Effectiveness and safety of a novel, collapsible pessary for management of pelvic organ prolapse.

BACKGROUND: Pessaries are an effective treatment for pelvic organ prolapse, yet currently available pessaries can cause discomfort during removal and insertion. An early feasibility trial of an investigational, collapsible pessary previously demonstrated mechanical feasibility during a brief 15-minute office trial. Longer-term, patient-centered safety and efficacy data are needed. OBJECTIVE: This study aimed to assess the effectiveness and safety of the investigational vaginal pessary for pelvic organ prolapse at 3 months. STUDY DESIGN: This was a prospective, 7-center, open-label equivalence study with participants serving as their own controls. Subjects were current users of a Gellhorn or ring pessary with ≥stage 2 prolapse. Subjective and objective data were collected at baseline for 1 month while subjects used their current pessary. Data were then collected throughout a 3-month treatment phase with the study pessary. The primary outcome was change in Pelvic Floor Distress Inventory-20 score. Secondary outcome measures included objective assessment of prolapse support, changes in the Pelvic Floor Impact Questionnaire-7, and pain with insertion and removal, measured using a visual analog scale. Data from subjects fitted with the study pessary were analyzed using an intention-to-treat approach, and those who dropped out were assigned scores at the upper limit of the predefined equivalence limits. Secondary per protocol analyses included subjects who completed treatment. The study was powered to 80% with a minimal important change equivalence limit of 18.3 points on the Pelvic Floor Distress Inventory-20 scale. Square root transformations were used for nonparametric data, and P values were adjusted for multiple comparisons. RESULTS: A total of 78 subjects were enrolled, however, 16 withdrew before study pessary placement. The study pessary was fitted in 62 subjects (50 ring and 12 Gellhorn pessary users), and 48 (62%) completed the 3-month intervention. The change in Pelvic Floor Distress Inventory-20 scores at 3 months demonstrated equivalence when compared with the subjects' baseline scores (mean difference, -3.96 [improvement]; 90% confidence interval, -11.99 to 4.08; P=.002). Among those completing study, the Pelvic Floor Distress Inventory-20 scores, equivalence was not demonstrated and scores favored the study pessary (mean difference, -10.45; 90% confidence interval, -20.35 to 0.54; P=.095). Secondary outcomes included objective measures of support, which were similar (mean difference: Ba, 0.54 cm; Bp, 0.04 cm, favoring study pessary; improvement in mean Pelvic Floor Impact Questionnaire-7 scores for those who completed the trial: before, 32.23; after, 16.86; P=.019), and pain with insertion and removal, which was lower with the study pessary than with the subject's own pessary (mean difference visual analog scale score insertion, 9.91 mm; P=.019; removal, 11.23 mm; P=.019). No serious adverse events related to the pessary were reported. CONCLUSION: Equivalence was demonstrated in the primary outcome of the study pessary when compared with current, noncollapsible pessaries in terms of change in severity and bother of pelvic floor symptoms. Among participants who completed the trial, the Pelvic Floor Impact Questionnaire-7 improved with study pessary use and change in Pelvic Floor Distress Inventory-20 scores were nonequivalent, favoring the study pessary. Subjects reported significantly lower pain scores with both pessary insertion and removal with the novel collapsible pessary when compared with their standard pessary.

Return to work following pelvic reconstructive surgery: secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss trial.

BACKGROUND: Patients' return to work is an important part of surgical counseling and quality of life. OBJECTIVE: This study aimed to evaluate the pattern of patients' return to work and loss of productivity after pelvic reconstructive surgery. STUDY DESIGN: This was a secondary analysis of the randomized controlled trial Operations and Pelvic Muscle Training in the Management of Apical Support Loss. The primary outcome was return to work defined by the answer to "How many calendar weeks or workdays did you not go to work after the original prolapse surgery?" Furthermore, loss of productivity included hours and days per week worked and discontinuation of paid work because of urogynecologic conditions. Moreover, predictors affecting the timing of return to work and loss of productivity were assessed. RESULTS: Here, 180 patients (49%) were working before surgery. Of these patients, half returned to work 35 days after surgery, with 21 (13%) returning to work immediately after surgery and 43 (27%) returning to work within ≤2 weeks. The number of days missed did not differ between patients who underwent sacrospinous ligament fixation and those who underwent uterosacral ligament suspension (P=.23). At 3 months, 15 patients (9%) who were working before surgery had stopped working, but those who continued to work had similar hours per week as before surgery (36±12 vs 35±13; P=.48). Of note, 17 patients (11%) reported being less productive, on average working at 60% effectiveness. Most patients (96%) reported not missing any hours of household chores by 3 months after surgery. Patients who returned to work within 6 weeks had a higher rate of retreatment with either pessary or surgery within 2 years (5 of 85 [6.8%] vs 0 of 76 [0%]; P=.03). Those who returned to work within 2 weeks worked fewer hours before surgery (30±15 vs 36±12; P=.013), were less likely to have private insurance (77% vs 91%; P=.03), and had a higher rate of retreatment (3 of 30 [13%] vs 2 of 131 [1.7%]; P=.007). There was no difference in bulge symptoms and anatomic failure based on return to work. CONCLUSION: Most patients returned to work within 35 days after surgery. Working less than full time and not having private insurance were predictors of earlier return to work.

From molecular to macro: the key role of the apical ligaments in uterovaginal support.

To explain the pathophysiology of pelvic organ prolapse, we must first understand the complexities of the normal support structures of the uterus and vagina. In this review, we focus on the apical ligaments, which include the cardinal and uterosacral ligaments. The aims of this review are the following: (1) to provide an overview of the anatomy and histology of the ligaments; (2) to summarize the imaging and biomechanical studies of the ligament properties and the way they relate to anterior and posterior vaginal wall prolapse; and (3) to synthesize these findings into a conceptual model for the progression of prolapse.

Is absorbable suture superior to permanent suture for uterosacral ligament suspension?

AIMS: The aims of this study were to compare surgical results and suture-related complications after uterosacral ligament suspension (USLS) with absorbable suture (AS) vs permanent suture (PS). METHODS: We systematically searched PubMed, Embase, clinicalTrial.gov, and Cochrane Library Central Register of Controlled Trials for articles that compared AS with PS for USLS. The primary outcomes were surgical success rate and suture-related complications (suture exposure/erosion and suture removal). Review Manager 5.3 (Cochrane Collaboration, Oxford, UK) was applied to conduct all analyses. RESULTS: Four articles involving 647 patients were eventually included. Our findings demonstrated that AS had a similar surgical success rates in comparison with PS (RR = 1.00; 95% CI, 0.94-1.06) and that no significant differences in anatomic failure rates were noted between two groups (RR = 1.10; 95% CI, 0.65-1.86). Subgroup analyses in anatomic failure revealed no statistical differences in apical prolapse ≥1/2 TVL (RR = 0.92; 95% CI, 0.48-1.75), recurrent prolapse beyond the hymen (RR = 1.18; 95% CI, 0.68-2.04), as well as in recurrent anterior, posterior or apical prolapse (P = .14, P = .08, P = .09, respectively). However, AS group indicated a lower risk in suture exposure/erosion (RR = 0.31; 95% CI, 0.15-0.63) and lower suture removal rate (RR = 0.35; 95% CI, 0.18-0.67). CONCLUSIONS: Due to similar surgical results, less suture exposure/erosion and less suture removal, the current data supported that AS is as effective as PS, but with a better safety profile.

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

OBJECTIVE: 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. METHODS: This retrospective descriptive study analyzed 24 months 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. RESULTS: 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 61 years, 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 33 min, and reoperation was 1.3% higher (0.3% vs 1.6%). CONCLUSION: Our results demonstrate that in the 2 years prior to ACOG's recommendation only 51.8% of women undergoing hysterectomy for pelvic organ prolapse received concurrent procedures to address apical support.

Associating genital hiatus size with long-term outcomes after apical suspension.

INTRODUCTION AND HYPOTHESIS: To describe associations between postoperative genital hiatus (GH) measurements and long-term anatomical and subjective outcomes following pelvic reconstructive surgery involving apical suspension. METHODS: This IRB-approved secondary analysis reports outcomes 3-7 years following robotic sacrocolpopexy (RSC) and uterosacral ligament suspension (USLS). Objective and subjective measures were obtained through clinical examinations and validated questionnaires. Subjective success was defined as the absence of a symptomatic bulge or retreatment. Objective success was defined as all Pelvic Organ Prolapse Quantification (POP-Q) points at or above -1 at the long-term examination. Postoperative GH measures were obtained at 6 weeks (early) and 3-7 years (long term) postoperatively. GH measurements were classified as either normal (<4 cm) or wide (≥4 cm). Logistic regression identified associations between postoperative GH measurements and long-term subjective and objective outcomes. RESULTS: A total of 154 subjects completed long-term POP-Q examinations (74 RSC and 80 USLS). The median time to follow-up (minimum, maximum) was 59 months (range 34-89); 97.4% were Caucasian. Subjective success was achieved in 134 (87%), and objective success in 139 (90.2%) subjects. The majority (79%) underwent a posterior repair during their index surgery. An early postoperative GH of less than 4 cm was associated with an 11-fold higher likelihood of subsequent objective success (11.8, 2.7-51.7; p = 0.001). Furthermore, a postoperative GH less than 4 cm was not associated with dyspareunia at long-term follow-up. CONCLUSIONS: Early postoperative GH <4 cm was associated with superior long-term objective success, without increasing dyspareunia. These data support correcting GH to <4 cm during prolapse repair with apical suspension to reduce objective long-term failure.

Defining normal apical vaginal support: a relook at the POSST study.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to reanalyze data from the original 2005 Pelvic Organ Support Study (POSST) data set to define normal values for apical Pelvic Organ Prolapse Quantification (POP-Q) points C and D and total vaginal length (TVL) in an asymptomatic population of women. METHODS: In this retrospective observational data-set review, patient were >18 years presenting for annual gynecologic exams to six centers in the United States. Data included demographics, questions about prolapse symptoms, and POP-Q points. Means and standard deviations were determined for each POP-Q point in the total population. RESULTS: The data set comprised 1011 women; 59 were excluded because they met criteria for having POP or were missing data. This left 948 for study. Mean age of our study population was 42 ± 14 years, and 45.6% were white, 25.1% black, and 25.2% Hispanic. One hundred fifty-six had a prior hysterectomy. Mean values with standard deviations (SD) for POP-Q values are as following: point C (vaginal cuff) -7.3 ± 1.5 cm, point C (cervix) -5.9 ± 1.5, point D -8.7 cm ± 1.5 cm, TVL (no hysterectomy) 9.8 cm ± 1.3 cm, and TVL (hysterectomy) 8.9 cm ± 1.5 cm. CONCLUSIONS: This data suggests normal values for POP-Q apical points in a population of patient with annual gynecological exams.

Vaginal hysterectomy with apical fixation and anterior vaginal wall repair for prolapse: surgical technique and medium-term results.

INTRODUCTION AND HYPOTHESIS: Stabilization of the vaginal apex (level 1) is an important component of operations to correct pelvic organ prolapse (POP). We report functional and anatomical results and patient-reported outcomes of our technique of vaginal vault fixation at the time of vaginal hysterectomy. METHODS: One hundred and nine patients-mean 69 years, range 50.4-83.8; body mass index (BMI) 26.3, range 17.7-39.5-with symptomatic stage 2-3 uterine prolapse combined with stage 3-4 cystocele underwent vaginal hysterectomy with anterior vaginal wall repair; the apex was formed with high closure of the peritoneum and incorporation of the uterosacral and round ligaments. Only absorbable sutures were used. Follow-up included clinical examination with Pelvic Organ Prolapse Quantification system (POP-Q) scoring, introital ultrasonography, quality of life (QoL) Likert scale, and the German Pelvic Floor Questionnaire. RESULTS: Seventy patients (64%) were available for a follow-up after a mean of 2.8 years (range, 1.6-4.2). At follow-up, point C was stage 0 in 55 (78.6%) women and stage 1 in 15 (21.4%). The anterior vaginal wall was stage 0 or 1 in 35 (50%), stage 2 (no cystocele beyond the hymen) in 34 (49%), and stage 3 in 1 (1.4%). Vaginal length (VL) was 9 cm. Four women (4%) were reoperated for prolapse: two for recurrent anterior compartment prolapse and two for de novo rectocele. Postvoid residuals >150 ml were seen in 21(30%) patients preoperatively and resolved postoperatively in 20. Urgency occurred in nine (13%), stress urinary incontinence (SUI) in ten (14%), and nocturia in 19 (27%). No patient had discomfort at the vaginal vault and 62 patients (87%) reported improved QoL, which did not correlate with anatomical results. Cystocele ≥ 2° at follow-up was associated with BMI >25 (p = 0.03). CONCLUSIONS: Our surgical technique without permanent material offers good apical support and functional and subjective results. Anatomical improvement was achieved in all cases of cystocele repair. Recurrent cystoceles are often asymptomatic.

McCall Culdoplasty during Total Laparoscopic Hysterectomy: A Pilot Randomized Controlled Trial.

STUDY OBJECTIVE: To assess the feasibility and safety of a McCall culdoplasty at the time of total laparoscopic hysterectomy and to evaluate the differences in the total vaginal length, vaginal apex during Valsalva, and sexual function 12 months after McCall culdoplasty compared with standard cuff closure. DESIGN: A pilot randomized controlled, single-masked trial (Canadian Task Force classification I). SETTING: An academic tertiary care hospital. PATIENTS: Women undergoing total laparoscopic hysterectomy for benign indications from June 2013 to December 2013. INTERVENTIONS: Women were randomized (1:1) to McCall culdoplasty followed by standard cuff closure versus standard cuff closure. Patients underwent Pelvic Organ Prolapse Quantification examination and completed the Female Sexual Function Index immediately before surgery and at 6 months and 12 months postoperatively. The primary outcome was the operative time. Secondary outcomes included estimated blood loss, complications, total vaginal length, vaginal apex during Valsalva, and sexual function. MEASUREMENTS AND MAIN RESULTS: This study included 50 patients. The groups were similar in terms of preoperative and surgical characteristics. The operative time did not differ between the groups. The estimated blood loss and complications were also similar. The loss to follow-up was similar in both groups. Changes in the total vaginal length, vaginal apex during Valsalva, sexual function, and pain with intercourse did not differ between the groups. CONCLUSION: In this pilot study, the addition of McCall culdoplasty to standard cuff closure during total laparoscopic hysterectomy was not associated with an increase in operative time, estimated blood loss, or surgical complications. No differences in the total vaginal length or vaginal apex during Valsalva were observed at the 12-month follow-up. There were no differences in sexual dysfunction or dyspareunia. Given the well-established risk reduction for the development of apical prolapse with McCall culdoplasty during vaginal hysterectomy, this procedure may be a feasible and safe addition to total laparoscopic hysterectomy.

Definitions of apical vaginal support loss: a systematic review.

OBJECTIVE: We sought to identify and summarize definitions of apical support loss utilized for inclusion, success, and failure in surgical trials for treatment of apical vaginal prolapse. BACKGROUND: Pelvic organ prolapse is a common condition affecting more than 3 million women in the US, and the prevalence is increasing. Prolapse may occur in the anterior compartment, posterior compartment or at the apex. Apical support is considered paramount to overall female pelvic organ support, yet apical support loss is often underrecognized and there are no guidelines for when an apical support procedure should be performed or incorporated into a procedure designed to address prolapse. STUDY DESIGN: A systematic literature search was performed in 8 search engines: PubMed 1946-, Embase 1947-, Cochrane Database of Systematic Reviews, Cochrane Database of Abstracts of Review Effects, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, Proquest Dissertations and Theses, and FirstSearch Proceedings, using key words for apical pelvic organ prolapse and apical suspension procedures through April 2016. Searches were limited to human beings using human filters and articles published in English. Study authors (M.R.L.M., J.L.L.) independently reviewed publications for inclusion based on predefined variables. Articles were eligible for inclusion if they satisfied any of the following criteria: (1) apical support loss was an inclusion criterion in the original study, (2) apical support loss was a surgical indication, or (3) an apical support procedure was performed as part of the primary surgery. RESULTS: A total of 4469 publications were identified. After review, 35 articles were included in the analysis. Prolapse-related inclusion criteria were: (1) apical prolapse (n = 20, 57.1%); (2) overall prolapse (n = 8, 22.8%); or (3) both (n = 6, 17.1%). Definitions of apical prolapse (relative to the hymen) included: (1) apical prolapse >-1 cm (n = 13, 50.0%); (2) apical prolapse >+1 cm (n = 7, 26.9%); (3) apical prolapse >50% of total vaginal length (-[total vaginal length/2]) (n = 4, 15.4%); and (4) cervix/apex >0 cm (n = 2, 7.7%). Sixteen of the 35 studies (45.7%) required the presence of symptoms for inclusion. A measurement of the apical compartment (relative to the hymen) was used as a measure of surgical success or failure in 17 (48.6%) studies. Definitions for surgical success included: (1) prolapse stage >2 in each compartment (n = 5, 29.4%); (2) prolapse >-[total vaginal length/2] (n = 2, 11.8%); (3) apical support >-[total vaginal length/3] (n = 1, 5.9%); (4) absence of prolapse beyond the hymen (n = 1, 5.9%); and (5) point C at ≥-5 cm (n = 2, 11.8%). Surgical failure was defined as: (1) apical prolapse ≥0 cm (n = 2, 11.8%); (2) apical prolapse ≥-1 cm (n = 2, 11.8%); (3) apical prolapse >-[total vaginal length/2] (n = 3, 17.6%); and (4) recurrent apical prolapse surgery (n = 1, 5.9%). Ten (28.6%) of the 35 studies also included symptomatic outcomes in the definition of success or failure. CONCLUSION: Among randomized, controlled surgical trials designed to address apical vaginal support loss, definitions of clinically significant apical prolapse for study inclusion and surgical success or failure are either highly variable or absent. These findings provide limited evidence of consensus and little insight into current expert opinion.

Intraoperative cervix location and apical support stiffness in women with and without pelvic organ prolapse.

BACKGROUND: It is unknown how initial cervix location and cervical support resistance to traction, which we term "apical support stiffness," compare in women with different patterns of pelvic organ support. Defining a normal range of apical support stiffness is important to better understand the pathophysiology of apical support loss. OBJECTIVE: The aims of our study were to determine whether: (1) women with normal apical support on clinic Pelvic Organ Prolapse Quantification, but with vaginal wall prolapse (cystocele and/or rectocele), have the same intraoperative cervix location and apical support stiffness as women with normal pelvic support; and (2) all women with apical prolapse have abnormal intraoperative cervix location and apical support stiffness. A third objective was to identify clinical and biomechanical factors independently associated with clinic Pelvic Organ Prolapse Quantification point C. STUDY DESIGN: We conducted an observational study of women with a full spectrum of pelvic organ support scheduled to undergo gynecologic surgery. All women underwent a preoperative clinic examination, including Pelvic Organ Prolapse Quantification. Cervix starting location and the resistance (stiffness) of its supports to being moved steadily in the direction of a traction force that increased from 0-18 N was measured intraoperatively using a computer-controlled servoactuator device. Women were divided into 3 groups for analysis according to their pelvic support as classified using the clinic Pelvic Organ Prolapse Quantification: (1) "normal/normal" was women with normal apical (C < -5 cm) and vaginal (Ba and Bp < 0 cm) support; (2) normal/prolapse had normal apical support (C < -5 cm) but prolapse of the anterior or posterior vaginal walls (Ba and/or Bp ≥ 0 cm); and (3) prolapse/prolapse had both apical and vaginal wall prolapse (C > -5 cm and Ba and/or Bp ≥ 0 cm). Demographics, intraoperative cervix locations, and apical support stiffness values were then compared. Normal range of cervix location during clinic examination and operative testing was defined by the total range of values observed in the normal/normal group. The proportion of women in each group with cervix locations within and outside the normal range was determined. Linear regression was performed to identify variables independently associated with clinic Pelvic Organ Prolapse Quantification point C. RESULTS: In all, 52 women were included: 14 in the normal/normal group, 11 in the normal/prolapse group, and 27 in the prolapse/prolapse group. At 1 N of traction force in the operating room, 50% of women in the normal/prolapse group had cervix locations outside the normal range while 10% had apical support stiffness outside the normal range. Of women in the prolapse/prolapse group, 81% had cervix locations outside the normal range and 8% had apical support stiffness outside the normal range. Similar results for cervix locations were observed at 18 N of traction force; however the proportion of women with apical support stiffness outside the normal range increased to 50% in the normal/prolapse group and 59% in the prolapse/prolapse group. The prolapse/prolapse group had statistically lower apical support stiffness compared to the normal/normal group with increased traction from 1-18 N (0.47 ± 0.18 N/mm vs 0.63 ± 0.20 N/mm, P = .006), but all other comparisons were nonsignificant. After controlling for age, parity, body mass index, and apical support stiffness, cervix location at 1 N traction force remained an independent predictor of clinic Pelvic Organ Prolapse Quantification point C, but only in the prolapse/prolapse group. CONCLUSION: Approximately 50% of women with cystocele and/or rectocele but normal apical support in the clinic had cervix locations outside the normal range under intraoperative traction, while 19% of women with uterine prolapse had normal apical support. Identifying women whose apical support falls outside a defined normal range may be a more accurate way to identify those who truly need a hysterectomy and/or an apical support procedure and to spare those who do not.

Utilization of apical vaginal support procedures at time of inpatient hysterectomy performed for benign conditions: a national estimate.

BACKGROUND: Apical vaginal support is considered the keystone of pelvic organ support. Level I evidence supports reestablishment of apical support at time of hysterectomy, regardless of whether the hysterectomy is performed for prolapse. National rates of apical support procedure performance at time of inpatient hysterectomy have not been well described. OBJECTIVE: We sought to estimate trends and factors associated with use of apical support procedures at time of inpatient hysterectomy for benign indications in a large national database. STUDY DESIGN: The National (Nationwide) Inpatient Sample was used to identify hysterectomies performed from 2004 through 2013 for benign indications. International Classification of Diseases, Ninth Revision, Clinical Modification codes were used to select both procedures and diagnoses. The primary outcome was performance of an apical support procedure at time of hysterectomy. Descriptive and multivariable analyses were performed. RESULTS: There were 3,509,230 inpatient hysterectomies performed for benign disease from 2004 through 2013. In both nonprolapse and prolapse groups, there was a significant decrease in total number of annual hysterectomies performed over the study period (P < .0001). There were 2,790,652 (79.5%) hysterectomies performed without a diagnosis of prolapse, and an apical support procedure was performed in only 85,879 (3.1%). There was a significant decrease in the proportion of hysterectomies with concurrent apical support procedure (high of 4.0% in 2004 to 2.5% in 2013, P < .0001). In the multivariable logistic regression model, increasing age, hospital type (urban teaching), hospital bed size (large and medium), and hysterectomy type (vaginal and laparoscopically assisted vaginal) were associated with performance of an apical support procedure. During the study period, 718,578 (20.5%) inpatient hysterectomies were performed for prolapse diagnoses and 266,743 (37.1%) included an apical support procedure. There was a significant increase in the proportion of hysterectomies with concurrent apical support procedure (low of 31.3% in 2005 to 49.3% in 2013, P < .0001). In the multivariable logistic regression model, increasing age, hospital type (urban teaching), hospital bed size (medium and large), and hysterectomy type (total laparoscopic and laparoscopic supracervical) were associated with performance of an apical support procedure. CONCLUSION: This national database study demonstrates that apical support procedures are not routinely performed at time of inpatient hysterectomy regardless of presence of prolapse diagnosis. Educational efforts are needed to increase awareness of the importance of reestablishing apical vaginal support at time of hysterectomy regardless of indication.

Ligament shortening compared to vaginal colpopexy at the time of hysterectomy for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The performance of a colpopexy at the time of hysterectomy for pelvic organ prolapse is a potential indicator of surgical quality. However, vaginal colpopexy has not been directly compared with the classic technique of ligament shortening and reattachment. We sought to test the null hypothesis that there is no difference in prolapse recurrence between the techniques. METHODS: We performed a retrospective chart review of 330 vaginal hysterectomies performed for prolapse, comparing symptomatic and/or anatomic recurrence rates between patients having a vaginal colpopexy (uterosacral ligament suspension or sacrospinous ligament suspension) and those having ligament shortening and reattachment. Clinically relevant variables significantly associated with recurrence in a univariate analysis were used to create a multivariable logistic regression model to predict recurrence. RESULTS: With a mean follow-up of 20 months, there was no significant difference between symptomatic and/or anatomic recurrence rates: 19.4 % of patients (41 of 211) having colpopexy vs. 11.8 % of patients (14 of 119) having ligament shortening (p = 0.07). Baseline prolapse stage was higher in patients having colpopexy (median 3, IQR 2 - 5) than in those having ligament shortening (median 2, IQR 1 - 3; p ≤ 0.0001). In the multivariable logistic regression analysis, the procedure performed was not associated with recurrence (OR 1.57, 95 % CI 0.79 - 3.12). A baseline prolapse of 4 cm or greater was associated with recurrence (OR 2.63, 95 % CI 1.32 - 5.22), as was the time since hysterectomy (OR 1.02 per month, 95 % CI 1.01 - 1.04). CONCLUSIONS: When compared with vaginal colpopexy, selective use of the ligament shortening technique at the time of vaginal hysterectomy was associated with similar rates of prolapse recurrence. Preoperative prolapse size was the factor most strongly associated with recurrence.

Genital hiatus size is associated with and predictive of apical vaginal support loss.

BACKGROUND: Recognition and assessment of apical vaginal support defects remains a significant challenge in the evaluation and management of prolapse. There are several reasons that this is likely: (1) Although the Pelvic Organ Prolapse-Quantification examination is the standard prolapse staging system used in the Female Pelvic Medicine and Reconstructive Surgery field for reporting outcomes, this assessment is not used commonly in clinical care outside the subspecialty; (2) no clinically useful and accepted definition of apical support loss exists, and (3) no consensus or guidelines address the degree of apical support loss at which an apical support procedure should be performed routinely. OBJECTIVE: The purpose of this study was to identify a simple screening measure for significant loss of apical vaginal support. STUDY DESIGN: This was an analysis of women with Pelvic Organ Prolapse-Quantification stage 0-IV prolapse. Women with total vaginal length of ≥7 cm were included to define a population with "normal" vaginal length. Univariable and linear regression analyses were used to identify Pelvic Organ Prolapse-Quantification points that were associated with 3 definitions of apical support loss: the International Consultation on Incontinence, the Pelvic Floor Disorders Network revised eCARE, and a Pelvic Organ Prolapse-Quantification point C cut-point developed by Dietz et al. Linear and logistic regression models were created to assess predictors of overall apical support loss according to these definitions. Receiver operator characteristic curves were generated to determine test characteristics of the predictor variables and the areas under the curves were calculated. RESULTS: Of 469 women, 453 women met the inclusion criterion. The median Pelvic Organ Prolapse-Quantification stage was III, and the median leading edge of prolapse was +2 cm (range, -3 to 12 cm). By stage of prolapse (0-IV), mean genital hiatus size (genital hiatus; mid urethra to posterior fourchette) increased: 2.0 ± 0.5, 3.0 ± 0.5, 4.0 ± 1.0, 5.0 ± 1.0, and 6.5 ± 1.5 cm, respectively (P < .01). Pelvic Organ Prolapse-Quantification points B anterior, B posterior, and genital hiatus had moderate-to-strong associations with overall apical support loss and all definitions of apical support loss. Linear regression models that predict overall apical support loss and logistic regression models predict apical support loss as defined by International Continence Society, eCARE, and the point C; cut-point definitions were fit with points B anterior, B posterior, and genital hiatus; these 3 points explained more than one-half of the model variance. Receiver operator characteristic analysis for all definitions of apical support loss found that genital hiatus >3.75 cm was highly predictive of apical support loss (area under the curve, >0.8 in all models). CONCLUSIONS: Increasing genital hiatus size is associated highly with and predictive of apical vaginal support loss. Specifically, the Pelvic Organ Prolapse-Quantification measurement genital hiatus of ≥3.75 cm is highly predictive of apical support loss by all study definitions. This simple measurement can be used to screen for apical support loss and the need for further evaluation of apical vaginal support before planning a hysterectomy or prolapse surgery.

Traction force needed to reproduce physiologically observed uterine movement: technique development, feasibility assessment, and preliminary findings.

INTRODUCTION AND HYPOTHESIS: This study aimed to describe a novel strategy to determine the traction forces needed to reproduce physiologic uterine displacement in women with and without prolapse. METHODS: Participants underwent dynamic stress magnetic resonance imaging (MRI) testing as part of a study examining apical uterine support. Physiologic uterine displacement was determined by analyzing uterine location in images taken at rest and at maximal Valsalva. Force-displacement curves were calculated based on intraoperative cervical traction testing. The intraoperative force required to achieve the uterine displacement measured during MRI was then estimated from these curves. Women were categorized into three groups based on pelvic organ support: group 1 (normal apical and vaginal support), group 2 (normal apical support but vaginal prolapse present), and group 3 (apical prolapse). RESULTS: Data from 19 women were analyzed: five in group 1, five in group 2, and nine in group 3. Groups were similar in terms of age, body mass index (BMI), and parity. Median operating room (OR) force required for uterine displacement measured during MRI was 0.8 N [interquartile range (IQR) 0.62-3.22], and apical ligament stiffness determined using MRI uterine displacement was 0.04 N/mm (IQR 0.02-0.08); differences between groups were nonsignificant. Uterine locations determined at rest and during maximal traction were lower in the OR compared with MRI in all groups. CONCLUSIONS: Using this investigative strategy, we determined that only 0.8 N of traction force in the OR was required to achieve maximal physiologic uterine displacement seen during dynamic (maximal Valsalva) MRI testing, regardless of the presence or absence of prolapse.

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.

INTRODUCTION: Transvaginal 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 of anterior and posterior vaginal wall prolapse in women undergoing transvaginal apical suspension remains unclear. The objective of this trial is to compare surgical outcomes of pelvic organ prolapse quantification (POPQ)-based surgery with outcomes of simulated apical support-based surgery for anterior or posterior vaginal wall prolapse at the time of transvaginal apical suspension. METHODS AND ANALYSIS: This is a randomised, multicentre, non-inferiority trial. While women who are assigned to the POPQ-based surgery group will undergo anterior or posterior colporrhaphy for all stage 2 or greater anterior or posterior vaginal prolapse, those assigned to simulated apical support-based surgery will receive anterior or posterior colporrhaphy only for the prolapse unresolved under simulated apical support. The primary outcome measure is the composite surgical success, defined as the absence of anatomical (anterior or posterior vaginal descent beyond the hymen or descent of the vaginal apex beyond the half-way point of vagina) or symptomatic (the presence of vaginal bulge symptoms) recurrence or retreatment for prolapse by either surgery or pessary, at 2 years after surgery. Secondary outcomes include the rates of anterior or posterior colporrhaphy, the changes in anatomical outcomes, condition-specific quality of life and sexual function, perioperative outcomes and adverse events. ETHICS AND DISSEMINATION: This study was approved by the institutional review board of each participating centre (Seoul National University College of Medicine/Seoul National University Hospital, Chonnam National University Hospital, Seoul St. Mary's Hospital, International St. Mary's Hospital). The results of the study will be published in peer-reviewed journals, and the findings will be presented at scientific meetings. TRIAL REGISTRATION NUMBER: NCT03187054.

Safety and efficacy of spider anchoring device for apical repair in laparoscopic sacrocolpopexy: Retrospective cohort study.

OBJECTIVE: The aim of the study was to assess safety and efficacy of apical support when using the soft-tissue metal fasteners of EndoFast Reliant™ SCP during laparoscopic sacrocolpopexy (LSCP). STUDY DESIGN: This is a single-center, retrospective cohort study including all patients which underwent LSCP between 2015 and 2017. Safety outcome included the procedure and the device related complications. Effectiveness outcomes included the anatomical success of apical repair and the functional results as were obtained from the clinic and from a Quality of life questionnaire (PFDI-20). RESULTS: Eighty-four patients, 54% with grade III and IV prolapse were included in the study. Uterus was preserved in 68% of patients with uterus. Mean follow-up period for the clinic visit was 4.5 ± 4 months. Short term anatomical success was achieved for 98.8% of the patients. Marked improvement was observed in the related symptoms including urinary incontinence. Three intra-operative complications occurred: 1 case of bladder injury, 1 case of intra-abdominal bleeding, and 1 case of post-operative vaginal bleeding. Later complications included only two patients (2.3%) complained of chronic abdominal pain. There were no cases of mesh erosion or de-novo dyspareunia. The mean follow-up period for the PFDI-20 questionnaire was 15.6 months. 75% of patients had no bulge symptoms at all. Quarter of the patients had some bulge symptoms, bothers them between somewhat to moderately according to the questionnaire grading. CONCLUSIONS: The use of Endofast SCP fasteners for laparoscopic promonto-fixation is a safe and effective surgery. Longer follow-up and larger studies should be performed to establish the results.

Long-term functional outcomes following mesh-augmented posterior vaginal prolapse repair.

OBJECTIVE: To assess long-term patient-centered functional outcomes following posterior vaginal wall repair using mesh implants. METHOD: The present prospective telephone interview study enrolled a cohort of women who had undergone posterior vaginal wall repair with mesh between January 1, 2006 and February 28, 2009, at a single center in Israel. Patients were asked to report long-term outcomes, and demographic, clinical, intraoperative, and postoperative follow-up data were retrieved from patients' medical files. Multivariable logistic regression models were used to asses associations between baseline characteristics and long-term outcomes. RESULTS: In total, 102 patients were contacted, with 80 (78.4%) at 61-83months after surgery agreeing to participate. A recurrence of prolapse symptoms was reported by 14 patients (18%) (12 required a corrective procedure), mesh had been removed from two patients owing to erosion/extrusion, and two others had undergone removal of granulation tissue. Long-term, bothersome symptoms were reported by 13 (16%) patients. Parity and previous hysterectomy were associated with lower odds of long-term adverse outcomes, and the location of the apical (C/D) pelvic organ prolapse quantification point and a change in its position following surgery were associated with increased odds of adverse outcomes. CONCLUSION: The long-term adverse-outcome rate was low for patients who underwent posterior vaginal mesh augmentation. These results highlight the importance of apical support for good long-term functional outcomes.