To evaluate the physical compatibility and chemical stability of mixtures of magnesium sulphate and lidocaine in order to determine the feasibility of manufacturing a prefilled syringe combining ...these two drugs for use as an intramuscular (IM) loading dose for eclampsia prevention and/or treatment. This ready-to-use mixture will provide a more tolerable and accessible route of administration appropriate for widespread use.
Physical compatibility (pH, colour, and formation of precipitate) and chemical stability (maintaining > 90% of initial concentrations) of mixtures of MgSO4, using both commercially available MgSO4 (50%) and MgSO4 reconstituted from salt (61%), with lidocaine hydrochloride (2%) were evaluated every 14 days over six months. The concentration of lidocaine was determined by a stability indicating high performance liquid chromatographic method, while the concentration of magnesium was determined by an automated chemistry analyzer.
No changes in pH, color or precipitates were observed for up to 6 months. The 95% confidence interval of the slope of the curve relating concentration to time, determined by linear regression, indicated that only the admixtures of commercially-available magnesium sulfate and lidocaine as well as the 61% magnesium sulfate solution (reconstituted from salt) maintained at least 90% of the initial concentration of both drugs at 25°C and 40°C at 6 months.
Commercially available MgSO4 and lidocaine hydrochloride, when combined, are stable in a pre-filled syringe for at least six months in high heat and humidity conditions. This finding represents the first step in improving the administration of magnesium sulphate in the treatment and prevention of eclampsia in under-resourced settings.
Évaluer la compatibilité physique et la stabilité chimique des mélanges du sulfate de magnésium et de lidocaïne, afin de déterminer la possibilité de fabriquer une seringue préremplie de ces deux médicaments, aux fins d'utilisation comme dose de charge, par voie intramusculaire (IM). Ce mélange prêt à l'utilisation permettra d'avoir une voie d'administration plus tolérable et plus accessible, dont l'usage pourrait être généralisé.
La compatibilité physique (pH, couleur, et formation de précipité), ainsi que la stabilité chimique (taux des concentrations initiales maintien à plus de 90 %) d'une combinaison de MgSO4, obtenu à partir de MgSO4 (50%) commercialisé et de MgSO4 reconstitué à partir du sel (61 %), et de chlorhydrate de lidocaïne (2 %) ont été évaluées tous les 14 jours, pendant six mois. La concentration de lidocaïne a été déterminée à l'aide de la chromatographie liquide à haute performance, tandis que la concentration de magnésium a été déterminée à l'aide d'un analyseur chimique automatisé.
Aucun changement du pH, de la couleur ou des précipités n'a été observé pendant une période allant jusqu'à 6 mois. L'intervalle de confiance à 95 % de la pente de la courbe reliant la concentration et le temps, déterminée par la régression linéaire, a indiqué que seuls les mélanges de sulfate de magnésium et de lidocaïne commercialisés, ainsi que la solution de sulfate de magnésium à 61 % (reconstitué à partir du sel) ont gardé au moins 90 % de la concentration initiale des deux médicaments, à 25°C et 40°C, après 6 mois.
Lorsqu'ils sont combinés dans une seringue préremplie, le MgSO4 commercialisé et le chlorhydrate de lidocaïne restent stables, pendant six mois au moins, dans un milieu très chaud et très humide. Ce résultat constitue un premier pas vers l'amélioration de l'administration du sulfate de magnésium pour le traitement et la prévention de l'éclampsie dans des milieux défavorisés.
To characterize hypertension management in an academic family medicine clinic.
Cross-sectional chart review.
Academic family medicine clinic in Edmonton, Alta.
A total of 210 patients with 1 or more ...visits for hypertension during the previous 3 years.
Patient characteristics, current antihypertensive therapies, most recent blood pressure measurements, and compelling indications according to the 2006 Canadian Hypertension Education Program recommendations.
A total of 185 subjects (88%) were prescribed antihypertensive medications, and 89 (42%) had controlled hypertension. Younger subjects, people with diabetes, and people not receiving antihypertensive medication therapy appeared less likely to have controlled hypertension. There were 76 subjects (36%) prescribed 1 antihypertensive medication, 65 subjects (31%) prescribed 2 antihypertensive medications, and 44 (21%) prescribed 3 or more antihypertensive medications. Angiotensin-converting enzyme inhibitors were prescribed for 51% of the subjects, diuretics for 47%, beta-blockers for 27%, calcium channel blockers for 23%, angiotensin receptor blockers for 20%, and alpha-blockers for 1%.
Hypertension treatment and control rates in this academic family medicine clinic appear to be better than those in the general population. Following the principles of a continuous quality improvement process, this information will serve as an important foundation for identifying areas to improve hypertension management in the clinic.
Background
Data on the incidence of perioperative complications of surgical procedures for pelvic organ prolapse (POP) and their contributing factors are limited, sometimes conflicting, and often ...mixed with other urogynecologic surgeries.
Objectives
To estimate the incidence and contributing factors for perioperative complications of POP procedures.
Methods
A cross-sectional study was carried out between November 2016 and June 2017. POP procedures of different approaches were included irrespective of the surgeon involved, type of surgery (primary or repeat), or concomitant hysterectomy or incontinence repair. Data on perioperative complications were recorded prospectively.
Results
A total of 366 women were included in the current analysis. The average age was 61.0 ± 13.4 years. The surgical procedures performed were vaginal (75.3%), abdominal (11.3%), or combined (13.4%). Approximately 18.2% of these procedures were repeat surgeries. A total of 38 (11.3%) women developed perioperative complications (3.6% severe and 7.7% minor). These included: 25 (7.4%) intraoperative complications (2.4% severe and 5.1% minor) and 17 (5.1%) postoperative complications (2.1% severe and 3.0% minor). In multivariate analysis, abdominal surgery and McCall culdoplasty were significant predictors of intraoperative complications (alone or when combined with other postoperative complications). On the other hand, concomitant hysterectomy and concomitant incontinence repair procedure were associated with higher postoperative complication rates while vaginal surgery had fewer postoperative complications.
Conclusion
There was a low rate of perioperative complications. Abdominal surgery and McCall culdoplasty showed higher intraoperative complications. These data should help in preoperative counseling and target ways to further decrease complication rates.
Introduction and hypothesis
To compare laparoscopic and vaginal approaches to uterosacral ligament vault suspension (USLS) by perioperative data, short-term complications, rates of successful ...concomitant adnexal surgery and procedural efficacy.
Methods
Retrospective cohort of USLS procedures performed at the time of hysterectomy at a tertiary care center over a 3-year period. Patient demographics, surgical data, concomitant adnexal procedures and complications were abstracted from a surgical database and compared using parametric or non-parametric tests as appropriate. Validated questionnaires (POPDI-6, UDI-6, PROMIS) were used to collect information on recurrence and long-term complications. Patients were analyzed according to both intention-to-treat analysis based on the intended approach and the completed route of surgery to deal with intraoperative conversions.
Results
Two hundred six patients met the criteria for inclusion; 152 underwent vaginal USLS (V-USLS) and 54 laparoscopic USLS (L-USLS). No statistically significant differences in mean case time, postoperative length of stay or perioperative infection were found. While no ureteric obstructions occurred in the L-USLS group, in the V-USLS group 14 (9%) obstructions occurred (
p
= 0.023). Postoperative urinary retention was higher with V-USLS (31% vs. 15%,
p
= 0.024). Rates of successfully completed adnexal surgery differed (56% vs. 98%,
p
< 0.001) in favor of L-USLS. Patient-reported symptomatic recurrence of prolapse was higher in the V-USLS group (41% vs. 24%,
p
= 0.046); despite this, re-treatment did not differ between the groups (0% vs. 7%,
p
= 0.113).
Conclusions
Perioperative case time and complications did not differ between approaches. However, rates of completed adnexal surgery were significantly higher in the laparoscopic group, which could influence surgical decisions concerning approaches to prolapse surgery.
Aims
Uterine fibroids are the most common tumor of the female reproductive tract Baird et al Am J Obstet Gynecol. 188:100‐107, 2003 and bladder symptoms are more prevalent in these women Pron et al ...Fertil Steril. 79:112‐119, 2003; Volkers et al Am J Obstet Gynecol. 196:519.e1‐e11, 2007 However, the effect of various fibroid debulking surgeries on different types of urinary incontinence symptoms is poorly understood. Our primary objective was to determine whether surgical debulking of uterine fibroids affects urinary symptoms. Secondary objectives were: to define the baseline prevalence of bladder symptoms in women undergoing fibroid surgery; to explore links between fibroid characteristics, size of debulked fibroids, type of surgery, and postoperative changes in bladder function.
Materials and methods
Prospective cohort study (2011‐2016) of women undergoing vaginal or abdominal myomectomy or hysterectomy. Baseline demographics were obtained. All women underwent a detailed pelvic ultrasound preoperatively. The Urinary Distress Inventory (UDI) questionnaire of the validated Pelvic Floor Distress Inventory (PFDI) was administered before and 6 weeks after surgery. Score changes were assessed using Wilcoxon signed rank test.
Results
Sixty‐one women completed the study. At baseline, regardless of fibroid characteristics, 96.6% of women had various bothersome urinary symptoms including storage, voiding, and incontinence. Following surgical fibroid debulking, median improvement in the UDI total score was clinically and statistically significant at 39.9 (P < 0.001). All urinary subscale scores were also significantly improved. 11/17 women (64.7%) and 11/18 women (61.1%) were cured of moderately to severely bothersome symptoms of urge and stress urinary incontinence respectively.
Conclusions
Urinary symptoms are common in women undergoing surgery for uterine fibroids. Fibroid debulking may be offered as treatment for bladder symptoms in symptomatic women.
To systematically review the literature on outcomes of pelvic organ prolapse (POP) surgery in patients from various body mass index (BMI) categories to determine the association between obesity and ...surgical outcomes.
PubMed, EMBASE, and Cochrane databases were searched from inception to April 12, 2022; ClinicalTrials.gov was searched in September 2022 (PROSPERO 2022 CRD42022326255). Randomized and nonrandomized studies of urogynecologic POP surgery outcomes were accepted in which categories of BMI or obesity were compared.
In total, 9,037 abstracts were screened; 759 abstracts were identified for full-text screening, and 31 articles were accepted for inclusion and data were extracted.
Studies were extracted for participant information, intervention, comparator, and outcomes, including subjective outcomes, objective outcomes, and complications. Outcomes were compared among obesity categories (eg, BMI 30-34.9, 35-40, higher than 40), and meta-analysis was performed among different surgical approaches. Individual studies reported varying results as to whether obesity affects surgical outcomes. By meta-analysis, obesity (BMI 30 or higher) is associated with an increased odds of objective prolapse recurrence after vaginal prolapse repair (odds ratio OR 1.38, 95% CI, 1.14-1.67) and after prolapse repair from any surgical approach (OR 1.31, 95% CI, 1.12-1.53) and with complications such as mesh exposure after both vaginal and laparoscopic POP repair (OR 2.10, 95% CI, 1.01-4.39).
Obesity is associated with increased likelihood of prolapse recurrence and mesh complications after POP repair.
PROSPERO CRD42022326255.
Repair of Vesicovaginal Fistulae: A Systematic Review Thompson, Jennifer C; Halder, Gabriela E; Jeppson, Peter C ...
Obstetrics and gynecology (New York. 1953),
2024-Feb-01, 2024-02-00, 20240201, Letnik:
143, Številka:
2
Journal Article
Recenzirano
To assess and compile the current level of evidence regarding successful surgical treatment of vesicovaginal fistulae and how these perioperative interventions affect anatomic, patient-centered, and ...adverse outcomes.
PubMed and EMBASE were searched from inception through September 9, 2022.
This review included comparative studies (of any sample size) and single-group studies (1,000 or more participants) of primary or recurrent vesicovaginal fistula (ie, vesicovaginal fistula, urethrovaginal fistula, and bladder neck-vaginal fistula). We evaluated preintervention assessment or management, various techniques for intraoperative management, and postoperative management. Outcomes of interest included anatomic and objective outcomes (such as successful repair, fistula closure, urinary incontinence, recurrent fistula, perioperative complications) and subjective outcomes (such as voiding symptoms and quality of life). Abstracts and full-text articles were screened in duplicate, and study descriptions and findings were extracted into standardized extraction forms. Risk of bias was assessed independently by two investigators and adjudicated by a third. Study quality was summarized with standardized tools. We conducted random-effects model and restricted maximum-likelihood meta-analyses of relative risks when at least three studies compared similar interventions and reported similar outcome measures.
Forty-six studies met the inclusion criteria. Studies were categorized into 11 domains: 1) preoperative assessment, 2) preoperative and postoperative physical therapy, 3) route of surgery, 4) incorporation of a flap, 5) trimming, 6) layered closure, 7) intraoperative antibiotics, 8) fibrin glue, 9) fascial sling, 10) postoperative Foley catheter duration, and 11) quality of life. Although the strength of the data is insufficient, preoperative phenazopyridine, physical therapy, layered closure, and intraoperative antibiotics seemed to improve the rate of successful fistula repair. Route of surgery (vaginal vs abdominal laparotomy) was determined primarily by surgeon preference and showed no difference in successful fistula repair. In addition, use of interpositional flaps, trimming fistula edges, fibrin glue, and fascial sling did not show significant improvement in rates of fistula cure. Overall, quality-of-life scores improved postoperatively regardless of route of repair and use of interpositional flaps.
Our findings highlight the limited information available to guide evidence-based treatment of vesicovaginal fistula repair. Overall, high-quality evidence is lacking to provide guidelines; therefore, expert opinion remains the primary influence for fistula repair recommendations.
PROSPERO, CRD42021214948.
OBJECTIVE:To evaluate whether the use of a Mayo Scissor as a suburethral spacer compared with a Babcock clamp holding a loop of tape under the urethra results in different rates of abnormal bladder ...outcomes 12 months after retropubic midurethral sling surgery.
METHODS:The MUST (Mid-Urethral Sling Tensioning) trial was a block-randomized, double-blind, multicenter clinical trial that allocated women to have their retropubic midurethral slings tensioned by Scissor or Babcock technique. The primary outcome (abnormal bladder) was a composite of persistent stress urinary incontinence (SUI), overactive bladder, and urinary retention. Secondary outcomes included outcomes of the composite, postoperative catheterization, incontinence-related questionnaires, repeat incontinence treatment, and uroflowmetry. Sample size of 159 in each arm (N=318) was planned for a superiority trial, hypothesizing a 10% difference in primary outcome.
RESULTS:From September 2015 to December 2017, 506 women were screened and 318 were randomized. Baseline characteristics were similar in each arm. At 12 months, 253 (79.6%) women provided information on primary outcome40 of 128 (31.3%) patients with midurethral slings tensioned by Scissor experienced abnormal bladder, compared with 23 of 125 (18.4%) of those with midurethral slings tensioned by Babcock (P=.018, relative difference 12.9%). Secondary analyses favored Babcock for median duration of catheterization and the proportions of women experiencing urinary retention requiring sling lysis. Uroflowmetry parameters suggest the Scissor technique is more restrictive. Rates of mesh erosion were lower for the Scissor arm. No differences occurred in proportions of women experiencing patient reported persistent SUI after surgery.
CONCLUSION:Abnormal bladder outcomes were 12.9% less frequent for women with midurethral slings tensioned by Babcock. Both techniques provided a comparable patient reported cure for SUI at 12 months. Women with midurethral slings tensioned by Scissors experienced more intervention for obstruction, whereas those with midurethral slings tensioned by Babcock experienced higher rates of mesh erosion. This information about how the postoperative courses differ allows surgeons to better counsel patients preoperatively or tailor their choice of technique.
CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT02480231.
FUNDING SOURCE:Boston Scientific.
(Abstracted from Obstet Gynecol 2024;143:539–549) Pelvic organ prolapse (POP) is a common condition, and surgical repair will take place for as many as 12.6% of women at some point in their lifetime.
Female stress urinary incontinence (SUI) is common and has a profound impact on quality of life. Suburethral slings are the most common treatment for SUI in this population. These can be placed with ...synthetic mesh or autologous fascia. Mesh-related complications after midurethral sling procedures are documented in the literature but the risk of complications and reoperation is lower than the use of transvaginal mesh for pelvic organ prolapse repair. In this study, we sought to evaluate local practice patterns of management of female SUI with specific emphasis on mesh use.
A survey created by an expert panel was disseminated to respective provincial societies.
Sixty-eight percent of respondents offer midurethral slings in their practice but only 60.6% of these respondents would offer surgical removal of the sling if there were complications, such as mesh erosion or pain. The majority (39.4%) of respondents are performing transobturator slings as compared to retropubic midurethral slings (36.3%) and only 8.5% have removed the leg component associated with the transobturator sling in their practice. Furthermore, compared to most respondents offering midurethral slings (64.8%), only a minority of surgeons offer alternatives: 23.9% of respondents offer periurethral bulking agent injections, 15.5% offer pubovaginal slings, and 12.7% offer retropubic urethropexies.
Our study supports that surgeons should continue to review surgical risks and alternative treatment options as part of the surgical consent process. As such, surgeons should be able to offer a variety of surgical approaches to manage female SUI.
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