Guideline-Based Strategies in the Surgical Treatment of Female Urinary Incontinence: The New Gold Standard is Almost the Same as the Old One.

The modern sling procedures for treating female stress urinary incontinence encompass numerous methods, materials and manufacturers. On the basis of the current S2e guidelines, the methods used most frequently in the diagnosis of and therapy for stress urinary incontinence in women are critically illustrated. An individualised procedure is necessary for the choice of the surgical method, especially in the presence of accompanying pathologies. This article is intended to help the treating physician to carry out quality-assured diagnostics and therapy for the patient and to offer the best possible urogynaecological management. In addition to the complications and chances of success of the surgical options, the legal aspects of therapy planning are also taken into consideration.

Correlation of the volume of ectopic pregnancy and MTX therapy outcome: a retrospective cohort study.

OBJECTIVE: To investigate a possible correlation between the volume of the tubal ectopic pregnancy (EP) measured by vaginal-ultrasound (VUS) and methotrexate (MTX) therapy outcome. STUDY DESIGN: Data of EP volume measured by one expert-sonographer, viability, clinical symptoms, previous IVF/insemination, follow-up of ß-hCG and progesterone levels, and treatment of EP was collected of 100 patients with sonographically diagnosed EP, who attended the Department of Obstetrics and Gynecology of the Medical University Vienna between March 2008 and September 2011. RESULTS: The mean volume of EP (mVol.) in the group with successful MTX therapy (n = 38) was 5.11 ml, 95%CI [2.4; 7.8] with a median 3.2 ml, IQR [5.0], in the group with unsuccessful MTX treatment (n = 11) it was 15.24 ml, 95%CI [-2.6; 33.1], with a median 4.4 ml, IQR [11.4]. We could observe a trend towards a lower mVol. in the successful MTX group (5.11 ml vs. 15.24 ml). We could not show a significant correlation (u-test p = 0.208). CONCLUSION: A clear tendency was observed towards a lower mVol. in the successful MTX therapy group, but we could not verify a statistically significant correlation of volume of EP and MTX therapy outcome most likely due to the small sample size. This was the first study investigating the correlation of volume of EP and MTX therapy outcome as principal question.

Cut-off value of initial serum ß-hCG level predicting a successful MTX therapy in tubal ectopic pregnancy: a retrospective cohort study.

OBJECTIVE: To determine the optimal serum ß-hCG cut-off level to predict MTX treatment success in tubal ectopic pregnancy (EP). STUDY DESIGN: Data of 240 women, who presented between 2003 and 2011 at the Department of Gynecology and Obstetrics, Medical University of Vienna, with tubal EP and who received MTX as primary treatment, were retrieved from the hospital information system (KIS). 198 patients could be included for final evaluation. Statistical analysis included area under the ROC curve, maximal Euclidean and Youden index, chi-squared and a five-fold cross validation. RESULTS: The serum ß-hCG level cut-off value was calculated at 2121mlU/ml with a specificity of 76.54% and sensitivity of 80.56% (AUC 0.789; p<0.001). Patients with an initial serum ß-hCG level below 2121mlU/ml (n=131) experienced MTX treatment failure in 5.3% (n=7), compared to 43.3% (n=29) of patients with an initial serum ß-hCG level equal to or above 2121mlU/ml (n=67). There was no statistically significant correlation between clinical symptoms and the MTX therapy outcome (p=0.580; likelihood quotient p=0.716). CONCLUSION: The correct decision of therapy in patients with tubal ectopic pregnancy still represents a challenge. In this study we can conclude that, according to our results there is no endpoint of initial serum ß-hCG levels, which can be clearly used as cut-off value for the optimal management of tubal EP. However, an initial serum ß-hCG level of less than 2121mlU/ml seems to be a good value to expect a successful MTX treatment. Limitations are the retrospective study design and the inability of classifying clinical symptoms like pain as an objective parameter. Wider implications of the findings may include more detailed patient information and more accurate selection of suitable patients for MTX therapy.

[Current developments and perspectives on the diagnosis and treatment of urinary incontinence and genital prolapse in women]. / Aktuelle Entwicklungen und Perspektiven in der Diagnostik und Therapie von Harninkontinenz und Genitalsenkung der Frau.

As a key area of gynaecology, urogynaecology has undergone impressive changes in the past few years. Together with the high prevalence of functional pelvic floor disorders, modern anaesthesia procedures and the introduction of new, innovative minimally invasive operation techniques have led to a dramatic increase in the number of operations for incontinence and prolapses. The increasingly subtle diagnostic options, such as, e. g., 2D and 3D sonography of the pelvic floor provide unambiguous findings and facilitate decision making. Tension-free vaginal slings in retro-pubic, trans-obturator or single-incision techniques show a high success rate with few complications and have almost completely replaced the more invasive abdominal surgical techniques for the operative management of stress incontinence. Especially for recurrent prolapse the use of alloplastic nets leads to a markedly improved anatomic and functional outcome. In spite of the euphoria about modern operation techniques and novel net materials, in-depth knowledge of pelvic floor anatomy, sufficient surgical experience and unequivocal guideline-conform indications are mandatory for satisfactory treatment outcomes. The afflicted women must be informed in detail about alternative procedures and more emphasis should be placed on conservative therapy. Novel surgical techniques should be monitored by registers or clinical trials. The professional society is called upon to improve the training curricula for pelvic floor surgery.

p53 is correlated with low BMI negative progesterone receptor status and recurring disease in patients with endometrial cancer.

OBJECTIVE: P53 tumor suppressor gene plays a role in endometrial carcinogenesis. Former studies described correlations between p53 protein overexpression in endometrial cancer and prognostic factors, measured by immunohistochemistry. But data is still controversial. The aim of this study was to measure p53 and phospho-p53 overexpression by Western blot and evaluate correlations between overexpression and prognostic and clinical factors. Phospho-p53 seems to be the functional p53 protein and was examined for the first time in endometrial cancer. METHODS: 40 patients with endometrial cancer were included in the study. A control group of 20 patients with normal endometrial tissue samples was used. Western blot was performed for detection of p53 and phospho-p53. Clinical and pathological parameters were obtained from medical records. Statistical analysis was performed using the log-rank test, the Mann-Whitney test for two independent groups and the Fisher's exact test for dichotomous groupings. RESULTS: In 17.5% of the patients with endometrial cancer a p53 overexpression could be evaluated. There was a correlation between a p53 overexpression and recurring disease (p: 0.014), a negative progesterone receptor status (p: 0.021) and a low BMI (p: 0.022). Only one of 40 patients had a phospho-p53 expression. CONCLUSION: Western blot is a valid method for the detection of p53 overexpression. As other authors described before, p53 overexpression seems to correlate with negative prognostic factors. The correlation between p53 overexpression and a low BMI may underline the relationship between p53 alterations and biological aggressive endometrial carcinomas.

Biomarkers in Breast Cancer - An Update.

The therapy of choice for breast cancer patients requiring adjuvant chemo- or radiotherapy is increasingly guided by the principle of weighing the individual effectiveness of the therapy against the associated side effects. This has only been made possible by the discovery and validation of modern biomarkers. In the last decades and in the last few years some biomarkers have been integrated in clinical practice and a number have been included in modern study concepts. The importance of biomarkers lies not merely in their prognostic value indicating the future course of disease but also in their use to predict patient response to therapy. Due to the many subgroups, mathematical models and computer-assisted analysis are increasingly being used to assess the prognostic information obtained from established clinical and histopathological factors. In addition to describing some recent computer programmes this overview will focus on established molecular markers which have already been extensively validated in clinical practice and on new molecular markers identified by genome-wide studies.

Skin-reducing Mastectomy with Primary Implant Reconstruction.

Background: We present a series of skin-sparing mastectomies (SSMs) with skin reduction and immediate breast reconstruction to treat large and ptotic breasts. The technique combines oncological mastectomy with immediate subpectoral implant placement as a single-step procedure. Methods: Data was collected from a prospective database from February 2009 to April 2011. A total of 24 patients with macromastia or pronounced ptosis fulfilled the criteria for skin-saving mastectomy. All operations were carried out as a single-step procedure with adaptation of the contralateral breast by reduction mastopexy. Results: A total of 27 SSMs were performed in 24 patients. The mean implant volume was 265 cm3. Immediate reconstruction of the nipple-areola complex was done in 22 patients. The cosmetic and functional results were assessed in all patients 6 months postoperatively; mean follow-up time was 13 months. Mean patient age was 49 years. The cosmetic result was assessed as "very good" or "good" by 22 patients; 2 patients graded the result as "unsatisfactory". There was one local recurrence. Conclusion: Our results support the use of this technique as a safe oncoplastic procedure which is well tolerated by patients.

Transvaginal Ultrasound for Endometrial Carcinoma Screening - Current Evidence-based Data.

The value of transvaginal ultrasound in gynaecological examinations is beyond dispute. But it is of particular forensic importance that the validity of this type of imaging with regard to the reliable detection of early-stage malignancy is properly understood. Vaginal ultrasound screening in asymptomatic patients for the early detection of endometrial carcinoma is not useful from a medical point of view, nor is it cost-efficient. However, even though the validity of transvaginal ultrasound for screening has currently not been proven, the method should still be an integral part of gynaecological examinations.

Single-Incision Slings (SIS) - a New Option for the Surgical Treatment of Female Stress Urinary Incontinence.

The new development of single-incision slings (SIS) for the treatment of female stress urinary incontinence offers comparable results with only minimal side effects and will find wide acceptance in modern incontinence surgery. This mini-sling is inserted over a single vaginal incision and fixed on both sides to the pelvic wall tissue with special anchors, without passing through the groin and avoiding a blind tape passage. Compared with the established sub-urethral tapes, there are comparable success rates with fewer complications. Randomised prospective studies are needed to evaluate whether, in the long run, the benefits of the single incision technique can be correlated with satisfying continence results.

Current Developments and Perspectives on the Diagnosis and Treatment of Urinary Incontinence and Genital Prolapse in Women.

As a key area of gynaecology, urogynaecology has undergone impressive changes in the past few years. Together with the high prevalence of functional pelvic floor disorders, modern anaesthesia procedures and the introduction of new, innovative minimally invasive operation techniques have led to a dramatic increase in the number of operations for incontinence and prolapses. The increasingly subtle diagnostic options, such as, e. g., 2D and 3D sonography of the pelvic floor provide unambiguous findings and facilitate decision making. Tension-free vaginal slings in retro-pubic, trans-obturator or single-incision techniques show a high success rate with few complications and have almost completely replaced the more invasive abdominal surgical techniques for the operative management of stress incontinence. Especially for recurrent prolapse the use of alloplastic nets leads to a markedly improved anatomic and functional outcome. In spite of the euphoria about modern operation techniques and novel net materials, in-depth knowledge of pelvic floor anatomy, sufficient surgical experience and unequivocal guideline-conform indications are mandatory for satisfactory treatment outcomes. The afflicted women must be informed in detail about alternative procedures and more emphasis should be placed on conservative therapy. Novel surgical techniques should be monitored by registers or clinical trials. The professional society is called upon to improve the training curricula for pelvic floor surgery.

Prospective randomized comparison of conventional instruments and the Harmonic Focus(®) device in breast-conserving therapy for primary breast cancer.

BACKGROUND: In recent years, surgeons have utilized Harmonic instruments to perform breast cancer resection. Retrospective and prospective studies have demonstrated that the use of this surgical device for mastectomy and axillary dissection can reduce perioperative blood loss, seroma formation, and duration and total amount of drainage. No study has analyzed the feasibility of Harmonic instruments in breast-conserving surgery. We conducted a prospective, randomized clinical trial comparing Harmonic instrument and conventional surgery in the performance of breast-conserving surgery and axillary procedures to determine differences in surgical procedures, postoperative outcome, and complications. METHODS: One hundred and six patients with operable breast cancer who underwent breast-conserving surgery at a single institution between December 2009 and January 2011 were included in the analysis. Surgery was performed in 52 patients with the Harmonic Focus(®) device and in 54 with scissors and electrocautery. This study focused on operative time, drainage volume, and postoperative outcome measures like blood loss, surgery related complications and patient-reported postoperative pain. RESULTS: We found a multivariable independent influence in axillary seroma formation and volume of breast drainage with HS. Evident difference in volume and duration of axillary and breast drainage, subjective and objective postoperative pain, reduction in serum hemoglobin, size and weight of resected breast tissue and length of hospital stay in favor of the Harmonic instrument could also be shown. DISCUSSION: The Harmonic instrument provides key benefits in surgical technique, postoperative outcome, and complication rates in breast cancer surgery.

[Clinical and economic challenges of moderate preterm babies born between 32+0 and 36+6 weeks of gestation]. / Klinische und ökonomische Herausforderung der moderaten Frühgeburt zwischen 32+0 und 36+6 SSW.

BACKGROUND: Preterm births show a worldwide increasing incidence. The majority of preterm births occur between 32+0 and 36+6 weeks of gestation and are associated with an increased rate of maternal and neonatal morbidity. The focus of our research is the clinical and economical analysis of all preterm births between 32+0 and 36+6 weeks of gestation in a German level 1 perinatal centre over a period of 3 years. MATERIALS AND METHODS: A retrospective analysis of all preterm births between 32+0 and 36+6 weeks of gestation in the University Hospital Mainz from 2007 to 2009 was undertaken. Data were collected using our electronic documentation system. Gestational age at delivery, mode of birth, indication for delivery, duration of the peripartum treatment, treatment of the newborn in the children's hospital, birth weight and therapy costs were evaluated. RESULTS: We recorded 407 moderate preterm births in total; this amounts to a rate of of 10% of all births. Major causes of prematurity were PPROM, preterm labour and preeclampsia/HELLP. Maternal and fetal systemic diseases were more uncommon. Rates of Caesarean sections (62%) and of neonatal inpatient treatment needs (58.5%) were high. Maternal treatment costs were 332 Euro/day. The mean duration of maternal inpatient treatment was 13.15 days. DISCUSSION: Moderate preterm birth is associated with maternal morbidity frequently due to a high rate of Caesarean sections. Neonatal morbidity is also increased. In comparison with previous research, we saw an increased rate of pregnancy complications. This could be typical for a level 1 perinatal centre. Moderate preterm birth is seen as the cause of considerable treatment costs.

["War of the slings": when do I do what and which concept will endure?]. / Krieg der Bänder : Wann mache ich was und welches Konzept hat Bestand?

The number of incontinence surgeries has drastically increased for female stress urinary incontinence requiring treatment. On the one hand, public perception of the problem has become widespread, increasingly removing the stigma of the condition, and on the other hand, newer surgical techniques and materials have been continually developed in the last 15 years. The use of tension-free vaginal slings for the treatment of stress incontinence is associated with high continence rates and minimal side effects and has meanwhile become the gold standard in the management of incontinence.

A prospective multicenter phase II study of oral and i.v. vinorelbine plus trastuzumab as first-line therapy in HER2-overexpressing metastatic breast cancer.

BACKGROUND: To evaluate the efficacy and safety of oral and i.v. vinorelbine plus trastuzumab as first-line regimen in a patient-convenient application for human epidermal growth factor receptor 2 (HER2)-overexpressing patients with metastatic breast cancer. PATIENTS AND METHODS: Forty-two women were enrolled in a multicenter study. The patients received i.v. vinorelbine at a dose of 25 mg/m(2) on day 1 followed by oral vinorelbine at a dose of 60 mg/m(2) on days 8 and 15 in a 3-week cycle. Standard dose trastuzumab was given at 3-week intervals. RESULTS: Complete response was observed in 7 patients (18.9%) and partial response in 19 patients (51.4%), for an overall response rate of 70.3% [95% confidence interval (CI) 53.0-84.1]. The disease control rate reached 91.9% (95% CI 78.1-98.3). The median time to progression was 9.3 months, while median overall survival reached 35.6 months. Hematological and non-hematological toxic effects were acceptable with grade 3-4 leukopenia of 14% and neutropenia of 38%; cardiac toxicity did not reach the level of clinical relevance. CONCLUSION: The combination of i.v. and oral vinorelbine plus trastuzumab demonstrates high activity and good tolerability in first-line treatment of HER2-overexpressing metastatic breast cancer. In addition, it offers convenience for the patients with only one i.v. treatment every 3 weeks.

Overactive Bladder and Continence Guidelines: implementation, inaction or frustration?

Guidelines for the management of continence and overactive bladder are generally available across Europe. For a majority of countries, these have been adopted by professional societies in either urology or gynaecology for local use. There has, however, been little monitoring of formal implementation of these guidelines and seldom any attempt to audit their operation. The state of continence care therefore remains largely unknown. This article reviews current guidelines and their status across Europe and examines what might be relevant from other disease areas to promote successful implementation.

Combination therapy with pegylated liposomal doxorubicin and carboplatin in gynecologic malignancies: a prospective phase II study of the Arbeitsgemeinschaft Gynäekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) and Kommission Uterus (AGO-K-Ut).

OBJECTIVE: A multicenter non-randomized phase II study was initiated to evaluate tolerability and efficacy of pegylated liposomal doxorubicin (PLD) in combination with carboplatin in gynecologic malignancies. METHODS: One hundred forty women with recurrent or advanced endometrial (n=31), cervical or vaginal cancer (n=31), uterine sarcomas (n=11), or recurrent platinum-sensitive ovarian cancer (n=67) received six courses of PLD 40 mg/m2 and carboplatin (AUC 6) every 28 days. RESULTS: Hematological toxicities with NCI-CTC grade 3/4 were anemia in 8%, thrombocytopenia in 14%, neutropenia in 24%, and febrile neutropenia in 2% of 652 cycles. Grade 3/4 non-hematological toxicities included fatigue (14% of patients), pain (10%), dyspnea (9%), palmar-plantar erythrodysesthesia (7%), and nausea/vomiting (7%). Dose intensity reached 87.2% for PLD and 88.2% for carboplatin. Seventy-four percent of all non-progressive patients received at least 5 cycles. Overall response rates were (116 patients evaluable for response): ovarian cancer (n=54) 68%, endometrial cancer (n=27) 44%, uterine sarcomas (n=9) 33%, and cervical/vaginal cancer (n=26) 12%. Median progression-free survival was 11.6 months (95%CI 9.6-14.1) for ovarian cancer and 9.5 months (95%CI 6.6-12.6) for endometrial cancer. Median overall survival was 23.8 months (95%CI 19.0-30.2) and 21.4 months (95%CI 11.9-), respectively. CONCLUSIONS: The combination of PLD and carboplatin was well tolerated and feasible in patients with gynecologic malignancies. Efficacy was low in cervical/vaginal cancer, but promising in patients with endometrial cancer. Efficacy was within the expected range in recurrent platinum-sensitive ovarian cancer and is currently under further investigation in a prospective randomized phase III trial comparing PLD/carboplatin with paclitaxel/carboplatin (CALYPSO-trial; AGO-OVAR 2.9).

Diabetes mellitus is a multivariate independent prognostic factor in endometrial carcinoma: a clinicopathologic study on 313 patients.

OBJECTIVE: The aim of this study was to analyse the influence of diabetes mellitus as a prognostic factor for overall survival in endometrial cancer. MATERIALS AND METHODS: Charts were reviewed from patients with endometrial carcinoma from 1985 to 2003. Data on clinicopathologic variables, adjuvant treatment, site of recurrence and survival were collected. The chi-square test was used to examine associations between variables. The Kaplan-Meier method was used for survival analysis and Cox's proportional hazards model for multiple regression analysis. RESULTS: Multivariate analysis revealed that diabetes mellitus, FIGO stage and depth of myometrial invasion were significantly associated with overall survival.

[Pathoanatomical preparation and reporting for dysplasias and cancers of the cervix uteri: cervical biopsy, conization, radical hysterectomy and exenteration]. / Pathologisch-anatomische Aufarbeitung und Befundung von Dysplasien und Karzinomen der Cervix uteri. Zervixbiopsien, Konisationen, radikale Hysterektomien und Exenterate.

A careful macroscopic description with selection of representative tissue for histological examination is required for quality assurance, for assessing prognostic factors and for answering legal questions in (pre)cancerous lesions of the cervix uteri. Exact and standardized gross inspection and preparation are decisive for the quality of the histopathological statement. The extent of cervical carcinomas should be given in three dimensions, including the relative depth of invasion into the cervical wall. The report should include size, type (according to the WHO classification) and grading of the tumor, the presence of lymphatic as well as blood vessel invasion and perineural involvement. The statement for resection margins should include the vaginal, parametrial, rectal and vesical directions. It is also mandatory to document the number of lymph nodes with metastatic disease in relation to the total number of nodes investigated. The staging should follow the TNM system. In the handling of conisation specimens, it is important to appropriately document localization, horizontal expansion, depth of invasion including microinvasion of any dysplastic or malignant lesions. Clockwise dissection of the conisation specimen, total submission, and step sections are recommended. The preparation of exenteration specimens is a highly skilled job: the exact tumor dimension should be given in its relation to all resected organs and structures with special focus on resection margins.