Effectiveness and safety of a novel, collapsible pessary for management of pelvic organ prolapse.

BACKGROUND: Pessaries are an effective treatment for pelvic organ prolapse, yet currently available pessaries can cause discomfort with removal and insertion. An early feasibility trial of an investigational, collapsible pessary previously demonstrated mechanical feasibility during a brief 15-minute office trial. Longer-term, patient-centered safety and efficacy data is needed. OBJECTIVES: To assess the effectiveness and safety of the investigational vaginal pessary for pelvic organ prolapse at three months. STUDY DESIGN: This was a prospective, seven-center, open-label equivalence study with participants serving as their own controls. Subjects were current users of a Gellhorn or ring pessary with ≥ Stage II prolapse. Baseline subjective and objective data were collected for one month using their current pessary, and then data were collected through a three-month treatment phase with use of the study pessary. The primary outcome was change in Pelvic Floor Distress Inventory-20 score. Secondary outcome measures included objective assessment of prolapse support, changes in the Pelvic Floor Impact Questionnaire-7, and pain with insertion and removal measured on a Visual Analog Scale. Subjects fitted with study pessary were analyzed as intention to treat and those who dropped out were assigned scores at the upper limit of the predefined equivalence limits. Secondary per protocol analyses included subjects who completed treatment. The study was powered to 80% with a minimal important change equivalence limit of 18.3 points on the Pelvic Floor Distress Inventory-20 scale. Square root transformations were used for non-parametric data and p-values adjusted for multiple comparisons. RESULTS: Seventy-eight subjects were enrolled, though 16 withdrew prior to study pessary placement. Sixty-two subjects (50 ring and 12 Gellhorn pessary users) were fitted with the study pessary, and 48 (62%) completed the three-month intervention. The change in Pelvic Floor Distress Inventory-20 scores at three months demonstrated equivalence compared to the subjects' baseline scores, (mean difference -3.96 (improvement), 90% confidence interval (CI) [-11.99, 4.08], p=0.002). Per protocol analysis of the Pelvic Floor Distress Inventory-20, equivalence was not demonstrated with scores favoring the study pessary (mean difference -10.45, 90% CI, [-20.35, 0.54] (p=0.095)). Secondary outcomes included: objective measures of support which were similar, mean difference Ba=0.54 cm, Bp=0.04 cm, favoring study pessary; improvement in mean Pelvic Floor Impact Questionnaire-7 scores for those who completed the trial (pre=32.23, post=16.86, p=0.019); and pain with insertion and removal, which was lower with the study pessary compared to subject's own pessary (mean difference Visual Analogue Scale insertion=9.91 mm (p=0.019), removal=11.23 mm (p=0.019)). No serious adverse events related to the pessary were reported. CONCLUSIONS: Equivalence was demonstrated in the study pessary primary outcome compared to current non-collapsible pessaries for change in severity and bother of pelvic floor symptoms. In participants who completed the trial, the Pelvic Floor Impact Questionnaire-7 improved with the study pessary and change in Pelvic Floor Distress Inventory-20 scores were non-equivalent, favoring the study pessary. Subjects reported significantly lower pain scores with both pessary insertion and removal with the novel collapsible pessary compared with their standard pessary.

Radiation exposure during sacral neuromodulation lead placement: Multi-institutional descriptive study.

OBJECTIVES: Fluoroscopy has significantly improved lead placement and decreased surgical time for implantable sacral neuromodulation (SNM). There is a paucity of data regarding radiation and safety of fluoroscopy during SNM procedures. Our study aims to characterize fluoroscopy time and dose used during SNM surgery across multiple institutions and assess for predictors of increased fluoroscopy time and radiation dose. METHODS: Electronic medical records were queried for SNM procedures (Stage 1 and full implant) from 2016 to 2021 at four academic institutions. Demographic, clinical, and intraoperative data were collected, including fluoroscopy time and radiation dose in milligray (mGy). The data were entered into a centralized REDCap database. Univariate and multivariate analysis were performed to assess for predictive factors using STATA/BE 17.0. RESULTS: A total of 664 procedures were performed across four institutions. Of these, 363 (54.6%) procedures had complete fluoroscopy details recorded. Mean surgical time was 58.8 min. Of all procedures, 79.6% were performed by Female Pelvic Medicine and Reconstructive Surgery specialists. There was significant variability in fluoroscopy time and dose based on surgical specialty and institution. Most surgeons (76.4%) were considered "low volume" implanters. In a multivariate analysis, bilateral finder needle testing, surgical indication, surgeon volume, and institution significantly predicted increased fluoroscopy time and radiation dose (p < 0.05). CONCLUSIONS: There is significant variability in fluoroscopy time and radiation dose utilized during SNM procedures, with differences across institutions, surgeons, and subspecialties. Increased radiation exposure can have harmful impacts on the surgical team and patient. These findings demonstrate the need for standardized fluoroscopy use during SNM procedures.

Risk Factors for De Novo Overactive Bladder After Midurethral Sling.

IMPORTANCE: The low incidence of de novo overactive bladder (OAB) symptoms after a midurethral sling (MUS) procedure better informs preoperative counseling. OBJECTIVE: The study aimed to measure the incidence and risk factors for de novo OAB after MUS. STUDY DESIGN: This was a retrospective cohort study of de novo OAB symptoms in patients who underwent MUS surgery in a health maintenance organization between January 1, 2008, and September 30, 2016. Patients were identified using Current Procedural Terminology codes for MUS and International Classification of Diseases, Tenth Revision codes for urinary urgency, frequency, nocturia, OAB, and urgency urinary incontinence (UUI). The cohort of patients was identified by the absence of these International Classification of Diseases, Tenth Revision codes 12 months preoperatively and the presence of these codes within 6 months after surgery. This cohort was used to calculate the rate of de novo OAB after MUS surgery. Clinical and demographic factors were abstracted. Statistical analysis was performed using descriptive, χ2 , simple logistic, and multiple logistic regression. RESULTS: During the study period, 13,893 patients underwent MUS surgery and 6,634 met the inclusion criteria. The mean age was 56.9 years, mean parity was 2.76, and mean body mass index was 28.9 (calculated as weight in kilograms divided by height in meters squared). Of these, 410 (6.1%) developed de novo OAB within 12 months. The most common symptoms were urgency (65.4%), UUI (42.2%), and frequency (19.8%). On multivariable regression modeling, de novo urgency and UUI were not associated with concurrent surgery ( P < 0.05). Increasing age and body mass index were associated with an increased risk of nocturia ( P < 0.05). CONCLUSIONS: The incidence of de novo OAB after MUS surgery was 6.1%. This aligns with current literature and critically informs preoperative counseling for MUS surgery.

Bowel Obstruction After Sacrocolpopexy: A Case Series.

OBJECTIVES: Bowel obstruction after sacrocolpopexy (SC) can cause significant morbidity. The aim of this study was to delineate clinical and surgical factors associated with bowel obstruction after SC and to describe its presentation, management, and sequelae. METHODS: We performed a retrospective case series of patients who underwent open, laparoscopic, or robotic SC within a large health maintenance organization and a single academic medical center between January 1, 2009, and December 31, 2019. RESULTS: Of 3,231 patients who underwent SC, 32 (1.0%) experienced a bowel obstruction. Sacrocolpopexy was performed laparoscopically or robotically in 19 (59.4%) and abdominally in 13 (40.6%). The mean time to bowel obstruction was 1.9 years (SD, 2.5; range, 3 days to 8.8 years). In patients who experienced bowel obstruction, medical management was undertaken in 19 (61.3%) cases. Eight of the 13 (61.5%) surgically managed cases underwent bowel resection, and 3 cases (23.1%) reported partial mesh excision. Recurrent obstruction was seen in 2 (10.5%) of the medically managed and 2 (15.4%) of the surgically managed cases. CONCLUSIONS: Bowel obstruction is a rare complication of SC and our rate of at least 1.0% corroborates those in the literature. Obstruction occurs from days to years after SC. Nonsurgical management was effective in most cases, with low rates of recurrent obstruction. In surgically managed cases, the majority included bowel resection or mesh excision; however, mesh excision was not associated with a subsequent identifiable procedural intervention for recurrent prolapse. These data inform patient counseling and surgical planning before SC and aid in diagnosis and management of bowel obstruction after SC.

Extraction of a large vaginal calculus utilizing an ear, nose, throat mallet and osteotomes.

BACKGROUND: Previous case reports on vaginal calculi extraction have described the removal of small calculi facilitated via episiotomy or transabdominal incision. This surgical video demonstrates a novel technique of transvaginal extraction of a large calculus utilizing an ear, nose, and throat (ENT) mallet and osteotomes. CASE: An 86-year-old female with urgency incontinence and limited mobility presented with obstipation and was found to have an 8.8 cm vaginal calculus. She had a history of prior vaginal mesh exposure after a mid-urethral sling that was managed expectantly without surgical resection. Cystourethroscopy and anoscopy excluded fistula. The calculus was extracted utilizing an ENT mallet and osteotomes in < 90 min, and no recurrent vaginal mesh exposure was identified. CONCLUSION: An ENT mallet and osteotomes can be safely utilized to expedite extraction of a vaginal calculus.

Medical management of appendicitis in early-term pregnancy.

A 19-year-old G1 at 37 weeks presented with acute non-ruptured appendicitis. Her advanced gestational age and surgical anatomy presented a complex surgical scenario. She was treated with intravenous antibiotics and induction of labour, which resulted in resolution of the appendicitis and an uncomplicated vaginal delivery at early term. This case is an example that appendicitis occurring in early-term pregnancy can be successfully managed with intravenous antibiotics, but this is a complex clinical scenario with a limited evidence base to make management decisions. Future studies of medical management of appendicitis in pregnancy, specifically in later gestation, are needed to provide additional information to guide clinicians.

Nicotinic acetylcholine receptors in glucose homeostasis: the acute hyperglycemic and chronic insulin-sensitive effects of nicotine suggest dual opposing roles of the receptors in male mice.

Cigarette smoking causes insulin resistance. However, nicotine induces anti-inflammation and improves glucose tolerance in insulin-resistant animal models. Here, we determined the effects of nicotine on glucose metabolism in insulin-sensitive C57BL/J6 mice. Acute nicotine administration (30 min) caused fasting hyperglycemia and lowered insulin sensitivity acutely, which depended on the activation of nicotinic-acetylcholine receptors (nAChRs) and correlated with increased catecholamine secretion, nitric oxide (NO) production, and glycogenolysis. Chlorisondamine, an inhibitor of nAChRs, reduced acute nicotine-induced hyperglycemia. qRT-PCR analysis revealed that the liver and muscle express predominantly ß4 > α10 > α3 > α7 and ß4 > α10 > ß1 > α1 mRNA for nAChR subunits respectively, whereas the adrenal gland expresses ß4 > α3 > α7 > α10 mRNA. Chronic nicotine treatment significantly suppressed expression of α3-nAChR (predominant peripheral α-subunit) in liver. Whereas acute nicotine treatment raised plasma norepinephrine (NE) and epinephrine (Epi) levels, chronic nicotine exposure raised only Epi. Acute nicotine treatment raised both basal and glucose-stimulated insulin secretion (GSIS). After chronic nicotine treatment, basal insulin level was elevated, but GSIS after acute saline or nicotine treatment was blunted. Chronic nicotine exposure caused an increased buildup of NO in plasma and liver, leading to decreased glycogen storage, along with a concomitant suppression of Pepck and G6Pase mRNA, thus preventing hyperglycemia. The insulin-sensitizing effect of chronic nicotine was independent of weight loss. Chronic nicotine treatment enhanced PI-3-kinase activities and increased Akt and glycogen synthase kinase (GSK)-3ß phosphorylation in an nAChR-dependent manner coupled with decreased cAMP response element-binding protein (CREB) phosphorylation. The latter effects caused suppression of Pepck and G6Pase gene expression. Thus, nicotine causes both insulin resistance and insulin sensitivity depending on the duration of the treatment.

Alcohol as a risk factor for sudden infant death syndrome (SIDS).

AIM: To test whether alcohol is a risk factor for sudden infant death syndrome (SIDS). DESIGN AND SETTING: US epidemiological study using computerized death certificates, linked birth and infant death dataset, and Fatality Analysis Reporting System. PARTICIPANTS: All SIDS cases (n = 129,090) and other infant deaths (n = 295,151) from 1973-2006; all persons involved in late-night alcohol-related crashes (n = 135,946) from 1994-2008. MEASUREMENTS: Three measures were used: the expected number of deaths on New Year versus the observed number (expected values were determined using a locally weighted scatterplot smoothing polynomial), the average number of weekend deaths versus the average number of weekday deaths, and the SIDS death rate for children of alcohol-consuming versus non-alcohol-consuming mothers. FINDINGS: These measures indicate that the largest spikes in alcohol consumption and in SIDS (33%) occur on New Year, alcohol consumption and SIDS increase significantly on weekends, and children of alcohol-consuming mothers are much more likely to die from SIDS than are children of non-alcohol-consuming mothers. CONCLUSIONS: Alcohol consumption appears to be a risk factor for sudden infant death syndrome, although it is unclear whether alcohol is an independent risk factor, a risk factor only in conjunction with other known risk factors (like co-sleeping), or a proxy for other risk factors associated with occasions when alcohol consumption increases (like smoking). Our findings suggest that caretakers and authorities should be informed that alcohol impairs parental capacity and might be a risk factor for sudden infant death syndrome; in addition, future research should further explore possible connections between sudden infant death syndrome and alcohol.