Retropubic versus transobturator tension-free vaginal tape (TVT vs TVT-O): Five-year results of the Austrian randomized trial.

AIMS: To compare outcomes of the retropubic versus the transobturator tension-free vaginal tape (TVT vs TVT-O) at 5 years. METHODS: A total of 569 women undergoing surgery for primary stress incontinence were randomized to receive a retropubic or a transobturator tensionfree vaginal tape (TVT or TVT-O). Follow-up at 5 years included clinical examination, urodynamic studies and quality of life. The primary outcome measure was continence defined as a negative cough stress test at a volume of 300 mL. Secondary outcomes included urodynamic parameters, complications and quality of life.ClinicalTrials.gov (NCT 0041454). RESULTS: Three hundred and thirty-one patients (59%) were evaluated at 5 years (277 were seen, examined and completed questionnaires; 54 only completed questionnaires). No significant differences were seen in rates of a negative cough stress test (83% vs 76%, respectively), urodynamic parameters and complications. Quality-of-life improved significantly in both groups, without significant differences between the groups. Erosion rates were 5.2% and 4.5%, and reoperation rates were 4.1% and 3.2% respectively. CONCLUSIONS: At 5 years, subjective and objective results after TVT and TVT-O are stable and similar, without statistical significant differences between the procedures. Major long-term problems appear rare.

The explicit mentioning of reporting guidelines in urogynecology journals in 2013: A bibliometric study.

AIMS: Poor reporting of research may limit critical appraisal and reproducibility, whereas adherence to reporting guidelines (RG) can guarantee completeness and transparency. We aimed to determine the explicit citing of RGs (CONSORT, PRISMA, STROBE) in urogynecology articles in 2013, the requirements of relevant journals and a potential difference between urogynecology and general gynecology journals. METHODS: All urogynecologic articles published between January and December 2013 in the journals NAU, IUJ, FPMRS, GREEN, AJOG, and BJOG were included. Issues were searched for systematic reviews, RCTs, cohort studies, case-control studies and cross-sectional studies. Each electronic article was searched for the term PRISMA, CONSORT, or STROBE according to the study design. Instructions to Authors of the six journals were screened for requirement of using RGs. RESULTS: We included 296 articles (243 observational studies, 40 RCTs, and 13 systematic reviews). The use of PRISMA guidelines was explicitly declared in 54% of systematic reviews, CONSORT guidelines were referenced in 25% of RCTs and STROBE in 1.2% of observational studies. The use of CONSORT is required by all journals except FPMRS. PRISMA and STROBE are only compulsory in the journals GREEN, AJOG, and BJOG. The overall rate of explicit mentioning of RGs comparing urogynecology and general gynecology journals was 6.7% versus 7.1%, respectively. CONCLUSIONS: The explicit mentioning of RGs was on a relatively low level. A slightly higher adherence was recognized among general gynecology journals compared to urogynecology journals. Stronger efforts should be taken to further promote the use of RGs in urogynecology.

CONSORT and the internal validity of randomized controlled trials in Female Pelvic Medicine.

AIMS: To investigate authors' adherence to the CONSORT reporting guideline for randomized controlled trials (RCTs) in the sub-specialty Female Pelvic Medicine and to detect any changes in adherence between the years 2008 and 2013. METHODS: Bibliometric study. We included Female Pelvic Medicine RCTs published in 2008 and 2012-2013 in 10 journals. Full-text versions of RCTs for the inclusion of the CONSORT checklist items Randomization, Allocation, Blinding, and Participants' flowchart were screened. Each CONSORT checklist item was categorized for each included RCT as either "complete reporting", "insufficient reporting", "no reporting," or "not applicable". We screened the "Instructions to authors" for the requirement to adhere to CONSORT. RESULTS: We included 94 Female Pelvic Medicine RCTs for analysis. Most RCTs in 2008, 2012, and 2013 were published by IUJ (n =n39), followed by NAU (n = 13), GREEN (n = 12), European Urology (n = 8), FMPRS (n = 6), AJOG (n = 4), Urology (n = 3), NEJM (n = 3), Lancet (n = 1), and BJOG (n = 1). Proportion of RCTs in the category "complete reporting" comparing 2008 and 2013 was (47 and 70%) for Randomization, (18 and 45%) for Allocation, and (29 and 52%) for Blinding; a flowchart was presented in (71 and 91%). The increase was not statistically significant in any of the investigated CONSORT items. CONCLUSIONS: Complete reporting of Female Pelvic Medicine RCTs has increased between 2008 and 2013. However, there are still a relevant number of published RCTs, which do not fulfill these criteria. Reporting according to the CONSORT guidelines should be further encouraged to improve internal validity of Female Pelvic Medicine RCTs. Neurourol. Urodynam. 35:826-830, 2016. © 2015 Wiley Periodicals, Inc.

Disclosures, conflict of interest, and funding issues in urogynecology articles: a bibliometric study.

INTRODUCTION AND HYPOTHESIS: The ethical behavior of authors, editors, and journals is increasingly placed in the spotlight, by both the public and the research community. Disclosures and conflict of interest (COI) statements of publishing authors represent one important aspect. We aimed to unravel the current management of disclosures, COI, and funding statements in the subspecialty urogynecology. METHODS: A bibliometric study was carried out. We included six journals that published urogynecology articles between January and December 2013. All original articles, reviews, and opinion articles were assessed for the presence of disclosure/COI and funding statements. Information given on the official disclosure form was compared with information given in the final article (International Urogynecology Journal). RESULTS: All journals investigated require disclosure and funding statements in their instructions to authors. Of the 434 articles included, almost all contained a disclosure statement (98-100 %). Funding statements were present in 41-100 % of articles, indicating a difference in journal type (50 % on average among urogynecology journals; 75 % on average among general gynecology journals). The main source of funding was "grants" (58 %), followed by "none" (16 %), "industry" (16 %), and lastly "hospital/university" (10 %). Disclosure statements in the article were identical to the official disclosure form in 80 % (IUJ). CONCLUSIONS: Disclosure/COI statements were included in almost all urogynecology articles investigated. Their content, however, is sometimes incomplete and should possibly be monitored more closely by journals and authors. Despite universal requirements of journals, the reporting of funding seems inconsistent. This issue in addition to the completeness of disclosures should be given more attention.

Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial.

BACKGROUND: We conducted a prospective randomized controlled noninferiority trial to compare objective and subjective outcomes of retropubic tension-free vaginal tape (TVT) with those of transobturator tape (TVT-O) as primary treatment for stress urinary incontinence (SUI) in women. STUDY DESIGN: The study was conducted at 25 gynecology units in Austria and Germany; regional and academic hospitals participated. A total of 569 patients were randomly assigned to undergo TVT or TVT-O. RESULTS: A total of 480 patients (85%) were examined at 3 months. A negative cough stress test with stable cystometry to 300 ml was seen in 87% of patients after TVT and in 84% after TVT-O; 64% and 59% of patients, respectively, reported no pad use, and 88% of patients in both groups considered themselves much or very much better on the Patient Global Impression of Improvement (PGI-I) scale. Quality of life (QoL) as assessed with the SF-12 Health Survey, Kings' Health Questionnaire, (KHQ), and EuroQol-5D (EQ-5D) was significantly improved in both arms, with no differences between arms. There were no significant differences in postoperative pain or complications. CONCLUSIONS: Results of this trial demonstrate noninferiority between TVT and TVT-O with regard to postoperative continence and QoL and suggest little difference in perioperative problems (ClinicalTrials.gov NCT 00441454).

Immunoexpression of B7-H3 in endometrial cancer: relation to tumor T-cell infiltration and prognosis.

OBJECTIVE: B7-H3, a member of the B7 family of immune regulatory ligands regulates T cell-mediated peripheral immune response. The purpose of this study was to correlate the expression of B7-H3 and number of lymphocytes in patients with endometrial cancer. MATERIAL AND METHODS: A total of 107 patients with primary endometrial carcinoma (type I/endometrioid, n=81; type II, n=18) and endometrial hyperplasia (n=8) were investigated. Expression of B7-H3 in endometrial hyperplasia, endometrial carcinoma, and the endothelium of tumor-associated vasculature was assessed using immunohistochemistry from paraffin-embedded tissue blocks. Detection of CD8-positive tumor-infiltrating lymphocytes (TIL) and CD8-positive tumor-associated lymphocytes (TAL) was correlated with the expression of B7-H3. RESULTS: Patients with high grade tumors and patients with type II carcinomas expressed significantly more B7-H3 than low grade and endometrioid tumors (p=<0.0001 and p=0.0001, respectively). The expression of B7-H3 in the endothelium of identified vasculature in the tumor specimens showed similar results with strong relation to high grade tumors (p=0.001) and type II carcinomas (p=0.004). We found a significant correlation between B7-H3 expression on cancer cells and tumor T-cell infiltration (TIL) (p=0.017). In a univariate survival analysis, overexpression of B7-H3 in tumor cells was associated with shortened overall survival (p=0.005). CONCLUSIONS: B7-H3 is overexpressed on cancer cells and in the endothelium of tumor-associated vasculature in high grade tumors (G3) and type II carcinomas. B7-H3 expression on cancer cells is correlated with the number of T cells infiltrating the tumor. Endometrium tumor development and progression may be associated with downregulation of T-cell-mediated antitumor immunity through B7-H3.