Pelvic Organ Prolapse Procedures Research Articles

Mid-term outcomes of laparoscopic vaginal stump?round (Kakinuma method) and stump?uterosacral (Shull method) ligament fixation for pelvic organ prolapse: a retrospective comparative study

BackgroundLaparoscopic sacrocolpopexy (LSC) and robot-assisted sacrocolpopexy (RSC) using mesh are popular approaches for treating pelvic organ prolapse (POP). However, it is not uncommon that native tissue repair (NTR) should be presented as an option to patients who are expected to have extensive intraperitoneal adhesion or patients for whom LSC or RSC is difficult owing to various risk factors. Laparoscopic vaginal stump–uterosacral ligament fixation (Shull method) has been introduced as a method for NTR in case of POP. However, effective repair using this surgical procedure may not be possible in severe POPs. To solve the problems of the Shull method, we devised the laparoscopic vaginal stump–round ligament fixation (Kakinuma method) in which the vaginal stump is fixed to the uterine round ligament, a histologically strong tissue positioned anatomically higher than the uterosacral ligament. This study aimed to retrospectively and clinically compare the two methods.MethodsOf the 78 patients who underwent surgery for POP between January 2017 and June 2022 and postoperative follow-up for at least a year, 40 patients who underwent the Shull method (Shull group) and 38 who underwent the Kakinuma method (Kakinuma group) were retrospectively analyzed.ResultsNo significant differences were observed between the two groups in patient background variables such as mean age, parity, body mass index, and POP-Q stage. The mean operative duration and mean blood loss in the Shull group were 140.5 ± 31.7 min and 91.3 ± 96.3 ml, respectively, whereas the respective values in the Kakinuma group were 112.2 ± 25.3 min and 31.4 ± 47.7 ml, respectively. Thus, compared with the Shull group, the operative duration was significantly shorter (P < 0.001) and blood loss was significantly less (P = 0.003) in the Kakinuma group. Recurrence was observed in six patients (15.0%) in the Shull group and two patients (5.3%) in the Kakinuma group. Hence, compared with the Shull group, recurrence was significantly less in the Kakinuma group (P = 0.015). No patients experienced perioperative complications in either group.ConclusionsThe results suggest that the Kakinuma method can serve as a novel and viable NTR procedure for POP.

Assessment of socioeconomic and racial differences in patients undergoing concurrent gynecologic oncology and urogynecology surgeries: a National Inpatient Sample (NIS) database study

ObjectiveTo assess social determinants of health impacting patients undergoing gynecologic oncology versus combined gynecologic oncology and urogynecology surgeries.MethodsWe identified patients who underwent gynecologic oncology surgeries from 2016 to 2019 in...

Rapid Onset of De Novo Rectal Prolapse Following Colpocleisis.

The aim of this video case series is to demonstrate our experience of the clinical findings and the surgical management of the rapid onset de novo rectal prolapse (RP) following colpocleisis METHODS: This is a case series of three patients who developed de novo RP within 1 month after colpocleisis, which was repaired by laparoscopic ventral mesh rectopexy (LVMR). The video shows the physical, radiological, and intraoperative findings of these patients. A retrospective review of our surgical cases of RP was also performed to analyze the onset timing of de novo RP after various pelvic organ prolapse (POP) procedures. The pathological condition of all three patients' RP was evacuation enterocele, and LVMR was feasible without postoperative complications or recurrences. In the retrospective case review of 158 RP surgeries in our institution (June 2015 to September 2023), 18 cases (11.4%) occurred following POP surgery. De novo RP following colpocleisis developed significantly earlier than those following other procedures (average: 6.1 vs 66.4months, p = 0.010). Although de novo RP following colpocleisis is relatively rare, this complication could have a detrimental effect on patients' quality of life. Preoperative informed consent may be advisable before planning colpocleisis.

Clinician perspectives on hysterectomy versus uterine preservation in pelvic organ prolapse surgery: A systematic review and meta-analysis.

Previous reviews on hysterectomy versus uterine-sparing surgery in pelvic organ prolapse (POP) repair did not consider that the open abdominal approach or transvaginal mesh use have been largely abandoned. To provide up-to-date evidence by examining only studies investigating techniques currently in use for POP repair. MEDLINE and Embase databases were searched from inception to January 2023. We included randomized and non-randomized studies comparing surgical procedures for POP with or without concomitant hysterectomy. Studies describing open abdominal approaches or transvaginal mesh implantation were excluded. A random effect meta-analysis was conducted on extracted data reporting pooled mean differences and odds ratios (OR) between groups with 95% confidence intervals (CI). Thirty-eight studies were included. Hysterectomy and uterine-sparing procedures did not differ in reoperation rate (OR 0.93; 95% CI 0.74-1.17), intraoperative major (OR 1.34; 95% CI 0.79-2.26) and minor (OR 1.38; 95% CI 0.79-2.4) complications, postoperative major (OR 1.42; 95% CI 0.85-2.37) and minor (OR 1.18; 95% CI 0.9-1.53) complications, and objective (OR 1.38; 95% CI 0.92-2.07) or subjective (OR 1.23; 95% CI 0.8-1.88) success. Uterine preservation was associated with a shorter operative time (-22.7 min; 95% CI -16.92 to -28.51 min), shorter hospital stay (-0.35 days, 95% CI -0.04 to -0.65 days), and less blood loss (-61.7 mL; 95% CI -31.3 to -92.1 mL). When only studies using a laparoscopic approach for both arms were considered, no differences were observed in investigated outcomes between the two groups. No major differences were observed in POP outcomes between procedures with and without concomitant hysterectomy. The decision to preserve or remove the uterus should be tailored on individual factors.

Urinary Tract Infections After Urogynecologic Surgery: Risk Factors, Timeline, and Uropathogens

ABSTRACT Postoperative urinary tract infection (PO-UTI) is seen in 6.4%–32% of stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP) surgeries despite perioperative antibiotic prophylaxis. Postoperative complications associated with PO-UTI include increased mortality and longer hospitalization. Increasing prevalence of resistance to antibiotics and antibiotic stewardship principles necessitate both the improvement of infection prevention strategies and judicious antibiotic prescriptions. Four factors are known to increase PO-UTI risk: (1) recurrent UTI (RUTI) history, (2) preoperative UTI, (3) day-of-surgery UTI, and (4) prolonged postoperative catheterization. This study intended to determine (1) risk factors of PO-UTI and PO-RUTI, (2) preoperative and postoperative UTI temporal distribution, and (3) detected uropathogens in a large database. The study used medical record data of all SUI/POP surgical procedures performed in the Kaiser Southern California Hospital system from January 1, 2008 to December 31, 2016 for women 18 years of age or older. Procedures used Current Procedural Terminology codes for identifying and subcategorizing surgical procedures and their route (SUI or POP; abdominal or vaginal, respectively). The study-wide definition of UTI was as follows: (1) positive standard urine culture of greater than 105 CFU/mL of ≤2 uropathogens, or (2) prescription of urinary antibiotics prescribed for the indication of UTI symptoms. The analysis consisted of 21,063 urogynecologic surgical procedures performed on 20,051 women (33,626 POP and/or SUI procedures), with 22,641 UTI events being diagnosed in 10,091 women. Mean age was 56.9 years, and mean BMI was 29.1. The cohort underwent surgery for only SUI (35.4%), only POP (32.7%), or POP/SUI combined (31.9%). In the 13.5 months postoperatively, 11,976 UTIs were diagnosed in 6733 women. The first month experienced a sharp increase compared with the preoperative year, the second month increased further, and the third month showed leveling of PO-UTI incidence. Prescribed antibiotics captured most UTI events (13,337 or 58.3%). Prescribed antibiotics, in order of most-prescribed to least-prescribed, were as follows: ciprofloxacin (33.7%), cephalexin (21.4%), nitrofurantoin (20.4%), and sulfamethoxazole-trimethoprim (17.6%). The study determined that most PO-UTIs occurred within the first 2 months, with many of these being diagnosed within 2 weeks of surgery. For those patients already having a history of RUTI, RUTI significantly increases in postoperative year 1 when compared with the preoperative year. All patients undergoing SUI procedures had increased PO-RUTI risks compared with their POP-only group peers. Escherichia coli was the most common pathogen found. Risk and event timing were affected by surgical indication: although surgery for only SUI had a lower 6-week PO-UTI risk, it was counterintuitively associated with a higher PO-RUTI risk. Multivariate regression revealed predictable risk factors for PO-UTI: OAB, history of diabetes, history of preoperative UTI within 6 weeks of surgery, history of RUTI, stent and catheter placement. A more confusing finding was the association of a vaginal estrogen prescription with increased short-term PO-UTI risk, possibly related to its use in women with a history of RUTI, but more probably related to the postmenopausal status of many of the women in the dataset. The study recommends preoperative assessment with the purpose of identifying and eliminating UTIs within 6 weeks before surgery, as well as development of protocols for enhanced prophylaxis for women at increased risk such as diabetics and women with preoperative RUTI.

Evaluation and acceptability of patient-reported outcome measures in women following pelvic organ prolapse procedures

BackgroundThe Australasian Pelvic Floor Procedure Registry (APFPR) captures clinical and surgical data in women undergoing pelvic floor procedures. The inclusion of patient reported outcome measures (PROMs) in the APFPR is a critical activity providing the additional patient perspective of their condition prior to surgery as well as monitoring beyond the usual post-surgical follow-up time. This study aimed to evaluate the acceptability of seven PROMs for women with pelvic organ prolapse (POP) and to determine the most suitable instrument for the APFPR.MethodsSemi-structured qualitative interviews were conducted with women with POP (n = 15) and their treating clinicians (n = 11) in Victoria, Australia. Interview topics covered appropriateness, content, and acceptability of seven POP-specific instruments identified through the literature to determine their suitability and acceptability for inclusion in the APFPR. We analysed the interview data using conventional content analysis.ResultsAll study participants agreed that PROMs were needed for the APFPR. Both women and clinicians suggested that some of the instruments were ambiguous, too long and confusing. The Australian Pelvic Floor Questionnaire was accepted widely amongst women and clinicians and recommended for inclusion in the APFPR. All participants agreed it would be appropriate to capture PROMs before surgery, and then followed up post-surgically. Email, phone call or postal mail-out were the preferred options for PROMs data collection.ConclusionMost women and clinicians supported incorporating PROMs in the APFPR. Study participants believed that capturing PROMs would have potential use in individual care and improve outcomes of women with POP.

MP48-07 NATIONAL TRENDS OF COMMON FEMALE PELVIC MEDICINE AND RECONSTRUCTIVE SURGERY PROCEDURES: 2016-2019

You have accessJournal of UrologyCME1 Apr 2023MP48-07 NATIONAL TRENDS OF COMMON FEMALE PELVIC MEDICINE AND RECONSTRUCTIVE SURGERY PROCEDURES: 2016-2019 Connie Wang, Daniel Schoenfeld, Joseph Marte, and Gregory Joice Connie WangConnie Wang More articles by this author , Daniel SchoenfeldDaniel Schoenfeld More articles by this author , Joseph MarteJoseph Marte More articles by this author , and Gregory JoiceGregory Joice More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003294.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To evaluate national trends in settings and charges of common female pelvic medicine and reconstructive surgery (FPMRS) procedures. METHODS: Common FPMRS procedures were identified by Current Procedural Terminology and International Classification of Diseases (10th Revision) Procedure Coding System codes and classified into 3 categories: 1) stress urinary incontinence procedures (SUI-p) 2) pelvic organ prolapse procedures (POP-p) and 3) overactive bladder procedures (OAB-p). Data from inpatient (IP) and outpatient (OP) encounters for included procedures between 2016-2019 were extracted from the Nationwide Inpatient Sample and Nationwide Ambulatory Surgery Sample from the Healthcare Cost and Utilization Project. Stratified cluster sampling was used to create weighted, national estimates. Student t-tests and multivariable linear regression was performed to compare procedural factors. RESULTS: A total of 893,450 weighted procedures were analyzed, of which 9.3% were performed IP and 90.7% were performed OP. Over the study period, there was a 4.3% increase in total number of procedures, and the proportion performed OP increased from 88.1% to 92.5%. Between 2016-2019, there was a 10.6% and 10.5% increase in SUI-p and POP-p performed OP, respectively. Over the study period, proportion of SUI-p performed OP increased from 96.4% to 99.7%, and proportion of POP-p performed OP increased from 76.5% to 82.8%. 99.9% of OAB-p were performed OP. Charges for SUI-p performed IP were $16,705 higher than those performed OP (p=0.007) and charges for POP-p performed IP were $21,864 higher than those performed OP (p<0.0001). Predictors of SUI-p and POP-p being performed OP included private insurance, fewer co-morbidities, and receiving care at a rural facility or at a center in the Midwest or South. Additionally, SUI-p were more likely to be performed OP for patients < 52 years of age. POP-p were more likely to be performed IP than SUI-p (OR 20.8; 95% CI 20.2 - 21.5), while OAB-p were less likely to be performed IP than SUI-p (OR 0.01; 95% CI 0.01 – 0.02). CONCLUSIONS: An increasing majority of SUI and OAB procedures performed nationwide are performed in OP settings. These procedures performed OP carry less charge than those performed IP and are more likely for younger, healthier patients with private insurance. Source of Funding: N/A © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e657 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Connie Wang More articles by this author Daniel Schoenfeld More articles by this author Joseph Marte More articles by this author Gregory Joice More articles by this author Expand All Advertisement PDF downloadLoading ...

Colpocleisis in the surgical treatment of pelvic organ prolapse: clinical experience

Aim: The objective of this study was to present the clinical experience with colpocleisis by evaluating patient characteristics and long-term follow-up data. Materials and Methods: This is a retrospective cohort study evaluating patients who underwent obliterative surgery for pelvic organ prolapse (POP) between 2010 and 2017. Patients who underwent colpocleisis without hysterectomy (C) (n=68) and colpocleisis of vaginal vault (CVV) (n=22) were included in this study. Results: The mean age of the study population was 72.7 years (range 55-89). The majority of the patients underwent colpocleisis as their primary surgical procedure for POP, as only 5.6% of the study group had a history of previous prolapse surgery. The mean follow-up duration was 49.5 months (range 1.5-109). Patient satisfaction with the surgery was high, with 98.9% of patients expressing they were “very satisfied” and 1.1% “satisfied”. There were two cases of recurrence (2.2%), and both were in the C group. One patient (1.1%) reported regret after surgery due to her husband's remorse about choosing an obliterative procedure. The recurrence rates, patient satisfaction, and regret were comparable between C and CVV groups. Conclusion: Colpocleisis is a viable option for the surgical treatment of POP, offering a high rate of success and patient satisfaction in long-term. Despite being an obliterative procedure, colpocleisis has acceptance as the primary surgical procedure by patients regardless of their marital status, and regret rate after surgery is low. Therefore, colpocleisis should be thoroughly discussed and included in the preoperative counseling and surgical planning of all patients with POP.

General anesthesia versus regional anesthesia in patients undergoing obliterative vaginal procedures for pelvic organ prolapse.

The objective was to compare outcomes in patients receiving general versus regional anesthesia when undergoing obliterative vaginal surgery for pelvic organ prolapse. Obliterative vaginal procedures performed from 2010 to 2020 were identified in the American College of Surgeons National Surgical Quality Improvement Program database using Current Procedural Terminology codes. Surgeries were categorized into general anesthesia (GA) or regional anesthesia (RA). Rates of reoperation, readmission, operative time, and length of stay were determined. A composite adverse outcome was calculated including any of the following: nonserious or serious adverse events, 30-day readmission, or reoperation. Propensity score-weighted analysis of perioperative outcomes was performed. The cohort included 6,951 patients, of whom 6,537 (94%) underwent obliterative vaginal surgery under GA and 414 (6%) received RA. When comparing outcomes under the propensity score-weighted analysis, operative times were shorter (median 96 vs 104 min, p<0.01) in the RA group versus GA. There were no significant differences between composite adverse outcomes (10% vs 12%, p=0.06), or readmission (5% vs 5%, p=0.83) and reoperation rates (1% vs 2%, p=0.12) between the RA and GA groups. Length of stay was shorter in patients receiving GA than in those receiving RA, especially when undergoing concomitant hysterectomy (67% discharged within 1 day in GA vs 45% in RA, p<0.01). Composite adverse outcomes, reoperation rates, and readmission rates were similar in patients who received RA for obliterative vaginal procedures compared with GA. Operative times were shorter in patients receiving RA than in those receiving GA, and length of stay was shorter in patients receiving GA than in those receiving RA.

Differences in Surgical Practice Patterns of Vaginal Native Tissue Repair for Pelvic Organ Prolapse Between Urologists and Gynecologists.

Surgeon specialty training may influence the combination of transvaginal procedures for pelvic organ prolapse (POP) repair. Isolated transvaginal anterior compartment repair (AR) without concurrent apical suspension (ApS) is a known risk factor for POP recurrence. Our primary aim was to compare the prevalence of isolated AR between urologists versus gynecologists. Our secondary aim was to compare associated postoperative complications. We queried the American College of Surgeons National Surgical Quality Improvement Program for vaginal POP repair procedures (Current Procedural Terminology codes 57240, 57260, 57265, 57268, 57282, 57283) over a 5-year period by designated surgical specialty. We analyzed the relationships between specialty, vaginal repair type, operative details, and 30-day postoperative complications. Between January 2015 and December 2019, we included 16,093 women who underwent transvaginal POP repair, 90% performed by gynecologists and 10% by urologists. Urologists were more likely to perform an isolated AR without concurrent ApS (56% vs 47%, P < 0.0001). Gynecologists performed more isolated ApS (11% vs 9%) and combined AR with ApS (43% vs 35%, P < 0.0001). Overall, concurrent urethral sling placement was performed in 27% of cases, regardless of POP repair type, with no difference between specialties (P > 0.05). There were no differences in 30-day reoperations, readmissions, surgical site infections, urinary tract infections, or hospital stay lengths between specialties (P > 0.05). Urologists perform a minority of vaginal POP repairs and were more likely to perform isolated AR than gynecologists. The absence of concurrent ApS may increase the likelihood of prolapse recurrence. Immediate complication rates for each procedure did not differ.

Stress Urinary Incontinence After Operations for Uterine Prolapse: A Nationwide Cohort Study.

Concomitant surgery for stress urinary incontinence (SUI) during pelvic organ prolapse (POP) operations are debated. We aimed to assess the risk of an SUI operation after a uterine prolapse operation and compare the risk after the Manchester procedure versus vaginal hysterectomy. We performed a nationwide historical cohort study including women with no history of hysterectomy undergoing the Manchester procedure (n = 6065) or vaginal hysterectomy (n = 9,767) for POP during 1998 to 2018. We excluded women with previous surgery for SUI and POP, concomitant surgery for SUI (n = 34, 0.2%), and diagnosed with gynecological cancer before or within 90 days from surgery. Women were followed up until SUI operation/death/emigration/diagnosis of gynecological cancer/December 31, 2018, whichever came first. Women undergoing the Manchester procedure were censored if they had undergone hysterectomy.We assessed the rate of SUI surgery with cumulative incidence plots. We performed Cox Regression to analyze the risk of SUI surgery, adjusting for age, calendar year, income level, concomitant surgery in anterior and posterior compartments, and diagnosis of SUI before POP operation. We found that 12.4% women with and 1.6% without SUI diagnosed before the POP surgery who underwent SUI surgery within 10 years.During follow-up (median, 8.5 years), 129 (2.1%) underwent SUI surgery after the Manchester procedure and 175 (1.8%) after vaginal hysterectomy (adjusted hazard ratio, 1.06 [0.84-1.35]). Of women diagnosed with SUI before POP operation 1 in 8 subsequently underwent SUI surgery. Few women not diagnosed with SUI subsequently underwent SUI surgery. There was no difference in risk of SUI after the Manchester procedure and vaginal hysterectomy.

Australian trends in the treatment of pelvic organ prolapse in the non-mesh era.

To assess the contemporary trends in the types and incidence of pelvic organ prolapse (POP) surgery in Australia after the removal of transvaginal mesh from the Australian market. This was a retrospective Australian cohort study utilizing three large Governmental databases covering all private and public POP procedures in Australia. All females ≥25 years old undergoing POP procedures between 2005 and 2021 were included. From 2005-2006 to 2020-2021 there have been a total of 408 881 POP procedures in Australia. The total number of procedures peaked in 2005-2006 at 537.8 procedures per 100 000 age-standardized female population, decreasing by an average of 3.5% per year to 329.0 procedures per 100 000 in 2018-2019, an overall 38.8% decrease (P< 0.001). A sudden growth in private operative procedures was noted between 2019-2020 and 2020-2021, from 218.2 to 268.6 procedures per 100 000 population, a 23.1% increase (P< 0.001). Laparoscopic and abdominal POP repair has seen a 115.8% increase from 13.7 procedures to 29.6 per 100 000 between 2005-2006 and 2020-2021. Over the last 15 years, the most common age group to undergo a procedure has changed from the 55 to 64 years demographic to a later decade of 65 to 74 years. Over the last 15 years, the total number of POP procedures performed has significantly decreased. There has however been a recent rise in interventions seen in the private sector and the utilization of laparoscopic or abdominal POP repair has increased, which has implications for procedural credentialing to ensure patient safety.

Comparison of first versus second line sacrocolpopexies in terms of morbidity and mid-term efficacy

To compare pelvic organ prolapse (POP) recurrence and morbidity between first and second line sacrocolpopexies. We conducted a retrospective chart review of all laparoscopic or robotic sacrocolpopexies for POP-Q stage ≥ 2, with or without a history of previous prolapse repair, performed with a similar technique between January 2012 and June 2019 in 3 European Gynecologic Surgery Departments. Patients were separated into two groups: first line sacrocolpopexy (FLS) and second line sacrocolpopexy (SLS). Each patient from the SLS group was age-matched with a patient from the FLS group. The primary outcome measure was reoperation procedures for recurrent POP defined as a symptomatic POP-Q stage ≥ 2 POP in at least one vaginal compartment. Secondary outcomes included operative time, intraoperative organ trauma, intraoperative blood loss, postoperative POP recurrence (operated on or not), global reoperation and mesh-related complications. During this period, 332 patients were included. After age-matching, 170 patients were analyzed: 85 patients in the FLS and SLS groups, respectively. After a mean follow-up of 3 years, there was no statistically significant difference between the two groups in terms of recurrent POP (9.4% versus 10.6%, p = 0.7), recurrent POP reoperation (3.5% versus 5.9% p = 0.7), mesh-related reoperation (0% versus 2.4%, p = 0.5), global reoperation (3.5 versus 8.2%, p = 0.3), operative time (198 ± 67 min versus 193 ± 60 min, p = 0.5), intraoperative complications such as organ injury (4.7% versus 7.1%, p = 0.7) and blood loss > 500 mL (2.4% versus 0%, p = 0.5). Patients who underwent a first or a second line sacrocolpopexy seemed to have similar rates of prolapse recurrence and complications.

Effectiveness of Self-cut vs Mesh-Kit Titanium-Coated Polypropylene Mesh for Transvaginal Treatment of Severe Pelvic Organ Prolapse

Transvaginal mesh (TVM) can increase the durability of vaginal surgical procedures for pelvic organ prolapse (POP) and may be indicated in certain situations despite concerns about mesh-related complications. In addition, the expense of commercial mesh kits has limited their use. The effectiveness, safety, and cost of a self-cut mesh procedure compared with a commercial mesh-kit procedure for the surgical treatment of women with POP is unclear. To assess the 1-year effectiveness and safety of self-cut titanium-coated polypropylene mesh compared with a precut commercial mesh kit for the transvaginal surgical treatment of women with severe symptomatic POP. This multicenter randomized noninferiority clinical trial was conducted at 11 hospitals in 8 provinces of China. A total of 336 women with symptomatic stage 3 to 4 POP were enrolled between January 22, 2018, and November 11, 2019, with follow-up through December 11, 2020. Participants were randomized to receive a TVM procedure using either self-cut mesh (self-cut mesh group) or a precut commercial mesh kit (mesh-kit group), both of which used the same titanium-coated polypropylene mesh. The primary outcome measure was composite surgical success at 1 year, which was defined as the absence of vaginal bulge symptoms, no additional retreatment for POP, and no vaginal prolapse at or beyond the hymen. Secondary outcomes included symptom-specific pelvic floor function and quality-of-life measures as well as perioperative complications, including mesh-related complications and hospitalization costs. Complications were categorized using the Clavien-Dindo system (with grade 1 indicating any deviation from the normal postoperative course but not requiring grade 2-4 interventions; grade 2, need for pharmacological treatment, blood transfusion, and/or total parenteral nutrition; grade 3, the need for surgical, endoscopic, and/or interventional radiological procedures; and grade 4, life threatening). Among 336 female participants (mean [SD] age, 63.3 [5.9] years; all of Chinese ethnicity), 169 patients were randomized to the self-cut mesh group, and 167 were randomized to the mesh-kit group. Three patients were unavailable for follow-up after 1 year. In the intention-to-treat analysis, 162 women (95.9%) in the self-cut mesh group had outcomes that met the definition of surgical success; this result was noninferior to the surgical success rate observed in the mesh-kit group (146 women [87.4%]; risk difference, 8.5%; 95% CI, 2.2%-14.3%; P = .006). The frequency of Clavien-Dindo grade 1 to 3 perioperative complications was not significant between groups (12 of 166 women [7.2%] in the self-cut mesh group vs 20 of 161 women [12.4%] in the mesh-kit group; P = .14). Vaginal mesh exposure rates in women examined at 1 year were similar (4 women [2.4%] in the self-cut mesh group vs 8 women [4.8%] in the mesh-kit group; P = .23). Median (IQR) total hospitalization costs were $3663.00 ($3258.90-$4495.10) in the self-cut mesh group vs $6144.00 ($5434.90-$7160.20) in the mesh-kit group (P < .01), representing savings of $2481.00 (40.4%) with the use of self-cut mesh. In this clinical trial, the composite surgical success rate of a self-cut mesh procedure was noninferior to that of a commercial mesh-kit procedure using the same titanium-coated polypropylene mesh and reduced hospitalization expenses by 40.4%. These findings suggest that the use of self-cut mesh procedures may be advantageous for the surgical treatment of some women with severe POP, particularly those in countries with low and middle income. ClinicalTrials.gov identifier: NCT03283124.

Incidence and Risk Factors for Genitourinary Tract Injury Within 1 Year After Surgery for Pelvic Organ Prolapse.

The rate of genitourinary tract injury (GUTI) following pelvic organ prolapse (POP) surgery is presently ill-defined and based on relatively small trials with short follow-up time. Given the potential for higher risk of injury with POP, a better understanding of this type of injury is important for patient counseling. The objective of this study was to identify the incidence and risk factors of GUTI related to POP surgery. Women undergoing POP surgery between 2010 and 2019 were identified using Current Procedural Terminology codes in the Premier Healthcare Database. The primary outcome was GUTI, defined as bladder or ureteral injury, and vesicovaginal or ureterovaginal fistula within 1 year of surgery. Genitourinary tract injury was identified using International Classification of Diseases and Current Procedural Terminology codes. Patients were divided into those with and without GUTI. Differences between groups were evaluated using the Student t test, Wilcoxon rank-sum test, and Fisher exact test as appropriate. Multivariable logistic regression was used to evaluate the independent predictors of GUTI. One hundred thirty-nine thousand one hundred fifty-eight surgical procedures for POP were captured between 2010 and 2019. The rate of GUTI was 1.10%: 0.48% bladder, 0.64% ureteral injuries, and 0.01% fistulas. The most significant variables associated with any GUTI were as follows: adhesiolysis (adjusted odds ratio [aOR], 2.64; 95% confidence interval [CI], 1.07-6.51), blood transfusion (aOR, 3.67; 95% CI, 1.34-10.04), and low-volume surgeons (<12 cases per year) (aOR, 1.68; 95% CI, 1.60-1.77), nonurologic or gynecologic surgeon specialty (aOR, 1.62; 95% CI, 1.49-2.00), and uterosacral suspension (aOR, 1.30; 95% CI, 1.13-1.49). The rate of GUTI following POP surgery is lower than has previously been reported. Surgeon experience and specialty and surgical approach may affect GUTI incidence.

AUGS-PERFORM: A New Patient-Reported Outcome Measure to Assess Quality of Prolapse Care.

ObjectivePatient-reported outcomes (PRO) are important for measuring quality of care, particularly for interventions aimed at improving symptom bother such as procedures for pelvic organ prolapse. We aimed to create a concise yet comprehensive PRO measurement tool to assess pelvic organ prolapse care in high-volume clinical environments.MethodsThe relevant concepts to measure prolapse treatment quality were first established through literature review, qualitative interviews, and a patient and provider-driven consensus-building process. Extant items mapping to these concepts, or domains, were identified from an existing pool of patient-reported symptoms and condition-specific and generic health-related quality of life measures. Item classification was performed to group items assessing similar concepts while eliminating items that were redundant, inconsistent with domains, or overly complex. A consensus meeting was held in March 2020 where patient and provider working groups ranked the remaining candidate items in order of relevance to measure prolapse treatment quality. After subsequent expert review, the revised candidate items underwent cognitive interview testing and were further refined.ResultsFifteen relevant PRO instruments were initially identified, and 358 items were considered for inclusion. After 2 iterative consensus reviews and 4 rounds of cognitive interviewing with 19 patients, 11 final candidate items were identified. These items map 5 consensus-based domains that include awareness and bother from prolapse, physical function, physical discomfort during sexual activity, pain, and urinary/defecatory symptoms.ConclusionsWe present a concise set of candidate items that were developed using rigorous patient-centered methodology and a national consensus process, including urogynecologic patients and providers.

Postoperative complications and pelvic organ prolapse recurrence following combined pelvic organ prolapse and rectal prolapse surgery compared with pelvic organ prolapse only surgery

There is a growing interest in combined pelvic organ prolapse and rectal prolapse surgery for concomitant pelvic floor prolapse despite a paucity of data regarding complications and clinical outcomes of combined repair. The primary objective of this study was to compare the <30-day postoperative complication rate in women undergoing combined POP+RP surgery with that of women undergoing pelvic organ prolapse-only surgery. The secondary objectives were to describe the <30-day postoperative complications, compare the pelvic organ prolapse recurrence between the 2 groups, and determine the preoperative predictors of <30-day postoperative complications and predictors of pelvic organ prolapse recurrence. This was a multicenter, retrospective cohort study at 5 academic hospitals. Patients undergoing combined pelvic organ prolapse and rectal prolapse surgery were matched by age, pelvic organ prolapse stage by leading compartment, and pelvic organ prolapse procedure compared with those undergoing pelvic organ prolapse-only surgery from March 2003 to March 2020. The primary outcome measure was <30-day complications separated into Clavien-Dindo classes. The secondary outcome measures were (1) subsequent pelvic organ prolapse surgeries and (2) pelvic organ prolapse recurrence, defined as patients who complained of vaginal bulge symptoms postoperatively. Overall, 204 women underwent combined surgery for pelvic organ prolapse and rectal prolapse, and 204 women underwent surgery for pelvic organ prolapse only. The average age (59.3±1.0 vs 59.0±1.0) and mean parity (2.3±1.5 vs 2.6±1.8) were similar in each group. Of note, 109 (26.7%) patients had at least one <30-day postoperative complication. The proportion of patients who had a complication in the combined surgery group and pelvic organ prolapse-only surgery group was similar (27.5% vs 26.0%; P=.82). The Clavien-Dindo scores were similar between the groups (grade I, 10.3% vs 9.3%; grade II, 11.8% vs 12.3%; grade III, 3.9% vs 4.4%; grade IV, 1.0% vs 0%; grade V, 0.5% vs 0%). Patients undergoing combined surgery were less likely to develop postoperative urinary tract infections and urinary retention but were more likely to be treated for wound infections and pelvic abscesses than patients undergoing pelvic organ prolapse-only surgery. After adjusting for combined surgery vs pelvic organ prolapse-only surgery and parity, patients who had anti-incontinence procedures (adjusted odds ratio, 1.85; 95% confidence interval, 1.16-2.94; P=.02) and perineorrhaphies (adjusted odds ratio, 1.68; 95% confidence interval, 1.05-2.70; P=.02) were more likely to have <30-day postoperative complications. Of note, 12 patients in the combined surgery group and 15 patients in the pelvic organ prolapse-only surgery group had subsequent pelvic organ prolapse repairs (5.9% vs 7.4%; P=.26). In the combined surgery group, 10 patients (4.9%) underwent 1 repair, and 2 patients (1.0%) underwent 2 repairs. All patients who had recurrent pelvic organ prolapse surgery in the pelvic organ prolapse-only surgery group had 1 subsequent pelvic organ prolapse repair. Of note, 21 patients in the combined surgery group and 28 patients in the pelvic organ prolapse-only surgery group reported recurrent pelvic organ prolapse (10.3% vs 13.7%; P=.26). On multivariable analysis adjusted for number of previous pelvic organ prolapse repairs, combined surgery vs pelvic organ prolapse-only surgery, and perineorrhaphy at the time of surgery, patients were more likely to have a subsequent pelvic organ prolapse surgery if they had had ≥2 previous pelvic organ prolapse repairs (adjusted odds ratio, 6.06; 95% confidence interval, 2.10-17.5; P=.01). The average follow-up times were 307.2±31.5 days for the combined surgery cohort and 487.7±49.9 days for the pelvic organ prolapse-only surgery cohort. Survival curves indicated that the median time to recurrence was not statistically significant (log-rank, P=.265) between the combined surgery group (4.2±0.4 years) and the pelvic organ prolapse-only surgery group (5.6±0.4 years). In this retrospective cohort study, patients undergoing combined pelvic organ prolapse and rectal prolapse surgery had a similar risk of <30-day postoperative complications compared with patients undergoing pelvic organ prolapse-only surgery. Furthermore, patients who underwent combined surgery had a similar risk of recurrent pelvic organ prolapse and subsequent pelvic organ prolapse surgery compared with patients who underwent pelvic organ prolapse-only surgery.

Trends in Performance of Anti-Incontinence Treatment at the Time of Pelvic Organ Prolapse Repair From 2011 to 2019.

There are no publications on national trends in performance of concomitant stress urinary incontinence (SUI) treatment with pelvic organ prolapse surgery over the past decade. The objective of this study was to describe trends in the performance and type of concomitant SUI treatment from 2011 to 2019. Surgical procedures for pelvic organ prolapse and coding for prolapse repair were identified from the American College of Surgeons National Surgical Quality Improvement Program database. An autoregressive interrupted time series model estimated temporal trends in concomitant SUI treatment associated with 3 consequential events: U.S. Food and Drug Administration's (FDA) requirement for postmarketing studies from mesh manufacturers (January 2012), publication of the Outcomes following Vaginal Prolapse Repair and Midurethral Sling (OPUS) trial (June 2012), and the FDA's reclassification of vaginal mesh as a high-risk device (January 2016). There were 43,370 cases identified. The rate of concomitant SUI treatment decreased from 46.1% to 35.7% across the analysis period. No significant trend before postmarketing studies (-0.2%; 95% confidence interval [CI], -0.8 to 1.1) was observed. After postmarketing studies, there was a downward deflection of -2.0% per quarter (95% CI, -3.6 to -0.4). After OPUS, we observed a flattening of the trend to -0.2% (95% CI, -0.8 to 0.4) that persisted after FDA reclassification. Sling procedures remained predominant (96.2% of SUI procedures) and performance of urethropexy decreased across the analysis period (-0.1%; 95% CI, -0.08 to -0.2). After the FDA's order for postmarketing studies, rates of concomitant SUI treatment significantly decreased. Rates stabilized after the OPUS trial at around 35% and did not subsequently change. Rates of nonmesh concomitant SUI treatment decreased during the analysis period.

Function, quality-of-life and complications after sacrospinous ligament fixation using an antegrade reusable suturing device (ARSD-Ney) at 6 and 12 months: a retrospective cohort study.

BackgroundPelvic organ prolapse (POP) is a common pathology in the female population. Sacrospinous ligament fixation (SSLF) is one of the traditional transvaginal procedures for POP and high sacrospinous ligament fixation (h-SSLF) optimizes it using an antegrade reusable suturing device (ARSD-Ney). Previous studies on h-SSLF have focused on the correction of anatomical positions, with less assessment of patients’ function, quality of life and complications. In this study, we evaluated post-operative complications, function, and quality-of-life after h-SSLF to confirm the safety and effectiveness of it.MethodsThis was a retrospective cohort study that included 71 patients between 2018 and 2021: 50 patients for h-SSLF and 21 patients for laparoscopic sacrocolpopexy (LSC) according to patient age and background, POP-Q stage, patient preference, and so on. A clinical evaluation took place before surgery and was repeated at 6 and 12 months postoperatively. Intra- and post-operative complications and anatomical results were recorded. Patients completed self-administered questionnaires for functional pelvic problems [Pelvic Floor Disability Index-20 (PFDI-20)], quality of life [Pelvic Floor Impact Questionnaire-7 (PFIQ-7)], and sexual function [Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12)] at each medical visit.ResultsPatients in both h-SSLF and LSC groups were similar in terms of demographic characteristics except for surgery time (86.04±28.70 vs. 153.19±54.88, P<0.05), postoperative indwelling catheter time (3.88±1.65 vs. 4.90±1.84, P<0.05), and hospital stay (8.94±2.38 vs. 10.57±2.06, P<0.05). There were no statistically significant differences between the 2 groups in scores of PFDI-20, PFIQ-7, and PISQ-12 at pre- and post-operative 6 and 12 months (P>0.05). Functional pelvic problems (PFDI-20 scores) and their impact on patients’ quality of life (PFIQ-7 scores) significantly improved at 6 and 12 months postoperatively (P<0.05). Improvements in sexual activity were noted at 6 and 12 months postoperatively (P<0.05).ConclusionsThis retrospective cohort study confirmed the positive results of h-SSLF in terms of improvement in function and quality of life following treatment for pelvic organ prolapse.

Geographic Variation in Apical Support Procedures for Pelvic Organ Prolapse.

To measure geographic variation in rates of apical support procedures for the treatment of pelvic organ prolapse (POP) among female Medicare beneficiaries. We conducted a retrospective, cross-sectional study and used 100% Medicare fee-for-service claims to identify a cohort of women aged 65-99 years who had an apical support procedure, defined by Current Procedural Terminology codes, in 2016-2018. We included all vaginal and abdominal approaches (native tissue and mesh colpopexies) and obliterative procedures. We excluded vaginectomies with a diagnosis of gynecologic cancer that did not have a diagnosis for prolapse. We created rates of apical POP procedures by hospital referral region and computed coefficients of variation to measure the degree of geographic variation. An average of 26,005 apical POP procedures were performed annually from 2016 to 2018. The majority of patients were aged 65-74 years (64.3%), and 28.5% had concomitant hysterectomy. From 2016 to 2018, there was a mean of 1.79 apical POP procedures per 1,000 female beneficiaries performed across hospital referral regions (95% CI 1.74-1.84). Rate estimates ranged between 0.87 (95% CI 0.63-1.11) apical POP procedures per 1,000 female beneficiaries (Alexandria, Louisiana) and 3.33 (95% CI 2.91-3.74) per 1,000 beneficiaries (Akron, Ohio), a nearly fourfold difference in rates. Variation between hospital referral regions for abdominal apical prolapse procedures was the greatest (coefficient of variation 0.52). Vaginal and obliterative approaches demonstrated less variation between hospital referral regions (respectively, coefficient of variation 0.36 and 0.40). There is wide geographic variation among hospital referral regions for the treatment of POP. Women may be treated differently based on where they live and seek care, which raises questions about possible overuse in some regions and concerns about underuse and lack of access in other regions.