Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial.

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 outcome: 40 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.

The effect of BCG vaccination on macrophage phenotype in a mouse model of intranasal Mycobacterium bovis challenge.

In order to develop improved vaccinations against tuberculosis, it is essential to understand the effect of vaccination on the immune response, and to overcome the mechanisms by which mycobacteria regulate this immune response. In this study, we examine the effect of intradermal vaccination with Mycobacterium bovis bacille Calmette-Guèrin on macrophage phenotype following intranasal challenge with virulent Mycobacterium bovis. Preserved lung tissues used in the present study were obtained from a previous vaccination trial in BALB/c mice. Vaccinated mice showed less extensive pulmonary lesions along with a significant decrease in bacterial lung burden when compared to control mice. Immunohistochemical markers of classically activated macrophages (iNOS) and alternatively activated macrophages (Arg1, FIZZ1) were applied to lung sections. Vaccination led to a statistically significant decrease in the number of Arg1+ macrophages. The presence of macrophages that expressed Arginase 1 in pulmonary lesions was much smaller than the presence of macrophages expressing iNOS. The low presence of Arg1+ macrophages induced by vaccination may be caused by Th1 polarization and may reduce alternative activation of macrophages, with an overall more effective intracellular killing of bacteria.

No. 383-Screening, Diagnosis, and Management of Placenta Accreta Spectrum Disorders.

BACKGROUND: Placenta accreta spectrum (PAS) disorders are a potentially life-threatening complication of pregnancy that demand coordinated interdisciplinary care to achieve safer outcomes. The rising incidence of this disease is due to a growing number of uterine surgical procedures, including the rising incidence of pregnancy following Caesarean section. OBJECTIVE: To provide current evidence-based guidelines on the optimal methods used to effectively screen, diagnose, and manage PAS disorders. METHODS: Members of the guideline committee were selected on the basis of their ongoing expertise in managing this condition across Canada and by practice setting. The committee reviewed all available evidence in the English medical literature, including published guidelines, and evaluated diagnostic tests, surgical procedures, and clinical outcomes. EVIDENCE: Published literature, including clinical practice guidelines, was retrieved through searches of Medline and The Cochrane Library to March 2018 using appropriate controlled vocabulary and key words. Results were restricted to systematic reviews, randomized controlled trials, and observational studies written in English. Searches were updated on a regular basis and incorporated in the guideline to July 2018. VALUES: The quality of evidence in this document was graded using the criteria described in the Report of the Canadian Task Force on Preventive Health Care. RESULTS: This document reviews the evidence regarding the available diagnostic and surgical techniques used for optimal management of women with suspected PAS disorders, including anaesthesia and practical considerations for interdisciplinary care. BENEFITS, HARMS, AND COSTS: Implementation of the guideline recommendations will improve awareness of this disease and increase the proportion of affected women receiving interdisciplinary care in regional centres. CONCLUSIONS: Interdisciplinary team-based care providing accurate diagnostic services, coordinated planning, and safer surgery deliver effective care with improved clinical outcomes in comparison with alternative management. SUMMARY STATEMENTS: RECOMMENDATIONS.

In vitro and in vivo evaluation of a single chain antibody fragment generated in planta with potent rabies neutralisation activity.

Rabies causes more than 60,000 human deaths annually in areas where the virus is endemic. Importantly, rabies is one of the few pathogens for which there is no treatment following the onset of clinical disease with the outcome of infection being death in almost 100% of cases. Whilst vaccination, and the combination of vaccine and rabies immunoglobulin treatment for post-exposure administration are available, no tools have been identified that can reduce or prevent rabies virus replication once clinical disease has initiated. The search for effective antiviral molecules to treat those that have already developed clinical disease associated with rabies virus infection is considered one of the most important goals in rabies research. The current study assesses a single chain antibody molecule (ScFv) based on a monoclonal antibody that potently neutralises rabies in vitro as a potential therapeutic candidate. The recombinant ScFv was generated in Nicotiana benthamiana by transient expression, and was chemically conjugated (ScFv/RVG) to a 29 amino acid peptide, specific for nicotinic acetylcholine receptor (nAchR) binding in the CNS. This conjugated molecule was able to bind nAchR in vitro and enter neuronal cells more efficiently than ScFv. The ability of the ScFv/RVG to neutralise virus in vivo was assessed using a staggered administration where the molecule was inoculated either four hours before, two days after or four days after infection. The ScFv/RVG conjugate was evaluated in direct comparison with HRIG and a potential antiviral molecule, Favipiravir (also known as T-705) to indicate whether there was greater bioavailability of the ScFv in the brains of treated mice. The study indicated that the approach taken with the ScFv/RVG conjugate may have utility in the design and implementation of novel tools targetting rabies virus infection in the brain.

Uterosacral vault suspension (USLS) at the time of hysterectomy: laparoscopic versus vaginal approach.

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.

Early voiding dysfunction after midurethral sling surgery: comparison of two management approaches.

INTRODUCTION AND HYPOTHESIS: Early voiding dysfunction (EVD) with urinary retention (UR) is a complication of midurethral sling (MUS) surgery. Management is not standardized. Our objective was to characterize management approaches at our center, and report outcomes including resolution of UR, persistent voiding dysfunction, and recurrent stress urinary incontinence (SUI). METHODS: All women requiring catheterization for ≥7 days after MUS surgery during the period March 2014 to 2016 were eligible for inclusion in this prospective study. The management plan for each patient was decided jointly by the surgeon and the patient. Questionnaires regarding urinary symptoms were administered at enrollment, and 3 and 6 months after surgery. The timing and type of any surgical intervention were recorded. RESULTS: During the 2-year period, 31 women experienced EVD for ≥7 days after MUS surgery. At 6 months, complete data were available for 30 women (97%). Two management approaches were identified: "early mobilization" to loosen the MUS intact (in 10 patients), and continued catheterization with delayed sling lysis as needed (in 21 patients). In eight of the ten women in the early mobilization group, UR resolved after one intervention. Two required a second mobilization. For all women in this group, UR resolved after one or two procedures. In 11 of the 21 women in the continued catheterization group UR resolved without intervention. The other ten women in the continued catheterization group opted for sling lysis ≤6 months after MUS surgery. None of the women in the mobilization group reported SUI at 6 months in contrast to 9 of 20 (45%) in the planned continued catheterization group (p = 0.029). Seven of the nine women experiencing recurrent SUI had undergone sling lysis. CONCLUSIONS: Patients experiencing EVD after MUS surgery can be informed that UR will resolve in 50% with continued catheterization. Mobilization should be an option for those not comfortable with prolonged catheterization. Early intervention by mobilization may be associated with a lower risk of recurrent SUI, compared to continued catheterization and delayed sling lysis.

Five years after midurethral sling surgery for stress incontinence: obesity continues to have an impact on outcomes.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the impact of preoperative body mass index ≥30 on objective and subjective cure rates 5 years after midurethral sling surgery. METHODS: Secondary analysis of the 5-year results of a randomized clinical trial evaluating tension-free vaginal tape vs transobturator tape surgery. Women (n = 176) were classified as obese or non-obese based on preoperative height and weight. Women self-reported symptoms and quality of life, and underwent standardized physical examinations and pad-testing. Categorical data were analyzed using Chi-squared or Fisher's exact tests, continuous data by Mann-Whitney U test. Primary outcome was objective cure defined as <1 g urine lost on pad-test at 5 years post-surgery. Secondary outcomes were subjective cure of incontinence, urinary urge incontinence symptoms, and quality of life scores. RESULTS: Non-obese women had a higher rate of objective cure, 87.4 % (n = 83 out of 95) compared with 65.9 % (n = 29 out of 44) in the obese group (P = 0.003, risk difference [RD] 21.5 %, 95 % CI 5.9-37.0 %). Subjectively, non-obese women also reported higher rates of cure, 76.7 % (n = 89 out of 116) compared with 53.6 % (n = 30 out of 56) of obese women (P = 0.002, RD 23.2 %, 95 % CI 8.0-38.3 %). Overall rates of urge incontinence symptoms were similar in the two groups, but rates of bothersome symptoms were higher for obese women (58.9 % vs 42.1 %, P = 0.039, RD 16.8 % 95 % CI 1.1-32.6). CONCLUSIONS: Five years after surgery, obese women continued to experience lower rates of cure compared with non-obese women.

Absorbable mesh augmentation compared with no mesh for anterior prolapse: a randomized controlled trial.

OBJECTIVE: To compare anatomical and patient-reported outcomes at 12 months postoperatively for women who had anterior compartment pelvic organ prolapse (POP) surgery using a repair augmented with porcine small intestine submucosa mesh (Mesh Group) compared with those who had a native tissue repair (No Mesh Group). METHODS: This was a randomized controlled trial with 12 months follow-up. The surgical procedure was identical in both groups except for the placement of intervening mesh. The primary outcome was anatomical "cure" (Ba of -1 or less on Pelvic Organ Prolapse Quantification [POP-Q]). Secondary outcomes included POP-Q stage, patient-reported outcomes, and patient satisfaction. The study was powered to detect a 40% difference at 80% power (α=0.05). RESULTS: Fifty-seven women were randomized (28 to Mesh Group, 29 to No Mesh Group). Forty-five (79%) underwent concomitant surgery. At the 12-month follow-up, 56% (15/27) in the Mesh Group and 61% (17/28) in the No Mesh Group were considered cured (relative risk 0.90, 95% confidence interval 0.52-1.54). There were no significant differences between groups in recurrent or persistent prolapse (7% in each group) nor in patient-reported outcomes at 12 months. Pelvic girdle pain occurred in 4 of 27 in the Mesh Group and 3 of 28 in the No Mesh Group. CONCLUSION: No significant differences were observed in anatomical or patient-reported outcomes outcome parameters at 12 months after correction of symptomatic anterior POP by mesh or no mesh repair. In our study, porcine small intestine submucosa mesh did not confer additional benefit over a native tissue repair. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT0095544. LEVEL OF EVEDIENCE: I.

Autologous muscle derived cell therapy for stress urinary incontinence: a prospective, dose ranging study.

PURPOSE: In this feasibility study we assessed the 12-month safety and potential efficacy of autologous muscle derived cells (Cook MyoSite Incorporated, Pittsburgh, Pennsylvania) as therapy for stress urinary incontinence. MATERIALS AND METHODS: A total of 38 women in whom stress urinary incontinence had not improved with conservative therapy for 12 or more months underwent intrasphincter injection of low doses (1, 2, 4, 8 or 16 × 10(6)) or high doses (32, 64 or 128 × 10(6)) of autologous muscle derived cells, which were derived from biopsies of their quadriceps femoris. All patients could elect a second treatment of the same dose after 3-month followup. Assessments were made at 1, 3, 6 and 12 months after the last treatment. The primary end point was the incidence and severity of adverse events. In addition, changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys. RESULTS: Of the 38 patients 33 completed the study. Treatment related complications were limited to minor events such as pain/bruising at the biopsy and injection sites. Of patients who received 2 treatments of autologous muscle derived cells who were eligible for analysis, a higher percentage of those in the high dose vs the low dose group experienced a 50% or greater reduction in pad weight (88.9%, 8 of 9 vs 61.5%, 8 of 13), had a 50% or greater reduction in diary reported stress leaks (77.8%, 7 of 9 vs 53.3%, 8 of 15) and had 0 to 1 leaks during 3 days (88.9%, 8 of 9 vs 33.3%, 5 of 15) at final followup. CONCLUSIONS: Injection of autologous muscle derived cells in a wide range of doses appears safe with no major treatment related adverse events reported. In addition, treatment with autologous muscle derived cells shows promise for relieving stress urinary incontinence symptoms and improving quality of life.

Vaginal paravaginal repair with porcine small intestine submucosa: midterm outcomes.

OBJECTIVE: : This study aimed to determine the midterm efficacy of porcine small intestine submucosa for paravaginal repairs of anterior vaginal prolapse. METHODS: : One hundred five women underwent repairs between 2003 and 2006 and met our inclusion criteria. Women were invited to return for a pelvic examination and to fill out validated questionnaires. Objective failure was defined as anterior prolapse recurrence at or beyond the hymen. RESULTS: : Fifty-nine women (56%) were available for follow-up. Median age of patients was 60 years (range, 26-80 years) and 83% had a parity of 2 or more. Ninety-seven percent of patients had a preoperative prolapse stage of 2 or more. Follow-up ranged from 1 to 5 years (median, 27.5 months; interquartile range, 14.5). The most common postoperative complication was transient voiding dysfunction (23.7%). Objective cure rate was 68.8%. A positive change in bladder, vaginal, and bowel symptoms (a little better, much better, or very much better) was reported by 69.5%, 59.3%, and 25.5% of women, respectively. Thirty-one women (52.5%) were sexually active at postoperative follow-up. Only 4 women (6.8%) were not sexually active because of pelvic symptoms. Dyspareunia was reported by 8.3% of the 48 women who returned for a clinic follow-up. Twenty-four women (40.7%) were not sexually active postoperatively, for reasons unrelated to their surgeries. CONCLUSIONS: : Vaginal paravaginal repair using porcine xenograft is a safe procedure whose long-term efficacy needs further evaluation through prospective trials.

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

OBJECTIVE: To compare the effectiveness of transobturator tape with tension-free vaginal tape (TVT) in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively. METHOD: Women with SUI were randomly allocated to either transobturator tape or TVT procedures and reviewed at 12 months after surgery. The primary outcome was objective evidence of "cure," evaluated by standardized pad test (cure defined as less than 1 g urine leaked). Other outcomes included complications, subjective cure, incontinence-related quality of life, return to usual sexual activity, and satisfaction with surgery. Primary analysis compared the proportion of patients in each group who were cured at 12-month follow-up. RESULTS: A total of 199 women participated (94 in the transobturator tape group, 105 in the TVT group). Sixty-eight women (81%) in the transobturator tape group were cured, compared with 67 (77%) in the TVT group (relative risk 1.05, 95% confidence interval 0.90-1.23, P=.577). On vaginal examination, the tape was palpable for 68 women (80%) in the transobturator tape group and for 24 (27%) in the TVT group (relative risk 0.22, 95% confidence interval 0.13-0.37, P<.001). More women in the transobturator tape group experienced groin pain during vaginal palpation (13 [15%] in the transobturator tape group and five [6%] in the TVT group, P=.044). Quality of life improved significantly from baseline in both groups (30-point improvement in IIQ-7 score for both groups). CONCLUSION: At 12 months, the majority of women had minimal leakage and their quality of life had improved significantly, but differences were not observed between groups. The presence of palpable tape, particularly among the transobturator tape group, is concerning; longer follow-up is needed to determine whether this outcome leads to extrusion or resolves over time. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00234754. LEVEL OF EVIDENCE: I.

Peripartum hysterectomy: 1999 to 2006.

OBJECTIVE: To estimate the rate of peripartum hysterectomy over the last 8 years in Calgary, the primary indication for peripartum hysterectomy (defined as any hysterectomy performed within 24 hours of a delivery), and whether there was an increase in the rate of peripartum hysterectomy during that time. METHOD: Detailed chart review of all cases of peripartum hysterectomy, 1999-2006, including previous obstetric history, details of the index pregnancy, indications for peripartum hysterectomy, outcome of the hysterectomy, and infant morbidity. RESULTS: The overall rate of peripartum hysterectomy was 87 of 108,154 or 0.8 per 1,000 deliveries. The primary indications for hysterectomy were uterine atony (32 of 87, 37%) and suspected placenta accreta (29 of 87, 33%). After hysterectomy, 46 (53%) women were admitted to the intensive care unit. Women were discharged home after a mean 6-day length of stay. The rate of peripartum hysterectomy did not appear to increase over time. CONCLUSION: Our population-based study found that abnormal placentation is the main indication for peripartum hysterectomy. The most important step in prevention of major postpartum hemorrhage is recognizing and assessing women's risk, although even perfect management of hemorrhage cannot always prevent surgery.

Trans-obturator surgery for stress urinary incontinence: 1-year follow-up of a cohort of 52 women.

This study was a 1-year follow-up of a cohort of 52 women who underwent trans-obturator tape (TOT) procedures using Obtape. Follow-up information was available for 45/52 (87%) women. The rate of erosions was 8/52 (15%). Among 34 women examined, 26% experienced tenderness on palpation of operative site, and 72% were objectively cured on pad test. Forty women completed questionnaires (median Incontinence Impact Questionnaire-7, 0; median Urogenital Distress Inventory-6, 17) and of those, 93% would recommend TOT to a friend. We found a high rate of erosions among our cohort. Our high rate of erosions may be a result of our review of the majority of the cohort, and it is likely related to the specific device used (Obtape). The majority of women were satisfied with the outcome. Before introducing new procedures into widespread clinical practice, it is important to rigorously investigate their outcomes.

Five cases of tape erosion after transobturator surgery for urinary incontinence.

BACKGROUND: Before introducing the transobturator tape into our practice we undertook 52 transobturator tape procedures. The transobturator tape procedures were undertaken with an "outside-in" approach, using nonwoven polypropylene mesh with average pore size of 50 mum. CASES: Five cases of vaginal erosions have been identified, 1 complicated by a groin abscess. All cases required further procedures to trim (n = 3), resect (n = 1) or remove (n = 1) the tape. One woman had a tension-free vaginal tape procedure. To date, 3 women remain incontinent. CONCLUSION: Possible reasons for the complications include 1) surgical inexperience (unlikely, given that we have undertaken more than 2000 tension-free vaginal tape procedures without similar complication rates); 2) inherent susceptibility of the "hammock" position of the transobturator tape; or 3) the nonwoven polypropylene tape with mesh size of 50 microm itself may predispose to erosion or abscess.

The use of prosthetics in pelvic reconstructive surgery.

With an ageing population, increasing numbers of women are presenting with pelvic floor disorders. The lifetime risk of undergoing prolapse or incontinence surgery in the USA is 1 in 11. With a recognized reoperation rate exceeding 30% for prolapse surgery, attempts are being made to improve our primary surgical outcomes. The introduction of synthetic and biological prostheses have been proposed to reduce recurrence rates whilst maintaining vaginal capacity and coital function. The role of synthetic prostheses is well established for use in continence surgery in the form of midurethral slings and for abdominal sacrocolpopexy to correct vault prolapse. However, postoperative morbidity-specifically the risk of mesh erosion-has limited their use for vaginal prolapse surgery. Biological prostheses have been introduced to offer an alternative for use in these repairs. While these grafts largely obviate the problem of erosion there are concerns regarding longevity, and only short-term outcome data are currently available. The role of prosthetics in pelvic floor surgery is an evolving and controversial field. Current and future research should be directed at evaluating the safety and efficacy of specific products and comparison of subjective and objective outcome parameters to standard surgical techniques for pelvic organ prolapse.

Emergency contraception.

OBJECTIVE: To review current knowledge about emergency contraception (EC), including available options, their modes of action, efficacy, safety, and the effective provision of EC within a practice setting. OPTIONS: The combined estradiol-levonorgestrel (Yuzpe regimen) and the levonorgestrel-only regimen, as well as post-coital copper intrauterine devices, are reviewed. OUTCOMES: Efficacy in terms of reduction in risk of pregnancy, safety, and side effects of methods for EC and the effect of the means of access to EC on its appropriate use and the use of consistent contraception. EVIDENCE: MEDLINE and the Cochrane Database were searched for English-language articles published from January 1998 through March 2003, to update the previous SOGC guidelines published in 2000. Clinical guidelines and position papers developed by health or family planning organizations were also reviewed. Key words used were: emergency contraception, post-coital contraception, emergency contraceptive pills, postcoital copper IUD. VALUES: The studies reviewed were classified according to criteria described by the Canadian Task Force on the Periodic Health Exam and the recommendations for practice were ranked based on this classification. BENEFITS, HARMS, AND COSTS: These guidelines are intended to help reduce unintended pregnancies by increasing awareness and appropriate use of EC. RECOMMENDATIONS: 1. Women who have had unprotected intercourse and wish to prevent pregnancy should be offered hormonal EC up to 5 days after intercourse. (II-2A) 2. A copper IUD can be used up to 7 days after intercourse in women who have no contraindications. (III-B) 3. Women should be advised that the levonorgestrel EC regimen is more effective and causes fewer side effects than the Yuzpe regimen. (I-A) 4. Either 1 double dose of the levonorgestrel EC regimen (1.5 mg) or the regular 2-dose levonorgestrel regimen (0.75 mg each dose) may be used, as they have similar efficacy with no difference in side effects. (I-A) 5. Hormonal EC should be started as soon as possible after unprotected sexual intercourse. (II-2B)6. Women of reproductive age should be provided with a prescription for hormonal EC in advance of need. (I-A) 7. The woman should be evaluated for pregnancy if menses have not begun within 21 days following EC treatment. (III-A) 8. A pelvic examination is not indicated for the provision of hormonal EC. (III-A) Validation: These guidelines have been reviewed by the Clinical Practice Gynaecology and Social and Sexual Issues Committees of the Society of Obstetricians and Gynaecologists of Canada. SPONSOR: The Society of Obstetricians and Gynaecologists of Canada.

The management of uterine leiomyomas.

OBJECTIVE: The objective of this document is to serve as a guideline to the investigation and management of uterine leiomyomas. OPTIONS: The areas of clinical practice considered in formulating this guideline are assessment, medical treatments, conservative treatments of myolysis, selective artery occlusion, and surgical alternatives including myomectomy and hysterectomy. The risk-to-benefit ratio must be examined individually by the woman and her health-care provider. OUTCOMES: Implementation of this guideline should optimize the decision-making process of women and their health-care providers in proceeding with further investigation or therapy for uterine leiomyomas, having considered the disease process and available treatment options, and reviewed the risks and anticipated benefits. EVIDENCE: English-language articles from MEDLINE, PubMed, and the Cochrane Database were reviewed from 1992 to 2002, using the key words "leiomyoma," "fibroid," "uterine artery embolization," "uterine artery occlusion," "uterine leiomyosarcoma," and "myomectomy." The level of evidence has been determined using the criteria described by the Canadian Task Force on the Periodic Health Examination. BENEFITS, HARMS, AND COSTS: The majority of fibroids are asymptomatic and will not require intervention or further investigations. For the symptomatic fibroid, hysterectomy offers a definitive solution. However, it is not the preferred solution for women who wish to preserve their uterus. The predicted benefits of alternative therapies must be carefully weighed against the possible risks of these therapies. In the properly selected woman with symptomatic fibroids, the result from the selected treatment should be an improvement in the quality of life. The cost of the therapy to the health-care system and to women with fibroids must be interpreted in the context of the cost of untreated disease conditions and the cost of ongoing or repeat treatment modalities. RECOMMENDATIONS: 1. Medical management should be tailored to the needs of the woman presenting with uterine fibroids and geared to alleviating the symptoms. Cost and side effects of medical therapies may limit their long-term use. (III-C) 2. In women who do not wish to preserve fertility and who have been counselled regarding the alternatives and risks, hysterectomy may be offered as the definitive treatment for symptomatic uterine fibroids and is associated with a high level of satisfaction. (II-A) 3. Myomectomy is an option for women who wish to preserve their uterus, but women should be counselled regarding the risk of requiring further intervention. (II-B) 4. Hysteroscopic myomectomy should be considered as first-line conservative surgical therapy for the management of symptomatic intracavitary fibroids. (I-B) 5. It is important to monitor ongoing fluid balance carefully during hysteroscopic removal of fibroids. (I-B) 6. Laparoscopic myolysis may present an alternative to myomectomy or hysterectomy for selected women with symptomatic intramural or subserous fibroids who wish to preserve their uterus but do not desire future fertility. (II-B) 7. Uterine artery occlusion may be offered as an alternative to selected women with symptomatic uterine fibroids who wish to preserve their uterus. (I-C) 8. Women choosing uterine artery occlusion for the treatment of fibroids should be counselled regarding possible risks, and that long-term data regarding efficacy, fecundity, pregnancy outcomes, and patient satisfaction are lacking. (III-C) 9. Removal of fibroids that distort the uterine cavity may be indicated in infertile women, where no other factors have been identified, and in women about to undergo in vitro fertilization treatment. (III-C) 10. Concern of possible complications related to fibroids in pregnancy is not an indication for myomectomy, except in women who have experienced a previous pregnancy with complications related to these fibroids. (III-C) 11. Women who have fibroids detected in pregnancy may require additional fetal surveillance when the placenta is implanted over or in close proximity to hen the placenta is implanted over or in close proximity to a fibroid. (III-C) 12. In women who present with acute hemorrhage related to uterine fibroids, conservative management consisting of estrogens, hysteroscopy, or dilatation and curettage may be considered, but hysterectomy may become necessary in some cases. (III-C) 13. Hormone replacement therapy may cause myoma growth in postmenopausal women, but it does not appear to cause clinical symptoms. Postmenopausal bleeding and pain in women with fibroids should be investigated in the same way as in women without fibroids. (II-B) 14. There is currently no evidence to substantiate performing a hysterectomy for an asymptomatic leiomyoma for the sole purpose of alleviating the concern that it may be malignant. (III-C) VALIDATION: This guideline was reviewed and accepted by the Clinical Practice Gynaecology Committee, and by Executive and Council of the Society of Obstetricians and Gynaecologists of Canada. SPONSOR: The Society for Obstetricians and Gynaecologists of Canada.

The role of synthetic and biological prostheses in reconstructive pelvic floor surgery.

PURPOSE OF REVIEW: Uterovaginal prolapse and urinary incontinence are common problems whose pathogenesis remains unclear. As life expectancy increases, significantly greater numbers of women will present with pelvic floor prolapse and incontinence requiring surgical intervention. Currently, the lifetime risk of undergoing prolapse or continence surgery in the USA is one in 11, and up to 30% of patients will require repeat prolapse and 10% repeat continence surgery. In an attempt to improve surgical outcomes and to preserve vaginal capacity and coital function, a number of synthetic and biological prostheses have been developed. This review aims to look at the controversies that exist as the 'ideal' prosthetic material is developed. RECENT FINDINGS: The recent literature has reflected the increasing interest in the use of biological prostheses (Allograft/Xenograft) and synthetic absorbable meshes. There has been a focus on the risk factors for erosion seen with the use of synthetic non-absorbable material and a review of techniques for the reduction and management of this complication. The advent of mesh placement in minimally invasive continence surgery (tension-free vaginal tape, intravaginal sling, and Supra Public ARC) is now seeing surgical success to 5 years, but the reporting of complications remains inconsistent. SUMMARY: The use of prosthetics in pelvic floor and continence surgery is an evolving field. Further randomized controlled trials are required to evaluate the role of both biological and synthetic prostheses in reconstructive surgery, to determine which type of prosthesis is most suitable for specific procedures. Prosthetic reinforcement should not be used to replace good surgical techniques.