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.

Primary care providers' experience, management, and referral patterns regarding pelvic floor disorders: A national survey.

INTRODUCTION AND HYPOTHESIS: Primary care physicians can impact womens' access to care. We assessed primary care providers' experience and management regarding pelvic floor disorders. METHODS: This Institutional Review Board approved study invited internal and family Medicine Program Directors to complete and distribute to faculty an online survey designed to query demographics, perceptions, management, and referral patterns regarding urinary incontinence (UI), overactive bladder (OAB), and pelvic organ prolapse (POP) in females. RESULTS: A total of 872 residency Program Directors were invited: 74 emails were incorrect; 391 physicians responded. Respondents were evenly distributed with respect to age, gender, and region. The majority practiced family Medicine, identified their practice as community/academic, and practiced >10 years. Forty-one percent perceived UI and 54% believed OAB prevalence to be 11-30%. Most initiated treatment for UI (97%) and OAB (96%), referring to urology when consultation was necessary. Half believed POP prevalence to be <10% of women, and often referred POP to Gynecology. Only 25% reported being 'very familiar' with urogynecology, and 46% were unaware of such providers in their area. Female providers were more likely to screen for OAB (p = .018) and POP (p = .004) and be familiar with urogynecology (p = 0.038). Providers practicing in the Midwest were most likely, while those in the West were least likely, to be aware of urogynecologists for referral, (p = < .001). CONCLUSIONS: Primary care providers nationally are familiar with UI and OAB, but less familiar with POP. Nearly half were uncertain of urogynecologists to whom they could refer. Outreach to these providers may improve patient access to care.

Liposomal bupivacaine decreases pain following retropubic sling placement: a randomized placebo-controlled trial.

BACKGROUND: Midurethral slings are commonly used to treat stress urinary incontinence. Pain control, however, may be a concern. Liposomal bupivacaine is a local anesthetic with slow release over 72 hours, demonstrated to lower pain scores and decrease narcotic use postoperatively. OBJECTIVE: The purpose of this study was to examine the impact of liposomal bupivacaine on pain scores and narcotic consumption following retropubic midurethral sling placement. STUDY DESIGN: This randomized, placebo-controlled trial enrolled women undergoing retropubic midurethral sling procedures with or without concomitant anterior or urethrocele repair. Subjects were allocated to receive liposomal bupivacaine (intervention) or normal saline placebo injected into the trocar paths and vaginal incision at the conclusion of the procedure. At the time of drug administration, surgeons became unblinded, but did not collect outcome data. Participants remained blinded to treatment. Surgical procedures and perioperative care were standardized. The primary outcome was the visual analog scale pain score 4 hours after discharge home. Secondary outcomes included narcotic consumption, time to first bowel movement, and pain scores collected in the mornings and evenings until postoperative day 6. The morning pain item assessed "current level of pain"; the evening items queried "current level of pain," "most intense pain today," "average pain today with activity," and "average pain today with rest." Likert scales were used to measure satisfaction with pain control at 1- and 2-week postoperative intervals. Sample size calculation deemed 52 subjects per arm necessary to detect a mean difference of 10 mm on a 100-mm visual analog scale. To account for 10% drop out, 114 participants were needed. RESULTS: One hundred fourteen women were enrolled. After 5 exclusions, 109 cases were analyzed: 54 women received intervention, and 55 women received placebo. Mean participant age was 52 years, and mean body mass index was 30.4 kg/m2. Surgical and demographic characteristics were similar, except for a slightly higher body mass index in the placebo group (31.6 vs 29.2 kg/m2; P=.050), and fewer placebo arm subjects received midazolam during anesthesia induction (44 vs 52; P=.015). For the primary outcome, pain score (millimeter) 4 hours after discharge home was lower in the intervention group (3.5 vs 13.0 millimeters; P=.014). Pain scores were also lower for subjects receiving liposomal bupivacaine at other time points collected during the first three postoperative days. Furthermore, fewer subjects in the intervention group consumed narcotic medication on postoperative day 2 (12 vs 27; P=.006). There was no difference in satisfaction with pain control between groups. Side-effects experienced, rate of postoperative urinary retention, and time to first bowel movement were similar between groups. Finally, no serious adverse events were noted. CONCLUSION: Liposomal bupivacaine decreased postoperative pain scores following retropubic midurethral sling placement, though pain was low in both the intervention and placebo groups. Participants who received liposomal bupivacaine were less likely to use narcotics on postoperative day 2. For this common outpatient surgery, liposomal bupivacaine may be a beneficial addition. Given the cost of this intervention, however, future cost-effective analyses may be useful.

Primary care providers' attitudes, knowledge, and practice patterns regarding pelvic floor disorders.

INTRODUCTION AND HYPOTHESIS: Understanding barriers to seeking care for pelvic floor disorders is necessary. We sought to assess familiarity with pelvic floor disorders, as well as identify screening and referral patterns among primary care providers. METHODS: This Institutional Review Board approved study was distributed through a secure online server (SurveyMonkey®). Primary care providers within a large healthcare system were invited to participate in a 14-question survey regarding the prevalence, diagnosis, and treatment of urinary incontinence (UI), overactive bladder (OAB) syndrome, and pelvic organ prolapse (POP). Demographic information was collected. Descriptive statistics and associations were calculated. RESULTS: A total of 360 emails were delivered, 108 responded (response rate 30.0 %). Respondents were evenly distributed with respect to age and years in practice. Providers correctly estimated the prevalence of UI and OAB, and most reported treating these conditions themselves (92.6 % and 88.9 %, respectively). If treatment failed, however, referral was most often (68.1 %) to urology. The majority reported not screening for POP, and 50.9 % believed the prevalence to be rare. Referrals for POP were most often (61.1 %) to urogynecology. Male providers were less likely to screen for POP than female providers (p < 0.001). Only a minority (35.2 %) described being 'very familiar' with urogynecology, and 19.4 % were unaware of such providers within the system. CONCLUSIONS: Primary care providers within a large healthcare system were more familiar with UI and OAB than POP, often underestimating the prevalence of POP. Nearly one-fifth were unaware of urogynecologists within their system. Educational outreach regarding pelvic floor disorders and the urogynecology specialty would likely improve patient access to care.

Survey of male perceptions regarding the vulva.

OBJECTIVE: The purpose of this study was to characterize male preferences of vulvar appearance, their awareness of labiaplasty, and their knowledge of genital anatomy. STUDY DESIGN: Men 18-80 years old were recruited via emails sent by an Internet provider to participate in a 27-question web-based survey. The questionnaire included images and queried demographics, men's familiarity with vulvar anatomy, preferences regarding labial appearance, and awareness of labiaplasty. Two deployments to >150,000 email addresses were sent. Demographic data were described using frequencies for categoric variables and mean measures of central tendency for continuous variables. Logistic regression models were used to analyze associations between demographics and responses. RESULTS: Two thousand four hundred three men responded to the survey. After excluding incomplete and ineligible surveys, 1847 surveys were analyzed. The median age of respondents was 55 years. The majority was white (87%), married (68%), employed (69%), and had completed high school or beyond (97%). One-third of the respondents lived in the South, with the other regions nearly equally represented. A significant majority, 95%, reported having been sexually active with women, and 86% felt comfortable labeling the vulvar anatomy. With regard to preferences, more respondents considered smaller labia attractive compared to large labia; yet 36% of the men remained neutral. Men also showed a preference for partially or completely groomed genitals compared to natural hair pattern. Whereas 51% of participants believed the appearance of a woman's labia influenced their desire to engage in sexual activity, 60% denied it affected sexual pleasure. Only 42% of men were familiar with labiaplasty, and 75% of all respondents would not encourage a female partner to change her genital appearance. Multivariable analysis revealed younger age to be associated with preferences for small labia and complete genital hair removal, as well as familiarity with labiaplasty. CONCLUSION: In this national survey, men demonstrated familiarity with the female anatomy, but many did not feel it impacted sexual desire or pleasure. Moreover, the majority lacked strong preferences for a specific vulvar appearance and would not encourage a female partner to alter her genital appearance surgically.

Effects of dexamethasone on quality of recovery following vaginal surgery: a randomized trial.

OBJECTIVE: Dexamethasone is a corticosteroid with minimal side effects that may improve quality of recovery. We sought to evaluate standard use of this medication prior to vaginal reconstructive surgery. STUDY DESIGN: This was a double-blind, randomized, placebo-controlled trial of women undergoing vaginal reconstructive surgery for pelvic organ prolapse. Patients scheduled for an intraperitoneal vaginal vault suspension, with general anesthesia and an overnight stay, were enrolled. The intervention arm received dexamethasone 60 minutes prior to surgery, and controls received placebo. Postoperative pain medications, antiemetics, and voiding trials were standardized. Our primary outcome was the difference in Quality of Recovery (QoR-40) scores on postoperative day 1. Secondary measures included Postoperative Nausea and Vomiting Intensity scores, and visual analog scales for nausea/vomiting, and pain. Our power calculation demonstrated 31 subjects in each group would be necessary to document difference in QoR-40 scores; to allow for attrition, a goal of 74 subjects was set. RESULTS: Seventy-four women were enrolled and randomized. Two withdrew, 9 were excluded, and 63 were analyzed (36 placebo, 27 dexamethasone). The mean age was 63 years. No significant differences were noted among demographics other than American Society for Anesthesiologists class; there were greater numbers of dexamethasone subjects that were class 3 (5 vs 11; P = .030). Postoperatively, more patients in the placebo group required promethazine as a rescue antiemetic for control of their nausea/vomiting (11 vs 2; P = .029). Placebo subjects also failed their voiding trials more frequently, which remained following a logistic regression controlling for suburethral sling (30 vs 15; P = .037). Regarding the QoR-40 following surgery, the emotional state domain declined less in dexamethasone patients (-14.3, interquartile range [IQR], 16.8 vs -4.6, IQR, 20.1; P = .042), indicating better symptoms. Whereas pain scales were similar, the visual analog scales for nausea/vomiting was lower in dexamethasone subjects (0.7; IQR, 4.1 vs 0.4; IQR, 1.4; P = .042). Postoperative Nausea and Vomiting Intensity scores were not significantly different; nevertheless, twice as many placebo subjects had severe range symptoms (4 vs 2; P = .47). No adverse effects from the dexamethasone were noted. CONCLUSION: Use of dexamethasone prior to vaginal reconstructive surgery was associated with less nausea/vomiting and need for antiemetics as well as greater success with voiding trials. Furthermore, quality of recovery was enhanced, suggesting use of dexamethasone should be considered for these patients.

The influence of personality and coping on female sexual function: a population survey.

INTRODUCTION: Female sexual dysfunction (FSD) is a common disorder with limited data investigating relationships with psychological influences, such as personality traits and coping mechanisms. AIM: To investigate the relationship and impact of personality traits and coping strategies on female sexual function. METHODS: A web-based survey was distributed to a sample of women representative of the area's demographic distribution. MAIN OUTCOME MEASURES: Participants completed the Female Sexual Function Index (FSFI), the Ten Item Personality Index (TIPI), and the Brief COPE. RESULTS: Five hundred twenty-six females responded. The mean total FSFI score was 24.56 (SD 6.77) with lowest scores in the desire domain. Personality scores were similar to published normative values. Subjects displaying stronger tendencies for introversion (r = 0.246, P < 0.001), not being open to new experiences (r = 0.159, P = 0.008), and emotional instability (r = 0.244, P < 0.001) were found to have significantly worse sexual function. Conscientiousness was significantly associated with better desire, orgasm, satisfaction, and total FSFI score (P = 0.029, P = 0.002, P = 0.005, P = 0.003). Moreover, the utilization of negative coping strategies such as self-blame, self-distraction, and behavioral disengagement, significantly correlated with poor sexual function (r = -0.298, P < 0.001, r = -0.360, P < 0.001, r = -0.398, P < 0.001, respectively). CONCLUSION: Personality and coping are linked to sexual function with introversion, not being open to new experiences, emotional instability, and the utilization of negative coping strategies being significantly associated with poor sexual function. Women presenting with sexual function complaints may need further evaluation of their personality and coping strategies in order to mitigate any negative impact of these tendencies.

Clitoral size and location in relation to sexual function using pelvic MRI.

INTRODUCTION: The female sexual response is dynamic; anatomic mechanisms may ease or enhance the intensity of orgasm. AIM: The aim of this study is to evaluate the clitoral size and location with regard to female sexual function. METHODS: This cross-sectional TriHealth Institutional Board Review approved study compared 10 sexually active women with anorgasmia to 20 orgasmic women matched by age and body mass index (BMI). Data included demographics, sexual history, serum hormone levels, Prolapse/Incontinence Sexual Questionnaire-12 (PISQ-12), Female Sexual Function Index (FSFI), Body Exposure during Sexual Activity Questionnaire (BESAQ), and Short Form Health Survey-12. All subjects underwent pelvic magnetic resonance imaging (MRI) without contrast; measurements of the clitoris were calculated. MAIN OUTCOME MEASURES: Our primary outcomes were clitoral size and location as measured by noncontrast MRI imaging in sagittal, coronal, and axial planes. RESULTS: Thirty premenopausal women completed the study. The mean age was 32 years (standard deviation [SD] 7), mean BMI 25 (SD 4). The majority was white (90%) and married (61%). Total PISQ-12 (P < 0.001) and total FSFI (P < 0.001) were higher for orgasmic subjects, indicating better sexual function. On MRI, the area of the clitoral glans in coronal view was significantly smaller for the anorgasmic group (P = 0.005). A larger distance from the clitoral glans (51 vs. 45 mm, P = 0.049) and body (29 vs. 21 mm, P = 0.008) to the vaginal lumen was found in the anorgasmic subjects. For the entire sample, larger distance between the clitoris and the vagina correlated with poorer scores on the PISQ-12 (r = -0.44, P = 0.02), FSFI (r = -0.43, P = 0.02), and BESAQ (r = -0.37, P = 0.04). CONCLUSION: Women with anorgasmia possessed a smaller clitoral glans and clitoral components farther from the vaginal lumen than women with normal orgasmic function.

Innervation and histology of the clitoral-urethal complex: a cross-sectional cadaver study.

INTRODUCTION: Despite its central role in sexual function, we lack a description of the nerve distribution and histology for the central components of the clitoris. AIM: This study aims to characterize microscopic anatomy of the clitoral-urethral complex (CUC) and aid our understanding of sexual sensation METHODS: The CUC was excised from three female fresh-frozen cadavers en bloc and prepared in 5-µm longitudinal sections with hematoxylin and eosin and S100 immunohistochemistry for neural elements. Approximately 20 sections were obtained from each specimen. On low power microscopy, the 30 most innervated fields on each section were identified. On high power, the total number of nerves per field was quantified, then was averaged. The histologic characteristics of each clitoral component were described. Two investigators evaluated all specimens. MAIN OUTCOME MEASURES: Descriptives of large (≥3 fibers) and small nerves based on location in the CUC. RESULTS: Nerve quantification revealed the glans to be the most populated by small nerves (52.1, standard deviation [SD] 26.2). As slices through each specimen moved caudad toward the urethra, the number of small nerves dramatically decreased from 40.4 (SD 10.8) in the body and 29.8 (SD 8.8) (superior CUC) near the bulb to 23.7 (SD 9.8) in the middle CUC and 20.5 (SD 10.4) (inferior CUC) near the urethra. Although the variation in small nerves was striking, large nerves were somewhat uniform and comprised a minority of the overall quantity. Neuroanatomy was consistent for all cadaver specimens. CONCLUSIONS: Our study provided a description of the nerve distribution throughout the central CUC. Increased density of small nerves in the glans suggests this is the location of heightened sensation. Decreasing quantity of nerves in segments closer to the urethra may indicate these zones are less important for sexual sensation. Knowledge of human clitoral innervation is important for understanding the complexities of the female sexual response cycle.

Intra-vaginal diazepam for high-tone pelvic floor dysfunction: a randomized placebo-controlled trial.

INTRODUCTION AND HYPOTHESIS: Intra-vaginal diazepam suppositories are commonly prescribed as a treatment option for high-tone pelvic floor myalgia. This triple-blinded placebo-controlled randomized trial sought to determine if 10 mg diazepam suppositories improve resting pelvic floor electromyography (EMG) compared with placebo. METHODS: Women ≥18 years of age with hypertonic pelvic floor muscles on examination, confirmed by resting EMG ≥2.0 microvolts (µv), administered vaginal suppositories containing either diazepam or placebo for 28 consecutive nights. Outcomes included vaginal surface EMG (four measurements), the Female Sexual Function Index (FSFI), the Short Form Health Survey 12 (SF-12), four visual analog scales (VAS), the Patient Global Impression of Severity (PGI-S), and the Patient Global Impression of Improvement (PGI-I). A priori sample size calculation indicated that 7 subjects in each group could detect a 2-µv difference in resting EMG tone with 90% power. RESULTS: Twenty-one subjects were enrolled. The mean age was 36.1 (SD 13.9) years, mean body mass index was 28.56 (SD 9.4), and the majority (85.7%) was Caucasian. When evaluating response to therapy, no difference was seen in any of the resting vaginal EMG assessments at any time point within subjects or between groups, nor was an interaction found. Additionally, no differences were noted in any of the validated questionnaires. CONCLUSIONS: When used nightly over 4 weeks, 10 mg of vaginal diazepam was not associated with improvement in resting EMG parameters or subjective outcomes compared with placebo. This suggests such that therapy alone may be insufficient in treating high-tone pelvic floor dysfunction.

Attitudes and compliance with research requirements in OB/GYN residencies: a national survey.

BACKGROUND/AIMS: The Accreditation Council for Graduate Medical Education (ACGME) requires that all Ob/Gyn residents accomplish scholarly activity. We hypothesize resident productivity is poor. METHODS: This was a web-based two-survey study using SurveyMonkey®. Surveys queried both program directors and residents regarding their adherence to ACGME guidelines. All 233 accredited Ob/Gyn programs were targeted. RESULTS: 70 program directors responded (30.4%). The majority (99%) felt research was a goal of their program and stated their residents are taught to read current literature (99%), design basic studies (99%), and interpret simple statistics (89%). 17% (53/313) of the residents did not agree that their training environment promoted research, 25% did not feel comfortable discussing basic study designs, and 54% did not feel comfortable interpreting basic statistics. Urban programs demonstrated improved resident attitudes toward research (p = 0.025), better research environments (p = 0.007) and curricula (p = 0.001) compared to rural programs. Furthermore, residents intending to pursue an academic career were more likely to be working with a research mentor (p = 0.038). CONCLUSION: The ACGME clearly delineates residency research requirements. A dichotomy exists between program director perception and resident compliance. Notwithstanding, it is reassuring that the majority of programs appear to promote scholarly activity and provide necessary support.

Patient-controlled versus scheduled, nurse-administered analgesia following vaginal reconstructive surgery: a randomized trial.

OBJECTIVE: To determine whether patient-controlled analgesia or scheduled intravenous analgesia provides superior pain relief and satisfaction with pain control after vaginal reconstructive surgery. STUDY DESIGN: Fifty-nine women scheduled for vaginal reconstructive surgery were enrolled in this randomized trial. Operative procedures and postoperative orders were standardized. Visual analog scales for pain and satisfaction with pain control were recorded during the hospital stay and 2 weeks after surgery. RESULTS: Patients receiving patient-controlled analgesia had less pain on postoperative day 1, 25 mm vs 39 mm, on visual analog scales (P = .007). Although this group used twice as much hydromorphone (3.57 mg vs 1.48 mg, P < .001), there was no difference in side effects, length of hospital stay, or complications. For the sample overall, larger amounts of narcotic used correlated with higher pain scores (r = 0.364, P = .009) and worse satisfaction scores (r = -0.348, P = .012). CONCLUSION: In patients undergoing vaginal surgery, patient-controlled analgesia offers superior pain relief on postoperative day 1 when compared with scheduled, nurse-administered hydromorphone.

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.

Critical Anatomy for Robotic Sacrocolpopexy: A Long-term Follow-up Study.

OBJECTIVE: This study aimed to assess anatomy relative to sacral sutures 20 to 24 months after robotic sacrocolpopexy. METHODS: This was an institutional review board-approved prospective anatomy study of women undergoing robotic sacrocolpopexy. After placement of suture into the anterior longitudinal ligament, a small vascular clip was secured on the base of the suture. Subjects were imaged at 6 weeks and between 20 and 24 months after surgery. Measurements were calculated by the primary investigator and radiologist coinvestigator. RESULTS: Of the 11 subjects enrolled in the initial 6-week postoperative study, 5 (45%) completed the long-term follow-up. Regarding the vascular anatomy, no significant changes were documented. Similarly, the major urologic structure, the right ureter, was stable at 16 mm from the clip. A significant change was noted, however, in the distance from the apex of the vagina to the sacral suture. At 6 weeks postoperatively, the mean (SD) distance from the vaginal apex to the clip was 69.3 (14) mm; this increased to 85.2 (11.3) mm at the long-term follow-up (P = 0.004). CONCLUSIONS: Reassuringly, the position of the clip remained stable, which is reflected in the constancy of the measurements to the vascular landmarks. Nevertheless, alteration in the distance to the vaginal apex suggests elongation of the mesh or vaginal tissue with time. Although the increase in length was greater than 1.5 cm, it may bear clinical relevance in certain patients. This information may help guide surgeons regarding appropriate mesh tensioning during this critical step of the procedure.

Uterosacral Ligament Suspension: A Radiographic Study of Suture Location in Live Subjects.

OBJECTIVES: This study aimed to describe uterosacral ligament suspension (USLS) suture location relative to the surrounding anatomy in a living model using computed tomographic imaging. METHODS: This was an institutional review board-approved prospective descriptive study. Women aged 18 to 85 years undergoing vaginal hysterectomy with USLS were eligible. A size 'small' titanium vascular clip was applied to the base of each USLS suture. Computed tomography of the pelvis was performed on postoperative day 1. Preoperative and postoperative neurologic questionnaires and physical examinations were performed. A sample size of 15 subjects was deemed appropriate for this pilot study. RESULTS: Seventeen subjects were enrolled: 2 excluded and 15 analyzed. The median (interquartile range) age of the subjects was 57 (22) years. The closest branch of the internal iliac complex was 2.6 (0.9) cm (median [interquartile range]) from the proximal suture on the right and 2.6 (0.5) cm on the left. The right ureter was 2.1 (0.7) cm from the right proximal suture. The left ureter was 2.3 (1.0) cm from the left proximal suture. The rectal lumen were 3.0 (1.6) cm from the right proximal suture and 2.8 (1.4) cm from the left proximal suture. No subjects were found to have neurologic involvement of the sutures based on neurologic questionnaire responses and physical examination. CONCLUSIONS: In live subjects, our study confirms that the vasculature, ureter, and rectum of the pelvic side wall are near suture placement for USLS. This information highlights the importance of careful dissection and awareness of anatomic landmarks.

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.

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.

Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial.

OBJECTIVE: To compare the safety and efficacy of the transobturator tape to tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence in patients with and without concurrent pelvic organ prolapse. METHODS: One-hundred seventy women with urodynamic stress incontinence, including those with and those without pelvic organ prolapse, from three academic medical centers were randomized to receive TVT or transobturator tape. Subjects with detrusor overactivity or previous sling surgery were excluded. The primary outcome was the presence or absence of abnormal bladder function, a composite outcome defined as the presence of any the following: incontinence symptoms of any type, a positive cough stress test, or retreatment for stress incontinence or postoperative urinary retention assessed 1 year after surgery. This study is a noninferiority study design. RESULTS: Of 180 women who enrolled in the study, 170 underwent surgery and 168 returned for follow-up, with a mean follow-up of 18.2+/-6 months. Mean operating time, length of stay, and postoperative pain scores were similar between the two groups. Bladder perforations occurred more frequently in the TVT group (7% compared with 0%, P=.02); otherwise, the incidence of perioperative complications was similar. Abnormal bladder function occurred in 46.6% of TVT patients and 42.7% of transobturator tape patients, with a mean absolute difference of 3.9% favoring transobturator tape (95% confidence interval -11.0% to 18.6%.). The P value for the one-sided noninferiority test was .006, indicating that transobturator tape was not inferior to TVT. CONCLUSION: The transobturator tape is not inferior to TVT for the treatment of stress urinary incontinence and results in fewer bladder perforations. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00475839.

Risk factors associated with failure 1 year after retropubic or transobturator midurethral slings.

OBJECTIVE: The objective of the study was to identify predictors of recurrent urinary incontinence (UI) 1 year after treatment with tension-free vaginal tape (TVT) and transobturator tape (TOT). STUDY DESIGN: One hundred sixty-two women with urodynamic stress urinary incontinence (SUI) were included in a clinical trial comparing TVT with TOT with at least 1 year of follow-up were included in this analysis. Potential clinical and urodynamic predictors for development of "any recurrent UI" or "recurrent SUI" 1 year after surgery were evaluated using logistic regression models. RESULTS: Subjects who received concurrent prolapse surgery and those taking anticholinergic medications preoperatively were more likely to develop any recurrent UI. Increasing age was independently associated with recurrent SUI. Risk factors were similar for TVT and TOT for both definitions of treatment failure. CONCLUSION: Concurrent prolapse surgery and preoperative anticholinergic medication use are associated with increased risk of developing recurrent UI 1 year after TVT or TOT. Increasing age is specifically associated with the recurrence of SUI symptoms.

Outcomes and Characteristics of Patients Undergoing Surgical Management for Mesh Related Complications.

OBJECTIVE: The aims of this study were to describe the characteristics of women presenting with mesh-related complications and evaluate postoperative quality of life, sexual functioning, and patient-perceived outcomes. METHODS: This institutional review board-approved study included a retrospective chart review and a cross-sectional follow-up with validated questionnaires. Demographics and medical histories were collected from charts of women treated for mesh-related complaints between 2010 and 2014. Subjects completed follow-up validated questionnaires regarding health, sexual functioning, postoperative symptom improvement/severity, satisfaction, and regret with the decision to pursue treatment. RESULTS: Ninety-three charts were analyzed. Mean subject age was 55 years, median body mass index was 28.7 kg/m, and median time from mesh placement to presentation was 2.7 years. Forty-nine had midurethral sling mesh only, 30 had prolapse-related mesh, and 14 had both. Forty-two subjects (48.9%) had mesh exposures, 19 involving prolapse-related mesh (52.4% transvaginal and 47.4% sacrocolpopexy). Surgical revisions were most often for exposure and pain. Seventy-five women were reached for follow-up; 71 agreed to participate, 53 (75%) returned the questionnaires. Thirty had sling revision, 22 had prolapse mesh revision, and 1 had both. Questionnaire results revealed no changes in health or sexual function after treatment. Postoperatively, subjects reported symptom improvement, low symptom severity, as well as high satisfaction and low regret with the decision to pursue surgical intervention. CONCLUSIONS: Women with mesh complications presented 2 years after initial placement, most often complaining of exposure or pain/dyspareunia. Although no changes in health or sexual functioning were noted postoperatively, participants reported symptom improvement after revision and satisfaction with the decision to pursue treatment.