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3.
Urogynecology (Phila) ; 29(10): 827-835, 2023 10 01.
Article in English | MEDLINE | ID: mdl-37093572

ABSTRACT

IMPORTANCE: Effective opioid-sparing postoperative analgesia requires a multimodal approach. Regional nerve blocks augment pain control in many surgical fields and may be applied to pelvic floor reconstruction. OBJECTIVE: This study aimed to evaluate the impact of pudendal nerve block on postoperative pain control and opioid consumption after vaginal surgery. STUDY DESIGN: In this randomized, double-blind, sham-controlled trial, we enrolled women undergoing pelvic reconstruction, excluding patients with chronic pelvic pain or contraindications to nonnarcotic analgesia. Patients were randomized to transvaginal pudendal nerve block (9 mL 0.25% bupivacaine and 1 mL 40 mg/mL triamcinolone) or sham injection (10 mL normal saline). Primary outcomes were pain scores and opioid requirements. Sixty patients were required to show a 20-mm difference on a 100-mm visual analog scale (VAS). RESULTS: We randomized 71 patients: 36 pudendal block and 35 sham. Groups were well matched in baseline characteristics and surgery type. Prolapse repairs were most common (n = 63 [87.5%]), and there was no difference in anesthetic dose or operative time. Pain scores were equivalent in the postanesthesia care unit (mean VAS, 53.1 [block] vs 56.4 [sham]; P = 0.517) and on postoperative day 4 (mean VAS, 26.7 [block] vs 35.5 [sham]; P = 0.131). On postoperative day 1, the intervention group reported less pain, but this did not meet our 20 mm goal for clinical significance (mean VAS, 29.2 vs 42.5; P = 0.047). A pudendal block was associated with lower opioid consumption at all time points, but this was not statistically significant. CONCLUSIONS: Surgeon-administered pudendal nerve block at the time of vaginal surgery may not significantly improve postoperative pain control or decrease opioid use.


Subject(s)
Analgesia , Pudendal Nerve , Humans , Female , Analgesics, Opioid/therapeutic use , Pain, Postoperative/drug therapy , Bupivacaine/therapeutic use
4.
Neurourol Urodyn ; 41(8): 1967-1974, 2022 11.
Article in English | MEDLINE | ID: mdl-35645033

ABSTRACT

INTRODUCTION: Overactive bladder (OAB) disproportionally affects older adults in both incidence and severity. OAB pharmacotherapy is often problematic in the elderly due to polypharmacy, adverse side effect profiles and contraindications in the setting of multiple comorbidities, and concerns regarding the risk of incident dementia with anticholinergic use. The burden of OAB in older patients coupled with concerns surrounding pharmacotherapy options should motivate optimization of nonpharmacologic therapies in this population. At the same time, several aspects of aging may impact treatment efficacy and decision-making. This narrative review critically summarizes current evidence regarding third-line OAB therapy use in the elderly and discusses nuances and treatment considerations specific to the population. METHODS: We performed an extensive, nonsystematic evidence assessment of available literature via PubMed on onabotulinumtoxinA (BTX-A), sacral neuromodulation, and percutaneous tibial nerve stimulation (PTNS) for OAB, with a focus on study in elderly and frail populations. RESULTS: While limited, available studies show all three third-line therapies are efficacious in older populations and there is no data to support one option over another. BTX-A likely has a higher risk of urinary tract infection and retention in older compared to younger populations, especially in the frail elderly. PTNS incurs the lowest risk, although adherence is poor, largely due to logistical burdens. CONCLUSION: Advanced age and frailty should not preclude third-line therapy for refractory OAB, as available data support their efficacy and safety in these populations. Ultimately, treatment choices should be individualized and involve shared decision-making.


Subject(s)
Electric Stimulation Therapy , Urinary Bladder, Overactive , Humans , Aged , Urinary Bladder, Overactive/drug therapy , Tibial Nerve , Cholinergic Antagonists/adverse effects , Frail Elderly , Treatment Outcome
5.
Urology ; 166: 140-145, 2022 08.
Article in English | MEDLINE | ID: mdl-35595075

ABSTRACT

OBJECTIVE: To assess the impact of duration of antibiotic prophylaxis on incidence of urinary tract infection (UTI) after intravesical OnabotulinumtoxinA (BTX) injection. METHODS: A retrospective cohort study of patients with overactive bladder who underwent office BTX injections from 2014 to 2020. UTI incidence within 30 days of BTX was compared between 3 durations of antibiotic prophylaxis: no antibiotic, single day, or multiple day course. Association of UTI with units of BTX, body mass index, history of diabetes, immunosuppression, neurogenic overactive bladder, chronic catheter, or recurrent UTI were investigated. RESULTS: Two hundred ninety patients and 896 cycles of BTX injections were included: 877 injections (97.7%) were women, with mean age 61.4 years (range 20-96; SD 13.3). No antibiotic prophylaxis was given to 112 (12.5%) patients, 595 (66%) received a single day, and 189 (21%) received a multiple day regimen (3-7 days). Overall incidence of UTI within 30 days was 11.4%. On multivariable logistic regression, use of any antibiotic prophylaxis was associated with a lower incidence of UTI (single odds ratio [OR] 0.34; 95% confidence interval [CI] 0.19-0.61; P < .001; multiple OR 0.47; 95% CI 0.24-0.92; P = .029), with no difference between single and multiple day regimens (OR 1.38; 95% CI 0.80-2.38; P = .249). History of recurrent UTI (OR 3.77; 95% CI 2.23-6.39; P < .001) and chronic suprapubic catheter (OR 2.88; 95% CI 1.04-7.95; P = .041) were additional predictors. CONCLUSION: A multiple day regimen of antibiotic prophylaxis was not more effective than a single day in preventing UTI for intravesical BTX injection. Use of any antibiotic prophylaxis was associated with a significantly lower incidence of UTI compared to no antibiotic.


Subject(s)
Antibiotic Prophylaxis , Botulinum Toxins, Type A , Urinary Bladder, Neurogenic , Urinary Bladder, Overactive , Urinary Tract Infections , Adult , Aged , Aged, 80 and over , Anti-Bacterial Agents/therapeutic use , Botulinum Toxins, Type A/therapeutic use , Female , Humans , Incidence , Male , Middle Aged , Retrospective Studies , Urinary Bladder, Neurogenic/complications , Urinary Bladder, Neurogenic/drug therapy , Urinary Bladder, Overactive/complications , Urinary Bladder, Overactive/drug therapy , Urinary Tract Infections/etiology , Urinary Tract Infections/prevention & control , Young Adult
6.
Neurourol Urodyn ; 41(4): 1031-1040, 2022 04.
Article in English | MEDLINE | ID: mdl-35347748

ABSTRACT

OBJECTIVES: This study aimed to determine factors associated with prolonged hospital admission following outpatient female pelvic reconstructive surgery (FPRS) and associated adverse clinical outcomes. METHODS: Using the National Surgical Quality Improvement Program database, we identified outpatient FPRS performed 2011-2016. Isolated hysterectomy without concurrent prolapse repair was excluded. Surgeries were classified as major or minor for analysis. The primary outcome was prolonged length of stay (LOS), defined as admission of ≥2 days. Secondary outcomes included complications, readmission and reoperation associated with prolonged LOS. We abstracted data on covariates, and following univariable analysis, performed backward stepwise regression analysis. RESULTS: A total of 29645 women were included: 12311 (41.5%) major and 17334 (58.5%) minor procedures. A total of 6.9% (2033) had a prolonged LOS. On full cohort multivariable regression analysis, patient characteristics associated with prolonged LOS were older age (odds ratio [OR]: 1.1 per 10 years, confidence interval [CI]: 1.06-1.1, p < 0.001), frailty (OR: 1.8, 95% CI: 1.3-2.6, p = 0.001), and Caucasian race (OR: 1.2, CI: 1.02-1.3, p = 0.024). Associated surgical factors included having a major surgical procedure (OR: 1.3, CI: 1.2-1.4, p < 0.001), use of general anesthesia (OR: 2.0, CI: 1.5-2.6, p < 0.001) and longer operative time (OR: 2.0, CI: 1.8-2.2, p < 0.001). The occurrence of any complication (10.3% vs. 4.7%, p < 0.001), hospital readmission (4.3% vs. 1.7%, p < 0.001), and reoperation (2.7% vs. 1.0%, p < 0.001) were more likely with prolonged LOS. CONCLUSIONS: After outpatient FPRS, 6.9% of patients experience an admission of ≥2 days. Prolonged LOS is more common in patients who are older, frail and Caucasian, and in those who have major surgery with long operative time and general anesthesia.


Subject(s)
Outpatients , Plastic Surgery Procedures , Female , Humans , Length of Stay , Male , Patient Readmission , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Plastic Surgery Procedures/methods , Retrospective Studies
7.
Urology ; 165: 36-43, 2022 07.
Article in English | MEDLINE | ID: mdl-35192863

ABSTRACT

OBJECTIVE: To present a recent clinical case of Skene's gland carcinoma and review all published literature of Skene's gland malignancy with associated treatment and outcomes. METHODS: We review a new case of metastatic Skene's gland adenocarcinoma. We then performed a systematic search of PubMed and Ovid-Medline through December 2021 and retrieved English language articles for review. Peer-reviewed articles were deemed eligible if they included patients with Skene's gland malignancy. Reports were reviewed for pathologic accuracy, patient characteristics, clinical presentation, tumor pathology, treatment and outcome. RESULTS: We reviewed 211 articles and included 15 cases from 1974 to 2022. The median patient age was 71 years (range 46-88). The most common presentation was an asymptomatic periurethral or urethral lesion in five cases (33.3%), followed by hematuria or vaginal bleeding in three patients (20.0%). In eight cases, a prostate-specific antigen was measured and found to be elevated, range 0.8-60.8 ng/mL. Treatment approaches varied and included local excision in eight cases, radical surgical resection in two cases, radiation therapy in two cases, and adjunctive androgen deprivation therapy in one case. Pathology was consistent with adenocarcinoma resembling prostate in all cases. In all cases tested, prostate-specific antigen normalized after definitive therapy of any type. Median follow up was 11.5 months, and there were no cases of recurrence or mortality secondary to Skene's gland adenocarcinoma. CONCLUSION: There are 15 published cases of a Skene's gland malignancy, all adenocarcinoma resembling prostate. Local excision is most often utilized for treatment, with androgen deprivation therapy emerging as a new treatment consideration.


Subject(s)
Adenocarcinoma , Prostatic Neoplasms , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Adenocarcinoma/pathology , Androgen Antagonists , Androgens , Prostate-Specific Antigen
8.
Female Pelvic Med Reconstr Surg ; 27(9): e620-e625, 2021 09 01.
Article in English | MEDLINE | ID: mdl-34432731

ABSTRACT

OBJECTIVES: The aim of this study was to compare the risk of complications associated with obliterative surgery versus reconstructive surgery in elderly and frail patients undergoing surgery for pelvic organ prolapse. METHODS: We performed a retrospective cohort study utilizing the American College of Surgeons National Surgical Quality Improvement Program Database from 2010 to 2017. We compared characteristics and perioperative complications in patients aged 80 years or older who underwent obliterative surgery versus reconstructive surgery. Multivariate logistic regression and propensity score matching were used to control for confounding. A subanalysis was performed that included patients who were considered frail as defined by the National Surgical Quality Improvement Program Modified Frailty Index 5. RESULTS: Of 1,654 total patients, reconstructive surgery was performed in 56.9% of patients, and obliterative surgery was performed in 43.1%. The respective composite complication rates were 9.2% and 9.8% (P = 0.69), whereas severe complications were experienced by 1.9% in the reconstructive group versus 0.8% in the obliterative group (P = 0.07). On multivariate logistic regression, reconstructive surgery was not significantly associated with the composite complication rate (adjusted odds ratio, 1.0; 95% confidence interval, 0.7-1.4; P = 0.80). After propensity score matching, composite complications did not differ between groups, but the rate of severe complications was significantly higher in patients who underwent reconstructive surgery compared with obliterative surgery (2.1% vs 0.8%; odds ratio, 2.53; 95% confidence interval, 1.01-6.36; P = 0.05). In frail patients only, complication rates did not differ between groups. CONCLUSIONS: In patients aged 80 years or older, the overall rate of complications did not differ between those who underwent reconstructive surgery versus obliterative surgery. However, propensity score matching identified an increased risk of the most severe complications in patients who underwent reconstructive surgery.


Subject(s)
Pelvic Organ Prolapse , Plastic Surgery Procedures , Aged , Female , Frail Elderly , Gynecologic Surgical Procedures/adverse effects , Humans , Pelvic Organ Prolapse/surgery , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Plastic Surgery Procedures/adverse effects , Retrospective Studies
9.
Am J Obstet Gynecol ; 225(3): 274.e1-274.e11, 2021 09.
Article in English | MEDLINE | ID: mdl-33894146

ABSTRACT

BACKGROUND: Postoperative urinary retention is common after female pelvic reconstructive surgery. Alpha receptor antagonists can improve dysfunctional voiding by relaxing the bladder outlet and may be effective in reducing the risk of postoperative urinary retention. OBJECTIVE: This study aimed to determine whether tamsulosin is effective in preventing postoperative urinary retention in women undergoing surgery for pelvic organ prolapse. STUDY DESIGN: This was a multicenter, double-blind, randomized controlled trial between August 2018 and June 2020, including women undergoing surgery for pelvic organ prolapse. Patients were excluded from recruitment if they had elevated preoperative postvoid residual volume, history of postoperative urinary retention, or a contraindication to tamsulosin. Those who experienced cystotomy were excluded from analysis. Participants were randomized to a 10-day perioperative course of tamsulosin 0.4 mg vs placebo, beginning 3 days before surgery. A standardized voiding trial was performed on postoperative day 1. The primary outcome was the development of postoperative urinary retention, as defined by the failure of the voiding trial or subsequent need for catheterization to empty the bladder. Secondary outcomes included the rate of urinary tract infection and the impact on lower urinary tract symptoms as measured by the American Urological Association Symptom Index. RESULTS: Of 119 patients, 57 received tamsulosin and 62 received placebo. Groups were similar in regard to demographics, preoperative prolapse and voiding characteristics, and surgical details. Tamsulosin was associated with a lower rate of postoperative urinary retention than placebo (5 patients [8.8%] vs 16 patients [25.8%]; odds ratio, 0.28; 95% confidence interval, 0.09-81; P=.02). The number needed to treat to prevent 1 case of postoperative urinary retention was 5.9 patients. The rate of urinary tract infection did not differ between groups. American Urological Association Symptom Index scores significantly improved after surgery in both groups (median total score, 14 vs 7; P<.01). Scores related to urinary stream improved more in the tamsulosin group than in placebo (P=.03). CONCLUSION: In this placebo-controlled trial, tamsulosin use was associated with a reduced risk of postoperative urinary retention in women undergoing surgery for pelvic organ prolapse.


Subject(s)
Pelvic Organ Prolapse/surgery , Postoperative Complications/prevention & control , Tamsulosin/therapeutic use , Urinary Retention/prevention & control , Double-Blind Method , Female , Humans , Middle Aged , Urological Agents/therapeutic use
10.
Female Pelvic Med Reconstr Surg ; 27(4): 230-237, 2021 04 01.
Article in English | MEDLINE | ID: mdl-33770806

ABSTRACT

OBJECTIVE: To evaluate national trends in major adverse cardiovascular and cerebrovascular events (MACCE) in female pelvic reconstructive surgery (FPRS). METHODS: Data from the National Inpatient Sample was used to identify women undergoing FPRS between 2012 and 2016. Demographic, procedural, and comorbidity data were collected. Patients were stratified into those with and without MACCE (defined as all-cause mortality, cardiac arrest, myocardial infarction (MI) and acute ischemic stroke). Descriptive statistics are expressed as medians and interquartile ranges. Pairwise analysis was performed using Wilcoxon rank-sum or Fisher exact test as appropriate. Multivariable logistic regression was used to identify independent risk factors for MACCE. RESULTS: During the study period, 53,540 patients underwent FPRS. The rate of MACCE was 4.8 per 1000 surgeries; MI, 3.7; acute ischemic stroke, 0.6; cardiac arrest, 0.4; and all-cause mortality, 0.3. Patients experiencing MACCE were more likely to have major preexisting cardiovascular comorbidities, coagulopathy, neurologic disease (ND), and diabetes and were more likely to undergo robotic colpopexy (20.7% vs 9.6%, P < 0.001), vaginal colpopexy (32.0% vs 28.5%, P = 0.04), and to receive a blood transfusion (8.2% vs 2.5%, P < 0.001).On logistic regression, preexisting coagulopathy was the strongest predictor of MACCE (adjusted odds ratio [aOR], 5.53; 95% confidence interval [CI], 2.39-12.78), followed by blood transfusion (aOR, 4.84; 95% CI, 1.89-12.45), congestive heart failure (aOR, 3.61; 95% CI, 1.56-8.37), ND (aOR, 3.14; 95% CI, 1.23-8.06), and electrolyte abnormalities (aOR, 1.99; 95% CI, 1.05-3.99). CONCLUSION: Major adverse cardiovascular and cerebrovascular events after FPRS is a rare event, with MI being the most common manifestation. Preexisting ND, congestive heart failure, coagulopathy, electrolyte disturbances, and perioperative transfusions are strongly associated with MACCE.


Subject(s)
Heart Arrest/epidemiology , Ischemic Stroke/epidemiology , Myocardial Infarction/epidemiology , Pelvic Floor Disorders/surgery , Postoperative Complications/epidemiology , Aged , Cohort Studies , Female , Gynecologic Surgical Procedures/adverse effects , Humans , Middle Aged , Retrospective Studies , United States/epidemiology , Urologic Surgical Procedures/adverse effects
11.
J Minim Invasive Gynecol ; 28(2): 275-281, 2021 02.
Article in English | MEDLINE | ID: mdl-32450226

ABSTRACT

STUDY OBJECTIVE: The objective of this study was to compare the morbidity of vaginal versus laparoscopic hysterectomy when performed with uterosacral ligament suspension. DESIGN: Retrospective propensity-score matched cohort study. SETTING: American College of Surgeons National Surgical Quality Improvement Program database. PATIENTS: We included all patients who had undergone uterosacral ligament suspension and concurrent total vaginal hysterectomy (TVH-USLS) or total laparoscopic hysterectomy (TLH-USLS) from 2010 to 2015. We excluded those who underwent laparoscopic-assisted vaginal hysterectomy, abdominal hysterectomy, other surgical procedures for apical pelvic organ prolapse, or had gynecologic malignancy. INTERVENTIONS: We compared 30-day complication rates in patients who underwent TVH-USLS versus TLH-USLS in both the total study population and a propensity score matched cohort. MEASUREMENTS AND MAIN RESULTS: The study population consisted of 3,349 patients who underwent TVH-USLS and 484 who underwent TLH-USLS. Patients who underwent TVH-USLS had a significantly higher composite complication rate (11.4% vs 6.4%, odds ratio [OR] 1.9, 1.3-2.8; p <.01) and a higher serious complication rate (5.6% vs 3.1%, OR 1.8, 1.1-3.1; p = .02), which excluded urinary tract infection and superficial surgical site infection. The propensity score analysis was performed, and patients were matched in a 1:1 ratio between the TVH-USLS group and the TLH-USLS group. In the matched cohort, patients who underwent TVH-USLS had a higher composite complication rate than those who underwent TLH-USLS (10.3% vs 6.4%, OR 1.7, 95% confidence interval [CI], 1.1-2.7; p = .04), whereas the rate of serious complications did not differ between the groups (4.3% vs 3.1%, OR 1.4, 95% CI, 0.7-2.8; p = .4). On multivariate logistic regression, TVH-USLS remained an independent predictor of composite complications (adjusted OR 1.6, 95% CI, 1.0-2.6; p = .04) but not serious complications (adjusted OR 1.4, 95% CI, 0.7-2.8; p = .3). CONCLUSION: In this large national cohort, TVH-USLS was associated with a higher composite complication rate than TLH-USLS, largely secondary to an increased rate of urinary tract infection. After matching, the groups had similar rates of serious complications. These data suggest that TLH-USLS should be viewed as a safe alternative to TVH-USLS.


Subject(s)
Hysterectomy, Vaginal , Hysterectomy , Laparoscopy , Pelvic Organ Prolapse/surgery , Postoperative Complications/epidemiology , Aged , Broad Ligament/pathology , Broad Ligament/surgery , Cohort Studies , Female , Humans , Hysterectomy/adverse effects , Hysterectomy/methods , Hysterectomy/statistics & numerical data , Hysterectomy, Vaginal/adverse effects , Hysterectomy, Vaginal/methods , Hysterectomy, Vaginal/statistics & numerical data , Laparoscopy/adverse effects , Laparoscopy/methods , Laparoscopy/statistics & numerical data , Ligaments/surgery , Middle Aged , Morbidity , Patient Readmission/statistics & numerical data , Pelvic Organ Prolapse/epidemiology , Perioperative Period , Postoperative Complications/etiology , Propensity Score , Retrospective Studies , United States/epidemiology , Uterus/surgery , Vagina/surgery
12.
Int Urogynecol J ; 32(4): 791-797, 2021 Apr.
Article in English | MEDLINE | ID: mdl-32507910

ABSTRACT

INTRODUCTION AND HYPOTHESIS: Support of the vaginal apex is paramount for a durable repair of pelvic organ prolapse (POP). Our aim is to assess national utilization of apical suspension procedures for the surgical treatment of complete POP. We hypothesize that there might be a high rate of apical suspension with advanced prolapse. METHODS: The 2006-2016 National Surgical Quality Improvement Program database was queried for a primary postoperative diagnosis of complete POP. The primary outcome was type of repair. Secondary outcomes included patient characteristics associated with apical suspension or colpocleisis. Procedures were delineated using CPT codes. Chi-squared and multivariate logistic regression analyses were used to evaluate factors associated with repair type. RESULTS: A total of 2,784 women underwent surgery for complete POP with a mean age of 64.6 ± 11.0 years. Overall, 1,300 (46.7%) patients underwent apical suspension: 487 sacrocolpopexies (17.5%), 428 extraperitoneal suspensions (15.4%), and 391 uterosacral suspensions (14.0%). 5.2% (144) underwent colpocleisis, and 47.5% (1,332) of women had a concurrent hysterectomy (CH). With CH, 38.6% (502) had apical suspension or colpocleisis versus 69.5% (940) of post-hysterectomy cases. On logistic regression, CH was inversely associated with apical suspension (adjusted odds ratio [aOR] 0.37, CI 0.32-0.44, p < 0.001). Colpocleisis was associated with older age (aOR 4.9 per 10 years, CI 3.8-6.3, p < 0.001), post-hysterectomy surgery (aOR 0.23, CI 0.1-0.4, p < 0.001 for CH), and higher comorbidity index (OR 1.7, CI 1.1-2.6, p = 0.009). Complication rates are similar with and without apical suspension (8.2% versus 7.0%, p = 0.269). CONCLUSIONS: During surgery for complete POP, an apical suspension procedure is performed in 46.7% of patients and is more common post-hysterectomy.


Subject(s)
Gynecologic Surgical Procedures , Pelvic Organ Prolapse , Aged , Female , Humans , Hysterectomy , Middle Aged , Pelvic Organ Prolapse/surgery , Suspensions , Treatment Outcome , United States , Vagina
13.
Female Pelvic Med Reconstr Surg ; 27(4): 255-259, 2021 04 01.
Article in English | MEDLINE | ID: mdl-31804234

ABSTRACT

INTRODUCTION: Malpractice litigations have significant implications for patients and physicians. Studies have investigated mesh litigations in female pelvic reconstructive surgery, but none on nonmesh pelvic organ prolapse (POP) surgery. Our purpose is to determine the reasons for and outcomes of medical malpractice after nonmesh POP surgery. METHODS: Westlaw (Thompson Reuters, New York, New York) is a legal research database of US court records. We identified completed POP litigations from 1987 to 2018 using the following: "pelvic organ prolapse," "enterocele," "rectocele," "cystocele," "uterine prolapse," and "vaginal wall prolapse." Mesh-related cases were excluded. Outcomes included reasons for litigation, verdict, injury, and payments. Statistical analysis was performed with nonparametric tests and χ2 independence test. RESULTS: Ninety-one litigations were included. The median plaintiff age was 53 years (range, 36-85 years). The leading allegation was negligence of surgery (n = 59; 65%). The jury sided with the defendant physician in 67% of cases (n = 61). There was no association between case verdict and patient age (P = 0.781), geographic region (P = 0.824), or allegation (P = 0.904). The primary complications were urinary tract injury (n = 24; 26%), need for additional surgery (n = 22; 24%), and new postoperative urinary symptoms (n = 22; 24%). The median payout was $280,000 (interquartile range, $137,250-$1,300,000), with no difference between plaintiff awards or settlements (P = 0.659). CONCLUSION: The leading allegation of malpractice litigations for nonmesh POP surgery is negligence of surgery, whereas the most common complication was urinary tract injury. A verdict in favor of the physician defendant was the most likely outcome. Plaintiff awards and settlements were not statistically different with no variation by region or time.


Subject(s)
Malpractice/legislation & jurisprudence , Pelvic Organ Prolapse , Adult , Aged , Aged, 80 and over , Female , Gynecologic Surgical Procedures , Humans , Middle Aged , Surgical Mesh , United States
14.
Eur Urol Oncol ; 4(1): 84-92, 2021 02.
Article in English | MEDLINE | ID: mdl-31368436

ABSTRACT

BACKGROUND: While female gender is considered a protective determinant in the majority of cancers, outcomes in women diagnosed with bladder cancer have continued to show disproportional mortality when compared with men. OBJECTIVE: The aim of this retrospective propensity score-matched analysis was to evaluate the intra- and postoperative differences among genders, as well as to evaluate reproductive organ-preserving radical cystectomy (ROPRC) as compared with radical cystectomy (RC) as a potential confounder in female cystectomy patients. DESIGN, SETTING, AND PARTICIPANTS: Utilizing the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), men and women undergoing a cystectomy between 2011 and 2017 were analyzed. In addition, females undergoing ROPRC and RC were analyzed for immediate postoperative outcomes. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Men and women undergoing a cystectomy were evaluated through propensity score matching (PSM) for baseline differences using a 1:1 caliper width of 0.2 to the nearest neighbor. Using multivariable logistic regression analysis, we evaluated differences in the risk of readmission, complications, and reoperation in the immediate postsurgical period in males and females. Similarly, differences were assessed in ROPRC and RC groups. RESULTS AND LIMITATIONS: We achieved a balance between males and females after PSM: 1263 males and 1263 females treated with cystectomy. The risks of readmission (adjusted odds ratio [aOR] 1.228 [1.005-1.510], p=0.045), superficial surgical site infection (aOR 1.507 [1.095-2.086], p=0.012), and transfusion (aOR 2.031 [1.713-2.411], p<0.001) were increased in females undergoing a cystectomy compared with males. No differences were observed in surgical outcomes in ovarian sparing/RC cohort. CONCLUSIONS: Using the 2011-2017 NSQIP database, we were able to demonstrate an increased rate of postoperative transfusion, readmission rate, and surgical site infection in females who underwent cystectomy. Our findings suggest that females experience an increased rate of complications in the immediate postoperative period. This may ultimately lead to worse oncologic outcomes in females after an RC. Lastly, we did not find any increased rate of complications in ROPRC as compared with RC. PATIENT SUMMARY: This study highlights differences in immediate postoperative outcomes between males and females undergoing cystectomy for bladder cancer. Some of these potential differences include higher risk of infection, transfusion, and readmission. These differences may predispose females to worse long-term outcomes. In addition, due to potential benefits of ovarian preservation in the recent literature, we also evaluated the risks and complications of ovarian sparing cystectomy. We found ovarian preservation to be a safe and feasible procedure in a highly selected group of patients.


Subject(s)
Cystectomy , Quality Improvement , Cystectomy/adverse effects , Female , Humans , Male , Postoperative Complications/epidemiology , Postoperative Period , Propensity Score , Retrospective Studies
15.
Female Pelvic Med Reconstr Surg ; 27(7): 415-420, 2021 07 01.
Article in English | MEDLINE | ID: mdl-32941316

ABSTRACT

OBJECTIVES: The objective of this study was to describe national practice patterns of hysterectomy type performed with concurrent sacrocolpopexy and determine clinical factors associated with surgical route. METHODS: We used the National Surgical Quality Improvement Program database with hysterectomy data for this retrospective cohort study. We identified sacrocolpopexy cases from 2014 to 2016 with concurrent hysterectomy and stratified patients into supracervical hysterectomy (SCH) or total hysterectomy (TH). As a secondary analysis, we compared the laparoscopic subset of cases. We performed χ2 and backward stepwise logistic regression analyses to identify factors associated with hysterectomy type and compare complication rates. RESULTS: A total of 4,615 women underwent SCP with hysterectomy: 55.8% TH and 44.2% SCH. Mean ± SD age was 56.5 ± 11.7 years. Gynecologists represent 96.3% of surgeons; 51.2% were urogynecologists. Urogynecologists were more likely than generalists to perform SCH (58.4% vs 41.6%, P < 0.001). Total hysterectomy was associated with younger age (adjusted odds ratio [aOR], 0.98 per year [0.97-0.99]), greater uterine weight (aOR, 1.05 per 10 g [1.03-1.06]), and non-Caucasian race (aOR, 0.73 [0.58-0.92]). Complication rates were equivalent between hysterectomy type (SCH, 6.2% vs TH, 6.2%; P = 0.956). Laparoscopy was used for 84.4% of surgical procedures. In this subgroup, TH was associated with greater uterine weight (aOR, 1.06 per 10 g [1.04-1.08]) and younger age (aOR, 0.97 per year [0.96-0.98]). Complication rates were similar (SCH, 5.1% vs TH, 5.0%; P = 0.824). CONCLUSIONS: At the time of sacrocolpopexy, TH is more common than SCH and is associated with younger age and greater uterine weight, although urogynecologists more commonly perform SCH. The overall risk of complications was low and similar between hysterectomy type.


Subject(s)
Clinical Decision-Making , Hysterectomy/methods , Pelvic Organ Prolapse/surgery , Adult , Age Factors , Aged , Comorbidity , Databases, Factual , Female , Humans , Hysterectomy/statistics & numerical data , Middle Aged , Pelvic Organ Prolapse/epidemiology , Postoperative Complications/epidemiology , Retrospective Studies
16.
World J Urol ; 39(6): 2191-2196, 2021 Jun.
Article in English | MEDLINE | ID: mdl-32671606

ABSTRACT

OBJECTIVE: To determine if graft augmentation with anterior colporrhaphy (AC+G) is associated with higher complication rates compared to native tissue repair (AC). MATERIALS AND METHODS: Retrospective cohort study using data from the ACS-NSQIP database between 2010 and 2017. CPT codes were used to identify women undergoing AC+G and AC. Propensity scores for the likelihood of undergoing AC+G were calculated and were used to match to women undergoing native tissue repair at a ratio of 1:2. The primary outcome was the composite complication rate. Descriptive statistics are reported as means with standard deviations for parametric data and as medians and interquartile ranges for non-parametric data. Pairwise comparisons were performed using Fisher's exact test, Wilcoxon rank-sum and Student's t test as appropriate. Multivariable logistic regression was then used to adjust for confounders to identify statistically significant factors associated with the likelihood of experiencing a complication after prolapse repair. RESULTS: 582 women met inclusion criteria for AC+G and were matched with 1164 women undergoing AC. There were no differences in preoperative characteristics between groups. There was no difference in the composite complication rate, (10.8% vs. 8.5%, p = 0.13) between groups. Dependent functional status (aOR 4.31, 95% CI 1.96-13.58) was the strongest predictor of the likelihood of a complication: other significant predictors were operating time greater than 20 min (aOR 1.68, 95% CI 1.19-2.38) and ASA class greater than 2 (aOR 1.44, 95% CI 1.01-2.05). CONCLUSION: There is no increase in 30-day complication rates in women undergoing AC+G compared to a matched cohort of those undergoing AC alone.


Subject(s)
Pelvic Organ Prolapse/surgery , Postoperative Complications/epidemiology , Vagina/surgery , Aged , Cohort Studies , Female , Gynecologic Surgical Procedures/methods , Humans , Middle Aged , Propensity Score , Retrospective Studies , Time Factors , Transplants
17.
Neurourol Urodyn ; 39(8): 2386-2393, 2020 11.
Article in English | MEDLINE | ID: mdl-32886811

ABSTRACT

AIMS: After pelvic reconstructive surgery, the risk of postoperative urinary tract infection (UTI) is significant; intraoperative cystoscopy may contribute to this risk. Intravesical antibiotics are used in the ambulatory setting and may be applied to the surgical arena. Our objective was to evaluate the efficacy of antibiotic irrigation during intraoperative cystoscopy to prevent postoperative UTI. METHODS: This double-blind randomized controlled trial enrolled 216 women undergoing cystoscopy with elective surgery for pelvic organ prolapse, stress urinary incontinence, or laparoscopic gynecologic surgery at an academic medical center 2016-2019. Participants were randomized to cystoscopic irrigation fluid type: normal saline (control) or 200,000 U polymyxin B + 40 mg neomycin solution in normal saline (antibiotic). Patients and providers who treated UTIs were blinded. The primary outcome was treatment of UTI within 6 weeks postoperatively, defined as positive culture or treatment for a symptomatic UTI. χ2 and multivariable logistic regression analyses were performed. RESULTS: We enrolled 216 women: 111 control (51.4%) and 105 antibiotic (48.6%). Mean age was 51.6 years. Groups were well matched in medical comorbidities and surgery type. Primary vaginal surgery was most common (n = 127, 58.8%). Overall, 10.7% of patients developed a postoperative UTI with no difference in incidence between groups: 9.9% of control (n = 11, 95% confidence interval [CI]: 4.0%-16.0%) versus 11.4% of antibiotic subjects (n = 12, 95% CI: 5.0%-18.0%), on χ2 (p = .718) and logistic regression analysis (adjusted odds ratio, 1.3; CI: 0.53-3.16; p = .569). CONCLUSION: When cystoscopy is performed during elective pelvic surgery, use of antibiotic irrigation does not impact the rate of postoperative UTI.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Cystoscopy/adverse effects , Gynecologic Surgical Procedures/adverse effects , Pelvic Organ Prolapse/surgery , Plastic Surgery Procedures/adverse effects , Urinary Incontinence, Stress/surgery , Urinary Tract Infections/prevention & control , Adult , Aged , Aged, 80 and over , Double-Blind Method , Female , Humans , Middle Aged , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Urinary Tract Infections/etiology
18.
Int Urogynecol J ; 31(10): 2089-2094, 2020 10.
Article in English | MEDLINE | ID: mdl-32556848

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The purpose of this study was to evaluate the accuracy of the American College of Surgeons National Surgery Quality Improvement Program (ACS NSQIP) surgical risk calculator in predicting postoperative complications in patients undergoing pelvic organ prolapse surgery. METHODS: We performed a retrospective review of 354 patients who underwent surgery for pelvic organ prolapse from 2013 to 2017 at a single academic institution. Patient medical information and surgical procedure were entered into the calculator to obtain predicted complication rates, which were compared with observed complications. Logistic regression, C-statistic, and Brier score were used to assess the accuracy of the calculator. RESULTS: Of 354 patients included in the analysis, 79.7% were under the age of 75, and 41.5% were classified as American Society of Anesthesiologists class ≥3. The majority of patients underwent robotic sacrocolpopexy (40.7%) or uterosacral ligament suspension (36.4%), followed by colpocleisis, abdominal sacrocolpopexy, and extraperitoneal suspension. Complications were experienced by 100 patients (28.3%). Most common complications were urinary tract infection (n = 57), surgical site infection (n = 42), and readmission (n = 16); other complications were rare. The surgical risk calculator displayed poor predictive ability for experiencing a complication (C-statistic = 0.547, Brier score = 0.25). CONCLUSIONS: The NSQIP surgical risk calculator displayed poor predictive ability in our cohort of patients undergoing surgery for pelvic organ prolapse, suggesting that this tool might have limited clinical applicability to individual patients in this population.


Subject(s)
Pelvic Organ Prolapse , Robotics , Humans , Pelvic Organ Prolapse/surgery , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Quality Improvement , Retrospective Studies , Risk Assessment , Risk Factors
19.
Obstet Gynecol ; 135(3): 599-608, 2020 03.
Article in English | MEDLINE | ID: mdl-32028502

ABSTRACT

OBJECTIVE: To evaluate the effects of old age and frailty on complication rates after surgery for pelvic organ prolapse. METHODS: The American College of Surgeons' National Surgical Quality Improvement Program database was used to identify patients who underwent surgery for prolapse from 2010 to 2017. We compared our control group (45-64 years, index population) to those aged 65-79 years (elderly) and 80 years and older (very elderly). Frailty was assessed using the National Surgical Quality Improvement Program Modified Frailty Index-5. The primary outcome was the composite rate of serious complications and mortality. RESULTS: We analyzed 27,403 patients in the index population, 20,567 in the elderly group, and 3,088 in the very elderly group. The composite rate of serious complications in the index population was 4.5%, compared with 4.7% in the elderly group (odds ratio [OR] 1.0, 95% CI 0.9-1.1) and 9.0% in the very elderly group (OR 2.1, 95% CI 1.8-2.4). Compared with the index group, the very elderly group had notably elevated risks of cardiac complications (OR 11.9, 95% CI 6.2-23.0), stroke (OR 26.6, 95% CI 5.4-131.8), and mortality (OR 39.9, 95% CI 8.6-184.7). On multivariate logistic regression, the only age group independently associated with serious complications was the very elderly group (adjusted odds ratio [aOR] 2.01, 95% CI 1.8-2.3). The Modified Frailty Index-5 score was independently predictive of complications (aOR 1.4, 95% CI 1.1-2.0). Stratified analysis using interaction terms revealed the Modified Frailty Index-5 score to be predictive of complications in the elderly age group (aOR 2.5, 95% CI 1.3-4.6), but not in the very elderly group. CONCLUSION: Serious complications surrounding prolapse surgery increase substantially in the cohort of patients older than 80 years of age, independent of frailty and medical or surgical risk factors.


Subject(s)
Frailty/complications , Gynecologic Surgical Procedures/adverse effects , Patient Safety , Pelvic Organ Prolapse/surgery , Postoperative Complications/etiology , Aged , Aged, 80 and over , Female , Humans , Middle Aged , Perioperative Period
20.
Int Urogynecol J ; 31(2): 373-379, 2020 02.
Article in English | MEDLINE | ID: mdl-31115610

ABSTRACT

INTRODUCTION AND HYPOTHESIS: Preoperative counseling about salpingectomy with pelvic surgery is recommended by the American College of Obstetrics and Gynecology for ovarian cancer risk reduction. Our objective was to determine recent practice patterns and patient factors associated with salpingectomy with vaginal hysterectomy (VH) for pelvic organ prolapse (POP) in the USA. We hypothesize that salpingectomy might have become more common in recent years. METHODS: We queried the 2014-2016 National Surgical Quality Improvement Program database for women with a postoperative diagnosis of POP who underwent VH with any combination of pelvic reconstructive procedures. CPT codes do not differentiate salpingectomy from salpingo-oophorectomy, so subjects were stratified by whether concurrent adnexectomy was performed. Chi-squared and multivariate logistic regression analyses were used to evaluate characteristics associated with adnexectomy. Propensity score matching was utilized when evaluating postoperative complication rates. RESULTS: Of 5,344 women who underwent VH, 2019 (37.8%) had adnexectomy. Adnexectomy rate increased from 34.4% in 2014 to 46.8% in 2016 (p < 0.001). Adnexectomy rates of fellowship-trained urogynecologists and general gynecologists were similar (36.0% vs 38.8%, p = 0.197). On logistic regression analysis, patients more likely to undergo adnexectomy were < 65 years old (OR 0.844, CI 0.75-0.95, p = 0.004), had BMI <30 (OR 0.76, CI 0.68-0.86, p < 0.001), and were non-smokers (OR 0.78, CI 0.64-0.95, p = 0.016). Mean operative time was 17 min longer with adnexectomy (145 vs 128 min, p < 0.001). There were no differences in postoperative complications or reoperation rates between groups. CONCLUSIONS: Adnexectomy during VH for POP is safe and increasingly utilized by gynecology surgeons in the USA.


Subject(s)
Gynecology/statistics & numerical data , Hysterectomy, Vaginal/statistics & numerical data , Pelvic Organ Prolapse/surgery , Practice Patterns, Physicians'/statistics & numerical data , Salpingectomy/statistics & numerical data , Aged , Combined Modality Therapy , Databases, Factual , Female , Humans , Hysterectomy, Vaginal/methods , Logistic Models , Middle Aged , Propensity Score , Plastic Surgery Procedures/statistics & numerical data , Salpingectomy/methods , Treatment Outcome , United States
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