The PSR13, a tool for evaluating patient-perceived recovery after vaginal prolapse repair surgery
Brandon, Caroline A; Friedman, Steven; Rosenblum, Nirit; Escobar, Christina M; Stewart, Lauren E; Brucker, Benjamin M
INTRODUCTION AND HYPOTHESIS/OBJECTIVE:Surgical recovery is the return to preoperative functional, psychologic, and social activity, or a return to normalcy. To date, little is known about the global post-surgical recovery experience from the patients' perspective. The aim of this study was to validate the Post-Discharge Surgical Recovery scale 13 (PSR13) in women undergoing vaginal prolapse repair procedures and evaluate the patient-perceived postoperative recovery experience over a 12-week period. METHODS:Fifty women undergoing vaginal prolapse repairs completed the PSR13 and global surgical recovery scale (GSR) at 1, 2, 4, 6, and 12 weeks post-surgery. Validity, the minimal clinically important difference (MCID), and responsiveness to change over time of the PSR13 was evaluated using descriptive statistics and linear regression models. The proportion of patients deemed fully recovered at each time point (defined as PSR13 score â‰¥ 80) was also assessed. RESULTS:The PSR13 correlated significantly (p < 0.001) with the single-item recovery scale and showed excellent internal consistency reliability (Cronbach Î± = 0.91, range 0.77 to 0.93). The MCID was estimated at 7.0 points. The PSR13 scores improved at varying rates over time, with the greatest amount of patient-perceived recovery occurring between 4 and 6 weeks after surgery. The proportion of patients deemed fully recovered at 6- and 12- weeks postoperatively was 37% and 56%, respectively. CONCLUSIONS:The PSR13 is a useful instrument to assess overall return to normalcy from the patient's perspective and can be applied to evaluate the recovery experience among women undergoing vaginal prolapse repairs, in both the research and clinical setting.
Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial
Stewart, Lauren E; Siddique, Moiuri; Jacobs, Kristin M; Raker, Christina A; Sung, Vivian W
BACKGROUND:The efficacy of intradetrusor onabotulinumtoxinA injections for the management of idiopathic overactive bladder has been well-established. The injections are typically performed in the office setting using local analgesia, most commonly a 20 to 30-minute intravesical instillation of lidocaine. There are limited data evaluating alternative bladder analgesics. OBJECTIVE:To compare pain scores with preprocedure oral phenazopyridine vs intravesical lidocaine in women undergoing intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder. STUDY DESIGN/METHODS:Nonpregnant adult females with idiopathic overactive bladder, scheduled for office injection of 100 units of intradetrusor onabotulinumtoxinA were randomized to either 200 mg of oral phenazopyridine taken 1 to 2 hours preprocedure or a 20-minute preprocedure intravesical instillation of 50 mL of 2% lidocaine. We excluded participants with neurogenic bladders, and those who had received intradetrusor onabotulinumtoxinA injections in the previous 12 months. The primary outcome was pain measured by a 100-mm visual analog scale. Demographic characteristics and overall satisfaction with the procedure were also recorded. Providers answered questions about cystoscopic visualization, ease of procedure, and perception of participant comfort. Prespecified noninferiority margin was set to equal the anticipated minimum clinically important difference of 14 mm. A planned sample of 100 participants, 50 in each treatment arm, provided 80% power to detect noninferiority at a significance level of.05. We performed a modified intention-to-treat analysis and compared variables with the t test or the Fisher exact test. RESULTS:A total of 111 participants were enrolled, and complete data were obtained for 100 participants; 47 participants were randomized to phenazopyridine and 53 to lidocaine. Baseline characteristics did not differ between groups. There were 19.6% and 20.8% of participants in the phenazopyridine and lidocaine groups, respectively, who previously underwent intradetrusor onabotulinumtoxinA injections. The mean postprocedure pain was 2.7 mm lower in the phenazopyridine group than in the lidocaine group (95% confidence interval,Â -11.3 to 10.7), demonstrating noninferiority. More than 90% of participants in both groups stated that the pain was tolerable. Slightly more participants reported being "very satisfied" in the lidocaine group, although this was not statistically significant (50.0% vs 40.4%; P=.34). Providers reported clear visualization in 89.4% of participants in the phenazopyridine group and in 100% of participants in the lidocaine group (P=.02). Provider perception of participant comfort and overall ease of procedure were not different between groups. Length of time in the exam room was significantly shorter in the phenazopyridine than in the lidocaine group (44.4 vs 57.5 minutes; P=.0003). CONCLUSION/CONCLUSIONS:In women receiving intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder, oral phenazopyridine was noninferior to intravesical lidocaine for procedural pain control. Phenazopyridine is well-tolerated by participants, allows for the procedure to be performed with similar ease, and is associated with shorter appointment times.
Oral phenazopyridine versus intravesical lidocaine for office onabotulinumtoxina analgesia: a randomized controlled trial [Meeting Abstract]
Siddique, M; Stewart, L; Jacobs, K M; Raker, C A; Sung, V
Objectives: To compare pain scores in women undergoing intradetrusor onabotulinumtoxinA for idiopathic overactive bladder (OAB) between women randomized to pre-procedure oral phenazopyridine versus intravesical lidocaine.
Material(s) and Method(s): Non-pregnant adult females scheduled for office injection of 100 units intradetrusor onabotulinumtoxinA were randomized to either 200mg of oral phenazopyridine taken 1-2 hours preprocedure versus a 20 minute preprocedure intravesical instillation of 50mL 2% lidocaine. We excluded patients with neurogenic bladder, and those who had received intradetrusor onabotulinumtoxinA injections in the previous 12 months. The primary outcome was pain measured by a 100mm visual analog scale (VAS). Demographic characteristics and overall satisfaction with the procedure were also collected. Providers answered questions about cystoscopic visualization, ease of procedure, and perception of patient comfort. In order to detect a difference of 14 (SD 25) or greater on the VAS with 80% power and a significance level of.05, we planned to obtain complete data for 100 patients, 50 in each treatment arm. We performed an intention to treat analysis and compared variables by T-test or Fisher's exact test.
Result(s): 111 patients were enrolled; complete data was obtained for 100 participants. 47 patients were randomized to phenazopyridine and 53 to lidocaine. Baseline characteristics did not differ between groups. 19.6% and 20.8% in the phenazopyridine and lidocaine groups, respectively, had previously undergone intradetrusor onabotulinumtoxinA injections. Pre-procedure pain scores did not differ between groups. The mean post-procedure pain score was not significantly different between groups, with a mean of 24 (28) in the phenazopyridine group compared to 28 (31) in the lidocaine group (p=0.52). A post-hoc power analysis with 47 and 53 patients per treatment arm showed similar power. Greater than 90% of patients in both groups stated the pain was tolerable. Slightly more patients reported being "very satisfied" in the lidocaine group, although this was not statistically different (50.0% vs 40.4%, p = 0.34). Providers reported clear visualization in 89.4% of patients in the phenazopyridine group versus 100% in the lidocaine group (p=0.02). Provider perception of patient comfort and overall ease of procedure was not different between groups. Length of time in the exam room was significantly shorter in the phenazopyridine versus the lidocaine group (44.4 vs 57.5 minutes, p=0.0003).
Conclusion(s): In women receiving intradetrusor onabotulinumtoxinA injections for idiopathic OAB, there was no difference in pain scores when comparing oral phenazopyridine versus intravesical lidocaine. Phenazopyridine is well-tolerated by patients, allows for the procedure to be performed with similar ease, and is associated with shorter appointment times. [Formula presented]
Evidence for the Appropriate Use of Telemedicine in Female Pelvic Medicine and Reconstructive Surgery
Barrett, Francesca; Stewart, Lauren E; Brucker, Benjamin M
Purpose of Review/UNASSIGNED:To summarize the available literature regarding telehealth interventions in the management of pelvic floor disorders. Recent Findings/UNASSIGNED:Most Female Pelvic Medicine and Reconstructive Surgery (FPMRS) patients own and feel comfortable operating the technology required to participate in telehealth interventions and would be willing to interact remotely with their providers. Telehealth may be an appropriate and effective tool for patient education about bladder and pelvic physiology and pathophysiology, remote pelvic floor muscle strengthening when in-person physical therapy is not accessible, overactive bladder follow-up and medication management, and for postoperative care following uncomplicated incontinence and prolapse surgery. Summary/UNASSIGNED:There is a growing body of literature specific to FPMRS supporting various telehealth interventions that could reasonably be expected to improve access to sub-specialty care while maintaining or improving healthcare quality and reducing costs to the patient and the healthcare system.
78 Adherence to national transfusion guidelines by benign gynecologic surgeons at an academic, tertiary-care women's hospital [Meeting Abstract]
Stewart, L E; Shah, N; Sung, V W
Objectives: Strong evidence supports the benefits of restrictive blood transfusion policies in non-cardiac surgery and national guidelines were adapted nearly a decade ago to recommend changes such as restrictive hemoglobin (hgb) thresholds and single unit transfusion. Whether these changes have modified transfusion practices in benign gynecologic surgery remains unclear as rates of perioperative transfusion remain high compared to other surgical specialties. We aimed to describe perioperative transfusion practices in benign gynecologic surgery at an academic, tertiary care women's hospital in order to assess adherence to national guidelines.
Material(s) and Method(s): We conducted an IRB-approved, retrospective case series including all planned, benign gynecologic surgeries between January 2013 and December 2017 with patients aged >18 years who received intra- or postoperative red blood cell transfusion. Patients were excluded if they had a preoperative diagnosis of gynecologic malignancy and if the primary procedure was emergency/unplanned or for an obstetrical indication. In line with national guidelines, acceptable indications for transfusion were hypotension and/or tachycardia not responsive to fluid resuscitation, suspected ongoing blood loss, hgb <7 g/dL or symptomatic anemia with hgb <8 g/dL. Demographic, clinical factors, surgical and postoperative details were abstracted from the medical record. Descriptive statistics were performed to describe transfusion practices.
Result(s): A total of 208 patients met criteria and received transfusion of >1 unit of allogeneic packed red blood cells (PRBC's) during the study period. Mean age was 46.5 (SD = 11.8) years, mean BMI was 30.8 (SD = 8.52) kg/m2. Of the surgeries performed, 147 (71.2%) involved a hysterectomy and 135 (64.6%) involved laparotomy. Median estimated blood loss was 700 mL (IQR = 300-1300 mL). Mean pre-transfusion hgb was 7.53 g/dL (SD = 1.66 g/dL). Forty-six (22.5%) patients had no documented or identifiable indication for transfusion in the medical record. Patients received a mean of 2.6 units of PRBC's and only 20 (9.5%) patients received the recommended single unit of PRBC's with reassessment of hgb prior to additional transfusion. Thirty-seven (17.8%) patients were transfused without measurement of a pre-transfusion hgb; of these, 0 had documented hemodynamic changes to indicate urgent transfusion, 35 (94.5%) received >1 unit PRBC's, 34 (91.9%) had a post-transfusion hgb >9 g/dL, and 23 (62.2%) had a post-transfusion hgb >10 g/dL.
Conclusion(s): Evidence-based utilization of allogeneic blood products can be improved in benign gynecologic surgery. Initial interventions could be focused on increasing the rate of single-unit red cell transfusion and mandating objective assessment of hemoglobin/hematocrit prior to red cell administration in hemodynamically stable patients.
40 Ultrasound evaluation for hydronephrosis in advanced pelvic organ prolapse: A cost effectiveness analysis [Meeting Abstract]
Siddique, M; Wang, R; Stewart, L; Harvie, H
Objectives: Hydronephrosis (HN) has been observed in up to 33% of patients with any stage of pelvic organ prolapse (POP) and as many as 66% of patients with stage IV POP. The exact mechanism of this association is not known but most theories involve extrinsic compression of the ureters due to the distorted anatomic relationships seen in POP. Left untreated, HN can lead to permanent renal impairment. Because POP treatment reverses HN in the majority of cases, screening for HN in patients with advanced (POP-Q stage III-IV) POP may help guide management decisions. We aimed to evaluate the cost-effectiveness of renal ultrasound (US) to screen for HN compared with usual care in patients with advanced POP.
Material(s) and Method(s): We designed a decision tree model from the healthcare sector perspective to compare costs (2019 U.S. dollars) and effectiveness (quality-adjusted life-years (QALY) of HN screening using renal US versus usual care in patients with advanced POP. Our primary outcome was the incremental cost-effectiveness ratio (ICER), defined as (screening cost - usual care cost)/(screening QA
37 The latzko procedure: A classic approach to vesicovaginal fistula repair [Meeting Abstract]
Brandon, C A; Stewart, L E; Hall, E; Siddique, M; Wohlrab, K
Objective: The objective of this video is to review the Latzko partial colpocleisis procedure for the management of vesicovaginal fistula. Description: The Latzko procedure, inspired by partial vaginectomies, is a low morbidity, simple, highly effective technique for repair of vesicovaginal fistula. This video considers several key aspects to ensure successful repair. First, optimal patient selection is necessary, paying particular attention to vaginal length for sexually-active women, exposure and descensus of tissue, and distance from the ureteral orifices to avoid the need for potential ureteral reimplantation. Second, helpful tips to assist with the procedure include maximizing exposure and access through the use of a pediatric foley catheter or stay sutures and adequate retraction of surrounding vaginal tissue. Wide denudement of vaginal epithelium is crucial to reapproximate the vesicovaginal adventitia in multiple imbricating tiers to disperse tension across multiple layers. Postoperative considerations are also addressed, including duration of bladder drainage, the use of post-operative antibiotics, and the need for a cystogram to confirm healing. Success rates following a Latzko closure are greater than 90% on the first repair.
Conclusion(s): The Latzko partial colpocleisis is an effective, minimally invasive, versatile, and safe vaginal approach to vesicovaginal fistula repair.
Impact of Cystotomy Location on Cystography Results
Napoe, Gnankang Sarah; Stewart, Lauren E; Myers, Deborah L
OBJECTIVES/OBJECTIVE:This study aimed to determine if the location of a repaired bladder injury (trigone vs dome) impacts the probability of an abnormal cystography result in obstetric/gynecologic surgical patients undergoing repair of an unanticipated cystotomy. METHODS:We conducted a retrospective review of adult obstetric and gynecologic surgical patients who underwent cystographic evaluation of bladder integrity after repair of iatrogenic cystotomy at a single institution between January 2006 and July 2018. We excluded patients who had undergone repair of genitourinary fistula or urethral diverticulum. Patients were dichotomized into 2 groups based on the location of the repaired bladder injury: trigone versus dome. Fisher exact and Student t tests were used to determine the proportion of abnormal cystogram results and factors associated with an abnormal cystography result. RESULTS:Two hundred ten cases met the inclusion criteria: 176 in the dome group and 34 in the trigone group. When comparing the dome and trigone groups, respectively, mean age (45.2 Â± 12.5 vs 48.4 Â± 11.2 years) and cystotomy size (3.2 Â± 3.2 vs 2.2 Â± 2.4 cm) were comparable. Duration of postoperative bladder catheterization was longer in the trigone group (13.7 vs 12.1 days, P = 0.03). Despite the additional bladder drainage, there were more abnormal cystogram results in the trigone group versus the dome (8.8% vs 1.1%; odds ratio, 8.4). CONCLUSIONS:A repaired cystotomy at the trigone is associated with increased odds of an abnormal cystography result. An abnormal cystography result after repair at the bladder dome is rare.
Perceptions of risk and reward in BRCA1 and BRCA2 mutation carriers choosing salpingectomy for ovarian cancer prevention
Ghezelayagh, Talayeh S; Stewart, Lauren E; Norquist, Barbara M; Bowen, Deborah J; Yu, Vivian; Agnew, Kathy J; Pennington, Kathryn P; Swisher, Elizabeth M
Salpingectomy with interval oophorectomy has gained traction as an ovarian cancer prevention strategy, but is not currently recommended for high risk women. Nevertheless, some choose this approach. We aimed to understand risk perception and plans for oophorectomy in BRCA1 and BRCA2 (BRCA) mutation carriers choosing salpingectomy for ovarian cancer prevention. This was a longitudinal survey study of BRCA mutation carriers who underwent bilateral salpingectomy to reduce ovarian cancer risk. An initial written questionnaire and telephone interview was followed by annual phone interviews. 22 women with BRCA mutations were enrolled. Median follow-up was three years. The median age at salpingectomy was 39.5 years (range 27-49). Perceived lifetime ovarian cancer risk decreased by half after salpingectomy (median risk reduction 25%, range 0-40%). At final follow-up, five (22.7%) had undergone oophorectomy and five women (22.7%) were not planning to undergo completion oophorectomy. BRCA mutation carriers who had salpingectomy after the recommended age of prophylactic surgery (vs. before the recommended age) were less likely to plan for future oophorectomy (28.6% vs. 66.7%, pâ€‰=â€‰0.037). All women were satisfied with their decision to undergo salpingectomy with eighteen (81.8%) expressing decreased cancer-related worry. There were no diagnoses of ovarian cancer during our study period. In conclusion, most BRCA mutation carriers undergoing risk-reducing salpingectomy are satisfied with their decision and have lower risk perception after salpingectomy, though some older mutation carriers did not plan on future oophorectomy. Salpingectomy with delayed oophorectomy in BRCA mutation carriers remains investigational and should preferably be performed within a clinical trial to prevent introduction of an innovation before safety has been proven.
Stress Urinary Incontinence Surgery in Washington State Before and After Introduction of the Mesh Midurethral Sling
Stewart, Lauren E; Eston, Michelle A; Symons, Rebecca G; Fialkow, Michael F; Kirby, Anna C
OBJECTIVES:Mesh midurethral slings (MUSs) are safe, effective treatments for female stress urinary incontinence (SUI), but many companies have ceased production because of controversies surrounding transvaginal mesh. To determine if introduction of MUS has increased the complication rate associated with SUI surgery, we compared women undergoing SUI surgery in the MUS era to those who had surgery prior its introduction. METHODS:This was a retrospective cohort study of a statewide hospital discharge database. Stress urinary incontinence surgeries from 1987 to 1996 and 2007 to 2013 were identified using International Classification of Diseases, Ninth Revision codes. RESULTS:A total of 30,723 SUI surgeries were performed during the study periods. After 2006, slings accounted for 91.8% of SUI surgeries. Patients were older (54.5 vs 53.0 years, P < 0.001) and sicker (22.6% vs 9.7% had â‰¥1 comorbid condition, P < 0.0001). Blood transfusion was more common in the MUS era (1.2% vs 0.4%, P < 0.001) however, other complications were either similar between groups or less common in the MUS era including 30-day readmission (2.5% vs 2.4%, P = 0.543), reoperation for urinary retention (0.1% vs 0.2%, P < 0.0375), and wound infection (0.1% vs 0.5%, P < 0.001), despite more concomitant prolapse surgeries (69.0 vs 26.9%, P < 0.001) and hysterectomies (53.0 vs 35.4%, P < 0.001) in the MUS era. Hospital stays were shorter after 2006 (1.0 vs 3.0 days, P < 0.001), and fewer women required reoperation for SUI within 2 years (0.5% vs 1.8%, P < 0.001). CONCLUSIONS:Following introduction of MUS, women who underwent SUI surgery were slightly older with more medical comorbidities yet did not appear to experience increased surgical complications. Fewer women underwent reoperation for recurrent SUI, and hospital stays were shorter, suggesting an improvement in care. This study supports the continued availability and use of MUSs.