Methenamine Hippurate With Cranberry Capsules Versus Cranberry Alone for Urinary Tract Infection Prevention in a Short-Term Indwelling Foley Catheter Population After Urogynecologic Surgery: A Double-Blinded Randomized Controlled Trial.

IMPORTANCE: There is little consensus on an effective nonantibiotic agent for the prevention of urinary tract infection (UTI) after pelvic reconstructive surgery. OBJECTIVE: The aim of the study was to investigate the impact of methenamine hippurate with cranberry capsules on rates of UTI after pelvic reconstructive surgery, among patients requiring short-term catheterization. STUDY DESIGN: In this randomized, double-blinded placebo-controlled trial, patients discharged with a catheter after pelvic reconstructive surgery were approached to participate. Participants were randomized to receive cranberry with methenamine or cranberry with placebo. Primary outcome was number of UTIs treated within 1 week after surgery. Secondary outcomes included incidence of UTIs treated within 6 weeks postoperatively, bacterial species on culture, urinary pH, catheter duration, patient adherence, and satisfaction. A sample size of 88 participants per arm was planned. RESULTS: From June 2019 to July 2021, 185 patients were randomized and 182 analyzed; 89 received placebo and 93 received methenamine. Both groups were similar. Incidence of UTI at 1 week was significantly higher in the placebo group (79.8%) compared with the methenamine group (66.7%; odds ratio, 1.97; 95% confidence interval, 1.01-3.87; P = 0.048). This difference increased by 6 weeks postoperatively (89.9% vs 72.0%; odds ratio, 3.45; 95% confidence interval, 1.51-7.87; P = 0.003). There were fewer pseudomonal UTIs in the methenamine group (P = 0.041). Duration of catheterization and urinary pH were similar. Overall adherence and level of satisfaction was high. CONCLUSIONS: In this high-risk population, methenamine was well tolerated and significantly reduced UTI rates. Methenamine with cranberry should be considered as an effective prophylactic therapy to reduce this common complication after pelvic surgery.

Chlorhexidine Versus Iodine for Vaginal Preparation Before Hysterectomy: A Randomized Clinical Trial.

OBJECTIVE: The American College of Obstetricians and Gynecologists does not provide a recommendation regarding the preferred vaginal preparation solution. We intended to compare the effectiveness of chlorhexidine versus iodine in decreasing vaginal bacterial counts. METHODS: In this institutional review board-approved study, participants undergoing total hysterectomy via vaginal or laparoscopic approach were randomized to 4% chlorhexidine or 10% iodine for presurgical vaginal preparation. Swabs were collected from the vaginal mucosa before, then 30, 60, and 90 minutes after preparation. Our primary outcome was the number of positive cultures (≥5,000 bacteria) at 90 minutes. The secondary outcomes included the presence of selected pathogens, postoperative complications, and infections. The sample size of 71 per arm was calculated using ɑP = 0.05, 80% power, and anticipating a 22% difference in positive cultures. RESULTS: Between May 2018 and August 2019, 85 participants were randomized. The average age was 59.8 years (SD, 11.4), and the median Charlson Comorbidity Index score was 2 (minimum, 0; maximum, 6). Baseline bacterial counts were similar in both groups. Chlorhexidine demonstrated a lower percentage of positive cultures at 90 minutes (47.6% vs 85.4%; odds ratio, 10.6; P = 0.001). In addition, the median bacterial count in the chlorhexidine group was significantly lower than the iodine group (3,000 vs 24,000 colony-forming units, P < 0.001) at 90 minutes. No surgical site infections were identified in either group during the 30-day postoperative period, and there were no reported adverse reactions to either solution. CONCLUSIONS: Chlorhexidine resulted in substantially lower bacterial counts after preparation compared with iodine. Gynecologic surgeons may consider switching to 4% chlorhexidine for vaginal preparation before hysterectomy.

Utilization of a Mirror During Pelvic Examinations: Does it Improve the Patient's Experience?

OBJECTIVE: This study was conducted to assess the utility of a mirror in improving pain and vulnerability during a pelvic examination. METHODS: In this prospective, institutional review board-approved, 2-cohort trial, all "new" patients presenting to a urogynecology office were offered to have a mirror or no-mirror present during their pelvic examination. Patients completed 100-mm visual analog scales regarding pain, anxiety, knowledge, control, embarrassment, and vulnerability before and after examination. The primary outcome was difference in level of pain and vulnerability between groups. Secondary outcomes included comparisons from baseline to postexamination scores within groups, patient satisfaction, and examination duration. A sample size of 68 participants in each arm was planned. RESULTS: From April 2019 to May 2020, 147 participants were enrolled. Two participants were excluded, 145 were included in the final analysis; 74 in the no-mirror group and 71 in the mirror group. The average age was 55.9 (±13) years, and the groups were overall similar. There was no difference in primary outcomes of pain or vulnerability, but the mirror group showed improved levels of control (P = 0.006) and knowledge (P = 0.018) following examination. All participants reported high satisfaction, and those that selected a mirror reported strong preference for future use. CONCLUSIONS: Patients who chose to use the mirror did not demonstrate a difference in pain or vulnerability scores; however, they exhibited benefit to their sense of control and knowledge after the pelvic examination. Although the mirror did not benefit all patients, this is a simple option that could improve the examination experience for some.Clinical Trial Registration:ClinicalTrials.gov, NCT03785548.

The influence of postoperative environment on patient pain and satisfaction: a randomized trial.

BACKGROUND: Improving the patient experience, controlling pain with nonopiate therapies, and preparing for value-based reimbursement are increasingly important foci for both physicians and hospitals. OBJECTIVE: We aimed to determine whether the addition of music and a natural landscape image to postoperative hospital rooms would result in improved pain and satisfaction scores among inpatients undergoing pelvic reconstructive surgery. STUDY DESIGN: This randomized controlled trial was approved by an Institutional Review Board. Eligible candidates were 18-85 years old, English speaking, and scheduled to undergo native tissue vaginal vault suspension for symptomatic pelvic organ prolapse. Patients with history of a chronic pain or substance abuse were excluded. Subjects were advised that the purpose of the study was to assess the effect of changes to the hospital environment on patient experience but were blinded to their group and intervention details. Changes included a landscape image mounted to the wall and access to a speaker with preprogrammed music selections. The intervention group was instructed to listen to their preferred music for a minimum of 2 30-minute sessions postoperatively. The control group had a standard hospital room, without music or landscape. All patient rooms were private. The primary outcome was the visual analog scale for pain in the morning of postoperative day 1. Secondary outcomes included narcotic use, likelihood to refer family to the same hospital facility, satisfaction with care and the hospital, and perception of a healing environment. A sample size of 43 subjects per arm was calculated to detect a difference of 10 mm in visual analog scale pain score. RESULTS: A total of 133 subjects were enrolled; primary outcome data were available for 92 (46 per arm). The mean age was 63.8 (standard deviation, 9.5) years, median Charlson comorbidity score was 2 (min, 0; max, 7), and 94.6% of subjects were white. On postoperative day 1, median visual analog scale pain scores were low (28.8 mm [0, 86]; 24.5 mm [0, 81]) and did not differ between intervention and control, respectively (P=.57). Total morphine equivalents (P=.817) and nursing pain scores (P=.774) were also similar. However, the intervention group displayed a higher likelihood to refer family members to the hospital (98 mm (47, 100); 96 mm (65, 100); P=.037). At postoperative 2 weeks, the intervention group indicated higher satisfaction with their care (98 mm, (34, 100); 95 mm (42, 100); P=.032), the hospital (98 mm (71, 100); 94 mm (6, 100); P=.004), and the healing environment provided during their stay (98 mm; 92 mm (19, 100); P=.020) than those in the standard hospital rooms. CONCLUSION: In this randomized trial, we found music and landscape imagery did not substantially affect postoperative pain scores; however, they had a positive effect on the postoperative experience. Furthermore, this effect appeared to broaden 2 weeks after surgery. Given the importance of value-based care, interventions such as these should be emphasized to enhance patient satisfaction, quality scores, and overall well-being.

Self-Removal of a Urinary Catheter After Urogynecologic Surgery: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether self-discontinuation of a transurethral catheter is noninferior to office discontinuation in patients requiring indwelling catheterization for postoperative urinary retention after pelvic reconstructive surgery. METHODS: In this randomized noninferiority trial, patients with postoperative urinary retention after pelvic reconstructive surgery were assigned to self-discontinuation or office discontinuation of their catheter 1 week after surgery. The primary outcome was a noninferiority comparison of postoperative urinary retention at 1 week. Self-discontinuation patients were instructed on home catheter removal on postoperative day 7. Office discontinuation patients underwent a standard voiding trial on postoperative day 6-8. Postoperative urinary retention at 1 week was defined as continued catheterization on postoperative day 6-8. Secondary outcomes included urinary tract infections (UTI), residual volume at 2 weeks, duration of catheter use, recurrent postoperative urinary retention, number of patient encounters, and visual analog scales (VAS) regarding patient experience. Given a known incidence of postoperative urinary retention at 1 week (16%) and 15% noninferiority margin, a sample size of 74 per group (n=148) was planned. RESULTS: From January 2017 through March 2019, 217 women were screened and 157 were analyzed: 78 self-discontinuation and 79 office discontinuation. Demographic characteristics and surgeries performed were similar. Eleven patients in each group experienced postoperative urinary retention at 1 week (14.1% self-discontinuation vs 13.9% office discontinuation, P=.97), establishing noninferiority (difference 0.2%, 95% CI: -1.00, 0.10). There were significantly fewer patient encounters with self-discontinuation (42/78, 53.8% vs 79/79, 100%). Self-discontinuation patients demonstrated better VAS scores regarding pain, ease, disruption, and likelihood to use the same method again (all P<.05). Though the rate of UTI was high, there was no difference between groups (59.0% self-discontinuation vs 66.7% office discontinuation, P=.32). Residual volume at 2 weeks, recurrent postoperative urinary retention, and duration of catheter use were also similar. CONCLUSION: Self-discontinuation of a transurethral catheter was noninferior to office-based discontinuation in the setting of postoperative urinary retention after pelvic reconstructive surgery. Self-discontinuation resulted in fewer patient encounters and improved patient experience. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02996968.

Uterosacral Ligament Suspension Versus Robotic Sacrocolpopexy for Treatment of Apical Pelvic Organ Prolapse.

OBJECTIVE: The aim of the study was to compare long-term outcomes of uterosacral ligament suspension (USLS) versus robotic sacrocolpopexy (RSC) in patients with pelvic organ prolapse. METHODS: This was an institutional review board-approved retrospective cohort study. Women 3 to 7 years after USLS or RSC were contacted for enrollment. Participants were asked to complete validated questionnaires and physical examinations. The primary outcomes were no symptoms of bulge or retreatment for prolapse (subjective) and POP-Q examination demonstrating prolapse above or equal to -1 (objective). For the subjective outcome, a noninferiority calculation with 10% noninferiority margin deemed 91 subjects in each group were required. RESULTS: We identified the following 770 eligible subjects: 205 were contacted, 19 declined, 186 subjects agreed to participate, and 2 were excluded. There were 92 subjects per group in the analysis for the primary subjective outcome, and 84% underwent examinations for the objective outcome. Baseline characteristics were overall similar; however, previous prolapse surgery was more common in the RSC group (P < 0.001). Subjective success was achieved in 83 subjects in the USLS group and 78 subjects in the RSC group (90.2% vs 84.4%, respectively, P = 0.265 [95% confidence interval = -0.036 to 1.000]). Objective success was noted in 93.2% and 91.3% of the USLS and RSC groups, respectively (P = 0.869). Postoperative complication rates were low and did not differ between groups. Mesh complications were noted in 6.6% of the RSC group. One subject in the USLS group reported pain related to surgery. CONCLUSION: Uterosacral ligament suspension was noninferior to RSC at 3- to 7-year postsurgery for subjective symptoms and similar for objective outcomes. Both approaches showed high success rates and strong patient satisfaction.

Relationship between pin type and depth of skull penetration during frame placement for Gamma Knife radiosurgery.

PURPOSE: Our retrospective study addresses the largely unknown effect of fixation pin type on depth of skull penetration during Gamma Knife frame placement. METHODS: Absolute and relative depths were compared for 404 pins of aluminum and titanium in 101 patients who underwent Gamma Knife frame placement at 0.4 Nm (3.5 lb-in) torque. RESULTS: Effect of pin type was significant: penetration was less in aluminum than titanium pins, for absolute (0.27 mm vs. 0.83 mm) and relative (5.16% vs. 15.53%) depths (p < 0.001 each). Fifty percent of aluminum pins did not measurably penetrate the outer table of the skull whereas 95% of titanium pins penetrated into cancellous bone. CONCLUSIONS: Although these pin penetration differences did not have a clear clinical correlate, we now recommend titanium pins for their consistent, deeper penetration, which may result in greater frame stability favorable for most clinical applications. Future studies may define optimal torque for aluminum pins.