Treatment Option For Women Research Articles

Complementary and Alternative (CAM) Treatment Options for Women with Pelvic pain.

I.To provide an overview of the current complementary and alternative (CAM) treatment options for women with chronic pelvic pain (CPP). II.Recent studies on chronic pain at cellular, molecular and network level and their interaction with the immune system has unfolded several mechanisms for pain making it promising to explore the alternative paradigm to manage the incredibly complex chronic pelvic pain condition where multifactorial etiology often limits successful outcomes. III.The multifactorial nature and complexity in establishing the underlying diagnosis in CPP limits predictable response to traditional medical and interventional options. Complementary and alternative options have been studied to improve outcomes. Incorporation of exercise-based CAM, pelvic floor physical therapy, acupuncture and cognitive behavioral therapy are suggested to show promising results but well powered randomized studies are needed to draw conclusions on their efficacy. Evidence for non-opioid alternatives such as oral cannabinoids are preliminary and may emerge to be safe and effective.

Vaginal laser for overactive bladder syndrome

Overactive bladder syndrome (OAB) is defined as urinary urgency, usually with urinary frequency and nocturia, with or without urge urinary incontinence. The prevalence of OAB in adult women ranges between 11% and 42%, is particularly common in elderly people, and can overlap with the genitourinary syndrome of menopause (GSM). There is a wide approach to the treatment of symptoms, often in a stepwise fashion, including lifestyle changes, bladder retraining and pelvic floor muscle rehabilitation, drug therapy, intra-vesical botulinum toxin injections or neuromodulation. Recently, vaginal laser therapy has been proposed as an emerging minimal invasive effective treatment option for women with OAB. We explore this further.

Efficacy of Topical Finasteride 0.5% vs 17α-Estradiol 0.05% in the Treatment of Postmenopausal Female Pattern Hair Loss: A Retrospective, Single-Blind Study of 119 Patients

Female pattern hair loss (FPHL) is a common form of scalp hair loss that occurs in 38% of females. Currently, minoxidil solution is the only therapy approved by the US Food and Drug Administration, but many other treatments are used, including cyproterone acetate, spironolactone, topical 17α-estradiol, and prostaglandin analogs. Systemic finasteride has been considered a treatment option in women even though its teratogenic effects tend to limit its prescription. Recently, topical finasteride has been evaluated to limit the side effect profile of the drug. The objective of the present study is to compare retrospectively the efficacy of topical 0.05% 17α-estradiol solution and a 0.5% finasteride lotion in the treatment of FPHL. We enrolled 119 postmenopausal female patients. The first group comprised 69 women treated with finasteride 0.5% and minoxidil 2%. The second group included 50 women treated with 17α-estradiol 0.05% and minoxidil 2%. At baseline and at 6- and 12- to 18-month follow-up, global photographs were systematically taken. Three operators blind to the prescribed treatment evaluated photographs using a 7-point scale. One-way analysis of variance and unpaired Student t tests were performed to analyze 7-point scale scores. The improvement was statistically significant from 6 months to 12-18 months, both for finasteride (P < 0.005) and 17α-estradiol (P < 0.05). The efficacy of topical finasteride was significantly greater than that of 17α-estradiol solution, both at the 6-month (P < 0.05) and at the 12- to 18-month follow-up (P < 0.005). In general, the highest improvement was observed after 12-18 months of treatment with topical finasteride therapy. Topical finasteride 0.5% in combination with minoxidil 2% could represent a valid therapeutic option for the treatment of postmenopausal FPHL, showing higher efficacy than topical 17α-estradiol with minoxidil 2% both at 6-month and 12- to 18-month follow-up.

Physical activity and prenatal depression: going beyond statistical significance by assessing the impact of reliable and clinical significant change.

Previous literature supports exercise as a preventative agent for prenatal depression; however, treatment effects for women at risk for prenatal depression remain unexplored. The purpose of the study was to examine whether exercise can lower depressive symptoms among women who began pregnancy at risk for depression using both a statistical significance and reliable and clinically significant change criteria. This study is a secondary analysis of two randomized controlled trials that followed the same exercise protocol. Pregnant women were allocated to an exercise intervention group (IG) or control group (CG). All participants completed the Center for Epidemiological Depression (CES-D) scale at gestational week 9-16 and 36-38. Women with a baseline score ⩾16 were included. A clinically reliable cut-off was calculated as a 7-point change in scores from pre- to post-intervention. Thirty-six women in the IG and 25 women in the CG scored ⩾16 on the CES-D at baseline. At week 36-38 the IG had a statistically significant lower CES-D score (14.4 ± 8.6) than the CG (19.4 ± 11.1; p < 0.05). Twenty-two women in the IG (61%) had a clinically reliable decrease in their post-intervention score compared to eight women in the CG (32%; p < 0.05). Among the women who met the reliable change criteria, 18 (81%) in the IG and 7 (88%) in the CG had a score <16 post-intervention, with no difference between groups (p > 0.05). A structured exercise program might be a useful treatment option for women at risk for prenatal depression.

Abstract P3-01-15: Targeting small G proteins in triple negative breast cancer

Abstract Breast Cancer (BC) is the most common cancer in women and second leading cause of cancer-associated mortality in women world-wide. Treatment for women with BC is complicated by the molecular heterogeneity of the disease which can be classified by expression of three key receptors: estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). Those BCs expressing none of these receptors are known as triple negative (TNBC). Importantly, TNBC patients have the highest mortality among BC subtypes. This inequity is due in large part to the lack of targeted treatment options for TNBC patients. While women with ER-positive or HER2-positive BC benefit from therapeutic advances that target these receptors, treatment options for women with TNBC have changed little since the 1960’s with toxic chemotherapy as the primary systemic treatment option. Thus, there is an urgent need to identify new molecular targets and innovative treatment strategies to improve outcome for women with TNBC. RalA and RalB are small GTPases implicated in tumor proliferation, survival, and metastasis in a variety of cancers. However, little is known of their roles in breast cancer. Utilizing publicly available BC patient gene expression datasets, we identified RALA as a potential prognostic biomarker and therapeutic target in TNBC. RALA expression is significantly elevated in TNBC relative to normal mammary tissue or other BC subtypes. Furthermore, RALA expression is highly prognostic of overall and distant metastasis-free survival in the greater BC patient population and specifically in patients with TNBC. Importantly, RALA remains an independent prognostic factor in TNBC when other clinicopathological variables are considered. BC patient tissue microarrays revealed RalA immunohistochemical (IHC) staining is also prognostic of worse overall survival in the ER-negative and TNBC populations but not in BC patients with ER-positive disease. Surprisingly, expression of RALB, which is highly homologous to RALA and has also been implicated as pro-tumorigenic/pro-metastatic in a number of solid tumor types, is decreased in TNBC relative to normal mammary tissue and is not prognostic of TNBC outcome. These data suggest RalA may have a unique and important role in the pathogenesis of TNBC. To determine the necessity of RalA in TNBC growth and metastasis, RalA was depleted in MVT1 cells, a murine TNBC cell line. Knockdown of RalA inhibited MVT1 orthotopic primary tumor growth and metastasis in immunocompetent mice. Similarly, knockdown of RalA in the human TNBC cell line MDA-MB-231 decreased orthotopic primary tumor growth and growth of spontaneous or experimental lung metastases in NOD scid gamma mice. Conversely, stable knockdown of RalB in MDA-MB-231 cells did not impair their tumor growth or metastatic capability in vivo. Recently, BQU57, an experimental small molecule inhibitor of both Ral isoforms was reported to slow growth of lung cancer cell lines in vitro and in vivo. We report BQU57 inhibits RalA and RalB GTP-binding and anchorage independent growth of MDA-MB-231 cells in vitro.In vivo, BQU57 treatment of mice bearing palpable MDA-MB-231 tumors significantly decreased both primary orthotopic tumor growth and spontaneous lung metastasis. BQU57 also slowed the growth of a PDX model derived from a TNBC lung metastasis. Combined, these results demonstrate an important role for RalA in the pathogenesis of TNBC that is not redundant with RalB and warrant further investigation of RalA as a target for the precise treatment of advanced TNBC. Citation Format: Rachel E Schafer, Katie A. Thies, Reena Shakya, Sue Knoblaugh, Gina M Sizemore, Steven T Sizemore. Targeting small G proteins in triple negative breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P3-01-15.

Investigating the microbial composition of Recurrent Vulvovaginal Candidiasis samples and biofilm formation of Candida clinical isolates

Recurrent vulvovaginal candidiasis (RVVC) is a chronic and debilitating condition that is estimated to affect 138 million women annually. In spite of this high prevalence and its associated economic burden, pathogenesis of disease is poorly understood. The biofilm-forming yeast Candida albicans is reported as the causative pathogen in up to 90% of VVC cases and around 50% in RVVC disease. Despite the identification of Candidabiofilms on the vaginal mucosa, their associated therapeutic challenge in RVVC is still disputed. A panel of 100 HVS and cervico-vaginal lavage (CVL) samples were obtained for this trial. Patient questionnaires collected data on patient’s vaginal thrush history, treatments and any contraception currently used. Microbiological screening of clinical samples was performed, and microbiome analysis was utilized to determine predominant microbes present in each cohort. Non-C. albicans species (NCAS) such as intrinsically azole-resistant C. glabrata were found to account for 27% of RVVC cases, notably higher than historically reported. Additionally, microbiome analysis showed a reduction in Lactobacillus species associated with a healthy microbiome in RVVC compared to health. This study supports a previous clinical trial by our group using 300 HVS to investigate the epidemiology of RVVC showing an increasing prevalence of NCAS responsible for disease. Additionally, this work strengthens the hypothesis that formation of Candida biofilms on the vaginal mucosa could negatively impact clinical treatment. Further research to identify triggers for RVVC, and the pathogenesis of the predominant microbes involved, could considerably improve prevention and treatment options for women with recurrent, azole-resistant infections.

Differentiation between benign and malignant ovarian masses using multiparametric MRI

PurposeTo investigate the capabilities of multiparametric MRI including dynamic contrast enhanced (DCE) perfusion and diffusion-weighted imaging (DWI) to discriminate between benign and malignant ovarian masses. MethodsA total of 43 women with a total of 43 ovarian masses were retrospectively included. They had a mean age of 51.26±18.05 (SD) years (range: 20–88years). Twenty women had benign and 23 had malignant ovarian tumors. All women had multiparametric MRI examinations including DWI (b50-b800) and DCE perfusion imaging at 1–5T. Results of DWI (apparent diffusion coefficient [ADC], b-800) and DCE imaging (volume transfer coefficient [Ktrans], rate constant [Kep], interstitial volume [Ve], initial area under the curve [iAUC]) were compared between benign and malignant ovarian masses. ResultsMean ADC was significantly lowed in malignant tumors (0.92±0.25 [SD]×10−3 mm2/s (range: 0.6–1.6×10−3 mm2/s) than in benign tumors (1.37±0.69 [SD]×10−3 mm2/s; range: 0.4–2.9×10−3 mm2/s) (P=0.011). B-800 was significantly greater in malignant tumors (80.61±24.73 [SD] s/mm2; range: 24–110 s/mm2) than in benign ones (61.15±22.17 [SD] s/mm2; range: 38–155 s/mm2) (P=0.010). Ktrans was lower in benign tumors (0.13±0.06 [SD] min−1; range: 0–0.2min−1) than in malignant ones (0.25±0.16 [SD] min−1; range: 0.1–0.8min−1) (P=0.002). Kep was significantly greater in malignant tumors (0.55±0.19 [SD] min−1; range: 0.1–1.9min−1) than in benign ones (0.44±0.38 [SD] min−1; range: 0.2–1.1min−1) (P=0.003). iAUC was greater in malignant tumors (15.59±7.98 [SD] mM/min; range: 6.6–42.1mM/min) than in benign ones (7.98±5.06 [SD] mM/min; range: 0.2–17.7mM/min) (P=0.001). No differences in Ve were found between benign and malignant masses (P=0.084). The area under the ROC curve was significant for all parameters but Ve. Logistic regression analysis revealed 5.590 and 11.637 times higher malignancy risk for an ADC≤0.93×10−3 mm2/s and an iAUC≥13.88mM/min, respectively. ConclusionMultiparametric MRI has high accuracy in discrimination between benign and malignant ovarian masses. Therefore, adding these methods to the more common MRI protocol can help select the best treatment option in women with ovarian mass.

Is it time to call for improvement in surgical techniques for minimally invasive radical hysterectomy?

Cervical cancer is the most common pelvic cancer in women worldwide with an annual incidence of 569,847 and 311,365 deaths expected in 2018.1 In the United States, about 13,000 women are diagnosed each year with cervical cancer. Radical hysterectomy (RH) and chemoradiation therapy are both treatment options for women with early-stage cervical cancer. Retrospective studies suggest that RH is as effective as radiation therapy (RT). The only randomized clinical trial comparing these two modalities for women with stage Ib-IIa cervical cancer showed equivalent 5-y overall survival (OS) and disease-free survival (DFS).2 RH as primary treatment is preferred over RT in women who desire the preservation of ovarian function and is associated with fewer long-term sexual dysfunction.3,–5 In the recent noninferiority study published in the New England Journal of Medicine by Pedro Ramirez et al., 631 women with stage IA1 (with lymphovascular invasion), IA2, and IB1 cervical cancer were randomized to undergo RH by minimally invasive surgery (MIS) (319 patients) or exploratory laparotomy (RAH) (312 patients) approach; in the MIS group, 84.4% underwent laparoscopic and 15.6% robotic-assisted laparoscopic RH. The RAH group had a slightly more than 10% advantage in 4.5-y DFS over MIS RH (96.5% vs 80.0%). Similarly, a 5% OS advantage at 3 y (99% vs 93.8%) was observed in the RAH group. After the first report of laparoscopic radical hysterectomy with pelvic and paraaortic lymphadenectomy by Nezhat et al. multiple studies have shown that both approaches resulted in equivalent DFS and OS, which is contrary to the results recently reported by Ramirez et al.6,7 Additionally, MIS was associated with benefits such as shorter length of stay, less blood loss, and fewer short- and long-term risks.8,–13 Further evaluation of these surgical approaches was reported in seven retrospective studies (Table 1). Table 1. Disease-free Survival Following MIS vs RAH

Supplements to Conventional Treatment After Hysteroscopic Lysis of Intrauterine Adhesions: A Systematic Review

Intrauterine adhesions (IUAs) are a result of trauma to the basalis layer of the endometrium and may lead to clinical sequelae such as miscarriage, infertility, and menstrual irregularities. Hysteroscopy is recognized as the gold standard in diagnosis and management, although the optimal treatment after surgical intervention remains unclear. This review aimed to provide an update on the treatment options available after hysteroscopic adhesiolysis and to facilitate clinical management of patients with IUAs. To avoid duplicating previous work, the review focused on studies that compared various adjunctive postoperative treatments in patients receiving hormone therapy. Of 548 studies, 15 papers fit our criteria that compared post-resection treatment options in women with IUAs. Meta-analysis of the use of Foley catheter or amnion graft as an adjunctive therapy after adhesiolysis failed to show a statistical difference (odds ratio 1.55; 95% confidence interval 0.60-3.99). Meta-analysis could not be done for the 13 remaining studies as a result of extensive heterogeneity, bias, or non-comparable end points. The lack of a universal classification system for IUAs and the use of variable outcomes to measure the success of adjunctive treatment pose challenges in generating standard treatment recommendations. This review calls for the development of a universal classification system and studies with consistent parameters and end points to allow for the generation of standard treatment guidelines. On the basis of the available evidence, recommendation of specific adjunctive treatments after hysteroscopic adhesiolysis is unjustified.

An international survey to inform priorities for new guidelines on von Willebrand disease.

von Willebrand disease (VWD) is an inherited bleeding disorder caused by a quantitative or qualitative dysfunction of von Willebrand factor. Clinicians, patients and other stakeholders have many questions about the diagnosis and management of the disease. To identify topics of highest importance to stakeholders that could be addressed by guidelines to be developed by the American Society of Hematology (ASH), the International Society on Thrombosis and Haemostasis (ISTH), the National Hemophilia Foundation (NHF) and the World Federation of Hemophilia (WFH). A survey to determine and prioritize topics to be addressed in the collaborative development of guidelines for VWD was distributed to international stakeholders including patients, caregivers and healthcare providers (HCPs). Representatives of the four organizations coordinated the distribution strategy. The survey focused on both diagnosis and management of VWD, soliciting 7-point Likert-scale responses and open-ended comments, in English, French and Spanish. We conducted descriptive analysis with comparison of results by stakeholder type, gender and countries' income classification for the rating questions and qualitative conventional content data analysis for the open-ended responses. A total of 601 participants responded to the survey (49% patients/caregivers and 51% healthcare providers). The highest priority topics identified were diagnostic criteria/classification, bleeding assessment tools and treatment options for women and surgical patients. In contrast, screening for anaemia and differentiating plasma-derived therapy versus recombinant therapies received lower ratings. This survey highlighted areas of importance to a diverse representation of stakeholders in the diagnosis and management of VWD, providing a framework for future guideline development and implementation.

Patient-Level Modeling Approach Using Discrete-Event Simulation: A Cost-Effectiveness Study of Current Treatment Guidelines for Women with Postmenopausal Osteoporosis.

Decision tree and Markov models have been the most commonly used modeling methods in health economic evaluations. Both methods are known for their limitations. Discrete-event simulation (DES), an event-driven model in continuous time at the patient level, is a relatively new method in health economic evaluations that addresses some limitations of the common modeling techniques. Specifically, with the advent of personalized medicine, conventional methods for value assessment that are based on population-level measures might not be appropriate. The best treatment would depend on patient characteristics and clinical profiles. Value assessment of health interventions can vary substantially and may lead to different health decision making due to patient heterogeneity. As such, modeling at the patient level is an appropriate approach for value assessment of health interventions. The DES model has several advantages, such as flexibility, ability to reflect patient heterogeneity, increased precision, and better characterization of modeling uncertainty, that may be preferred to decision tree and Markov models. In addition, with increasing health care spending and drug prices, it is important to quantify value of available treatment options for women with postmenopausal osteoporosis (PMO). The purpose of this Viewpoints article was to describe and demonstrate an application of a DES model to evaluate the cost-effectiveness of the current treatment guidelines for women with PMO. In particular, the DES model indicated that the optimal treatment at the common willingness-to-pay thresholds between $100,000 per quality-adjusted life-year (QALY) and $150,000 per QALY was denosumab. Analysis of patient heterogeneity in terms of low, medium, high, and very high risk of fractures resulted in a similar conclusion. DISCLOSURES: Funding for this study was received through the PhRMA Foundation Value Assessment Challenge Award. The author has no conflicts of interest to declare.

Real-World Delivery of Rucaparib to Patients with Ovarian Cancer: Recommendations Based on an Integrated Safety Analysis of ARIEL2 and Study 10.

Treatment options for women with recurrent ovarian cancer who have received two or more prior lines of chemotherapy have recently expanded with the U.S. Food and Drug Administration (FDA) and European Commission (EC) approvals of the poly(ADP‐ribose) polymerase (PARP) inhibitor rucaparib. As more oncologists begin to use rucaparib and other PARP inhibitors as part of routine clinical practice, awareness of possible side effects and how to adequately manage toxicities is crucial. In this review, we summarize the safety and tolerability of rucaparib reported in an integrated safety analysis that supported the FDA's initial approval of rucaparib in the treatment setting. Additionally, drawing on clinical data and our personal experience with rucaparib, we provide our recommendations on the management of common side effects observed with rucaparib, including anemia, blood creatinine elevations, alanine aminotransferase and aspartate aminotransferase elevations, thrombocytopenia, gastrointestinal‐related events (e.g., nausea, vomiting), and asthenia and fatigue. These side effects, many of which appear to be class effects of PARP inhibitors, are often self‐limiting and can be managed with adequate interventions such as treatment interruption and/or dose reduction and the use of supportive therapies. Supportive therapies may include blood transfusions for patients with anemia, prophylactic medications to prevent nausea and vomiting, or behavioral interventions to mitigate fatigue. Understanding and appropriate management of potential side effects associated with rucaparib may allow patients with ovarian cancer to continue to benefit from rucaparib treatment.Implications for PracticeRucaparib was recently approved in the U.S. and European Union for use as treatment or maintenance for recurrent ovarian cancer. This review focuses on the safety and tolerability of rucaparib in the treatment setting. Similar side effects are observed in the maintenance setting. Drawing on the authors’ clinical experience with rucaparib, rucaparib prescribing information, and published supportive cancer care guidelines, this review discusses how to optimally manage common rucaparib‐associated side effects in patients with advanced ovarian cancer in the real‐world oncology setting. Adequate management of such side effects is crucial for allowing patients with ovarian cancer to remain on treatment to receive optimal efficacy benefit.

181 Is Adjuvant Radiotherapy Alone (Without Hormone Therapy) a Treatment Option for Women 70 Years or Older with Early Stage Breast Cancer?

181 Is Adjuvant Radiotherapy Alone (Without Hormone Therapy) a Treatment Option for Women 70 Years or Older with Early Stage Breast Cancer?

Macroplastique for women with stress urinary incontinence secondary to intrinsic sphincter deficiency

ABSTRACTObjective To evaluate the subjective and objective outcomes of Macroplastique® (MPQ) in women with stress urinary incontinence (SUI) secondary to intrinsic sphincter deficiency (ISD).Materials and Methods Following Institutional Review Board (IRB) approval, charts of non-neurogenic women with SUI secondary to ISD who underwent MPQ injection and had 6 months minimum follow-up were reviewed from a prospectively maintained database. Patients were divided into 3 groups: Naïve (Group I), Prior Anti-Incontinence Surgery (Group II), and combined Prior Bulking Agent and Anti-Incontinence Surgery (Group III). Data collected included SUI self-report, Urogenital Distress Inventory (UDI-6) Question 3, and VAS Quality of Life (QoL) Questionnaire scores at baseline and in follow-up. Three-dimensional ultrasound (3DUS) evaluated volume/configuration of MPQ. Success was defined after the last MPQ injection as a UDI-6 Question 3 score of 0 (dry) or 1, and no reoperation for SUI.Results From 2011-2017, 106 of 142 women met study criteria. At a median follow-up of 20 months (mean=26 months; range: 6-71), success rate was 41% for Group I, 40% for Group II, and 65% for Group III (p = 0.22). QoL scores were significantly improved over baseline in all groups. There was no significant difference in clinical outcome between the asymmetrical and symmetrical group on 3DUS. The completely dry rate was highest in Group III at 29%, compared to 4% for Group I and 15% for Group II (p = 0.05).Conclusion Macroplastique® improved subjective and objective outcome measures for SUI secondary to ISD as both a primary and secondary treatment option in women.

Detrusor underactivity in women: A current understanding

To examine the current understanding and management of detrusor underactivity (DUA) and underactive bladder (UAB) in women. A review of the current literature was performed with a specific focus on new management strategies and treatment options for women with DUA and UAB. DUA has become an area of increased interest in recent years. Affecting up to 45% of older women undergoing urodynamic evaluation for non-neurogenic lower urinary tract symptoms, DUA is common. There are a variety of possible etiologies including neurogenic or myogenic dysfunction. As there is currently no cure for DUA and no way to restore the ability of the detrusor muscle to contract, management of DUA in women is mostly focused on effective bladder drainage by urinary catheterization. Clean intermittent catheterization is the gold standard for bladder drainage however for a variety of reasons, women with DUA often are managed with indwelling urethral catheter or suprapubic tube. Medications, sacral neuromodulation, and the inFlow urinary prosthesis are also treatment alternatives or additions to catheterization. Novel therapies using stem cells and gene therapy are also under investigation for the treatment of DUA and UAB. DUA is likely more prevalent than recognized and undertreated in women. It is vital that further research in treatment options beyond catheterization be developed for these patients to offer patients a variety of treatment options.

Interdisciplinary surgery for advanced gynecologic malignancies: Outcome and complication rate.

e17002 Background: Advanced gynecologic malignancies are known to have a poor prognosis. Due to local invasion in adjacent organs, finding the most suitable therapeutic option is often difficult. This study aims to assess the outcome of interdisciplinary surgery for locally advanced gynecologic malignancies focusing on women treated by pelvic exenteration (PE). Methods: All women that were treated with PE at the University Hospital Marburg between 04/2011 and 06/2016, were enrolled in this retrospective study. A data sheet was prepared assessing e.g. demographic informations, tumor type and previous therapies. Furthermore, complication rate (Clavien Dindo, follow-up and outcome were evaluated. Results: From the 57 women identified, the indications for PE were malignancies of the cervix (47.2%), vagina (15.1%), vulva (13.2%), endometrium (11.3%), ovaries (5.7%) and undifferentiated (uterus) (1.9%). 51.9% were treated for recurrent cancer. 26% received no treatment prior to PE, 16%, 38%, 20% received 1, 2 or 3 previous treatments respectively (chemotherapy, radiation, surgery). 54.7% of the patients underwent anterior, 37.8% total and 7.5% posterior PE. Urinary diversion was predominantly ileum conduit (76%). Major complications (Clavien Dindo &gt; 2) were observed for 40.4%, 19.2% had no complications. No correlation with clinical parameters (e.g. BMI, age, time of surgery), previous therapy or urinary diversion could be shown. Renal function improved significantly postoperatively (p &lt; 0.05). Mean hospital stay was 25 d. Median overall survival (OS) was 15.2 months. It was not influenced by the entity of the tumor. Two years survival rate (SR) was 38.2%; 3 years SR 27.3%. After 47 months median follow-up time, 23.7% of the treated women were still alive. Conclusions: PE remains to be a meaningful treatment option for women with invasive gynecologic malignancies also after multiple previous therapies, showing acceptable complication rates and satisfactory OS in regard to the extensive nature of the malignancies and the procedure.

Role of Injection Depo Medoroxy Progesterone Acetate in the Management of Abnormal Uterine Bleeding in Norplant User

Background &amp; objective: This prospective study was undertaken to determine the role of Depomedroxy progesterone acetate (DMPA) in the management of abnormal uterine bleeding associated with norplant use.&#x0D; Methods: The study was carried out in the Department of Family Planning Model Clinic of Sir Salimullah Medical College and Mitford Hospital, Dhaka between June, 2003 to December, 2005. A total 54 clients were consecutively selected, based on predefined enrolment criteria.&#x0D; Results: Over two-thirds (70.6%) of the patients were multipara (2-3 live births), 22% primipara and the rest 7.4% grand-multipara (4 or more live births). Among 54 cases, 45(84%) responded to treatment. Of the 9 (16%) cases who failed to respond to DMPA treatment, 4 cases were given 2nd dose of DMPA. Three cases dropped out after failing the 1st dose and 2 cases refused to receive 2nd dose and their norplant was removed on request. Abnormal per vaginal (P/V) bleeding began from the 1st month of insertion of Norplant with 15 (27.7%) cases in the 1st month, 7(12%) cases between 2nd to 5th months, 16(28%) cases between 6-12 months, 11(20%) between 13-24 months and 5 (9.3%) cases between 25-36 months.&#x0D; Conclusion: The study showed that DMPA is a simple and effective modality of treatment for women with abnormal or irregular uterine bleeding associated with norplant implant use. With increased compliance from clients’ perspective, it could be a good option for treatment of women with abnormal or irregular uterine bleeding caused by norplant implant.&#x0D; Ibrahim Card Med J 2017; 7 (1&amp;2): 80-83

Comparison of two retropubic tension-free vaginal tape procedures in women with stress urinary incontinence: a randomized controlled multicenter trial.

Midurethral slings are a well-established treatment option in women suffering stress urinary incontinence. Various different products and methods are used, therefore, the aim of our study was to compare two inside-out retropubic slings (TVT exact® vs. RetroArc®) inserted in two different ways regarding perioperative and mid-term outcomes. In this prospective randomized controlled non-inferiority multicentre trial, primary endpoint was postoperative cure rate, both objective (negative cough test) and subjective (absence of leakage during physical activity using the UDI-6 questionnaire). Secondary endpoints were patients' satisfaction (Likert scale; ICIQ-UI-SF questionnaires). In addition, intra-and postoperative complications were evaluated. The TVT®-group was operated with an empty bladder, a 18 CH catheter was used with a straight inserter as instructed. Patients randomized into the RetroArc®-group were operated without inserter leading to a reduced catheter size (14 CH), bladder was filled (200ml) during the procedure. Of the 303 women, 152 were randomized to the TVT® and 151 to the RetroArc® operation. At 3 months, n = 288 (95.0%) and at 12months n = 229 (75.6%) were assessed. In postoperative objective cure the RetroArc®-procedure was not inferior to TVT® (p = 0.144). In subjective cure, however, the TVT exact® procedure achieved significant better results (TVT® 76.1%, RetroArc® 54.3%, p = 0.002). Perioperative complications were in majority voiding difficulties and lower after the TVT exact®-procedure. Retropubic sling procedures are safe and successful to treat female stress urinary incontinence. However, different materials and techniques result in differences between outcomes also experienced surgeons should be aware of.

Randomised trial of two embolic agents for uterine artery embolisation for fibroids: Gelfoam versus Embospheres (RAGE trial)

BackgroundUterine artery embolisation (UAE) is an established treatment option for women with symptomatic uterine fibroids who wish to avoid surgery. However the most efficacious embolic agent remains uncertain.MethodsWe conducted a pilot double blind randomized controlled trial comparing Gelfoam with Embospheres in women undergoing UAE. Outcomes recorded at baseline, 24-h, 1 and 6 months included complications, inflammatory, haematological markers and ovarian function. Contrast enhanced MRI (CEMRI) was acquired at baseline, 24-h and 6 months. Pain score (visual analogue) was measured at 24-h, quality of life (UFS-Qol) at baseline, 1 and 6 months. All patients were followed to 6 months.ResultsTwenty patients were randomized 1:1 to receive either Gelfoam (G) or Embospheres (E). The UFS-Qol symptom score improved in both groups at 6 months mean of 64 ± 18 to 23 ± 16 and 54 ± 15 to 32 ± 26 in the E and G groups respectively. UFS-Qol HRQL also improved in both groups at 6 months, mean 41 ± 28 to 79 ± 20 and 53 ± 19 to 78 ± 21 in the E and G groups respectively.Uterine volume at 6 months reduced from 1018 ± 666mls to 622 ± 436 (p = 0.001) and from 1026 ± 756 to 908 ± 720 (p = 0.15) in the E and G groups respectively. There was a significant difference between groups for this parameter p = 0.01. All uterine arteries were patent at 24-h and 6 months. Complete (100%) fibroid infarction rates were 5(50%) and 2(20%) in the E and G groups respectively. None of the other outcome measures showed any between group differences. There were no re-interventions in either group.ConclusionThe only significant between group differences was for a greater reduction in uterine volume at 6 months in the E group. A larger trial (estimate 172 subjects) is required to determine whether other apparent differences are clinically and statistically significant.Trial registrationISRCTN67347987

86: Brexanolone iv efficacy in postpartum depression in three pivotal trials: montgomery-åsberg depression rating scale assessment

The investigational, positive allosteric modulator of ɣ-aminobutyric acid A (GABAA) receptors, brexanolone iv (BRX), was evaluated for efficacy and safety in women with postpartum depression (PPD) in 3 double-blind, placebo-controlled, randomized trials. BRX met the primary efficacy endpoint with a significantly greater change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score at Hour 60 than placebo (PBO). This abstract presents the results of a secondary measure, the Montgomery-Åsberg Depression Rating Scale (MADRS). An umbrella protocol for the 3 studies allowed integrated dataset analysis. Women aged 18-45 years, ≤ 6 months postpartum, with PPD (i.e. major depressive episode no earlier than third trimester and no later than 4 weeks post-delivery) and a qualifying 17-item HAM-D total score (≥ 26 in Studies A and B; 20-25 in Study C) were enrolled. Randomized subjects received a single, continuous 60-hour infusion of PBO, BRX 60 μg/kg/hour (BRX60), or 90 μg/kg/hour (BRX90) and were followed through Day 30. Change from baseline in MADRS total score (MADRSts) was a secondary endpoint, analyzed by a mixed effects model for repeated measures (BRX90). Safety and tolerability were assessed by adverse event (AE) reporting and clinical laboratory testing (BRX60 and BRX90). Least squares mean (SE) change from baseline in MADRSts at Hour 60 in the PBO (N=107) or BRX90 (N=102) groups was -17.7 (1.2) or -23.5 (1.2) respectively. A significantly greater mean reduction versus PBO was achieved with BRX90 starting at Hour 24 and maintained through Day 7 (Figure). At Day 30, the mean reduction of BRX90 versus PBO was numerically greater. The most common AEs (≥ 10%) reported in all BRX subjects included headache, dizziness, and somnolence. Brexanolone iv was generally well tolerated and showed statistically significant greater reductions of depressive symptoms in women with PPD compared to PBO, as measured by MADRSts. The proposed mechanism of action of brexanolone iv (i.e., positive allosteric modulation of GABAA receptors) is a novel approach in the development of a therapeutic agent for PPD and, if regulatory approval is obtained, has the potential to provide meaningful new treatment options for women with PPD.