Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Controlled Trial.

OBJECTIVE: To compare postoperative urinary retention rates in the early postoperative period between home and office catheter removal. Secondary outcomes included pain, difficulty, satisfaction, likelihood to use again, and health care utilization. METHODS: We conducted a nonblinded, randomized controlled, noninferiority trial of women undergoing surgery for stress incontinence and prolapse from March 2021 to June 2022. Exclusion criteria were preoperative voiding dysfunction (need for self-catheterization or postvoid residual [PVR] greater than 150 mL), urethral bulking, and need for prolonged postoperative catheterization. Participants discharged with indwelling catheters because of an initial failed void trial were randomized 1:1 to home compared with office removal on postoperative day 3-4. For home removal, participants were instructed to remove the catheter at 7 am and to drink two glasses of water. If they had difficulty voiding 5 hours after catheter removal, they came to the office for a void trial. For office removal, participants returned for a backfill void trial with PVR assessment. Our primary outcome was rate of early postoperative urinary retention , defined as confirmed retention (PVR greater than half the voided volume) after catheter removal. Secondary outcomes were assessed at a 2-week call. Health care utilization (telephone calls and office visits) related to catheter issues was also assessed. At 80% power and α=0.05, we needed 100 participants (50/group) to detect a noninferiority margin of 11%. RESULTS: Among 117 participants, the home (n=59) and office (n=58) removal groups were similar in mean age (60 years vs 61 years), mean body mass index (29 vs 30), pelvic organ prolapse quantification system stage 3 or 4, and proportion who underwent hysterectomy or apical suspension. Sling procedures were more common in the office group (45.8% vs 77.6%). For our primary outcome, the rate of early postoperative retention was 11.9% in the home group and 22.4% in the office group ( P =.13). Our predetermined noninferiority margin was greater than the upper bound of our 95% CI; thus, we conclude noninferiority of home removal. For secondary outcomes, the home removal group was more likely to report "no pain" ( P =.02) and "very likely" to use this method again ( P =.004). There were no differences in difficulty or satisfaction between groups. Number of nursing calls was not different ( P =.66); however, number of office visits was higher in the office group (median 0 [interquartile range 0-1] vs 1 [1-1], P <.001). CONCLUSION: Postoperative urinary catheter removal by the patient at home was noninferior to office removal when early urinary retention rates were compared. Participants in the home removal group had fewer office visits and reported low pain, low difficulty, and high satisfaction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT04783012.

Are Formal Voiding Trials Necessary After Posterior Compartment Reconstructive Surgery?

IMPORTANCE: Posterior compartment surgery is considered a risk factor for postoperative urinary retention because of the impact of postoperative pain on the pelvic floor; however, few studies have examined the association between posterior compartment reconstructive surgery and urinary retention. OBJECTIVE: The aim of the study was to compare rates of urinary retention in patients undergoing vaginal reconstructive surgery, without hysterectomy, in the posterior compartment only versus any apical and/or anterior compartment (with or without posterior compartment). STUDY DESIGN: In this retrospective cohort study, we evaluated patients who underwent surgery, without hysterectomy, in the posterior compartment only versus any apical and/or anterior compartment (with or without posterior compartment) from January 2015 to November 2020. Our primary outcome was rate of postoperative urinary retention, defined as a failed voiding trial before discharge. Secondary outcome was days of catheterization. Multivariable logistic regression was performed to assess variables associated with a failed voiding trial. RESULTS: Of 362 patients, 141 (39.0%) underwent surgery in the posterior compartment only and 221 (61.0%) underwent vaginal apical and/or anterior compartment surgical procedures. Rate of retention was significantly lower in the posterior compartment only group (9.9% vs 41.6%, P < 0.001). The median numbers of days of catheterization were significantly fewer in the posterior compartment only group (0 [0,0] vs 0 [0,3], P < 0.001). In multivariable logistic regression, posterior compartment only surgery was associated with passing the voiding trial (odds ratio, 6.0; 95% confidence interval, 2.97-12.03). CONCLUSIONS: Rates of postoperative urinary retention after surgery in the posterior compartment are low, and these patients may not require formal voiding trials after surgery.

A Randomized Clinical Trial Comparing the Efficacy and Safety of 2% Versus 4% Chlorohexidine Gluconate for Surgical Preparation of the Vagina.

IMPORTANCE: There have been no studies comparing 2% and 4% chlorhexidine gluconate (CHX) for vaginal surgical site preparation despite both commonly being used. OBJECTIVES: The primary objective was to assess the noninferiority of 2% CHX versus 4% CHX to reduce bacterial contamination rates at 60 minutes after surgical preparation of the vagina. Secondary objectives were to assess differences in colony-forming units and the sensation of postoperative vaginal burning and pain. STUDY DESIGN: This is a single-blinded randomized controlled trial of women who underwent vaginal prolapse surgery. Study participants were randomized into 2 groups: 2% CHX versus 4% CHX. Two vaginal bacterial cultures were collected: (1) preoperatively before vaginal preparation and (2) intraoperatively at 60 minutes. A questionnaire on vaginal pain and burning was administered preoperatively and postoperatively. For our sample size, assuming that 2% CHX would have double the contamination rate of 4% CHX, 26 participants were needed per group to demonstrate noninferiority. RESULTS: Sixty-one women participated in the study. There were no differences in baseline demographics, length of surgery, or surgical procedures. For our primary outcome, the postpreparation contamination rates were 7% for 2% CHX versus 10% for 4% CHX, with a difference of 3% ( P = 0.52). This difference did meet the criteria for noninferiority. Secondary outcomes were not different between groups. CONCLUSIONS: Two percent CHX is noninferior to 4% CHX in reducing vaginal bacterial contamination at 60 minutes after vaginal surgical site preparation, with low rates of postpreparation contamination and vaginal discomfort.

Cost-effectiveness of agents used for evaluation of ureteral patency during intraoperative cystoscopy in gynecologic and urogynecologic surgery.

BACKGROUND: Intraoperative evaluation of ureteral patency is often performed in gynecologic and urogynecologic surgery. Many agents are used to help assess the patency, each with its own associated cost, ease of use, and adverse reactions. Some agents, such as dextrose, are used as an instillation fluid to create a viscosity difference and aid the visualization of a ureteral jet. Others, such as oral phenazopyridine or the intravenous use of sodium fluorescein and indigo carmine, cause a color change of the urine to directly aid the visualization of ureteral jets. Recently, numerous studies have examined the efficacy and surgeon satisfaction of these agents. The studies have also emphasized certain options as associated with a lower cost. However, there have not been any cost studies comparing these agents. OBJECTIVE: To compare the cost-effectiveness of the following 4 agents that are commonly used in assessing ureteral patency intraoperatively: oral phenazopyridine, dextrose instillation, intravenous sodium fluorescein, and intravenous indigo carmine. STUDY DESIGN: We constructed a decision-analytic model to compare cystoscopy using oral phenazopyridine, dextrose instillation, intravenous sodium fluorescein, and intravenous indigo carmine. Failure to see efflux resulted in work-ups for ureteral obstruction. The probabilities were obtained from published studies, and the probability of successfully seeing efflux ranged from 0.92 with oral phenazopyridine to 0.99 with intravenous indigo carmine. The costs of the agents, adverse effects, and ureteral obstruction work-ups were obtained from the University of North Carolina at Chapel Hill Department of Pharmacy, the Healthcare Cost and Utilization Project 2016 database and the FAIR Health Consumer database. The cost of a ureteral obstruction work-up used in our model ranged from $9755 for intraoperative evaluation with retrograde pyelograms and stents to $29,034 for hospitalization. Our primary outcome was the incremental cost-effectiveness ratio per unnecessary work-up for ureteral obstruction avoided. Sensitivity analyses were performed to identify the key uncertainties. RESULTS: Oral phenazopyridine, followed by an intravenous agent if needed, had a mean cost of $110 per patient. Dextrose averaged $151 more per patient, with only a slight improvement in avoiding unnecessary ureteral obstruction work-ups and a higher cost associated with adverse reactions (incremental cost-effectiveness ratio, $62,000). Intravenous agents cost approximately $1000 more per patient and were less effective at preventing unnecessary work-ups. Sensitivity analyses did not identify any thresholds that would significantly change the outcomes. CONCLUSION: Our model suggests that oral phenazopyridine and dextrose instillation are the least expensive and the most effective agents to aid in the visualization of ureteral patency during intraoperative cystoscopy, although dextrose is associated with higher costs owing to a higher rate of adverse reactions (primarily urinary tract infections). Intravenous sodium fluorescein and indigo carmine are historically popular first-choice agents. However, they were found to be more expensive and less effective as primary agents in our model and should likely be reserved for use as secondary agents in the event that the visualization of ureteral jets is unclear with the initial use of phenazopyridine or dextrose.

Assessing pelvic organ prolapse recurrence after minimally invasive sacrocolpopexy: does mesh weight matter?

INTRODUCTION AND HYPOTHESIS: There has been a trend toward the use of ultra-lightweight mesh types for minimally invasive sacrocolpopexy. We hypothesized that ultra-lightweight mesh would have a greater proportion of composite anatomical pelvic organ prolapse recurrence than lightweight mesh. METHODS: Retrospective cohort study of minimally invasive sacrocolpopexies at two academic institutions from 2009 to 2016. Our primary outcome was composite anatomical prolapse recurrence, defined as prolapse beyond the hymen or retreatment with pessary or surgery, compared between ultra-lightweight (≤21 g/m2 [range 19-21]) and lightweight (>21 g/m2 [range 35-50]) mesh types. We assessed time to prolapse recurrence using Kaplan-Meier and Cox regression. RESULTS: The cohort consisted of 1,272 laparoscopic (n = 530, 41.7%) and robotic-assisted sacrocolpopexies (n = 742, 58.4%). Lightweight mesh was used in 745 procedures (58.6%) and ultra-lightweight mesh in 527 (41.4%). The lightweight mesh had longer median follow-up than the ultra-lightweight group (344 [IQR 50-670] vs 143 days [IQR 44-379], p < 0.01). There was no difference in composite anatomical prolapse recurrence between lightweight and ultra-lightweight mesh (54 [7.2%] vs 35 [6.6%], p = 0.68). Ultra-lightweight mesh demonstrated a shorter time to prolapse recurrence (p < 0.01), which remained significant on multivariate Cox regression (HR 2.38 [95% CI 1.47-3.87]). The lightweight mesh had significantly more mesh complications (43 [5.8%] vs 7 [1.3%], p < 0.01). CONCLUSIONS: Ultra-lightweight mesh for minimally invasive sacrocolpopexy was not associated with a higher proportion of composite anatomical prolapse recurrence; however, it was associated with a shorter time to recurrence. Longer follow-up is needed to assess the clinical importance of this finding, particularly given the trade-off of more complications with lightweight mesh.

Does Mesh Weight Affect Time to Failure After Robotic-Assisted Laparoscopic Sacrocolpopexy?

OBJECTIVE: The objective of this study was to compare time to anatomic failure after robotic sacrocolpopexy with use of ultralightweight versus heavier weight mesh types. METHODS: We performed a retrospective cohort study of women who underwent robotic sacrocolpopexy, from January 2012 to September 2016. We compared (1) sacrocolpopexy with ultralightweight mesh (≤20 g/m) versus (2) sacrocolpopexy with heavier weight mesh (≤35 g/m). Our primary outcome was time to anatomic failure, defined as recurrent prolapse beyond the hymen, or retreatment for prolapse with surgery or pessary. Secondary outcomes were compartment of failure and mesh exposure. Cox proportional hazards modeling was used to estimate the hazard of failure based on mesh type. RESULTS: Of 461 patients, 248 (53.8%) underwent sacrocolpopexy with ultralightweight mesh and 213 (46.2%) with heavier weight mesh. Failures occurred in 37 women, with 21 in the ultralightweight mesh group and 16 in the heavier weight mesh group. Time to failure was statistically significant between groups (P = 0.03). Ultralightweight mesh had twice the hazard of failure within 3 years compared with heavier weight mesh (hazard ratio, 2.15; 95% confidence interval, 1.10-4.21; P = 0.03). Among failures, use of ultralightweight mesh was associated with almost 5 times the hazard of anterior compartment failure (hazard ratio, 4.46; 95% confidence interval, 1.39-14.27; P = 0.01). There was no difference in time to posterior failure. Of 17 mesh exposures, there were fewer in the ultralightweight mesh group, although this group was followed for less time (1.6% ultralightweight vs 6.0% heavier weight, P = 0.01). CONCLUSIONS: Women receiving ultralightweight mesh are more likely to experience earlier anatomic failure in the anterior compartment.

Robotic-assisted sacrocolpopexy: early postoperative outcomes after surgical reduction of enlarged genital hiatus.

BACKGROUND: Currently, the decision to perform a concurrent posterior repair/perineoplasty at the time of robotic-assisted sacrocolpopexy is not standardized. OBJECTIVE: We sought to compare anatomic failure after robotic-assisted sacrocolpopexy among 3 groups of patients categorized by their preoperative and postoperative genital hiatus size. STUDY DESIGN: We performed a retrospective cohort study of women who underwent robotic-assisted sacrocolpopexy, from January 2013 through September 2016. We defined a wide genital hiatus as ≥4 cm and a normal genital hiatus as <4 cm. We compared 3 groups: (1) wide preoperative and postoperative genital hiatus (persistently wide); (2) wide preoperative and normal postoperative genital hiatus (improved); and (3) normal preoperative and postoperative genital hiatus (stably normal). Our primary outcome was composite anatomic failure defined as either recurrent prolapse in any compartment past the hymen or retreatment for prolapse with either surgery or pessary. Our data were analyzed using 1-way analysis of variance and χ2 test. Logistic regression was performed to evaluate for independent risk factors for anatomic failure among the 3 groups. P < .05 was considered significant. RESULTS: Our study population consisted of 452 women with a mean age of 59.3 ± 10.0 years and a mean body mass index of 27.8 ± 5.3 kg/m2. Of the women with reported race, 394/447 (88.1%) were white. The genital hiatus groups were distributed as follows: 57 (12.6%) were persistently wide, 296 (65.5%) were improved, and 99 (21.9%) were stably normal. The stably normal group had less advanced preoperative prolapse (stage ≥3) than the other groups (P < .01). A similar percentage of patients among groups had a concomitant posterior repair/perineoplasty (P = .09) with a total of 84 (18.6%) women undergoing this procedure. There was a statistically significant difference in overall composite anatomic failure among the groups (P = .03). There was an increase in failure in the persistently wide group (14.0%) compared to the improved group (5.7%, P = .04) and compared to the stably normal group (4.0%, P = .03). In a logistic regression model, controlling for number of vaginal deliveries and posterior repair/perineoplasty, there was a 5.3-fold increased odds of composite anatomic failure in the persistently wide group (adjusted odds ratio, 5.3; 95% confidence interval, 1.4-19.1; P = .01) compared to the stably normal group. In a subanalysis of failure by compartment, there was an increase in failure of the posterior compartment in the persistently wide group compared to the improved group (8.8% vs 2.0%, P < .01), but not the stably normal group (3.0%, P = .12). There was not a statistically significant difference in failure of the combined apical and anterior compartments among groups (P = .29). CONCLUSION: Surgical reduction of an enlarged preoperative genital hiatus decreases early composite anatomic failure, after robotic sacrocolpopexy, specifically related to the posterior compartment. Studies investigating the correlation of intraoperative measurement of genital hiatus to postoperative genital hiatus are needed to help clinicians determine who may benefit from a concomitant posterior repair/perineoplasty at the time of robotic-assisted sacrocolpopexy.