The Impact of Vaginal Probiotics on Pessary Use: A Randomized Controlled Trial.

IMPORTANCE: Pessary-related adverse effects are common, and treatment options are limited. Probiotics may improve pessary-related adverse effects by altering the vaginal microenvironment. OBJECTIVE: This study aimed to evaluate the effect of a vaginal probiotic suppository on the vaginal microenvironment among pessary users. STUDY DESIGN: Women who used pessaries were randomized to vaginal probiotic suppository use versus without use. The intervention was a vaginal probiotic suppository and moisturizing vaginal gel. The vaginal microenvironment was assessed using Gram stain and Nugent's criteria at baseline and 3 months by a microbiologist blinded to group allocation. Symptoms and experience with use of the probiotic were assessed using questionnaires. The primary outcome was change in lactobacilli count on Nugent subscore at 3 months. RESULTS: A total of 147 postmenopausal women were randomized (86 to the intervention arm and 61 to the control arm), and 124 (87.9%) presented for a 3-month follow-up. There was no difference between the arms in age, race, body mass index, and Charlson Comorbidity Index. A majority of participants had the pessary managed by the health care professional (intervention arm vs control arm, 46 [76.7%] vs 55 [68.8%]; P = 0.30). Composition of the vaginal microenvironment did not differ with or without probiotic treatment at 3 months. Bother from vaginal symptoms, including discharge, itching, and discomfort, did not differ between arms. Adverse effects from the intervention were minor, resolved with discontinuation, and occurred at 39.1%. CONCLUSION: Vaginal probiotic suppository use did not affect the composition of the vaginal microenvironment, patient satisfaction, or vaginal symptoms after 3 months of use in pessary users.

The Impact of Preoperative Pain on Outcomes After Vaginal Reconstructive Surgery and Perioperative Pelvic Floor Muscle Training.

IMPORTANCE: The impact of preoperative pain on outcomes can guide counseling. OBJECTIVE: The objective of this study was to compare outcomes after vaginal reconstructive surgery and pelvic muscle training between women with and without preoperative pain. STUDY DESIGN: This is a secondary analysis of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) trial, which randomized patients to a surgical intervention (sacrospinous ligament fixation versus uterosacral vaginal vault suspension) and a perioperative behavioral intervention (pelvic floor muscle training vs usual care). Preoperative pain was defined as a response of "5" or greater on the pain scale or answering "moderately" or "quite a bit" on the Pelvic Floor Distress Inventory question "Do you usually experience pain in the lower abdomen or genital area?" RESULTS: The OPTIMAL trial included 109 women with preoperative pain and 259 without pain. Although women with pain had worse pain scores and pelvic floor symptoms at baseline and postoperatively, they had greater improvement on pain scores (-2.3 ± 2.4 vs -0.2 ± 1.4, P < 0.001), as well as Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire scores. Among women with pain who underwent a sacrospinous ligament fixation, those who received pelvic floor muscle training had a greater reduction in pain compared with those in the usual care group (-3.0 ± 2.3 vs -1.3 ± 2.1, P = 0.008). Persistent or worsening pain was present at 24 months in 5 (16%) women with preoperative pain. CONCLUSIONS: Women with preoperative pain experience significant improvements in pain and pelvic floor symptoms with vaginal reconstructive surgery. Pelvic floor muscle training perioperatively may be beneficial for select patients.

Return to work and normal activities after mid-urethral sling: secondary analysis of the Trial of Mid-Urethral Slings.

INTRODUCTION AND HYPOTHESIS: We aim to evaluate the timing of patients returning to work and to normal daily life following mid-urethral sling surgery. METHODS: This is a secondary analysis of the Trial of Mid-Urethral Slings (TOMUS). Our primary outcome is the timing of return to work and normal activities. Secondary outcomes included paid days off, number of days to return to normal daily life, and objective and subjective failures. Predictors affecting the timing of return to work and normal activities were also assessed. Patients who underwent concomitant surgery were excluded. RESULTS: Among patients undergoing a mid-urethral sling, 183 (41.5%) returned to normal activities within 2 weeks. Within 6 weeks of surgery, 308 (70.0%) had returned to normal activities including work. At the 6-month follow-up, 407 (98.3%) had returned to normal activities including work. Patients took a median of 14 days (interquartile range 1-115 days) to return to normal activities including work and took a median of 5 (interquartile range 0-42 days) paid work days off. Those who returned within 2 weeks versus after 2 weeks did not have significantly different characteristics, or failure and complication rates. In the multivariate regression analysis, there was no significant predictor of the timing of returning to normal activity/work. CONCLUSIONS: Less than half of patients returned to work and normal activities within 2 weeks of a mid-urethral sling surgery and took many fewer paid days off. The timing of return to work was not associated with significant differences in treatment failure or adverse outcomes.

Cost Effectiveness of Concurrent Midurethral Sling at the Time of Prolapse Repair: Results From a Randomized Controlled Trial.

IMPORTANCE: The relative cost per improvement in quality of life can help guide decisions about adding a midurethral sling at the time of prolapse surgery. OBJECTIVE: This study aimed to assess the cost-effectiveness of prophylactic midurethral slings placed at the time of prolapse surgery to reduce de novo urinary incontinence based on a randomized controlled trial. STUDY DESIGN: Costs and effectiveness were collected as part of a planned secondary analysis from the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial, where 337 women without symptomatic stress urinary incontinence were randomly assigned to a midurethral sling or sham incisions during vaginal prolapse surgery. Within-trial cost-effectiveness analysis was performed from the societal perspective. Effectiveness was measured in quality-adjusted life-years (QALYs) and de novo urinary incontinence. We calculated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. RESULTS: Within-trial societal costs were higher for the sling group than for the control group ($18,170 [95% confidence interval (CI), $16,420-$19,920] vs $15,700 [95% CI, $14,110-$17300], P = 0.041). The changes in QALY were 0.04 (95% CI, 0.02-0.06) versus 0.03 (95% CI, 0.02-0.05; P = 0.54). The incremental cost-effectiveness ratio for prophylactic sling was $309,620/QALY. This is above the generally accepted range of willingness-to-pay thresholds of $50,000 to $150,000/QALY. At 1 year, urinary incontinence was more common in the control group, and the cost to prevent 1 case was $91. The probability that prophylactic sling is cost-effective is 24%. CONCLUSIONS: Prophylactic sling placed during vaginal prolapse surgery reduced the rate of de novo urinary incontinence, but was not cost-effective.

Return to work following pelvic reconstructive surgery: secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss trial.

BACKGROUND: Patients' return to work is an important part of surgical counseling and quality of life. OBJECTIVE: This study aimed to evaluate the pattern of patients' return to work and loss of productivity after pelvic reconstructive surgery. STUDY DESIGN: This was a secondary analysis of the randomized controlled trial Operations and Pelvic Muscle Training in the Management of Apical Support Loss. The primary outcome was return to work defined by the answer to "How many calendar weeks or workdays did you not go to work after the original prolapse surgery?" Furthermore, loss of productivity included hours and days per week worked and discontinuation of paid work because of urogynecologic conditions. Moreover, predictors affecting the timing of return to work and loss of productivity were assessed. RESULTS: Here, 180 patients (49%) were working before surgery. Of these patients, half returned to work 35 days after surgery, with 21 (13%) returning to work immediately after surgery and 43 (27%) returning to work within ≤2 weeks. The number of days missed did not differ between patients who underwent sacrospinous ligament fixation and those who underwent uterosacral ligament suspension (P=.23). At 3 months, 15 patients (9%) who were working before surgery had stopped working, but those who continued to work had similar hours per week as before surgery (36±12 vs 35±13; P=.48). Of note, 17 patients (11%) reported being less productive, on average working at 60% effectiveness. Most patients (96%) reported not missing any hours of household chores by 3 months after surgery. Patients who returned to work within 6 weeks had a higher rate of retreatment with either pessary or surgery within 2 years (5 of 85 [6.8%] vs 0 of 76 [0%]; P=.03). Those who returned to work within 2 weeks worked fewer hours before surgery (30±15 vs 36±12; P=.013), were less likely to have private insurance (77% vs 91%; P=.03), and had a higher rate of retreatment (3 of 30 [13%] vs 2 of 131 [1.7%]; P=.007). There was no difference in bulge symptoms and anatomic failure based on return to work. CONCLUSION: Most patients returned to work within 35 days after surgery. Working less than full time and not having private insurance were predictors of earlier return to work.

The Value of a Support Person During the Surgical Consent Process: A Prospective Cohort Study.

OBJECTIVE: The objective of this study is to investigate the impact of support person participation during the preoperative appointment. METHODS: This is a prospective cohort study involving patients scheduled to undergo pelvic reconstructive surgery. Eligible patients were enrolled at the preoperative appointment and compared by presence or absence of a support person. Questionnaires were completed before and after the preoperative appointment, 1-3 days before surgery, and at the postoperative appointment. Previsit questionnaires included the Generalized Anxiety Disorder-7, 6-item short form of the Spielberger State-Trait Anxiety Inventory (STAI-6), and Brief Health Literacy screen. Postvisit questionnaires included the STAI-6, satisfaction with decision scale for pelvic floor disorders, preoperative preparedness questionnaire, and knowledge questionnaire. At the postoperative appointment, participants completed the patient global impression of improvement and postoperative symptom and satisfaction questionnaire. Primary outcome was patient anxiety measured by the STAI-6. RESULTS: Seventy-six patients participated in the study: 37 were categorized in the support person cohort and 39 were categorized in the no support person cohort. The mean scores of the STAI-6 did not differ between the support person and no support person cohorts at all time points (previsit: 42.97 ± 13.23 vs 41.53 ± 17.11, P = 0.68; postvisit: 38.11 ± 12.76 vs 36.33 ± 11.72, P = 0.53, and 1-3 days before surgery: 42.61 ± 13.0 vs 41.05 ± 16.39, P = 0.65). Overall preparedness, satisfaction with decision scale for pelvic floor disorders, and knowledge questionnaire did not differ between cohorts at both time points. Perioperative phone calls were similar between cohorts. CONCLUSION: Our study suggests that the presence of a support person at preoperative counseling for pelvic floor surgery should be a personal preference and not a recommendation.

The impact of preoperative pelvic pain on outcomes after vaginal reconstructive surgery.

BACKGROUND: Pelvic pain is a debilitating condition that is common among women with pelvic floor disorders. Limited information is known about the impact of preoperative pelvic pain on outcomes after vaginal reconstructive surgery. OBJECTIVE: This study aimed to compare the outcomes after vaginal reconstructive surgery between women with and without preoperative pelvic pain. STUDY DESIGN: Baseline and postoperative data were analyzed from the "Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial." The multicenter trial involved women with anterior prolapse without symptoms of stress incontinence randomized to receive either a midurethral sling or sham incisions during a vaginal reconstructive surgery. Participants completed the visual analog scale adapted for suprapubic pain and Pelvic Floor Distress Inventory at baseline, 3 months, and 12 months. Preoperative pelvic pain was defined as a response of "5" or greater on pain on the visual analog scale or answering "moderately" or "quite a bit" on the Pelvic Floor Distress Inventory question, "Do you usually experience pain in the lower abdomen or genital area?" Outcomes and complication rates were compared between women with and without pelvic pain. RESULTS: The "Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial" participants included 112 women with pelvic pain (58 had a midurethral sling and 54 had sham incisions) and 212 women without pelvic pain (105 had a midurethral sling and 107 had sham incisions). Women who had a midurethral sling and pelvic pain were younger than women without pelvic pain (60.3±12.1 vs 65.1±8.6; P=.004). Women who had sham incisions and pelvic pain were more likely of Hispanic ethnicity than women without pelvic pain (27.8% vs 9.4%; P=.002). Patient improvement based on the Patient Global Impression of Improvement scale did not differ between arms. Women with pelvic pain had greater improvement on the visual analog scale pain scores after a surgical procedure at 3 months (-3.1±2.9 vs -0.4±1.6; P<.001) and at 12 months (-3.4±3.0 vs -0.6±1.6; P<.001) than women without pain, although their pain scores remained higher than those without preoperative pelvic pain at all time points (P<.001 for all). Similar improvements were found on the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. The differences observed were not affected by whether women were in the midurethral sling or sham arm of the trial. Postoperative urinary tract infection and incomplete bladder emptying did not differ between the groups. CONCLUSION: Women with preoperative pelvic pain experienced significant improvements in pain and pelvic floor symptoms with vaginal reconstructive surgery and had similar subjective improvement postoperatively compared with women without preoperative pelvic pain. Reassuringly, the performance of a midurethral sling did not have an impact on the results.

Beef Tongue Surgical Simulation Model for Posterior Vaginal Repair.

BACKGROUND: This surgical simulation model for vaginal posterior repair is designed to enhance vaginal surgical training. METHODS: A beef tongue simulation model was previously described and validated to practice the repair of obstetric laceration. The model was modified for surgical simulation of vaginal posterior repair. Chicken skin was used to simulate the anal canal. The model was secured in a PVC (polyvinyl chloride) pipe attached to a wooden base to simulate operating within the vaginal canal. EXPERIENCE: Materials can be obtained from the local supermarket and hardware store. The total cost of the model is $35.47 for initial setup and $7.11 per use. Residents performing on the model felt it was realistic and useful for practicing the steps and skills for this procedure. CONCLUSION: The beef tongue simulation model of vaginal posterior repair is realistic, easy to construct, and affordable. It can be incorporated into a vaginal surgery curriculum to augment resident surgical education.

Rethinking Second-Line Therapy for Overactive Bladder to Improve Patient Access to Treatment Options.

Idiopathic overactive bladder (OAB) is a chronic condition that negatively affects quality of life, and oral medications are an important component of the OAB treatment algorithm. Recent literature has shown that anticholinergics, the most commonly prescribed oral medication for the treatment of OAB, are associated with cognitive side effects including dementia. ß3-adrenoceptor agonists, the only alternative oral treatment for OAB, are similar in efficacy to anticholinergics with a more favorable side effect profile without the same cognitive effects. However, there are marked cost variations and barriers to access for OAB medications, resulting in expensive copays and medication trial requirements that ultimately limit access to ß3-adrenoceptor agonists and more advanced procedural therapies. This contributes to and perpetuates health care inequality by burdening the patients with the least resources with a greater risk of dementia. When prescribing these medications, health care professionals are caught in a delicate balancing act between cost and patient safety. Through multilevel collaboration, we can help disrupt health care inequalities and provide better care for patients with OAB.

Perioperative Adverse Events for Stress Urinary Incontinence Surgery: A National Analysis.

OBJECTIVE: The aim of the study was to compare perioperative morbidity of stress urinary incontinence surgery using data from a nationwide cohort. METHODS: This is a retrospective cohort study of the American College of Surgeons' National Surgical Quality Improvement Program database from 2005 to 2016. Stress urinary incontinence surgery was defined using current procedural terminology (CPT) for abdominal retropubic colposuspension (CPT 51840, 51841), laparoscopic retropubic colposuspension (CPT 51990, 51992), and suburethral sling (CPT 57288). Patients were excluded if they underwent any concomitant surgery except for cystoscopy (CPT 52000). Surgical approach and perioperative morbidity were examined using suburethral sling as the referent population. Patient characteristics, operative data, and 30-day postoperative events were collected. RESULTS: Overall, 19,093 women underwent a stress urinary incontinence surgery: 317 abdominal retropubic colposuspension, 357 laparoscopic retropubic colposuspension, and 18,419 suburethral sling. Patients undergoing abdominal retropubic suspension had more inpatient procedures compared with suburethral sling and laparoscopic retropubic colposuspension (65% vs 10.4% and 17.6%, P < 0.001) and longer length of stay (1.6 ± 2.9 vs 0.3 ± 2.7 and 0.3 ± 0.6, respectively, P < 0.001). Abdominal retropubic colposuspension had the longest odds ratio time compared with suburethral sling (72.0 ± 64.6 vs 38.1 ± 34.2 minutes, P < 0.001). Composite morbidity was significantly higher for abdominal retropubic colposuspension compared with suburethral sling and laparoscopic retropubic colposuspension (7.9% vs 3.4% and 2.0%, P < 0.001). After adjusting for comorbidities, composite morbidity was higher for abdominal retropubic suspension (P = 0.007) compared with suburethral sling. CONCLUSIONS: Compared with suburethral sling, laparoscopic retropubic colposuspension had the lowest 30-day comorbidity and abdominal retropubic colposuspension had the highest 30-day comorbidity.

Predictors of delayed postoperative urinary retention after female pelvic reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: Risk factors can be used to determine what patients will develop delayed postoperative urinary retention after female pelvic reconstructive surgery. METHODS: A case-control study was performed including all female pelvic reconstructive surgeries necessitating a voiding trial. All patients passed their previous voiding trial. Cases had an acute encounter for urinary retention. Controls did not have acute postoperative urinary retention. Cases and controls were stratified based on procedure. Demographics, medical/surgical histories, voiding symptoms, urodynamic testing, and intraoperative data were collected. Cases were matched to controls in a 1:3 ratio. Mann-Whitney U and chi-square tests were used for univariate analyses; logistic regression was used to determine predictors of delayed postoperative urinary retention (DPOUR). RESULTS: A total of 1219 patients underwent pelvic reconstructive surgery that met eligibility; 51 cases of DPOUR (4.3%) were identified and matched with 153 controls without postoperative urinary retention. Of the procedures performed, 41.2% had prolapse surgery, 10.3% had incontinence surgery, and 48.5% had both prolapse and incontinence surgery. There were no differences between cases and controls in age, race, prior surgery, medical comorbidities, prolapse stage ≥ 3, voiding symptoms, and surgical characteristics. Cases had a lower BMI than controls (p < 0.001). There was no difference in preoperative urodynamic variables. Cases had lower percent voided volume on their last voiding trial than controls (90.2% ± 28.6% vs. 110.7% ± 39.5%, respectively; p = 0.001); however, clinically we consider a voided volume of two-thirds or greater of the instilled volume to be a normal result. CONCLUSIONS: DPOUR is an uncommon postoperative event. Demographic and clinical factors and urodynamic findings were unable to predict DPOUR. Percent voided volume on voiding trial was greater in controls.

Cerebral arteriovenous malformation rupture in pregnancy.

A 30-year-old nulliparous woman at 38 5/7 weeks of gestation developed a sudden, severe headache at work and subsequent loss of consciousness. She underwent evaluation in the emergency department. CT and CT angiogram head revealed a large intraparenchymal haematoma with intraventricular extension secondary to ruptured cerebral arteriovenous malformation (cAVM). She was intubated and transferred to a tertiary care centre. The patient underwent caesarean section followed by partial embolisation of the cAVM with planned second embolisation and resection 1 week later. Due to drowsiness and headache, the planned repeat embolisation and cAVM resection were performed 3 days earlier. The patient had a full recovery. Emergency medicine physicians and obstetrician-gynaecologists should be familiar with differential diagnosis of sudden headache in pregnancy and signs of a ruptured cAVM to facilitate early diagnosis, multidisciplinary team approach and timely treatment. Early diagnosis and management of ruptured cAVM are important due to associated morbidity and mortality.

Laparoscopic Entry Technique Using a Veress Needle Insertion with and without Concomitant CO2 Insufflation: A Randomized Controlled Trial.

STUDY OBJECTIVE: To compare the time and number of attempts needed for successful Veress needle entry during laparoscopic surgery using concomitant versus subsequent CO2 insufflation approaches. DESIGN: Randomized controlled trial. SETTING: University teaching hospital. PATIENTS: One hundred consecutive patients scheduled for laparoscopic surgery by 2 high-volume laparoscopic surgeons were screened and randomized, and 95 of these were included in the final analysis. Ninety (45 in each group) was the precalculated priori number of patients needed to detect a 50% difference in the time (seconds) to obtain adequate insufflation with 90% power and alpha of 5%. INTERVENTIONS: Patients were randomized to either Veress needle entry with concomitant (Con) or subsequent (Sub) CO2 insufflation. MEASUREMENTS AND MAIN RESULTS: Forty-six patients were randomized to the Con group and 49 to the Sub group. Patient age, body mass index, prior surgical history, presence of adhesions, and type of procedure performed were similar between both groups. The median time required for adequate insufflation in the Con group was 103.5 seconds (Q1-Q3, 80.0-130.0) compared with 113.0 seconds (Q1-Q3, 102.0-144.0) in Sub group (p = .16). Approximately 89% (95% confidence interval, 80.1%-98.1%) of patients in Con group achieved successful entry in the first attempt compared with only 67% (95% confidence interval, 54.2%-80.0%) in Sub group (p = .01). The incidence of preperitoneal insufflation and failed entry was comparable between the 2 groups. No patient developed solid organ, visceral, or vascular injuries; gas embolism; or case conversion to laparotomy in relation to the Veress needle entry technique. CONCLUSION: Veress needle entry with concomitant CO2 insufflation was associated with a higher rate of successful entry during the first attempt of Veress needle insertion. The total time required for insufflation and rates of complications between the 2 techniques were similar.

Comparison of patients' reported pain following office hysteroscopy with and without endometrial biopsy: a prospective study.

BACKGROUND: When performing office based gynecologic procedures, one must provide patients with appropriate counseling on anticipated pain prior to the procedure. The goal of this study was to investigate whether there is any difference in patients' pain perception when office hysteroscopy (OH) is performed alone compared with when it is performed with endometrial biopsy (EMB) for various gynecologic indications. METHODS: A prospective study was performed of patients undergoing office hysteroscopy alone or in combination with endometrial biopsy between October 2015 and February 2017. Procedures were performed using standard gynecologic techniques. Patients described their post procedural pain using the visual analogue scale from 0-10 and data was compared between groups using SPSS version 24. RESULTS: Group 1 had OH alone (N.=243) and group 2 had OH combined with EMB (N.=80). Patients who underwent both procedures had significantly higher reported median (range) pain scores than those undergoing OH alone (7 [0-10]. vs. 5 [0-10], P=0.004). The patients in-group 2 were significantly older than those in group 1 (42.6±7.6 vs. 36.6±6.5, P<0.0001). The patients in group 2 had higher gravidity (2 vs. 1, P=0.04), were more likely to have a tenaculum used during the procedure (36.3% vs. 21.4%, P=0.01) and were more likely to be diagnosed with uterine fibroids (73% vs. 31%, P<0.0001). After controlling for patients age, gravidity, tenaculum use and diagnosis of fibroids using a multivariable regression model, patients undergoing OH with EMB had a 0.51-unit pain score greater than those that had OH alone; however, this difference was not statistically significant (95% CI: -0.32, 1.33 P=0.23). CONCLUSIONS: Patients undergoing both OH and EMB appear to report similar pain scores as those undergoing OH alone after controlling for confounding variables. The presence of fibroids was found to contribute to higher reported pain in the patients having OH in combination with EMB.

A Simplified Novel Approach for Total Laparoendoscopic Single-Site (LESS) Hysterectomy.

Total laparoendoscopic single-site (LESS) hysterectomy is a technically challenging minimally-invasive gynecologic procedure. Multiple technological innovations assist surgeons to overcome the challenges that are usually encountered during this advanced approach. Simplifying the steps of this advanced surgery is an invaluable addition in overcoming associated challenges with this procedure. We present our novel technique for a total laparoscopic hysterectomy that will optimize a single-site approach (LESS) for surgeons.

Pregnancy and susceptibility to infectious diseases.

To summarize the literature regarding susceptibility of pregnant women to infectious diseases and severity of resulting disease, we conducted a review using a PubMed search and other strategies. Studies were included if they reported information on infection risk or disease outcome in pregnant women. In all, 1454 abstracts were reviewed, and a total of 85 studies were included. Data were extracted regarding number of cases in pregnant women, rates of infection, risk factors for disease severity or complications, and maternal outcomes. The evidence indicates that pregnancy is associated with increased severity of some infectious diseases, such as influenza, malaria, hepatitis E, and herpes simplex virus (HSV) infection (risk for dissemination/hepatitis); there is also some evidence for increased severity of measles and smallpox. Disease severity seems higher with advanced pregnancy. Pregnant women may be more susceptible to acquisition of malaria, HIV infection, and listeriosis, although the evidence is limited. These results reinforce the importance of infection prevention as well as of early identification and treatment of suspected influenza, malaria, hepatitis E, and HSV disease during pregnancy.