Psycho-Oncological Care Provision in Highly Distressed Breast Cancer Patients.

Objective To evaluate the proportion of breast cancer (BC) patients with distress or psychological comorbidity as well as offer and use of psychological support in subgroups of BC patients with different extents of distress. Methods 456 patients with BC were evaluated at baseline (t1) and until 5 years after diagnosis (t4) at the BRENDA certified BC centers. Logistic regression was used to analyze if patients with distress at t1 received offers and actual psychological support more often than patients without distress at t1. Regression analyses were used to examine if acute, emerging or chronic disease was associated with higher rates of offer and use of psychotherapy as well as intake of psychotropic drugs. Results In 45% of BC patients psychological affection was detected at t4. The majority of patients with moderate or severe distress at t1 (77%) received the offer for psychological service, while 71% of those received the offer for support at t4. Patients, who were psychologically affected at t1, have not been offered psychological services more often than those without, but they significantly more often used services if offered. Especially patients with acute comorbidity received significantly more often an offer for psychotherapy compared to unimpaired patients, while those patients with emerging or chronic disease did not. 14% of BC patients took psychopharmaceuticals. This mainly concerns patients with chronic comorbidity. Conclusion Psychological services were offered to and used by a fair amount of BC patients. All subgroups of BC patients should be addressed, in order to improve the comprehensive supply with psychological services.

Predictors of Decreased Quality of Life in Breast Cancer Survivors Five Years After Diagnosis.

PURPOSE: Due to improved therapy, early diagnosis, and growing incidence rates, the number of long-term breast cancer survivors is increasing. Survivors can still be affected by aftercare, resulting in reduced quality of life (QoL). Thus, in this study, we investigated possible predictors of decreased physical and social functioning in breast cancer survivors. METHODS: In a German multicenter prospective study, we enrolled 759 female patients with breast cancer before surgery (t1), and contacted them again 5 years after surgery (t4). Data on QoL were assessed at t4 using the European Organization for Research and Treatment of Cancer QoL Core Questionnaire (EORTC QLQ-C30) and its breast cancer module EORTC QLQ-BR23. Predictors of decreased physical and social functioning were analyzed using logistic regression with odds ratios as effect estimates and 95% confidence intervals. Thresholds for the clinical importance of detrimental effects on QoL were defined according to Giesinger. RESULTS: Questionnaires from 759 patients were retrieved at t1. Of these, 456 participated in the study at t4. Poor QoL 5 years after diagnosis was reported by 20%-50% of the participants. Age, mastectomy, chemotherapy, education, employment, cohabitation, psychiatric comorbidities at t1, anxiety, depression, and intensity of physical activity emerged as predictors of decreased physical and social functioning 5 years after diagnosis. CONCLUSION: Relief of symptoms and improvement in the QoL should be priorities in aftercare. Detecting patients with a decreased QoL is a rising challenge. Healthcare providers should take special care of patients aged 50-59 years, patients with psychiatric comorbidities and depression, and patients who have undergone mastectomy.

Awareness, offer, and use of psychosocial services by breast cancer survivors in Germany: a prospective multi-centre study.

PURPOSE: This study examined the pattern of psychosocial care in breast cancer survivors. METHODS: In a prospective study with measurements before surgery, 1 month, 8 months, and 5 years thereafter, we examined the proportion of breast cancer survivors who were aware about, had been offered and received various types of psychosocial services from psychologists, social workers, doctors, self-help groups etc. The degree of helpfulness per service among users was ascertained with Likert scales. Determinants of awareness, offer and use were investigated using binary logistic regression analyses. How the services are inter-related was tested with principal component analyses. RESULTS: Among 456 breast cancer survivors who participated until 5 years, psychological services were known by 91%, offered to 68%, and used by 55% of patients. Social services were known by 86%, offered to 65%, and used by 51%. Women ≥ 65 years were less likely to be informed about (odds ratio (OR) 0.2) and get offers for psychosocial services (OR 0.4 for social and 0.5 for psychological services) than women < 65 years. The services rated most helpful were social services in the hospital, psychological counselling by a consultant and psychotherapy in private practices. CONCLUSION: These findings underline the importance of psychosocial support by physicians in addition to the "professional" mental health and social care providers. They also show that elderly women in need for support might be in danger of not being well-informed about the services available.

Association of social service counseling in breast cancer patients with financial problems, role functioning and employment-results from the prospective multicenter BRENDA II study.

BACKGROUND: This study examined the relationship between social service counseling (SSC) and financial and role functioning problems in primary breast cancer (BC) patients over a 5-year observation period. METHODS: In the multicenter prospective study, patients were approached before surgery (t1), before initiation of adjuvant treatment (t2), after therapy completion (t3), and 5 years after surgery (t4). We examined the proportion of BC survivors who had financial and role functioning problems and the proportion who were employed at t4. We examined how frequently patients were informed about, offered, or used SSC, and we used multivariate logistic regression analyses to examine the relationship between this and financial and role functioning problem prevalence. RESULTS: Of the 456 BC survivors, 33% had financial problems and 22% reported role functioning problems at t4. There was no evidence that women with increased financial problems were informed about SSC more often than those without (OR 1.1, p = 0.84) or that they used SSC more often (OR 1.3, p = 0.25). However, women with role functioning problems were informed about SSC significantly more often (OR 1.7, p = 0.02) and attended counseling significantly more often (OR 1.6, p = 0.03). Among participants aged < 65 years at t4 (n = 255), 70% were employed. Patients who had received SSC were more likely to be employed at t4 than patients who did not (OR 1.9, p = 0.04). CONCLUSION: These findings underline the importance of SSC for BC patients with role functioning issues. They indicate that individuals who use SSC are more likely to be employed later on than individuals who do not.

Outcome of breast cancer patients treated with chemotherapy during pregnancy compared with non-pregnant controls.

BACKGROUND: A diagnosis of breast cancer during pregnancy (PrBC) does not impact prognosis if standard treatment is offered. However, caution is warranted as gestational changes in pharmacokinetics may lead to reduced chemotherapy concentration. METHODS: Survival of PrBC patients treated with chemotherapy during pregnancy was compared to non-pregnant breast cancer patients treated with chemotherapy, diagnosed after 2000, excluding patients older than 45 years or with a postpartum diagnosis. The data was registered in two multicenter registries (the International Network of Cancer, Infertility and Pregnancy and the German Breast Group). Cox proportional hazards regression was used to compare disease-free (DFS) and overall survival (OS) between both groups, adjusting for age, stage, grade, hormone receptor status, human epidermal growth factor 2 status and histology, weighted by propensity scoring to account for the differences in baseline characteristics between pregnant patients and controls. RESULTS: In total, 662 pregnant and 2081 non-pregnant patients were selected. Pregnant patients were more likely to have stage II breast cancer (60.1% vs 56.1%, p = 0.035), grade 3 tumors (74.0% vs 62.2%, p < 0.001), hormone receptor-negative tumors (48.4% vs 34.0%, p < 0.001) or triple-negative breast cancer (38.9% vs 26.9%, p < 0.001). Median follow-up was 66 months. In multivariable analysis, DFS and OS were comparable for pregnant and non-pregnant patients (DFS: HR 1.02, 95% CI 0.82-1.27, p = 0.83; OS: HR 1.08, 95% CI 0.81-1.45, p = 0.59). CONCLUSION: Outcome of women with breast cancer treated with chemotherapy during pregnancy is comparable to young non-pregnant women. These results support chemotherapy for PrBC when indicated.

Outcome analysis of primary breast cancer patients who declined adjuvant chemotherapy-results from the prospective multi-center BRENDA II study.

BACKGROUND: This study examined 5-year overall, recurrence and distant metastasis-free survival (OS, RFS, MFS) of high- and intermediate-risk breast cancer (BC) patients who declined guideline-recommended adjuvant chemotherapy (CHT). METHODS: In the prospective multicenter cohort study BRENDA II, patients with primary BC were sampled over a period of four years (2009-2012). A multi-professional team (tumorboard) discussed recommendation for adjuvant CHT according to the German guideline. Potential differences in 5 year survival were analyzed using Kaplan-Meier curves and Cox regression. The hazard ratios (HR) were adjusted for age, Charlson Comorbidity Score, American Society of Anesthesiologist (ASA) physical status classification, and endocrine therapy. RESULTS: A total of 759 patients were enrolled of which 688 could receive CHT according to the guidelines (n = 219 had a clear indication, in n = 304 it was possible). For 360 patients, the tumorboard advised to perform CHT, for 304 it advised against and in 24 cases, no decision was documented. Of those with a positive suggestion, 83% received CHT. Until 5 years after diagnosis, 57 patients were deceased, 41 had at least one distant metastasis and 29 a recurrence. There was no evidence for differences in OS and MFS in patients who declined CHT despite tumorboard recommendation (HR 3.5, 95% CI 0.8-15.1 for OS, HR 1.9, 95% 0.6-6.6 for MFS). Patients who received CHT had significantly better 5-year RFS compared to those who declined (HR 0.3, 95% CI 0.1-0.9, p = 0.03). There was no evidence for different survival in those who had no CHT because of comorbidity and those who declined actively, neither for OS, MFS nor RFS. CONCLUSION: The prospective BRENDA II study demonstrates benefit in RFS by guideline adherence in adjuvant breast cancer treatment, indicating prospectively the value of internationally validated guidelines in breast cancer care.

Cardiac Arrest during Cesarean Section - A Case Report and Review of the Differential Diagnosis.

AIM: According to the World Health Organization, approximately 810 pregnant women die every day as a consequence of peripartum complications. A large proportion of deaths happen in developing countries. Peripartum cardiac arrest is a rare event that must be treated immediately. It is important to consider the differential diagnoses in order to save lives. METHODS: In this review, we discuss a differential diagnosis of cardiac arrest according to the BEAU-CHOPS scheme of the American Heart Association in the relation to the case report of our 40-year-old G5/P3 patient who went into cardiac arrest during cesarean delivery. RESULTS: Typical differentials for cardiac arrest during labor are bleeding, embolism, anesthetic complications, cardiovascular diseases, eclampsia, and sepsis. All of them were considered and ruled out in this patient. In the end, we suspect that physiological cardio-inhibitory reflexes triggered by sudden profound hypovolemia after placental separation along with the patient's risk factors, especially obesity and maternal age, and the administration of spinal anesthesia all potentially contributed to the cardiac arrest. CONCLUSIONS: This review highlights that the cardiac arrest during labor can be triggered by the multifactorial etiology, but firstly the typical differential diagnosis needs to be excluded.

Survival benefit of tamoxifen in male breast cancer: prospective cohort analysis.

BACKGROUND: Due to the lack of prospective data, current treatment of male breast cancer (MBC) is based on information obtained from retrospective analysis or by extrapolation from studies on female patients. In this prospectively enrolled cohort study, we retrospectively examined the survival effect of tamoxifen in MBC patients. METHODS: In this prospectively enrolled cohort study, 448 patients with MBC were treated between May 2009 and June 2018. The primary endpoint was disease-free survival (DFS). RESULTS: Between May 2009 and June 2018, 448 men with breast cancer were identified, with a median age at diagnosis of 69 years (range 27-96 years). The median follow-up was 39 months (range 3-89 months). Most tumours were larger than 20 mm; invasive ductal carcinoma was of no special histological type and with an intermediate grade of differentiation. Almost half of the men were diagnosed with positive axillary lymph nodes (43.5%). Hormone receptor (HR) positivity was observed in 98.4% of the patients. Notably, DFS among men who did not receive tamoxifen was significantly reduced as compared with those who underwent tamoxifen therapy (P = 0.002). The recurrence rate and mortality in the group of patients without and with tamoxifen treatment were 18.2% and 11.2%, respectively. The most common localisation of metastases was the bone. After adjustment for prognostic factors, we found that tamoxifen was found to reduce the recurrence rate by 68% (hazard ratio HR = 0.32; 95% confidence interval, CI: 0.14-0.74). CONCLUSIONS: Tamoxifen treatment was associated with improved DFS for MBC patients. CLINICAL TRIAL REGISTRATION: DRKS00009536.

Survivors of primary breast cancer 5 years after surgery: follow-up care, long-term problems, and treatment regrets. Results of the prospective BRENDA II-study.

PURPOSE: This study aims to answer the questions where breast cancer patients in Germany receive follow-up care (with what types of doctors) and what are the long-term problems and treatment regrets of breast cancer patients. METHODS: In the prospective multicenter cohort study BRENDA II ("Breast Cancer under Evidence-Based Guidelines"), 456 patients with primary breast cancer were sampled consecutively over a period of 4 years (2009-2012) and contacted again 5 years after surgery. Long-term problems were elicited on a 4-point Likert scale ranging from 0 ('not at all') to 3 ('very much'). RESULTS: 82% of the patients receive follow-up (FU) at the private practice gynecologist. In 22%, the initial treating hospital is involved in the FU, and in 20% the general practitioner does this (multiple answers possible). Long-term problems attributed to the treatment were most often related to endocrine therapy (mean 1.29) and to chemotherapy (mean 0.94). Most of the patients were happy to have had radiotherapy (95%). For chemotherapy, endocrine therapy, and antibody therapy, the satisfaction for the treatment decision was 87%, 87%, and 84% respectively. Among patients who reported they regretted having undergone a recommended treatment, it was most often for endocrine therapy (5%) and chemotherapy (4%). CONCLUSION: In Germany, different specialists are involved in the patients' FU care for BC. The detection of long-term problems due to BC treatment is an essential part of FU care.

Feasibility of a large multi-center translational research project for newly diagnosed breast and ovarian cancer patients with affiliated biobank: the BRandO biology and outcome (BiO)-project.

INTRODUCTION: Large translational research projects may contribute to further progress in cancer treatment by exploring molecular biology, immunologic approaches and identification of new prognostic and predictive factors. Therefore, the BRandOBio-project combines a clinical registry for collection of patient and tumor characteristics with a biobank comprising tumor and liquid biopsies. In addition, sociodemographic, environmental and lifestyle factors of included patients with primary newly diagnosed breast or ovarian cancer, other rare malignant ovarian tumors or gestational trophoblastic disease are prospectively collected. METHODS: The target population includes the German "Alb-Allgäu-Bodensee Region" which constitutes the outreach area of the University Hospital Ulm with affiliated academic centers and private practices. Clinical data combined with primary tumor tissue samples and longitudinal repeatedly collected blood samples [before, 6 (in high-risk situations), 12, 36 and 60 months after treatment and at relapse] will be acquired from more than 4000 patients within the next years. Standardized questionnaires are given to patients of the University Hospital Ulm and eight selected external sites for assessing life style and cancer risk factors. Concomitantly, storage of paraffin-embedded tumor samples as well as liquid biopsy samples will allow translational research projects, for example in terms of investigating circulating DNA and germ line DNA from cell pellets. RESULTS: Starting in January 2016 at the University Hospital Ulm, 19 additional external sites started recruiting patients in March 2017. As of September 15th 2019, 2151 patients with newly diagnosed cancers could be recruited (2044 breast cancer; 107 ovarian cancer). Nearly all patients provided biological samples (tumor and liquid biopsy) and about 80% returned the standardized questionnaire. After 1 year follow-up, blood samples were available from more than 80% of the participating patients. CONCLUSIONS: The BRandO BIO study is a large prospective cohort study with integrated comprehensive biobank and evaluation of sociodemographic and life style factors of gynecological cancer patients in a well-defined geographical area in the South West of Germany. Continuous high patient recruitment and stable rates over 80% for returned questionnaires as well as for repeated blood sampling show high acceptance of the BRandO study program and confirms feasibility of the project.

Association between cognitive impairment and guideline adherence for application of chemotherapy in older patients with breast cancer: Results from the prospective multicenter BRENDA II study.

BACKGROUND: This study examined the association between cognitive impairment and guideline adherence for application of chemotherapy in older patients with breast cancer. PATIENTS AND METHODS: In the prospective multicenter cohort study BRENDA II, patients aged ≥65 years with primary breast cancer were sampled over a period of 4 years (2009-2012). A multiprofessional team (tumor board) discussed recommendation for adjuvant chemotherapy according to the German S3 guideline. Cognitive impairment was screened by the clock-drawing test (CDT) prior to adjuvant treatment. RESULTS: Two hundred and sixty-three patients were included in the study and CDT data were available for 193 patients. Thirty-one percent of the patients had cognitive impairment with different degree of severity. In high-risk patients (n = 61) tumor board recommendation in favor of chemotherapy was 90% and in intermediate-risk patients (n = 170) 27%. Not receiving recommendation for chemotherapy in spite of guideline recommendation was more frequent in patients with cognitive impairment (67%) vs patients without cognitive impairment (46%) with P = 0.02 (OR 2.4, 95% confidence interval (CI) 1.2-4.9). Age, education, migration background and comorbidities were not associated with chemotherapy recommendation by the tumor board among cognitively impaired patients. Once the tumor board had recommended chemotherapy, application of chemotherapy was similar in both groups of patients with or without cognitive impairment. CONCLUSION: Almost one third of older patients with breast cancer are affected by cognitive impairment prior to adjuvant treatment. In these patients, cognitive impairment was associated with tumor board decision against chemotherapy in spite of a positive guideline recommendation.

Which patient- and physician-related factors are associated with guideline adherent initiation of adjuvant endocrine therapy? Results of the prospective multi-centre cohort study BRENDA II.

BACKGROUND: We analysed factors that might influence patients' and physicians' decisions against the initiation of guideline adherent adjuvant endocrine therapy (ET). METHODS: In a prospective multi-centre study, including four certified breast cancer centres in Germany, patients with primary breast cancer were included from 2009 to 2012. Patients completed a questionnaire prior to surgery, adjuvant therapy, and 6 months after adjuvant therapy. This questionnaire assessed health-related quality of life (QoL), psychiatric co-morbidity, demographic characteristics, and the intensity of fear for ET. Guideline adherence was classified based on an algorithm derived from international guidelines. The tumour board's (TB) decisions against or for ET was documented. The TB was blinded regarding the guideline results. RESULTS: In 666 patients, adjuvant ET was indicated according to the guideline recommendations. The TB decided in 92.3 % (n = 615) of those that adjuvant ET was indicated. TB's decision against ET was associated with the younger age of patients (OR = 0.5; 95 % CI 0.3-0.9) and poor QoL (OR = 1.7; 95 % CI 1.0-2.8). In 93 patients, ET was not indicated according to the guidelines, and the TB decided in 84 of those not to prescribe ET. The TB decided in 93.4 % of the cases according to the guidelines. Of the patients, where the TB prescribed ET, 5 % (n = 31) decided against ET. This decision was associated with fear of ET (OR = 2.2; 95 % CI 1.0-5.2) and higher age (OR 9; 95 % CI 1.0-48.1). Psychiatric co-morbidity (OR = 1.8; 95 % CI 0.7-4.2), poor QoL (OR = 0.4; 95 % CI 0.2-1.2), and education (OR = 1.2; 95 % CI 0.5-2.6) were not associated with the decision. DISCUSSION: Guideline adherent implementation of adjuvant ET is high. Physicians' decision against ET is mainly associated with patients' younger age and poor quality of life, whereas patients' decision, once the TB decided to initiate ET and if ET is indicated by guidelines, is associated with higher age and fear of ET.

Exploring patient- and physician-related factors preventing breast cancer patients from guideline-adherent adjuvant chemotherapy-results from the prospective multi-center study BRENDA II.

BACKGROUND: This study examined which patient- and physician-related factors influence guideline violations in adjuvant chemotherapy. PATIENTS AND METHODS: In a prospective multi-center cohort study, patients with primary breast cancer were sampled consecutively over a period of four years (2009-2012). Patients completed a questionnaire prior to surgery and prior to adjuvant therapy. This questionnaire assessed health-related quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, psychiatric co-morbidity with the Patient Health Questionnaire (PHQ), demographic characteristics (age, education), and the intensity of fear for chemotherapy. After surgery, a multi-professional team discussed recommendation for adjuvant chemotherapy, and this decision was documented in a database together with the indication for chemotherapy according to the German S3 guideline. This multi-professional team was blinded to that algorithm-based decision. Six months later, it was documented whether the patient had received adjuvant chemotherapy or not. RESULTS: Altogether, 857 patients were included in the study. In 391 of these patients, the tumor board (TB) decided to recommend chemotherapy. The most important reasons for not recommending chemotherapy were somatic co-morbidity not allowing adjuvant chemotherapy and age >75 years. Of these 391 patients, 73 (19 %) patients eventually did not receive chemotherapy. Deviations from the initial therapy decision were more frequent in older patients (≥75 years) with poor QoL. If the QoL was good, higher age was not related to deviation. There was some evidence that patients with higher education less frequently received chemotherapy (CT). Furthermore, if patients were very afraid of chemotherapy, deviations from the initial therapy decision were more likely. Co-morbidity and fear of CT were not related to the likelihood of deviating from the initial therapy decision. CONCLUSION: Nineteen percent of patients eventually did not receive chemotherapy, despite guideline and TB recommendations. In these patients, this mainly occurred in association with poor QoL in elderly patients >75 years old. In the group with a chemotherapy recommendation, patients' fear of chemotherapy is another factor preventing patients from undergoing adjuvant chemotherapy.

The course of psychiatric co-morbidity in patients with breast cancer--results from the prospective multi-centre BRENDA II study.

PURPOSE: This study examined the frequency of psychiatric co-morbidity in patients with breast cancer, its changes over time and predictors for these changes. METHODS: In a prospective study with measurements before surgery (t1, baseline), 1 month (t2) and 8 months thereafter (t3) using the Patient Health Questionnaire, we examined the course of psychiatric co-morbidity in breast cancer patients. The co-morbidity courses were grouped into healthy (no co-morbidity during the study), acute (co-morbidity at t1 and/or t2, but not at t3), emerging (no co-morbidity at t1, but at t3) and chronic (co-morbidity at t1 and t3). RESULTS: Of the 598 participants, 19% had acute, 10% emerging and 9% chronic psychiatric co-morbidity. Acute co-morbidity was more common in patients with poor quality of life (odds ratio (OR) 9.6, 95% confidence interval (CI) 4.4-20.8) and somatic co-morbidity (OR 3.8, CI 1.1-12.4). Patients who perceived support from their doctors had acute co-morbidity less frequently (OR 0.7, CI 0.5-1.0). Emerging co-morbidity occurred more often in younger patients (OR 2.4, CI 1.2-4.7) and in patients with another cancer in their own (OR 2.0, CI 1.1-3.9) or family (OR 2.1, CI 1.1-4.3) histories, less often in patients with support from doctors (OR 0.6, CI 0.4-1.0). Chronic co-morbidity was related to poor quality of life (OR 12.1, CI 3.6-39.9). CONCLUSION: We found acute and emerging psychiatric co-morbidities less often in patients who reported having a supportive doctor-patient relationship. Patients that require psycho-oncological support often have poor quality of life and have experienced cancer before. Copyright © 2015 John Wiley & Sons, Ltd.

Breast Cancer Patients' Fear of Treatment: Results from the Multicenter Longitudinal Study BRENDA II.

BACKGROUND: Fear of cancer treatment can become overwhelming. It is important to understand what patients are mainly afraid of and what factors are correlated with intense fear of treatment. METHODS: Patients with primary breast cancer (n = 761) completed questionnaires about fear of treatment before surgery (t1), and before (t2) and after (t3) adjuvant treatment. Psychological comorbidity was assessed using the Patient Health Questionnaire. Logistic regression identified predictors of intense fear of treatment. RESULTS: Patients were most afraid of chemotherapy (mean score 3.5), and fear remained high throughout follow-up; fear of radiotherapy and of surgery was lower and decreased over time (from 2.7 to 2.2, p < 0.0001; and from 2.6 to 2.2, p < 0.0001, respectively). Patients with psychological co-morbidity (odds ratios (OR) 1.7-3.0) and those who had heard reports of negative experiences with cancer treatments from others (OR 3.8-16.2) were more likely to have intense fear of all the treatments. Patients with a previous cancer less often expressed fear of surgery (OR 0.6, 95% confidence interval 0.4-1.0). CONCLUSION: Fear of treatment, especially of chemotherapy, is prevalent in many patients with primary breast cancer. Patients with psychological co-morbidity and those who have heard reports of negative experiences with cancer treatment are at higher risk of experiencing intense fear.

Long-term results of the tension-free vaginal tape procedure in an unselected group: a 7-year follow-up study.

OBJECTIVES: To evaluate long-term effectiveness and late complications after treatment of female stress urinary incontinence with tension-free vaginal tape (TVT). METHODS: We performed a prospective observational study. Follow-up examinations included a standardized questionnaire, medical history, voiding diary, gynecologic examination with cough test, and introital ultrasound. RESULTS: One-hundred-eight women (68.8%) from the initial cohort of 157 patients and 79.6% of those alive and able to cooperate were assessed. The median follow-up time was 102 months (range 85-124). The objective cure rate was 89.8%. The subjective cure rate was 82.4%, 13% had improved, 2.8% regarded the continence situation as unchanged, and 1.8% had an impaired stress urinary incontinence. No late-onset adverse effects of the surgery were found. Urge incontinence was the main reason for dissatisfaction with the surgery (in 90% of discontent patients). CONCLUSIONS: Our data showed good results more than 7 years after TVT, demonstrating a high level of long-lasting efficacy for this minimally invasive incontinence procedure.

Voiding dysfunction after the tension-free vaginal tape procedure.

AIM: To assess the incidence of voiding dysfunction in women undergoing a tension-free vaginal tape (TVT) procedure and report our experience with nonsurgical and surgical management. METHODS: Pre- and postoperative introital ultrasonographic measurement of the residual volume was performed in a prospective observational study. Patients' perception of micturition and continence status was assessed by questionnaire. RESULTS: Of 478 women, 4 (0.8%) suffered from micturition disturbance within the first 2 weeks. In the mean of 3 months after surgery, 7.1% of the patients had residual volume between 50 and 100 ml, and 2.6% had residual volume >100 ml. 243 women were investigated after 39 months (range 12-74). The rate of residual volume exceeding 50 ml decreased to 6.5% and was approximated to the preoperative period. CONCLUSION: Incomplete bladder emptying is a possible problem after TVT. In our cohort, 93% of the women had no voiding disturbances or marginally affected voiding after 12-74 months.

Retziusscopy: a minimal invasive technique for the treatment of retropubic hematomas after TVT procedure.

OBJECTIVES: Retropubic hematomas are rare but typical complications during or after the tension-free vaginal tape (TVT) procedure. We investigated the possibility of treating these hematomas with retziusscopy, as an update of a previous study by our group. STUDY DESIGN: Over a 10-year period the clinical course of all 685 consecutive patients undergoing the tension-free vaginal tape procedure (TVT, Gynecare) was prospectively recorded, including management strategies for clinically relevant hematomas. We report on 10 patients with hematoma and our following surgical management. RESULTS: In twenty-eight patients (4.1%) a symptomatic retropubic hematoma developed. In 10 cases (1.5%) volume exceeded 250 mL (range 250-1000 mL). These patients required surgical intervention because of moderate or severe symptoms. In the first case we performed open laparotomy, whereas in the following cases the hematomas could be successfully drained by retziusscopy. CONCLUSIONS: In cases of large masses, intervention may be necessary because of significant discomfort. This can usually be achieved by a minimally invasive retziusscopy.

Pregnancy and delivery after tension-free vaginal tape (TVT) procedure: literature review and case report.

The popularity of the TVT procedure for treating stress urinary incontinence has led to more women of childbearing age undergoing this surgery. Therefore the incidence of pregnancy after TVT procedure is likely to increase. We present a review of the current literature and we report the case of a 26-year-old woman previously treated with TVT-O. In the literature there is no evidence that an elective caesarean section protects against stress urinary incontinence in cases of pregnancy after TVT procedure. In our case an elective caesarean section was performed at 39 weeks' gestation. Postnatal pelvic floor exercises successfully controlled the incontinence with a recurrence of the stress urinary incontinence 4 months after delivery on terminating physiotherapy. At 17 months after delivery the woman remained well with no incontinence or further treatment. In our opinion, vaginal delivery after TVT is not contraindicated. However, the mode of delivery must be considered individually and after fully advising the pregnant woman.

Influence of bladder volume on pelvic organ prolapse quantification results.

AIMS: To compare the degree of pelvic organ prolapse between examinations performed with full and empty bladder in patients without any prolapse and with pelvic organ prolapse stage I or II using the pelvic organ prolapse quantification (POPQ) system. METHODS: A prospective observational study with 120 consecutive patients with and without symptoms of pelvic organ prolapse was evaluated. All women were examined with full and empty bladder. The data were analyzed by Wilcoxon's signed-rank test. RESULTS: With empty bladder 54% had the same stage, 41% had a one-step higher stage and 5% had a two-step higher stage of prolapse. There was an increase in the extent of prolapse in the empty bladder setting at all six site-specific points (Aa, Ba, C, D, Ap, Bp; p < 0.001) but not in the results of genital hiatus, perineal body and total vaginal length. CONCLUSION: Our results suggest that the full extent of prolapse may be only assessed with an empty bladder.