Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial.

BACKGROUND: Opioids are routinely prescribed for postoperative pain control after gynecologic surgery with growing evidence showing that most prescribed opioids go unused. Restrictive opioid prescribing has been implemented in other surgical specialties to combat the risk for opioid misuse and diversion. The impact of this practice in the urogynecologic patient population is unknown. OBJECTIVE: This study aimed to determine if a restrictive opioid prescription protocol is noninferior to routine opioid prescribing in terms of patient satisfaction with pain control after minor and major surgeries for prolapse and incontinence. STUDY DESIGN: This was a single-center, randomized, noninferiority trial of opioid-naïve patients who underwent minor (eg, colporrhaphy or mid-urethral sling) or major (eg, vaginal or minimally invasive abdominal prolapse repair) urogynecologic surgery. Patients were excluded if they had contraindications to all multimodal analgesia and if they scored ≥30 on the Pain Catastrophizing Scale. Subjects were randomized on the day of surgery to the standard opioid prescription protocol (wherein patients routinely received an opioid prescription upon discharge [ie, 3-10 tablets of 5 mg oxycodone]) or to the restrictive protocol (no opioid prescription unless the patient requested one). All patients received multimodal pain medications. Participants and caregivers were not blinded. Subjects were asked to record their pain medication use and pain levels for 7 days. The primary outcome was satisfaction with pain control reported at the 6-week postoperative visit. We hypothesized that patient satisfaction with the restrictive protocol would be noninferior to those randomized to the standard protocol. The noninferiority margin was 15 percentage points. Pain level scores, opioid usage, opioid prescription refills, and healthcare use were secondary outcomes assessed for superiority. RESULTS: A total of 133 patients were randomized, and 127 (64 in the standard arm and 63 in the restrictive arm) completed the primary outcome evaluation and were included in the analysis. There were no statistically significant differences between the study groups, and this remained after adjusting for the surgery type. Major urogynecologic surgery was performed in 73.6% of the study population, and minor surgery was performed in 26.4% of the population. Same-day discharge occurred for 87.6% of all subjects. Patient satisfaction was 92.2% in the standard protocol arm and 92.1% in the restrictive protocol arm (difference, -0.1%; P=.004), which met the criterion for noninferiority. No opioid usage in the first 7 days after hospital discharge was reported by 48.4% of the patients in the standard protocol arm and by 70.8% in the restrictive protocol arm (P=.009). Opioid prescription refills occurred in 8.5% of patients with no difference between the study groups (9.4% in the standard arm vs 6.7% in the restrictive arm; P=.661). No difference was seen in the rate of telephone calls and urgent visits for pain control between the study arms. CONCLUSION: Among women who underwent minor and major surgery for prolapse and incontinence, patient satisfaction rates were noninferior after restrictive opioid prescribing when compared with routine opioid prescribing.

Hysterectomy versus Uterine Preservation for Pelvic organ prolapse Surgery (HUPPS): A prospective cohort study.

BACKGROUND: One in five females will have surgery to treat pelvic organ prolapse in their lifetime. Uterine-preserving surgery involving suspension of the uterus is an increasingly popular alternative to the traditional use of hysterectomy with vaginal vault suspension to treat pelvic organ prolapse; however, comparative evidence with native tissue repairs remains limited in scope and quality. OBJECTIVE: To compare 1-year outcomes between hysterectomy-based and uterine-preserving native tissue prolapse surgeries performed through minimally invasive approaches. STUDY DESIGN: We used a non-randomized design with patients self-selecting their surgical group to integrate a pragmatic, patient-centred, and autonomy-focused approach. Participants chose between uterine-preserving surgery or hysterectomy-based surgery, guided by neutral, evidence-based discussions and individualized decision-making, with support from fellowship-trained urogynecologists. Inverse probability of treatment weighting based on high-dimensional propensity scores was used to balance baseline differences across surgical groups in an effort to resemble a randomized clinical trial. A prospective cohort study of 321 participants with stage ≥2 prolapse involving the uterus who desired surgical treatment were recruited between 2020 and 2022 and followed to 1 year (retention >90%). Patients chose to receive uterine-preserving POP surgery through hysteropexy (n=151) or hysterectomy with vaginal vault suspension (n=170; reference group), with repair of anterior and/or posterior prolapse if indicated. The primary outcome was anatomic prolapse recurrence within one year, defined as apical descent ≥50% of the total vaginal length. Secondary outcomes were peri-operative, functional, clinical, and healthcare outcomes measured at 6 weeks and 1 year. Inverse probability of treatment weighted linear regression and modified Poisson regression were used to estimate adjusted mean differences (aMD) and relative risks (aRR), respectively. RESULTS: Apical anatomic recurrence rates at 1 year were 17.2% following hysterectomy and 7.5% following uterine-preservation, resulting in an adjusted relative risk of 0.35 (95% CI 0.15, 0.83). Uterine-preserving surgery was associated with shorter length of surgery (aMD -0.68 hours [-0.80, -0.55]) and hospitalization (aMD -4.34 hours [-7.91, -0.77]), less use of any opioids within 24 hours (aRR 0.79 [0.65, 0.97]), and fewer procedural complications (aRR 0.19 [0.04, 0.83]) than hysterectomy. Up to 1 year, uterine-preserving surgery was associated with lower risk of composite recurrence (stage ≥2 prolapse in any compartment or retreatment; aRR 0.47 [0.32, 0.69]) than hysterectomy, driven by anatomic outcomes. There were no clinically meaningful differences in functional or healthcare outcomes between surgical groups. CONCLUSION: This study adds real-world evidence to the growing body of research supportive of uterine-preserving surgery as a safe, efficient, and effective alternative to hysterectomy during native tissue prolapse repair. Given mounting evidence on safety, efficiency, and effectiveness of uterine-preserving surgery and its alignment with the preferences of approximately half of patients to keep their uterus, the standard of care should include routine offering and patient choice between uterine-preserving and hysterectomy-based surgery for pelvic organ prolapse.

Impact of preoperative pelvic floor muscle function on the success of surgical treatment of pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to identify the potential characteristics of pelvic floor muscles (PFM) in the preoperative assessment that could be associated with post-surgical prolapse severity. We hypothesized that the same variables, if identified, could be addressed in preoperative rehabilitation to improve surgical results. METHODS: This was a single-center prospective observational study that included women who underwent surgical pelvic organ prolapse repair between 2020-2022. Genital prolapse was evaluated according to the Pelvic Organ Prolapse Quantification (POP-Q) system. All the participants underwent a PFM assessment, including a vaginal digital assessment and manometry (Peritron™ 9300 V) before surgery and at 1-, 3-, and 6-month follow-ups. Several PFM variables were recorded: vaginal resting pressure, vaginal pressure during maximal voluntary contraction (MVC), area under the curve during a 10-second MVC, ability to correctly contract the PFMs, and reflexive activation during cough and relaxation. The primary endpoint of the analysis was objective surgical success defined as POP-Q 0 or 1 at the 6-month follow-up. Additionally, a change in pelvic floor muscle function was recorded during postoperative visits. RESULTS: A total of 106 females were included in the study. Fifty-one were lost during the 6-month follow-up, which is a major limitation of the study. None of the examined parameters evaluating PFM were associated with surgical success. No statistically significant difference was found in MVC and PFM endurance before and after surgery. Post-surgery, a significant change was observed in the vaginal resting pressure and the ability to correct PFM activation and relaxation. CONCLUSIONS: Preoperative PFM function is not associated with surgical success 6 months after surgery.

Pelvic Organ Prolapse Surgery: Postoperative Quality of Life in Ethiopian Women.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) has a profound influence on a woman's quality of life (QoL). Assessment of QoL using patient-reported outcome (PRO) measures in pelvic organ prolapse surgery is common practice in developed countries, but despite the burden of POP in developing countries, such as Ethiopia, the use of PROs to record preoperative and postoperative QoL scores is limited. This study is aimed at assessing the QoL among Ethiopian women with POP before and after surgery using the validated Pelvic Organ Quality of Life (P-QoL) questionnaire. Additionally, we will compare postoperative QoL measurements of reconstructive procedures with those of obliterative procedures. METHODS: This is a prospective observational study conducted at a single hospital in Ethiopia on women who were scheduled for surgery for symptomatic POP. Patients' QoL was assessed preoperatively using the P-QoL questionnaire and at each subsequent follow-up visit for 1 year (3, 6, 9, and 12 months). Patients undergoing an obliterative procedure were evaluated and compared with those having reconstructive procedures. RESULTS: The mean score for general health perceptions, prolapse impact, role limitations, physical limitations, social limitations, and emotions was 0 at 12 months postoperatively. Despite significant improvements from baseline, personal relationships, sleep or energy disturbance, and symptom severity measures continued to negatively impact QoL at 12 months postoperatively. CONCLUSIONS: Quality of life among Ethiopian women with POP is poor across all domains. Native tissue repair employing either reconstructive or obliterative methods significantly improves QoL across all domains up to 12 months postoperatively. The use of validated tools to assess PROs is essential to provide evidence-based care that improves QoL in ways that are meaningful to patients.

Effect of Body Mass Index on Complications After Vaginal and Laparoscopic Apical Prolapse Surgery.

INTRODUCTION AND HYPOTHESIS: Obesity is increasing worldwide, and data are limited on how body mass index (BMI) affects surgical risk in pelvic organ prolapse. This study is aimed at evaluating the impact of obesity on outcomes after apical pelvic organ prolapse surgery. We hypothesize that obese patients have higher rates of postoperative complications. METHODS: This is a retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program database from 2014 to 2018. Current Procedural Terminology codes identified subjects aged 18-89 who underwent apical prolapse repair, including vaginal colpopexy and laparoscopic or robotic sacrocolpopexy. Minor and major complications were analyzed using the World Health Organization BMI category. Regression analysis was performed to adjust for confounders. RESULTS: The total cohort was 24,718 with 15,137 vaginal colpopexy and 9,581 laparoscopic/robotic sacrocolpopexy. The average age was 60.1, 76.5% were white, 24.2% were American Society of Anesthesiologists (ASA) class 3 or 4, and 44.7% had a major medical comorbidity. Eight hundred and eighty-five patients (5.4%) experienced a minor complication, 324 (2.0%) a major complication, and 1,167 (7.2%) any complication. There was no difference in any, major, or minor complication by BMI and this persisted after adjusting for age, race, ASA class, smoking, and surgical approach. CONCLUSIONS: There is no difference in complication rates after apical prolapse surgery by BMI regardless of age, race, ASA class, smoking use, and surgical approach. Patients and surgeons should be reassured that minimally invasive apical prolapse surgery is safe, with low complication rates. Randomized controlled trials are needed to verify these findings.

Early Removal of Indwelling Catheter and Vaginal Pack After Vaginal Prolapse Surgery: A Retrospective Cohort Study.

INTRODUCTION AND HYPOTHESIS: After vaginal pelvic organ prolapse (POP) surgery a vaginal pack and indwelling bladder catheter are inserted to reduce blood loss and bladder overdistension. The ideal timing of removal remains unclear. In this study we compared removal of vaginal pack and indwelling catheter 3 h post-surgery with removal the next day. METHODS: This retrospective cohort study performed in the Netherlands included patients undergoing POP surgery between 1 January 2019 and 31 December 2020. Patients in whom the vaginal pack and catheter were removed the day after surgery (group A) were compared with patients in which the vaginal pack and catheter were removed 3 h post-surgery (group B). Both groups were compared regarding urinary retention and the need for re-intervention owing to active blood loss within 6 weeks postoperatively. RESULTS: Baseline characteristics, such as age, type of operation and type of anaesthesia in group A (n = 280) and group B (n = 207) were comparable. No significant differences were found regarding complications such as urinary retention (17.2 versus 23.2%; p = 0.255). The rates of re-intervention because of active blood loss and occurrence of infection were also comparable. CONCLUSIONS: Removal of the indwelling catheter and vaginal pack 3 h after vaginal POP surgery does not lead to more postoperative complications than removal the 1st day after surgery. Therefore, early removal is a feasible and safe alternative to the standard timing of removal the morning after surgery of women undergoing POP surgery. In the future this could help with introducing same-day discharge.

Minimally Invasive Sacrocolpopexy: Impact on Sexual Function.

INTRODUCTION AND HYPOTHESIS: Sacrocolpopexy (SCP) is the gold standard surgical management of apical pelvic organ prolapse (POP), and increasingly, minimally invasive SCP is being adopted as a primary treatment for advanced uterovaginal prolapse. Patients undergoing surgery for POP consider postoperative improvement in sexual function to be a highly important outcome, and sexual dysfunction and dyspareunia severe adverse events. Therefore, it is crucial to understand the impact of minimally invasive SCP on postoperative sexual function. We aimed to analyze the current literature available to discuss the impact of minimally invasive SCP on postoperative sexual function. METHODS: We performed a narrative review of minimally invasive SCP and its impact on sexual function. PubMed and EMBASE were searched from inception through 28 January 2024 for studies that reported sexual function following surgery for POP. Baseline and postoperative sexual activity, dyspareunia, and validated questionnaire scores for sexual function were documented. RESULTS: Minimally invasive SCP is associated with improved postoperative sexual function, increased rates of postoperative sexual activity, and low rates of dyspareunia. Dyspareunia was not associated with mesh related complications. Patients with baseline dyspareunia or pain were more likely to experience persistent dyspareunia after surgery. CONCLUSION: The rates of POP are increasing in our aging population, and sexual function is very important to patients undergoing surgery for POP. Clinicians should consider all factors related to sexual function when planning surgery for POP and address dyspareunia prior to surgery. Sexual function appears to improve overall after minimally invasive SCP and de novo dyspareunia rates are low.

Changes in Stress Urinary Incontinence Symptoms after Pelvic Organ Prolapse Surgery: a Nationwide Cohort Study (FINPOP).

INTRODUCTION AND HYPOTHESIS: Various strategies are employed to manage stress urinary incontinence (SUI) during pelvic organ prolapse (POP) surgery. This study was aimed at facilitating shared decision-making by evaluating SUI symptom changes, staged SUI procedures, and their prognostic factors following POP surgery without concomitant SUI intervention. METHODS: We analyzed 2,677 POP surgeries from a population-based observational cohort, excluding patients with prior SUI surgery. The outcome measures were subjective SUI utilizing the Pelvic Floor Distress Inventory-20 questionnaire and number of subsequent SUI procedures. Multivariable linear models were applied to identify predictors of persistent SUI, procedures for persistent SUI, and de novo SUI. The primary assessment occurred at the 2-year follow-up. RESULTS: At baseline, 50% (1,329 out of 2,677) experienced SUI; 35% (354 out of 1,005) resolved, an additional 14% (140 out 1,005) improved, and 5.1% (67 out of 1,308) underwent a procedure for persistent SUI. De novo SUI symptoms developed in 20% (218 out of 1,087), with 3.2% (35 out of 1,087) reporting bothersome symptoms; 0.8% (11 out of 1,347) underwent a procedure for de novo SUI. High baseline symptom severity increased the risk of persistent SUI (adjusted odds ratio [aOR] 2.04, 95% confidence interval [CI] 1.65-2.53), whereas advanced preoperative apical prolapse decreased the risk (aOR 0.89, 95% CI 0.85-0.93). De novo SUI was more common with advancing age (aOR 1.03, 95% CI 1.01-1.05), baseline urgency urinary incontinence (aOR 1.21, 95% CI 1.06-1.38), and after transvaginal mesh surgery (aOR 1.93, 95% CI 1.24-3.00). It was not dependent on the compartment or preoperative degree of prolapse. CONCLUSIONS: In a pragmatic setting, POP surgery results in a low rate of subsequent SUI procedures.

Transition to surgery after pessary among female Medicare beneficiaries with pelvic organ prolapse.

BACKGROUND: The American College of Obstetricians and Gynecologists recommends offering a vaginal pessary to women seeking treatment of pelvic organ prolapse. However, single-institution series have suggested that a sizable proportion of women fitted with a pessary will transition to surgery within the first year. OBJECTIVE: This study aimed to estimate the proportion of female US Medicare beneficiaries with pelvic organ prolapse who undergo surgery after pessary fitting, to describe the median time to surgery from pessary fitting, and to identify factors associated with the transition from pessary to surgery. STUDY DESIGN: The Medicare 5% Limited Data Set was queried from 2011 to 2016 for women aged ≥65 years with a diagnosis of prolapse who underwent pessary fitting. Cases with at least 3 years of follow-up in the Medicare Data Set were followed longitudinally for the primary outcome of surgery for prolapse. The cumulative incidence of prolapse surgery following index pessary fitting was calculated. Characteristics of women who underwent surgery and those who did not were compared using time-varying Cox regression analysis. RESULTS: Among 2032 women fitted with a pessary, 608 underwent surgery within 7 years. The median time to surgery was 496 days (interquartile range, 187-1089 days). The cumulative incidence of prolapse surgery was 12.2% at 1 year and 30.9% at 7 years. After adjusting for covariates, factors significantly associated with the transition to surgery included previous prolapse surgery (adjusted hazard ratio, 1.50; 1.09-2.07) and a diagnosis of urinary incontinence at the time of pessary fitting (adjusted hazard ratio, 1.20; 0.62-0.99). Factors associated with a lower hazard of surgery included age (adjusted hazard ratio, 0.96 per year; 95% confidence interval, 0.95-0.97), dual Medicare/Medicaid eligibility (adjusted hazard ratio, 0.75; 95% confidence interval, 0.56-1.00), and pessary fitting by a nongynecologist (adjusted hazard ratio, 0.78; 95% confidence interval, 0.62-0.99). CONCLUSION: In this population of Medicare beneficiaries, within 7 years of pessary fitting, almost one-third of women aged >65 years underwent surgery for prolapse. These results add to our current understanding of the demographics of pessary use in an older population and may aid in counseling older patients presenting for treatment of symptomatic pelvic organ prolapse.

Lateral extension and attachment of mesh to the lateral vagina during laparoscopic sacrocolpopexy: a modified technique aimed at lowering recurrences in the anterior vaginal compartment. A surgical video.

PURPOSE/OBJECTIVE: Laparoscopic sacrocolpopexy has been demonstrated to be the gold standard of prolapse surgery in cases with apical defect. Most recurrences seem to occur in the anterior compartment, especially if a paravaginal defect is present. To reduce the incidence of anterior recurrence after laparoscopic sacrocolpopexy we modified our previous published technique by placing the anterior mesh not only deep under the bladder but also laterally and fixing it to the lateral edge of the vagina. With this video article, we would like to show and explain our modified technique and demonstrate how lateral mesh placement can be easily and safely performed using laparoscopy. METHODS: The video demonstrates our modified technique with lateral extension and fixation of the anterior mesh to the lateral vagina during laparoscopic sacrocolpopexy in a patient with severe uterine prolapse (grade III) and a large cystocele (grade III). Special emphasis is given to the topographical anatomy of the paravaginal space and the surgical technique of lateral fixation. RESULTS: This modified new technique shows excellent perioperative results in more than 100 cases without any occurrences of lesions of the ureters. Our initial experience also shows very good anatomical results in all three compartments. CONCLUSIONS: Paravaginal dissection and exposure of the ureters to extend the mesh placement and fixation to the lateral border of the vagina in the anterior compartment during laparoscopic sacrocolpopexy seem to be feasible and safe, helping to significantly reduce the risk of anterior recurrences. Prospective data are needed to evaluate this interesting technique.

Patient experiences following prolapse surgery implementing a same-day discharge model: a prospective study.

INTRODUCTION AND HYPOTHESIS: Previous research has not evaluated patient experiences following vaginal reconstructive surgery using a same-day discharge model. The objective of this study was to describe patient experiences following major vaginal reconstructive surgery and same-day discharge. METHODS: In this descriptive study, patients undergoing vaginal hysterectomy with pelvic reconstruction were preoperatively enrolled. Questionnaires detailing experience with same-day discharge, surgical recovery, and advice for prospective patients were completed. Our primary outcome was question 7 of the Surgical Satisfaction Questionnaire: Looking back, if you "had to do it all over again" would you have the surgery again? Descriptive statistics were performed, and correlations were performed with Spearman's rank test. RESULTS: Sixty patients were enrolled; 54 underwent surgery. Eighty-seven percent of patients completed the 12-week questionnaire. At 12 weeks, 96% of patients (n = 45) would have the surgery again, and 91% (n = 42) were satisfied with the results of surgery. Twelve weeks postoperatively, the most common patient-reported complications were urinary tract infection (n = 8, 17%), catheter concerns (n = 5, 11%), and constipation (n = 5, 11%). When asked to list the best parts of their surgical experience, half of patients felt that this was the office staff or physician themselves (n = 24, 51%). When asked what advice they would provide to future patients, the most common responses included having a support person at home and taking time for recovery. CONCLUSIONS: In this sample of women receiving same-day discharge following vaginal hysterectomy with pelvic reconstruction, we present a unique insight into the most common patient concerns postoperatively. Rates of satisfaction and comfort were high.

The clinical utility of routine postoperative hemoglobin and creatinine after reconstructive surgery for apical pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Postoperative laboratory tests are routinely ordered after apical prolapse repair on asymptomatic patients. We hypothesize that routine serum hemoglobin (Hb) and creatinine (Cr) have limited clinical utility in the postoperative period in asymptomatic patients. METHODS: This is a retrospective cohort study of patients who underwent surgical repair of apical prolapse between 2017 and 2019 at our institution. Subjects were divided into two groups postoperatively: symptomatic and asymptomatic anemia. Symptomatic patients were defined as having one or more of the following: blood pressure (BP) <90/60, heart rate (HR) >100, urine output <30 cc/h, subjective dizziness, flank pain, or abdominal pain. The primary aim was to evaluate the utility of postoperative serum Hb and Cr in symptomatic and asymptomatic patients. Fisher's exact and Mann-Whitney tests analyzed categorical and continuous data respectively. A total of 325 patients were included. RESULTS: Patients with symptomatic anemia had a larger decrease in Hb on postoperative day 1 (POD1) with a mean decrease of -18.11% (± 6.64) compared with asymptomatic patients, who had a mean difference of -15.49% (± 5.63; p < 0.001). The total cost of tests evaluating Hb was US$61,745. Patients with symptomatic acute kidney injury had an increase in Cr on POD1 compared with asymptomatic patients, with a mean increase of 0.23% (± 16.06) and -3.07% (± 13.10) respectively (p < 0.05). The total cost of tests including Cr was US$131,812. CONCLUSIONS: Our results indicate that routine postoperative Hb and Cr testing for apical prolapse should be reserved for symptomatic patients as it has minimal clinical value in asymptomatic patients and contributes to increased overall health care cost.

Antibiotic prophylaxis in posterior colporrhaphy does not reduce postoperative infection: a nationwide observational cohort study.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to explore if antibiotic prophylaxis prevents postoperative infection after a posterior colporrhaphy. METHODS: In this register-based nationwide cohort study data were collected from the "The Swedish National Quality Register of Gynecological Surgery" (GynOp). Women 18 years or older who underwent a primary posterior colporrhaphy between 1 January 2015 and 31 December 2020 were included. Patients undergoing any concomitant prolapse procedure, mesh surgery, or incontinence procedure were excluded. The cohort was divided into two groups based on administration of antibiotic prophylaxis (n = 1,218) or not (n = 4,884). The primary outcome of this study was patient-reported infectious complication requiring antibiotic treatment. Secondary outcome measures included patient satisfaction and prolapse-related symptoms at 1 year postoperatively. RESULTS: A total of 7,799 patients who underwent posterior colporrhaphy and met the inclusion criteria and did not meet the exclusion criteria were identified in the register database. Of these patients 6,102 answered the primary outcome question (79%). In the antibiotic prophylaxis group a total of 138 reported a postoperative infection (11%) and in the no antibiotic prophylaxis group the corresponding data were 520 (11%). There were no significant differences regarding either the primary or the secondary outcomes between the study groups. CONCLUSION: In this nationwide Swedish register study antibiotic prophylaxis was not associated with a reduced risk of postoperative infection after a posterior colporrhaphy.

How does office assessment of prolapse compare to what is seen in the operating room?

INTRODUCTION AND HYPOTHESIS: It is not known whether the measurements of pelvic organ assessment under anesthesia accurately estimate prolapse severity. We compared Pelvic Organ Prolapse Quantification (POP-Q) measurements in the office to exams under anesthesia. METHODS: We prospectively enrolled patients undergoing prolapse surgery between February 2020 and July 2020. POP-Qs at rest and with Valsalva were performed at pre- and postoperative visits. POP-Q under anesthesia was performed, without traction, at the start of case (pre-surgical), following apical suspension, and at the end of case (post-surgical). Primary outcome was change in POP-Q between the office and operating room. Due to the COVID-19 pandemic, additional patients were recruited to maintain the follow-up time frame. RESULTS: Out of 66 patients, 63 underwent surgery and 33 had postoperative exams within 6 weeks. Mean age was 61.3 ± 11.9 years, and mean BMI was 28.4 ± 6.5 kg/m2. Preoperative Aa, Ba, C, Ap, Bp, and D with Valsalva had greater descent than pre-surgical measurements. However, preoperative Gh with Valsalva (4.1 ± 1.3 cm) was not different from pre-surgical Gh (4.0 ± 1.0 cm) (P = 0.60). Postoperative Aa, Ba, Ap, Bp, and D were not different from post-surgical measurements. In contrast, postoperative Gh at rest (2.3 ± 0.7 cm) and with Valsalva (2.4 ± 0.8 cm) were both narrower than post-surgical Gh (2.8 ± 0.6 cm) (P < 0.05). Gh was also narrowed after apical suspension (3.6 ± 1.0 cm, P = 0.005) prior to posterior repair. CONCLUSIONS: Surgeons should rely on preoperative POP-Q for surgical decisions. Gh should be reassessed after apical suspension, and further correction should consider that Gh may be exaggerated compared to the measurement postoperatively when the patient is awake.

Predictors of persistent overactive bladder following surgery for advanced pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Reliable risk factors for persistent urgency following pelvic organ prolapse (POP) surgery are still unclear. We aimed to identify preoperative parameters related to persistent postoperative urgency in a cohort of women following surgery for POP stage 3-4 with concomitant overactive bladder (OAB). METHODS: In this retrospective analysis, women with POP stage 3-4 and OAB who underwent POP repair during November 2012-December 2020 were included. Preoperative evaluation included history, Pelvic Organ Prolapse Quantification (POP-Q), multi-channel urodynamic studies and Pelvic Floor Distress Inventory (PFDI-20). Surgical procedures included: anterior and posterior colporrhaphy, sacrospinous ligament suspension, anterior vaginal wall mesh repair and robotic-assisted laparoscopic sacrocolpopexy. At the 12-month follow-up, urogynecological history, POP-Q evaluation, cough stress test and the PFDI-20 questionnaire were repeated. RESULTS: One hundred seventy-three patients were included in the analysis. Resolution of urgency was observed in 56% of women. Variables associated with persistent postoperative urgency included body mass index (BMI) (27 kg/m2 vs 25.7 kg/m2, p = 0.04), preoperative increased daytime frequency (46.39% vs 61.84%, p = 0.05), urgency urinary incontinence (UUI) (51.46% vs 80.26%, p = 0.0001), detrusor overactivity (DO) (40.2% vs 61.84%, p = 0.009) and lower maximum flow rate on UDS (13.9 ml/s vs 15 ml/s, p = 0.04). Multivariate analysis confirmed preoperative DO (OR: 12.2 [95% CI: 1.4-16.6]; p = 0.01), preoperative UUI (OR 3.8 [95% CI: 1.3-11.0]; p = 0.008) and BMI > 25 kg/m2 (OR 1.8 [95% CI: 1.1-7.2]; p = 0.04) as predictive factor for persistent urgency. CONCLUSIONS: In women with advanced POP and OAB, being overweight, preoperative UUI and DO are related to persistent postoperative urgency. These findings will guide our future preoperative counseling and reinforce the role of UDS in POP management.

Comparative anatomy of the ovine and human pelvis for laparoscopic sacrocolpopexy: evaluating the effectiveness of the ovine model.

INTRODUCTION AND HYPOTHESIS: Laparoscopic sacrocolpopexy (LSC) is a functional reconstructive surgery used to treat pelvic organ prolapse (POP) in middle-aged women. Although LSC is widely used, its implementation is hindered by perceived technical difficulties and surgical learning curves. Surgeons require adequate experience with LSC prior to performing the procedure on patients to improve their quality of life. This study is aimed at demonstrating the effectiveness of the ovine model (OM) for training and research in LSC, while also comparing anatomical differences between ovine and human models during the procedure. METHODS: The animal model and training were provided by the Jesús Usón Minimally Invasive Surgery Centre. Urologists and gynecologists with experience in LSC participated in a course and their findings were recorded and documented. RESULTS: Differences in patient positioning, trocar placement, and reperitonealization were identified between the ovine and human models. Hysterectomy is always performed in the ovine model, whereas it is not mandatory in humans. There are also differences in the dissection of the levator ani muscle and attachment point of the posterior mesh to the uterus between the two models. Despite differences in some areas, the ovine pelvic structure and vagina are similar in size to those of humans. CONCLUSIONS: The ovine model is a valuable tool for surgeons in their learning curve for LSC, allowing for safe and effective practice prior to performing the procedure on patients. The use of the OM can help to improve the quality of life for women affected by pelvic organ prolapse.

Development and validation of the Value of Uterus instrument and visual analog scale to measure patients' valuation of their uterus.

BACKGROUND: Currently, there are no clear frameworks or tools to objectively or subjectively evaluate patient attitudes toward uterine preservation and how they influence the decision to proceed with hysterectomy vs uterine preservation when undergoing prolapse surgery. OBJECTIVE: This study aimed to develop a reliable and valid instrument to measure patients' valuation of their uterus. STUDY DESIGN: The Value of Uterus instrument was developed on the basis of existing literature and created with structured patient-reported outcome measurement development methodology. An initial 14-question instrument was administered to 152 patients, and the instrument was revised on the basis of an analysis of internal consistency. The resulting Value of Uterus instrument has 6 items and includes a visual analog scale for the question "How important is it to you to keep your uterus when you have a gynecologic condition?" To validate the instrument, we recruited 51 patients aged >45 years with uterovaginal prolapse who presented to the urogynecology department and were scheduled to undergo vaginal surgery with or without hysterectomy. Internal reliability of the instrument was measured with Cronbach alpha. For known-groups validity, Value of Uterus summary scores were compared between women who underwent hysteropexy and those who underwent hysterectomy using the t test. Intraclass correlation coefficient was used to assess test-retest reliability with Value of Uterus administered to women twice. Lastly, a receiver-operating characteristic curve analysis was conducted to identify a cutoff Value of Uterus and visual analog scale score for predicting whether a woman would undergo hysteropexy (vs hysterectomy). RESULTS: A total of 51 patients were recruited (26 patients in the hysterectomy and 25 in the hysteropexy group), with a mean age of 64±10 years; 87.8% of patients self-identified as White. There were no differences in demographics between the groups. Cronbach's alpha was 0.94, suggesting excellent internal consistency of the items in the Value of Uterus instrument. The Value of Uterus instrument was highly correlated with the visual analog scale question, with r=0.82 (95% confidence interval, 0.69-0.89; P<.001). Patients in the hysteropexy group had significantly higher Value of Uterus scores (indicating greater value placed on the uterus) than women who underwent hysterectomy (20.8 vs 12.2; P<.001). Receiver-operating characteristic curve analysis identified a Value of Uterus cutoff score ≥14, with good accuracy for predicting hysteropexy (area under the curve, 0.87; sensitivity, 92.0%; specificity, 68%). CONCLUSION: Value of Uterus is a reliable and valid 6-item instrument that measures patients' valuation of the uterus and preferences for uterine preservation when undergoing surgery for pelvic organ prolapse. Value of Uterus and visual analog scale were shown to reliably predict whether a patient undergoes uterine-preserving prolapse surgery. The Value of Uterus instrument and visual analog scale tool can be useful tools to ensure that the patient's preferences are included in the medical decision-making. Value of Uterus may be useful for future research in other gynecologic conditions where uterine preservation is an option.

The association between surgeon subspecialty training and postoperative outcomes following surgery for pelvic organ prolapse.

BACKGROUND: Symptomatic pelvic organ prolapse is common and affects 25% to 35% of women worldwide. As this growing patient need is being met by surgeons from diverse training backgrounds, it is important to both characterize the differences in surgeon practice patterns and examine postoperative outcomes to ensure optimal patient care. OBJECTIVE: To determine the association between surgeon specialty and postoperative outcomes following surgery for pelvic organ prolapse. STUDY DESIGN: This was a retrospective analysis using the American College of Surgeons National Surgical Quality Improvement Program Gynecologic reconstructive surgery targeted database between 2014 and 2018. Pelvic organ prolapse surgeries were identified using Current Procedural Terminology codes, and surgical cases performed by urogynecologists or obstetrician-gynecologists were included for analysis. The primary outcome was any 30-day postoperative complication following prolapse surgery. The secondary outcomes were any major or minor postoperative complications, genitourinary complications, reoperation, or readmission within 30-days following surgery. Descriptive statistics were used to characterize the cohort, and pairwise analyses were used to describe the differences between the cases performed by the surgeon specialties. Multivariable logistic regression was used to control for potential confounders. RESULTS: A total of 3358 women underwent prolapse surgery-68% performed by urogynecologists and 32% by obstetrician-gynecologists. The 30-day postoperative complication rate was higher for surgeries performed by obstetrician-gynecologists than for surgeries performed by urogynecologists (10.7% vs 7.0%, respectively; P<.001). There was no difference in the readmission rates between the 2 groups (2.1% vs 2.0%; P=1.000). However, the reoperation rates were higher for surgeries performed by obstetrician-gynecologists (1.8% vs 1.0%; P=.040). In a multivariable logistic regression model controlling for age, body mass index, American Society of Anesthesiology class, smoking, and type of concomitant surgery (hysterectomy, apical suspension, other prolapse surgery, obliterative procedure, or sling), prolapse surgery performed by a urogynecologist remained associated with nearly 40% lower odds of any 30-day postoperative complication (adjusted odds ratio, 0.62; 95% confidence interval, 0.48-0.80). CONCLUSION: Prolapse surgery performed by a urogynecologist is associated with lower odds of any 30-day postoperative complication than that performed by an obstetrician-gynecologist.

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

BACKGROUND: Although several different apical suspension procedures are available to women with pelvic organ prolapse, data on long-term efficacy and safety profiles are limited. OBJECTIVE: The primary aim of this study was to analyze longitudinal reoperation risk for recurrent prolapse among the 4 apical suspension procedures over 2 to 15 years. Secondary aims included evaluation of all-cause reoperation, defined as a repeated surgery for the indications of recurrent prolapse and adverse events, and total retreatment rate, which included a repeated treatment with another surgery or a pessary. STUDY DESIGN: This was a multicenter, retrospective cohort study within Kaiser Permanente Southern California that included women who underwent sacrocolpopexy, uterosacral ligament suspension, sacrospinous ligament fixation, or colpocleisis from January 2006 through December 2018. Women who underwent concomitant rectal prolapse repair or vaginal prolapse repair with mesh augmentation were excluded. Data were abstracted using procedural and diagnostic codes through July 2021, with manual review of 10% of each variable. Patient demographics and pessary use were compared using analysis of variance or chi square tests for continuous and categorical variables, respectively. Time-to-event analysis was used to contrast reoperation rates. A Cox regression model was used to perform an adjusted multivariate analysis of the following predictors of reoperation for recurrence: index surgery, concomitant procedures, patient demographics, baseline comorbidities, and year of index surgery. Censoring events included exit from the health maintenance organization and death. RESULTS: The cohort included 9681 women with maximum follow-up of 14.8 years. The overall incidence of reoperation for recurrent prolapse was 7.4 reoperations per 1000 patient-years, which differed significantly by type of apical suspension (P<.0001). The incidence of reoperation was lower after colpocleisis (1.4 events per 1000 patient-years) and sacrocolpopexy (4.8 events per 1000 patient-years) when compared with uterosacral ligament suspension (9 events per 1000 patient-years) and sacrospinous ligament fixation (13.9 events per 1000 patient-years). All pairwise comparisons between procedures were significant (P=.0003-.0018) after correction for multiplicity, except for uterosacral ligament suspension or uterosacral ligament hysteropexy vs sacrospinous ligament fixation or sacrospinous ligament hysteropexy (P=.05). The index procedure was the only significant predictor of reoperation for recurrence (P=.0003-.0024) on multivariate regression analysis. Reoperations for complications or sequelae (overall 2.9 events per 1000 patient-years) also differed by index procedure (P<.0001) and were highest after sacrocolpopexy (4.4 events per 1000 patient-years). The incidence of all-cause reoperation for recurrence and adverse events after sacrocolpopexy, however, was comparable to that of the other reconstructive procedures (P=.1-.4) in pairwise comparisons with Bonferroni correction. Similarly, frequency of pessary use differed by index procedure (P<.0001) and was highest after sacrospinous ligament fixation at 9.3% (43/464). CONCLUSION: Among nearly 10,000 patients undergoing prolapse surgery within a large managed care organization, colpocleisis and sacrocolpopexy offered the most durable obliterative and reconstructive prolapse repairs, respectively. All-cause reoperation rates were lowest after colpocleisis by a large margin, but similar among reconstructive apical suspension procedures.

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

BACKGROUND: 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. OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: 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). CONCLUSION: 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.