This technique could be considered an alternative technique to other modes of apical support.

Addressing apical support during hysterectomy for prolapse: a NSQIP review.

To describe national practice patterns regarding apical support procedures at time of hysterectomy for prolapse prior to the American College of Obstetricians and Gynecologists (ACOG) 2017 Practice Bulletin on pelvic organ prolapse. This retrospective descriptive study analyzed 24months of data from the National Surgical Quality Improvement Program (NSQIP) database, from 2015 and 2016. Patients undergoing hysterectomy for the indication of pelvic organ prolapse were included. Surgical details, diagnostic codes, subspecialty, patient demographics, and postoperative complications were collected. Comparisons were conducted between those who did and did not undergo apical support procedures. Further comparisons, including logistic regressions, were performed using subspecialty designation. During the study period, 3458 hysterectomies were performed for the indication of pelvic organ prolapse. Of this population, 76% were White, with an average age of 61years, BMI of 27.6, and parity of 2, and 90.5% carried the diagnosis of apical prolapse. Slightly over half (51.8%) had a concurrent procedure to support the vaginal apex. When performed by Female Pelvic Medicine and Reconstructive Surgery (FPMRS) physicians, 65.7% underwent an apical suspension at time of hysterectomy for prolapse compared with 40.2% of non-FPMRS (p < 0.001). Annual rates of apical support procedures showed significant improvement from 49.5% in 2015 to 55.2% in 2016 (P < 0.001). Regarding surgical data, addition of apical support procedures increased operative time by 33min, and reoperation was 1.3% higher (0.3% vs 1.6%). Our results demonstrate that in the 2years prior to ACOG's recommendation only 51.8% of women undergoing hysterectomy for pelvic organ prolapse received concurrent procedures to address apical support.

10: Preoperative levator ani muscle and pudendal nerve injections for pain control after vaginal reconstructive surgery: A three-arm randomized controlled trial

To test the hypothesis that preoperative levator ani muscle (LAM) and transvaginal pudendal nerve (PN) injections with bupivacaine and dexamethasone would improve postoperative pain after vaginal apical prolapse repair. We performed a 3-arm, double-blind, randomized trial of bilateral LAM and PN injections administered prior to vaginal apical support procedures [uterosacral ligament suspension (USLS), sacrospinous ligament fixation (SSLF), levator myorrhaphy or colpocleisis] under standardized general anesthesia. Women were randomized to 0.9% saline, 0.25% bupivacaine, or 0.25% bupivacaine with 4mg dexamethasone injected into 4 sites (bilateral LAM via transobturator approach and transvaginal PN blocks). Primary outcome was a numeric rating scale (NRS) pain score on postoperative day (POD) 1 (higher scores = worse pain). Secondary outcomes included same day discharge, voiding status, analgesic use, nausea/vomiting, activity level, and adverse events. Women were followed for 12 weeks. Twenty-one per arm were required to detect a 2-point change on the NRS (a=0.05, 90% power). Of 281 women screened, 139 (49.5%) were eligible and 75 (26.7%) were randomized with no differences in demographics or procedural characteristics among study arms. There were no significant differences in POD 1 NRS pain scores or other secondary outcomes among study arms (Table). One week after surgery, 73.0% were at or better than their preoperative activity level, increasing to 83.3% by 12 weeks. There was no difference in timing of return to baseline activity among study arms (p>0.25). At POD 3, SSLF had significantly higher NRS scores than USLS or obliterative procedures [4.5 (4.0-7.0) vs. 2.0 (0.5-4.75) vs. 2.5 (2.0-5.0), p = 0.049]. A trend towards higher NRS scores for SSLF occurred at 6 hours and POD 1 (p = 0.09 and p = 0.06). In women undergoing vaginal native tissue apical prolapse repair, preoperative LAM and PN injections with bupivacaine and dexamethasone did not improve postoperative pain control. Most women were at or better than their preoperative activity level 1 week after surgery. SSLF may induce more postoperative pain than USLS or obliterative procedures.

28: Prevalence of pelvic organ prolapse after vaginal hysterectomy with prophylactic apical support

To evaluate the five year prevalence and patient demographics of pelvic organ prolapse (POP) after vaginal hysterectomy (TVH) for benign indications with simultaneous McCall's culdoplasty. An IRB exempt retrospective chart review was conducted for women ≥ 45 years old undergoing McCall’s culdoplasty at time of TVH for benign indications at two different sites of a tertiary care, academic medical institution. The follow-up period was 4.5-5.5 years. A total of 1,289 TVH were performed for women ≥ 45 years old between May 1, 2000 and May 1, 2013. 916 were excluded for these one or more reasons: 669 (73.0%) had POP at time of TVH; 115 (12.6%) had no prophylactic McCall’s; 91 (9.9%) had a known neoplasm; 29 (3.2%) were missing operative reports; 9 (1.0%) died before 5 years; 4 (0.4%) were abdominal conversions from vaginal attempts. Of the 262 remaining, 9 (3.4%) developed POP within a 5-year period. No differences were found in demographics between women who did and did not develop POP. For primarily white, multiparous women of average BMI who received a McCall’s at time of TVH, there were no observed differences between patients who did and did not develop POP. Additionally, women had lower post-hysterectomy POP rates compared to rates in the literature among McCall’s non-specific patients.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Ultrasonography and robotic-assisted laparoscopic sacrocervicopexy with pubocervical fascia reconstruction: comparison with standard technique.

The objective of this study was to evaluate our technique of ultrasonography and robotic-assisted sacrocervicopexy with pubocervical fascia reconstruction (u-RALS-PFR) versus standard robotic-assisted laparoscopic sacrocervicopexy (s-RALS) in the treatment of patients with symptomatic apical/anterior vaginal prolapse. A retrospective analysis was done using the data in two community hospitals. Thirty women presented with symptomatic vaginal apical prolapse and desired minimally invasive surgery (video): (a) standard robotic-assisted laparoscopic sacrocervicopexy (s-RALS) (n = 15) or (b) ultrasound and robotic-assisted sacrocervicopexy with pubocervical fascia reconstruction (u-RALS-PFR) (n = 15) were eligible to participate. All participants underwent a standardized evaluation, including a structured urogynecologic history and physical examination with pelvic organ prolapse quantitative staging. There was longer operating room time in the u-RALS-PFR group compared with the s-RALS group (average difference 35min); however, sacral promontory dissection time was less in the u-RALS-PFR (average difference of 15min). The anterior/posterior vaginal dissection and mesh tensioning time was longer in the u-RALS-PFR, as expected. There was only one surgical and anatomic failure (7%) in the s-RALS group after 6months of surgery (POP Q = Aa + 1, Ba0, Ap-2, Bp-3, C-7). Our technique of ultrasonography and pubocervical fascia reconstruction during RALS appears to be feasible and safe. It aims to improve anterior and apical support, minimize the use of mesh and improve visualization during surgery. u-RALS-PFR approach will add some additional time during surgery but may provide better outcomes.

Anterior repair versus no anterior repair for anterior vaginal wall prolapse resolved under simulated apical support at the time of uterosacral ligament suspension.

The aim of this study was to compare treatment outcomes 1year after uterosacral ligament suspension (USLS) with or without concomitant anterior repair (AR) for anterior vaginal wall prolapse resolved under simulated apical support. This retrospective cohort study included 179 women who underwent USLS with or without concomitant AR for Pelvic Organ Prolapse Quantification (POPQ) stage 2-4 anterior vaginal wall prolapse resolved under simulated apical support, and who completed a 1-year follow-up. The primary outcome was composite surgical failure defined as anterior anatomical recurrence (point Ba>0), symptomatic recurrence (presence of vaginal bulge symptoms), or retreatment for prolapse. Secondary outcomes included changes in POPQ values and Urogenital Distress Inventory-6 (UDI-6) scores, perioperative outcomes, and complications. Eighty-six women underwent concomitant AR, and 93 did not. The group receiving AR had more advanced anterior and apical prolapse. Surgical failure rates were significantly higher in the group not receiving AR than in the group receiving AR (21.5% vs 7.0%, p < 0.01). However, there were no differences in the mean point Ba and C values and UDI-6 scores through 12months postoperatively between the two groups. Operating times were longer, and adverse events, such as immediate postoperative urinary retention and minor wound complications, were more frequent in the group receiving AR (p < 0.05). Concomitant AR at the time of USLS seems to reduce the recurrence of anterior vaginal wall prolapse without significant morbidity. Considering the small difference in anatomical outcomes, a longer follow-up period will be required to confirm this.

Risk factors for vaginal mesh erosion after sacrocolpopexy in Korean women.

Although sacrocolpopexy (SCP) can provide durable apical support, the use of mesh may give rise to various complications, including vaginal mesh erosion. The aim of this study was to identify the risk factors for vaginal mesh erosion after SCP in Korean women. This retrospective cohort study included 363 women who underwent SCP with type 1 polypropylene mesh. They were evaluated at 1, 4, and 12 months after surgery and then annually thereafter with respect to anatomy and complications. Univariate and multivariate analyses using the Cox proportional hazard model were performed to identify the risk factors for mesh erosion. During the median 2-year follow-up period, vaginal mesh erosion was found in 29 women (8.0%). Among them, 19 (65.5%) required surgical correction. Estrogenic status was the only independent risk factor for mesh erosion. The risk for mesh erosion was 4.5 times higher in premenopausal women than in menopausal women not on estrogen replacement therapy (ERT) (95% confidence intervals [CI] 1.9-10.9, p<0.01). Menopausal women on ERT also had an increased risk, with a statistically marginal significance (hazard ratio 2.5, 95% CI 0.9-6.6; p = 0.07). Premenopausal or menopausal women on ERT are at high risk for mesh erosion after SCP with type 1 polypropylene mesh, and two-thirds of mesh erosion cases require reoperation. This information should be incorporated into patient counseling and treatment decisions.

Laparoscopic Sacrocolpopexy vs Transvaginal Mesh Repair for Advanced Pelvic Organ Prolapse: 1 Year Results of a Multicenter Randomized Study

Backgrounds: Laparoscopic sacrocolpopexy is considered the most durable operation for the repair of advanced uterovaginal prolapse. However, there is still disagreement about whether the efficacy and safety of vaginally implanted mesh to address advanced uterovaginal prolapse is comparable to sacrocolpopexy. Our goal was to evaluate the anatomical and subjective outcomes of laparoscopic sacrocolpopexy versus transvaginal mesh in a randomized trial in China. Methods: A multicenter randomized trial was carried out at 6 tertiary hospitals in China. Patients with symptomatic advanced prolapse (stages III-IV) were enrolled. Between January 2013 and June 2014, a total of 100 women were randomized. 40 laparoscopic sacrocolpopexy procedures and 42 transvaginal mesh procedures were performed. Patients were randomized to undergo either laparoscopic sacrocolpopexy or transvaginal mesh. Results: At 1 year, the anatomic success rate was 92.5% in the laparoscopic sacrocolpopexy arm, compared with 83.3% in the transvaginal mesh group (P=0.35). Laparoscopic sacrocolpopexy was associated with better apical support. The laparoscopic sacrocolpopexy group had a longer operative time. Mesh exposures occurred in 2.5% of laparoscopic repairs vs. 2.4% of transvaginal mesh repairs. Conclusion: In a randomized trial, 1-year objective cure rates were not statistically different. However the success rate was 9.2% higher for laparoscopic sacrocolpopexy. The two procedures had comparable mesh exposure rates, and other complications were rare in both groups. Trial registration: clinicaltrials.gov (NCT01762384). The date of registration was Jan 7th, 2013. URL was https://clinicaltrials.gov/ct2/show/NCT01762384?term=NCT01762384&draw=2&rank=1.

Preoperative POPQ versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension (PREPARE trial): study protocol for a randomised controlled trial

IntroductionTransvaginal reconstructive surgery is the mainstay of treatment for symptomatic pelvic organ prolapse. Although adequate support for the vaginal apex is considered essential for durable surgical repair, the optimal management...

The role of conventional pelvic floor reconstructive surgeries in obstructed defecation symptoms change: CARE and OPTIMAL trials sub-analysis of 2-year follow-up data.

The current study was aimed at addressing two questions: first, is any conventional vaginal prolapse repair effective in curing obstructed defecation symptoms, and second, is there evidence to suggest that a sacrocolpopexy will increase the risk of worsening or new-onset obstructed defecation symptoms? This is a sub-analysis of two major clinical trials performed by the Pelvic Floor Disorders Network: the Colpopexy and Urinary Reduction Efforts (CARE) trial and the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) trial. Two-year follow-up data were included. Demographics, pelvic organ prolapse quantification examination, and symptoms were compared between first, two surgical arms in the OPTIMAL study and second, CARE and OPTIMAL datasets using Chi-squared test for categorical variables and Student's t test or Mann-Whitney U test for continuous variables. A total of 353 subjects form the OPTIMAL study and 279 subjects from the CARE study met the inclusion criteria. Regardless of trial, obstructed defecation symptoms were present in more than half of the patients at the initial visit before the surgical intervention, and interestingly, about one third of the patients were symptomatic at the 24-month follow-up in all surgical groups. The conventional vaginal prolapse surgeries, with or without posterior vaginal wall repair, improved obstructed defecation symptoms by 50%, but about 35% of patients were suffering from at least one of the aspects of obstructed defecation at the 24-month follow-up. It is also important to note that about a quarter of the patients experienced persisting or worsening of their obstructed defecation symptoms in the absence of anatomical failure.

2340 Novel Surgical Approach Incorporating A Dermal Allograft with the Sacropinous and Uterosacral Ligaments to Address Apical Prolapse

Video Objective To show a novel approach to support the apex in a post-hysterectomy vaginal vault prolapse. Increasing data shows the importance of apical support, and we know from prior studies that the anterior compartment recurs more often. This technique offers support of both the anterior and posterior apex in a manner that augments the apex to reduce recurrences. Setting 64 year old female with multi-compartment post-hysterectomy vaginal vault prolapse. Interventions The video explains the surgical technique utilized in a step by step approach. Conclusion The procedure shown combines different techniques that have been described separately with the addition of combining them and augmenting the apex. This offers a vaginal procedure that increases support of the apex both anteriorly and posteriorly to reduce recurrent prolapse. To show a novel approach to support the apex in a post-hysterectomy vaginal vault prolapse. Increasing data shows the importance of apical support, and we know from prior studies that the anterior compartment recurs more often. This technique offers support of both the anterior and posterior apex in a manner that augments the apex to reduce recurrences. 64 year old female with multi-compartment post-hysterectomy vaginal vault prolapse. The video explains the surgical technique utilized in a step by step approach. The procedure shown combines different techniques that have been described separately with the addition of combining them and augmenting the apex. This offers a vaginal procedure that increases support of the apex both anteriorly and posteriorly to reduce recurrent prolapse.

Robotic Sacrospinous Ligament Suspension

Video Objective To describe a robotic approach for performing a sacrospinous ligament suspension. Setting A 78 year-old woman presented with stage 3 uterine prolapse with the sole complaint of vaginal pressure. She had no urinary or bowel dysfunction. Her gynecologic surgical history included anterior and posterior vaginal wall mesh-augmented repairs. On examination, she had uterovaginal prolapse with underlying palpable uterus and calcified fibroid and the leading edge of he cervix at +6 cm from the hymen. Anterior, posterior and introital measurements on POP-Q were normal. This represented an isolated stage 3 Uterine Prolapse. Interventions A robotic hysterectomy with bilateral salpingo-oophorectomy was completed. Uterosacral ligaments were attenuated and could not be utilized for vaginal apical support. Alternatively, a robotic right sacrospinous ligament suspension was attempted successfully. Steps for this procedure include: developing the right pararectal space, identifying the levator ani muscles and sacrospinous ligament followed by suspension of the vaginal cuff to the sacrospinous ligament using resorbable suture. This surgical clip demonstrates the technique. Conclusion A robotic approach can be utilized for vaginal apical suspension to the sacrospinous ligament when uterosacral ligaments are attenuated. Pelvic floor and sidewall anatomic knowledge is required for successful completion of this procedure.

Extraperitoneal Sacral Hysteropexy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery: A Single-center Case Series Study

Study Objective This study evaluated the feasibility, safety and short-term clinical outcomes from extraperitoneal sacral hysteropexy by transvaginal natural orifice transluminal endoscopic surgery in treating uterine prolapse. Design Retrospective study. Setting The First Affiliated Hospital of Third Military Medical University, Chongqing, China Patients or Participants The medical records of patients with POP-Q stage 2 or greater uterine prolapse who were treated with vNOTES-ESH between December 2016 to June 2018(to ensure 1-year follow-up or more) in the Southwest Hospital at the Third Military Medical University were reviewed retrospectively. Interventions Extraperitoneal sacral hysteropexy were performed by vNOTES. Measurements and Main Results 21 patients underwent surgery; 20 were successfully completed, and one that could not maintain pressure at the extraperitoneal cavity site due to peritoneal rupture during surgery who underwent multi-port laparoscopic surgery. Median patient age was 50 years. The body mass index (BMI) was 23.7 kg/m2, the median operative time was 126 min, and the median intraoperative blood loss was 60 mL. One case had presacral hemorrhage that was circumvented by bipolar electrocoagulation. Preoperative POP-Q scores were: Aa-0, Ba-1, C-2, Ap-3, and Bp-3. The average post-operative follow-up was 12 months. The POP-Q scores were: Aa-2, Ba-2, C-7, Ap-3, and Bp-3. Associated symptoms disappeared or improved significantly without sexual discomfort or pain on intercourse, mesh erosion, exposure, infection or other complications. The objective cure rate was 100 percent. Conclusion vNOTES was a feasible approach in completing extraperitoneal sacral hysteropexy for apical support, with promising short-term efficacy and safety. However, further studies across multiple sites are needed in evaluating long-term efficacy and safety profile of vNOTES extraperitoneal sacrocolpopexy.

Association between adjuvant posterior repair and success of native tissue apical suspension

Posterior repairs and perineorrhaphies are often performed in prolapse surgery to reduce the size of the genital hiatus. The benefit of an adjuvant posterior repair at the time of sacrospinous ligament fixation or uterosacral ligament suspension is unknown. We aimed to determine whether an adjuvant posterior repair at transvaginal apical suspension is associated with improved surgical success. This secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) trial compared 24-month outcomes in 190 participants who had a posterior repair (posterior repair group) and 184 who did not (no posterior repair group) at the time of sacrospinous ligament fixation or uterosacral ligament suspension. Concomitant posterior repair was performed at the surgeon's discretion. Primary composite outcome of "surgical success" was defined as no prolapse beyond the hymen, point C ≤-2/3 total vaginal length, no bothersome bulge symptoms, and no retreatment at 24 months. The individual components were secondary outcomes. Propensity score methods were used to build models that balanced posterior repair group and the no posterior repair group for ethnographic factors and preoperative Pelvic Organ Prolapse Quantification values. Adjusted odds ratios were calculated to predict surgical success based on the performance of a posterior repair. Groups were also compared with unadjusted χ2 analyses. An unadjusted probability curve was created for surgical success as predicted by preoperative genital hiatus. Women in the posterior repair group were less likely to be Hispanic or Latina, and were more likely to have had a prior hysterectomy and to be on estrogen therapy. The groups did not differ with respect to preoperative Pelvic Organ Prolapse Quantification stage; however, subjects in the posterior repair group had significantly greater preoperative posterior wall prolapse. There were no group differences in surgical success using propensity score methods (66.7% posterior repair vs 62.0% no posterior repair; adjusted odds ratio, 1.07; 95% confidence interval, 0.56-2.07; P= 0.83) or unadjusted test (66.2% posterior repair vs 61.7% no posterior repair; P= 0.47). Individual outcome measures of prolapse recurrence (bothersome bulge symptoms, prolapse beyond the hymen, or retreatment for prolapse) also did not differ by group. Similarly, there were no differences between groups in anatomic outcomes of any individual compartment (anterior, apical, or posterior) at 24 months. There was high variation in performance of posterior repair by surgeon (interquartile range, 15-79%). The unadjusted probability of overall success at 24 months, regardless of posterior repair, decreased with increasing genital hiatus, such that a genital hiatus of 4.5 cm was associated with 65.8% success (95% confidence interval, 60.1-71.1%). Concomitant posterior repair at sacrospinous ligament fixation or uterosacral ligament suspension was not associated with surgical success after adjusting for baseline covariates using propensity scores or unadjusted comparison. Posterior repair may not compensate for the pathophysiology that leads to enlarged preoperative genital hiatus, which remains prognostic of prolapse recurrence.

Apical Pelvic Support in Infertility Patients

Apical Pelvic Support in Infertility Patients

Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.

In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05. Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being "very satisfied" overall with study information (97.7% vs 88.5%, p = 0.01); "strong agreement" for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being "very important" (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group. The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.

Recurrent apical prolapse after high uterosacral ligament suspension \u2013 in a heterogenous cohort characterised by a high prevalence of previous pelvic operations

BackgroundThe apical prolapse is probably the most complex form of pelvic organ prolapse (POP). Adequate apical support is essential in the treatment of POP, as it contributes to the support in all vaginal compartments. This study aimed to evaluate the rate of symptomatic recurrent apical prolapse after high uterosacral ligament suspension (HUSLS), in a cohort of women characterised by a high prevalence of previous pelvic operations and a significant degree of prolapse.MethodsThis is a retrospective chart review of 95 women who underwent HUSLS for symptomatic apical prolapse from 2002 to 2009 at Aarhus University Hospital, Denmark. Of these women, 97% attended a six-month clinical control. Recurrence was defined as symptomatic vaginal vault prolapse stage 2 or more (according to the International Continence Society (ICS) quantification system). Medical charts were reviewed for a mean period of 7.2 years. Any new contacts due to prolapse were noted.ResultsBefore the operation, 73% of the women were hysterectomised, and 52% had previous prolapse surgery. Stage 2 apical prolapse was reported in 71% of the women, whereas 26% had stage 3 or 4.At six-month follow-up, 19% of the women had recurrent symptomatic apical prolapse, and 9% of the women had symptomatic recurrent prolapse in other compartments 6 months after operation. In all, 35% of the women had a renewed prolapse operation during the long-term follow-up period.Perioperative adverse events were seen in 7%.Two women were re-operated due to postoperative complications.ConclusionsThis retrospective study of 95 women with a significant degree of prolapse and a high prevalence of previous pelvic operations demonstrates that the rate of recurrent prolapse associated with HUSLS might be higher than originally described. In conclusion, HUSLS may not be the optimal first choice of operation in this group of patients.