Tension-Free Vaginal Tape Versus Transobturator Suburethral Tape: Five-Year Follow-up Results of a Prospective, Randomised Trial

Background: Many studies have assessed the equivalent effectiveness of tension-free vaginal tape (TVT) and transobturator suburethral tape (TVT-O) at short- to medium-term follow-up, but no long-term randomised trials appear in the literature. Objective: We compared the use of TVT to TVT-O, providing a longer follow-up than currently appears in the literature. Design, setting, and participants: Seventy-two consecutive patients affected by stress urinary incontinence (SUI) were included in this randomised, controlled trial. Patients were randomly allocated to the TVT or TVT-O procedure using a predetermined, computer-generated randomisation code. Intervention: After preoperative assessment, patients were randomly allocated to the TVT or TVT-O procedure. Measurements: This 5-yr study represents the extension of our original randomised trial, which was designed to assess the incidence of long-term complications (primary end point) and successes (secondary end point) for both techniques. Results and limitations: At 60-mo follow-up, 52 patients (72%) were objectively cured of SUI (72.9% after TVT-O and 71.4% after TVT), but only 44 patients (61%) were satisfied. The late complication rate was 16.6% (10 women): five women (16.1%) in the TVT-O group and five women (17.2%) in the TVT group (p = 1). In this follow-up, 62% of the patients from the TVT-O group and 60% from the TVT group (p = 1) expressed that they were satisfied or very satisfied with the results. The mean cause of dissatisfaction was the development of sexual dysfunction resulting from dyspareunia or incontinence during intercourse, which was found in 6 of 16 dissatisfied patients (37.5%). The limitations of our study included the adequate but small sample size and the lack of questionnaires. Conclusions: Both surgical techniques are safe, with similar results (72.9% and 71% of patients objectively cured after TVT-O and TVT, respectively) and low complication rates (16.6%: 16.1% and 17.2%, respectively, for TVT-0 and TVT), even after 5-yr follow-up. © 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved

An ultra-miniinvasive treatment for stress urinary incontinence in complicated older patients

Objective: To evaluate use of bulking agents (polydimethylsiloxane) as an alternative treatment of female stress urinary incontinence (SUI) in older patients. Study design: Prospective cohort study. Main outcome measures: Women with age >75 years old, affected by stress urinary incontinence, presenting to our institution between January 2005 and January 2008 were considered for eligibility in this prospective study. All patients were submitted to transurethral implantation using Macroplastique Implantation System (MIS) (Uroplasty, Minneapolis, Minnesota). Cure of SUI was defined as the resolution of SUI symptoms. Objective cure rate was assessed by urogynecological physical examination and urodynamic assessment performed at 6 and 12 months after surgery respectively. Subjective cure rate was assessed during the interview of the 12th month with a visual analogue scale (VAS) for quantification of SUI severity and a standardized question about the repeatability of the procedure. Results: A total of 27 consecutive patients were enrolled in this study. After 12 months of surgery the objective cure rate was 44% (12 of 27 patients), the improvement rate was 33% (9 of 27) and the failure rate was 22% (6 of 27). The overall success rate was 77% (12 patients cured and 9 improved). 23 (85%) patients would like to repeat this surgical procedure if necessary. Conclusion: Transurethral implantation of bulking agents should be considered as alternative treatment of SUI in complicated older patients. © 2009 Elsevier Ireland Ltd. All rights reserved

Aortic lymphadenectomy in cervical cancer: Anatomy, classification and technique

Lymphatics are the main pathway of dissemination for gynaecologic malignancies and in particular those with preferential regional spread, so the evaluation of lymph node status has an important role in diagnosis, prognosis and treatment of patients with gynaecologic cancer. Hence, gynecologic oncologist must be familiar with lymphatic anatomy and the ability to perform a systematic retroperitoneal pelvic and aortic lymph node dissection is an important skill in their surgical armamentarium. This review will focus on the performance of systematic aortic lymphadenectomy in cervical cancer

Resistance to CD95-mediated apoptosis of CD40-activated chronic lymphocytic leukemia B cells is not related to lack of DISC molecules expression

In B-cell chronic lymphocytic leukemia (CLL), accumulation of neoplastic B cells may be the result of dysregulated apoptosis. One of the major molecules triggering apoptosis, CD95 (FAS), is not expressed on CLL B cells at resting conditions. However, CD40 triggering of CLL B cells upregulates receptors belonging to the tumor necrosis factor (TNF) superfamily, like CD95. In the present study, we analyzed in B cells from 20 CLL patients the effect of CD40/CD40L interaction on: (i) CD95 modulation; (ii) CD95-mediated apoptosis and (iii) mRNA and protein expression of the death-inducing signaling complex (DISC) molecules. CD40 activation of CLL B cells was carried out by coculture with CD40L-transfected cells and cytofluorimetric analyses were performed to Study CD95 modulation and apoptosis induction by an anti-CD95 moAb. Despite strong CD95 upregulation on the membrane of all the cases studied, only a minority of cases analyzed (3/20) proved weakly responsive to CD95-mediated apoptosis. Multiplex RT-PCR was used to analyze FLICE, FAS, FADD and TRADD mRNAs before and after CD40 triggering. In agreement with the cytofluorimetric data, FAS mRNA appeared significantly increased after CD40 triggering: the other molecules involved in DISC formation and in CD95-mediated apoptosis were also expressed without relevant differences between resting and activated conditions. Western blot analyses further confirmed FLICE and FADD protein expression by resting and activated CLL cells. Our findings demonstrate that, following CD40 triggering,CLL B cells are resistant to CD95-mediated apoptosis despite a strong CD95 upregulation on the membrane and a normal mRNA or protein expression of the DISC components

Does extensive upper abdomen surgery during primary cytoreduction impact on long-term quality of life?

The objective of this study was to evaluate the feasibility in terms of safety and quality of life in a sample of Italian patients affected by advanced ovarian cancer and submitted to either extensive upper abdomen or standard surgery, through validated questionnaires. Methods: From January 2006 to November 2011, a prospective, observational study was conducted to compare quality of life in patients affected by advanced ovarian cancer and submitted to primary cytoreduction in the Division of Gynecology of the University Campus Bio-Medico of Rome. After surgery patients were stratified into 2 groups (group A: standard surgery or group B: extensive upper abdomen surgery). All patients were submitted to standard chemotherapy. At completion of treatment, during the first follow-up visit, all eligible patients were asked to fill in Quality of Life Questionnaire-C30 (QLQ-C30) (version 3.0) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-OV28 (QLQ-OV28) questionnaires. Results: Eighty-nine patients were enrolled into our study. Ninewere excluded, so finally 80 patients were considered in this study. Group A included 40 patients and underwent standard surgery (pelvic surgery); group B, included 40 patients and underwent extensive upper abdomen surgery. There were no statistical differences in terms of major surgical complication rates (15%vs 10%).We registered sametimes of beginning of chemotherapy (median, 19 vs 21 days) and no severe related toxicities. Quality-of-life scores of both questionnaires were comparable between groups, with the exception of Global Health Status in QLC-30. Conclusions: Upper abdomen surgery is a feasible and safe therapeutic option. Patients present same times of beginning of chemotherapy without an increase in chemorelated toxicities and experience the same general quality of life. © 2013 by IGCS and ESGO

Update on lymphadenectomy in early and advanced ovarian cancer

Pelvic and para-aortic lymphnode sampling is an integral part of the staging system of ovarian cancer. The issue concerning lymphadenectomy in the management of the disease is still debated, however. The purpose of this paper is to review the role of systematic lymphadenectomy in patients affected by early and advanced-stage ovarian cancer. Some retrospective studies have revealed an increased survival rate in early-stage ovarian cancer patients after lymphadenectomy. Recently, the first randomized prospective trial, on lymphadenectomy in advanced-stage disease, was published. It evidenced an improvement in progression-free survival in patients who had undergone lymphadenectomy. Systematic lymphadenectomy has a diagnostic value in early-stage ovarian cancer, thanks to the possibility of accurate clinical staging. As up to 22% of women, who were presumed to have early-stage ovarian cancers, are upstaged during the lymphadenectomy procedure, accurate staging can help to avoid unnecessary postoperative chemotherapy. In patients affected by advanced ovarian cancer, systematic lymphadenectomy statistically significantly improves progression-free survival and reduces recurrence rates despite a higher incidence of postoperative complications. As improvement of overall survival is not statistically significant, further studies are needed to balance risks and benefits of systematic lymphadenectomy in advanced-stage disease

Quality of life in patients with endometrial cancer treated with or without systematic lymphadenectomy

Objective: To compare the quality of life (QoL) of women affected by endometrial cancer treated with surgery with or without systematic lymphadenectomy. Study design: Consecutive patients affected by stages I and II endometrial cancer and treated with surgery between 2008 and 2011 were selected. Eligible subjects were divided into two groups: Group A consisted of 36 patients who had hysterectomy plus bilateral salpingo-oophorectomy without lymphadenectomy; Group B consisted of 40 patients who had hysterectomy plus salpingo-oophorectomy plus pelvic and aortic lymphadenectomy. The EORTC Quality of Life Questionnaire-Cancer Module (QLQ-C30) and Quality of Life Questionnaire-Endometrial Cancer Module (QLQ-EN24) were administered to selected patients. All data were recorded and then analyzed using the scoring manual of the EORTC Quality of Life Group. Results: Among symptom scales, only lymphedema gave a statistically significant difference among two groups, with a score of 10.64 ± 17.43 in Group A and 21.66 ± 24.51 in Group B (p = 0.0285). The p value obtained comparing the "Global Health Status" (items 29 and 30) in Group A and in Group B was not statistically significant. Conclusion: Lymphadenectomy did not influence negatively global health status, but lymphadenectomy maintained its importance in determining a patient's prognosis and in tailoring adjuvant therapies. We therefore support its practice as part of the surgical procedure in patients affected by high risk endometrial cancer. © 2013 Elsevier Ireland Ltd. All rights reserved

Update on urodynamic bladder dysfunctions after radical hysterectomy for cervical cancer

Introduction: Bladder dysfunctions are a common sequela after radical hysterectomy (RH, former type III sec Piver) ranging from 8 to 80%. This discrepancy, probably, reflects the different bladder function evaluation methods utilized in literature. Material and methods: We searched English-language medical reports published from 1952 to 2010, on MEDLINE. Inclusion criteria were: (1) studies of urological dysfunctions in patients with cervical cancer, treated with type III sec Piver (C2 sec Querleu) radical hysterectomy; (2) use of urodynamic measurement. Results: The overall incidence of urodynamic bladder dysfunctions is 72%. Follow-up >12 months studies report a high incidence of overactive detrusor low compliance (34%). Eight out of 19 studies show a decrease of the maximal urethral closure pressure (MUCP). Discussion and conclusions: Follow-up timing seems to be the major factor influencing the wide range of incidence of bladder dysfunction. Urodynamic data could help physicians to formulate appropriate evaluation and treatment for patients having urge incontinence (UI) after RH. © 2011 Elsevier Ireland Ltd

Ovarian cancer recurrence and early detection: may HE4 play a key role in this open challenge? A systematic review of literature

Despite the improvement in overall survival for ovarian cancer (OC) patients, a fraction of patients with advanced-stage disease fails to respond to primary therapy and relapses in 70% of cases. For this reason, new predictive and monitoring tools are needed to identify OC recurrence and new biomarkers were studied, among which human epididymis 4 (HE4), primarily expressed in the reproductive and respiratory tracts, is one of the most promising, reporting a good sensitivity and specificity in detecting OC, overcoming the traditional role of carbohydrate antigen 125 (CA-125). In this review, we aim to discuss the latest evidence reported in the literature about the use of HE4 to monitor ovarian cancer treatment and to detect OC recurrence. We searched MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials, IBECS, BIOSIS, Web of Science, SCOPUS, congress abstracts, and Grey literature (Google Scholar; British Library) from January 1952 to June 2017. The search identified seven papers in line with eligibility criteria for this systematic review; all of them demonstrated a good performance of HE4 in OC recurrence. The challenge to anticipate the diagnosis of OC recurrence and to translate this early diagnosis of relapse in a survival and quality of life improvement is still open, and as reported in this review, HE4 may play a key role in this scenario. More studies are needed to validate and reinforce the role of HE4 in ovarian cancer recurrence and in its early detection

Does HE4 have a role as biomarker in the recurrence of ovarian cancer?

Human epididymis protein 4 (HE4) was recently approved by the Food and Drug Administration to monitor recurrence or progressive disease in epithelial ovarian cancer in conjunction with CA125. This is the first prospective controlled study in literature evaluating the sensitivity and specificity of HE4 and CA125 in detecting recurrent ovarian cancer. Serum samples were obtained 24 h before surgery from 34 patients with suspicious recurrent ovarian cancer and from 34 patients with benign adnexal pathology, operated from November 2010 to November 2011 at University Campus Bio-Medico of Rome. The CA125 normal value is considered less than 35 U/mL. Two HE4 cut-off are considered: less than 70 pmol/L and less than 150 pmol/L. The specificity analysis was performed using the parametric t test to compare the CA125 series and the Mann-Whitney test for the HE4 series. The level of statistical significance is set at p < 0.05. The CA125 sensitivity and specificity in detecting recurrent ovarian cancer is 35.29 and 58.82 %, respectively. The HE4 sensitivity is 73.53 and 26.47 %, for 70 pmol/L and 150 pmol/L cut-off, respectively. The HE4 specificity is 100 %. Combining CA125 and HE4 at cut-off of 70 pmol/L, the sensitivity to detect recurrent ovarian cancer is 76.47 % with a specificity of 100 %. The combination of CA125 and HE4 at cut-off of 70 pmol/L improves the overall sensitivity and specificity of CA125 alone, suggesting a useful application of HE4 in strategies for surveillance of ovarian cancer recurrence. © 2012 International Society of Oncology and BioMarkers (ISOBM)