The Role of Chronic Mesh Infection in Delayed-Onset Vaginal Mesh Complications or Recurrent Urinary Tract Infections: Results From Explanted Mesh Cultures.

OBJECTIVES: Vaginal mesh complications necessitating excision are increasingly prevalent. We aim to study whether subclinical chronically infected mesh contributes to the development of delayed-onset mesh complications or recurrent urinary tract infections (UTIs). METHODS: Women undergoing mesh removal from August 2013 through May 2014 were identified by surgical code for vaginal mesh removal. Only women undergoing removal of anti-incontinence mesh were included. Exclusion criteria included any women undergoing simultaneous prolapse mesh removal. We abstracted preoperative and postoperative information from the medical record and compared mesh culture results from patients with and without mesh extrusion, de novo recurrent UTIs, and delayed-onset pain. RESULTS: One hundred seven women with only anti-incontinence mesh removed were included in the analysis. Onset of complications after mesh placement was within the first 6 months in 70 (65%) of 107 and delayed (≥6 months) in 37 (35%) of 107. A positive culture from the explanted mesh was obtained from 82 (77%) of 107 patients, and 40 (37%) of 107 were positive with potential pathogens. There were no significant differences in culture results when comparing patients with delayed-onset versus immediate pain, extrusion with no extrusion, and de novo recurrent UTIs with no infections. CONCLUSIONS: In this large cohort of patients with mesh removed for a diverse array of complications, cultures of the explanted vaginal mesh demonstrate frequent low-density bacterial colonization. We found no differences in culture results from women with delayed-onset pain versus acute pain, vaginal mesh extrusions versus no extrusions, or recurrent UTIs using standard culture methods. Chronic prosthetic infections in other areas of medicine are associated with bacterial biofilms, which are resistant to typical culture techniques. Further studies using culture-independent methods are needed to investigate the potential role of chronic bacterial infections in delayed vaginal mesh complications.

A systematic review of the quality of evidence of ablative therapy for small renal masses.

PURPOSE: We critically assessed the methodological and reporting quality of published studies of ablative techniques for small renal masses. MATERIALS AND METHODS: We performed a systematic PubMed® and EMBASE® literature search from January 1966 to March 2010 to identify all full text, original research publications on ablative therapy for renal masses. Six reviewers working independently in 3 teams performed duplicate data abstraction using Strengthening the Reporting of Observational Studies in Epidemiology criteria, which were pilot tested in a separate sample. RESULTS: A total of 117 original research publications published in a 15-year period (1995 to 2009) met eligibility criteria. No randomized, controlled trials were identified. All studies were observational and 88.9% had 1 arm with no comparison group. Median sample size was 18 patients (IQR 5.5, 40.0) and 53.8% of studies included 20 or fewer patients. Median followup was 14.0 months (IQR 8.0, 23.8) and only 19.7% of studies had an average followup of greater than 24 months. Of the studies 20.5% mentioned the number of operators involved and only 6.0% provided information on their experience level. Of the studies 66.7% addressed the recurrence rate. Disease specific and overall survival was reported in only 15.4% and 16.2% of studies, respectively. CONCLUSIONS: The published literature on the therapeutic efficacy of ablative therapy for renal masses is largely limited to uncontrolled, 1-arm observational studies. In the absence of higher quality evidence ablative therapy outside research studies should be limited to select patients who are not candidates for surgical intervention.

Low quality of evidence for robot-assisted laparoscopic prostatectomy: results of a systematic review of the published literature.

BACKGROUND: Robot-assisted laparoscopic prostatectomy (RALP) is displacing radical retropubic prostatectomy as the gold standard surgical approach for clinically localised prostate cancer in the United States and is also being increasingly used in Europe and other parts of the world. This trend has occurred despite the paucity of high-quality evidence to support its relative superiority to more established treatment modalities. OBJECTIVE: We performed this study to critically assess the quality of published evidence on RALP to support this major shift in practice patterns. DESIGN, SETTING, AND PARTICIPANTS: We conducted a systematic review of the published literature through Medline and Embase (1966 to December 2008). All original research publications on RALP were included. Editorials, letters to the editor, and review articles were excluded. MEASUREMENTS: Two reviewers independently performed the data abstraction using a standardised form derived from the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria. RESULTS AND LIMITATIONS: Seventy-five original research publications met eligibility criteria. Fifty-five (73.3%) studies were published between 2005 and 2008, and 20 studies (26.7%) were published between 2001 and 2004. Approximately three-quarters of the studies were case series (74.7%), and only two (2.7%) randomised, controlled trials (RCT) were identified. Twelve authors cowrote 72% (54 of 75) of the published studies. Reporting of STROBE criteria ranged from 100.0% (scientific rationale/background explained) to 1.3% (consideration of sample size), with no improvement over time. The study was limited to published literature in the English language. CONCLUSIONS: The published RALP literature is limited to observational studies of mostly low methodologic quality. Our findings draw into question to what extent valid conclusions about the relative superiority or equivalence of RALP to other surgical approaches can be drawn and whether published outcomes can be generalised to the broader community. There is an urgent need to raise the methodologic standards for clinical research on new urologic procedures and devices.