Einleitung Die TVT (Tension-free vaginal tape) -Operation ist die Standardoperation zur Behandlung der weiblichen Belastungsinkontinenz. Eine typische Komplikation ist die Miktionsstörung, welche früh- oder spätpostoperativ auftreten kann. In einer vorherigen Studie wurden an einem großen Kollektiv die Normwerte für die Bandenge definiert [1]. In der aktuellen Studie wurden das langfristige Outcome und die sonographischen Charakteristika des TVT´s bei Frauen untersucht, welche sich auf Grund einer postoperativen Miktionsstörung einer frühzeitigen Bandlockerung unterzogen.

Purpose We aimed to explore the trajectory of financial difficulties among breast cancer survivors in the German health system and its association with migration background. Methods In a multicentre prospective study, breast cancer survivors were approached four times (before surgery, before and after adjuvant therapy, five years after surgery) and asked about their migration history and financial difficulties. Migrants were defined as born/resided outside Germany or having citizenship/nationality other than German. Financial difficulties were ascertained with the financial difficulties item of the European Organisation for Research and Treatment of Cancer Core Instrument (EORTC QLQ-C30) at each time-point (cut-off > 17). Financial difficulties were classified in trajectories: always (every time-point), never (no time-point), initial (first, not fourth), delayed (only fourth), and acquired (second and/or third, not first). A logistic regression was conducted with the trajectories of financial difficulties as outcome and migration background as exposure. Age, trends in partnership status, and educational level were considered as confounders. Results Of the 363 participants included, 49% reported financial difficulties at at least one time-point. Financial difficulties were reported always by 7% of the participants, initially by 5%, delayed by 10%, and acquired by 21%. Migrants were almost four times more likely to report delayed (odds ratio [OR] = 3.7; 95% confidence interval [CI] 1.3, 10.5) or acquired (OR = 3.6; 95% CI 1.6, 8.4) financial difficulties compared to non-migrant participants. Conclusion Survivors with a migration background are more likely to suffer from financial difficulties, especially in later stages of the follow-up. A linguistically/culturally competent active enquiry about financial difficulties and information material regarding supporting services/insurances should be considered.

Einleitung In dieser Studie wurde untersucht, inwieweit sich Patientinnen über ihre Krankheit und Behandlung gut informiert fühlen, in welchen Bereichen sie sich mehr oder weniger Informationen wünschen und welche Faktoren mit dem Bedarf an Informationen über die Krankheit, medizinische Untersuchungen und die Behandlung zusammenhängen.

Objective In this study, we investigated to which extent patients feel well informed about their disease and treatment, which areas they wish more or less information and which variables are associated with a need for information about the disease, medical tests and treatment. Methods In a German multi-centre prospective study, we enrolled 759 female breast cancer patients at the time of cancer diagnosis (baseline). Data on information were captured at 5 years after diagnosis with the European Organisation for Research and Treatment of Cancer (EORTC) Information Module (EORTC QLQ-INFO24). Good information predictors were analysed using linear regression models. Results There were 456 patients who participated at the 5-year follow-up. They reported to feel well informed about medical tests (mean score 78.5) and the disease itself (69.3) but relatively poorly about other services (44.3) and about different places of care (31.3). The survivors expressed a need for more information concerning: side effects and long-term consequences of therapy, more information in general, information about aftercare, prognosis, complementary medicine, disease and therapy. Patients with higher incomes were better informed about medical tests (β 0.26, p 0.04) and worse informed with increasing levels of fear of treatment (β − 0.11, p 0.02). Information about treatment was reported to be worse by survivors > 70 years old (β -0.34, p 0.03) and by immigrants (β -0.11, p 0.02). Survivors who had received additional written information felt better informed about disease, medical tests, treatment and other services (β 0.19/0.19/0.20/0.25; each p < 0.01). Conclusion Health care providers have to reconsider how and what kind of information they provide. Providing written information, in addition to oral information, may improve meeting those information needs.

Eine 32 jährige Patientin, IIIG/IIP, stellte sich in der 31+2 Schwangerschaftswoche (SSW) mit vorzeitiger Wehentätigkeit (vWT) und einer intakten Einlingsschwangerschaft vor.

Abstract Background: Further progress in the treatment of breast cancer will likely come from contributions of molecular biology and immunologic approaches. The search for druggable molecular aberrations may enable treatment based on the molecular profile. A better identification of patients with a high risk of relapse facilitates the selection of these pts for clinical trials investigating early therapeutic molecular-based interventions. Trial Design: The BRandO BiO Registry is a multi-center regional registry to record clinical, epidemiological, and biological data from patients with newly diagnosed breast and ovarian cancer at the University of Ulm, Dept. of Gynecology and 19 affiliated network hospitals and practices in the Alb-Allgäu Bodensee region (outreach area of the Comprehensive Cancer Center Ulm). Longitudinal biobanking is included with collection of paraffin-embedded samples of the primary tumor as well as blood samples at first diagnosis, after 6 and 12 months and at first relapse to isolate and investigate cell-free and germline DNA. Epidemiological, life style and quality of life (QOL) questionnaires are collected at first diagnosis, after 12, 36 and 60 months. The follow up is planned for 10 years. Eligibility criteria: Patients with primary newly diagnosed untreated breast or ovarian cancer of ≥ 18 years are eligible; primary metastatic untreated disease is allowed. Exclusion criteria comprise severe neurological or psychiatric disorders interfering with the ability to give an informed consent, no consent for registration, storage and processing of the individual disease characteristics and bio samples, and any malignant tumor in the last 3 years (except in situ disease). Specific aims: To register the majority of patients with newly diagnosed breast or ovarian cancer in all BRandO-BiO participating centers of a well-defined geographical area. To assess clinical characteristics and outcome data (event-free survival, overall survival) of these patients. To evaluate the primary tumor of all patients for mutational (druggable) aberrations. Further to assess cell-free DNA in the serial blood samples at baseline, 6 and 12 months and correlate these results with clinical outcome data as well as tumor and patient characteristics to look for early markers predicting relapse. To perform a longitudinal assessment of the patients' sociodemographic factors, comorbidities, lifestyle and QOL factors by analyzing serial questionnaires collected at recruitment and at 12, 36 and 60 months. Present accrual and target accrual: The BRandO BiO Registry started January 2016 in the Dept. of Gynecology, University of Ulm and February 2017 at the network hospitals and practices. Until June 2018, 1180 patients with primary breast or ovarian cancer have been enrolled. The current adherence to serial blood testing and serial questionnaires is good with a return rate of 90%. A sample size of 3000 patients is planned. Contact information: Jens Huober, University of Ulm, Dept of Gynecology, Breast Center, jens.huober@uniklinik-ulm.de Amelie de Gregorio, University of Ulm, Dept of Gynecology, Breast Center, Amelie.de Gregorio@uniklinik-ulm.de Citation Format: Huober J, Nagel G, Rempen A, Schlicht E, Flock F, Fritz S, Thiel F, Wiesmüller L, Felderbaum R, Heilmann V, Bekes I, Fink V, Albrecht S, De Gregorio N, Tzschaschel M, Ernst K, Wolf C, Kuhn P, Friedl T, Janni W, De Gregorio A. The BRandO BiO registry – A multicenter regional registry for patients with primary breast and ovarian cancer with longitudinal biobanking and evaluation of epidemiological, life style and quality of life factors [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT1-11-01.

Das BRandO-Bio Projekt kombiniert eine klassische Registerstudie mit einer Biomaterialbank sowie einer epidemiologischen Zusatzbefragung für gynäkologische Tumorpatienten der Alb-Allgäu-Bodenseeregion. Durch teils wiederholte molekulare Untersuchungen sollen im untersuchten Patientenkollektiv neben Prognose- und Prädiktivmarkern auch Risikopatientinnen mit einer hohen Rezidivwahrscheinlichkeit identifiziert sowie potentielle neue Targets für zielgerichtete Therapien charakterisiert werden.

Abstract Background: The incidence of brain metastases (BM) in breast cancer patients is rising and has become a major clinical challenge. So far, limited therapeutic options and insights into the biology of BM exist since only a few studies analyzed exclusively data of breast cancer patients. In order to improve this situation, our multicenter registry was initiated in 2014: Brain Metastases in Breast Cancer Network Germany (BMBC, GBG79). Materials and Methods: Patients with BM diagnosed since 2000, a history of breast cancer and no history of other malignant or neurologic disease can be included. Registration is allowed retrospectively as well as prospectively into a web–based database ("MedCodes"). Characteristics of the primary tumor, metastatic disease and BM as well as treatment details are documented. For this first analysis, 548 patients from 39 German centers were included. Results: Median age at first diagnosis of BM was 55 years (25 – 90 years). 43% of patients (233/548) were HER2 positive, 19% (n=105) were triple–negative and 25% (n= 138) had luminal primary tumors indicating a selection of patients with specific tumor biology who develop BM. 54 % of the patients (n=267) had up to three BM whereas 45% (n=223) had more than three BM. 19% of patients (n=106) had BM without evidence of extracranial disease. 27% of the patients (n=146) underwent surgery of the BM. Of these patients, 61% (n= 89) were treated with whole brain radiotherapy and 16% (n=23) with stereotactic radiotherapy. In patients without surgery (n=397), 73% (n=289) received whole brain radiotherapy and 7% (n=28) stereotactic radiotherapy. Median time from diagnosis of primary breast cancer to BM was 38.5 month for the entire cohort (CI95% 35.4 – 43.3). The time from first diagnosis to BM was shorter for triple–negative patients (20.9 month, CI95% 15.5 – 25.9) compared with patients with HER2–positive (37.0 month, CI95% 30.5 – 42.0) or luminal tumors (48.3 month, CI95% 38.2 – 54.0) (p<0.001). Median time from first diagnosis of BM to death in the entire cohort was 6.1 months (CI95%: 5.2 – 7.3). One year survival rate from diagnosis of BM was 32.2 % (CI95%: 2.2 – 67.8). Regarding tumor subtypes, HER2–positive patients had the longest median survival with 9.4 months (CI95%: 7.1 – 13.4) compared with 6 months (CI95%: 4.0 – 7.3) for luminal primary tumors and 3.2 months (CI95%: 2.1 – 4.6) for triple–negative patients (p<0.001). HER2 positive patients receiving HER2–directed therapy after the diagnosis of BM lived longer than those without (median 9.6 vs. 5.5 months, p=0.029). Regarding the number of BM, no difference in survival was observed between one, two or three BM (median survival of 7.8 months). However, survival was shorter in those patients with more than three BM (5.2 months; p=0.007). Conclusion: This is so far the largest analysis of breast cancer patients with BM treated in Germany. In this cohort, triple–negative subtype or more than three BM were associated with shorter survival from the diagnosis of BM. HER2 positive patients with no HER2 directed therapy after the diagnosis of BM showed a shorter survival. The recruitment of the registry is ongoing and we aim to include more than 1000 patients by the end of 2015. Citation Format: Witzel I, Loibl S, Laakmann E, Augustin D, Flock F, Dohmen H-H, Durmus G, Frank M, Hesse T, Ignatov A, Kühn T, Neunhöffer T, Park-Simon T-W, Schmidt M, Stefek A, Weide R, Würschmidt F, Fehm T, Moebus V, von Minckwitz G, Burchardi N, Mueller V. Brain metastases in breast cancer network Germany (BMBC, GBG 79): First analysis of 548 patients from the multicenter registry. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P6-17-08.

Die Angst vor der Behandlung des Mammakarzinoms kann so tiefgreifend sein, dass Diagnosestellung oder Therapie beeinflusst oder sogar verzögert werden.

Preterm birth is the most common reason for perinatal morbidity and mortality in the western world. It has been shown that in euthyreotic pregnant women with thyroid autoimmune antibodies, L-Thyroxine replacement reduces preterm delivery rate in singleton pregnancies. We investigated in a nonrandomized retrospective observational study whether L-Thyroxine replacement, maintaining maternal free thyroxine serum level in the high normal reference range prescribed for nonpregnant women also influences the rate of preterm delivery in women without thyroid autoimmune antibodies. As control group for preterm delivery rate, data from perinatal statistics of the State of Baden-Württemberg from 2006 were used. The preterm delivery rate in the study group was significantly reduced. The subgroup analysis shows no difference in primiparous but a decline in multiparous by approximately 61% with L-Thyroxine replacement. Maintaining free thyroxine serum level in the high normal reference range prescribed for nonpregnant women may reduce the preterm delivery rate.

Alloplastische Materialien werden in der operativen Inkontinenztherapie und zur Behandlung eines Descensus genitalis häufig implantiert. Während die Verwendung von Fremdmaterial bei der Einlage von spannungsfreien Vaginalschlingen und bei der Sakrokolpopexie etabliert ist, besteht noch ein Mangel an aussagekräftigen Studien bezüglich der vaginalen Netzeinlage zur Senkungstherapie. Der Beitrag fasst die aktuelle Datenlage und die entsprechenden Empfehlungen zusammen.

Ziel: Material und Methoden: Ergebnisse: Schlussfolgerung: Purpose: Materials and Methods: Results: Conclusion:

PURPOSE:To date, no standardization for the visualization of tension-free vaginal tape (TVT) has been established in clinical practice. The aim of this prospective observational study was to evaluate the shape and position of the tape using ultrasound and to compare this data with clinical postoperative results.MATERIALS AND METHODS:In a three-year period, 296 patients with clinically and urodynamically proven stress urinary incontinence (SUI) were treated with TVT and received follow-up in our department. An additional 12 patients, who were initially treated in other hospitals and had postoperative problems, were included in this study. Depending on the outcome after 3 months, the patients were divided into groups with and without specific disorders. The TVT was evaluated by introital ultrasound. The position of the tape was established by its location in relation to the urethral length and the distance to the hypoechoic center of the urethra (HCU).RESULTS:A suitable TVT position was determined in patients without any postoperative disorders. The mean value for the TVT position at rest in relation to the urethral length was 61 %. The distance to the HCU was 4.6 ± 1.5 mm. In patients with persistent SUI, the tape was more often located under the inner (3 % vs. 0 %) or outer quarter (29 % vs. 13 %, p = 0.004). In patients with residual volume, the distance to the urethra was significantly lower (2.7 vs. 4.6, p < 0.001).CONCLUSION:TVT may be regularly investigated using ultrasound. In combination with the clinical outcome, it represents an important method of evaluating the tape and assists in the planning of a future therapeutic course of action in cases of postoperative problems.

Einleitung Die Einlage eines spannungsfreien Vaginalbandes nach dem TVT-Verfahren ist eine erfolgreiche und komplikationsarme Operation zur Behandlung der weiblichen Belastungsinkontinenz. Eine typische Komplikation ist das symptomatische retropubische Hämatom, das meist offen chirurgisch behandelt wird. Wir stellen ein endoskopisches Verfahren zur Behandlung dieser Komplikation vor. Methode In einem Zeitraum von 8 Jahren wurden an unserer Klinik 508 TVT-Operation durchgeführt. Wir konnten alle 508 Patientinnen im Verlauf prospektiv verfolgen. Wir berichten von 7 Patientinnen mit hämorrhagischer Komplikation und dem folgenden operativen Management. Ergebnisse Bei 23 Patientinnen (4,5%) trat ein retrosymphysäres Hämatom auf. In 7 Fällen (1,4%) betrug das sonografische Hämatomvolumen über 250ml (250–1000ml). Diese Hämatome waren symptomatisch und bedurften einer chirurgischen Intervention. Die erste Patientin wurde laparotomiert, wonach die weiteren 6 Fälle erfolgreich endoskopisch mit Absaugen des Hämatoms, Elektrokoagulation der Blutung und Drainageneinlage, therapiert werden konnten. Zusammenfassung Retropubische Hämatome nach TVT-Operation sind seltene aber typische Komplikationen. Bei symptomatischen Hämatomen ist der chirurgische Eingriff nötig. In unserem Kollektiv konnte dies erfolgreich endoskopisch mit einer Retziusskopie durchgeführt werden, so dass diese Komplikation nach einem minimal-invasiven Eingriff ebenfalls minimal-invasiv behandelt werden kann.