Evaluating single-incision slings in female stress urinary incontinence: the usefulness of the CONSORT statement criteria.

OBJECTIVE: To evaluate the usefulness and applicability of the Consolidated Standards of Reporting Trials (CONSORT) for journal articles reporting randomized, controlled trials evaluating single-incision slings in the treatment of female stress urinary incontinence. METHODS: Original articles reporting randomized, controlled trials assessing single-incision slings in the treatment of female stress urinary incontinence were searched for in the PubMed and Embase databases in 2011. Reporting quality was studied by 2 hospital pharmacists and 2 urologic surgeons. Primary outcome was the score out of 20 in the abstract CONSORT checklist. Secondary outcomes were the scores in the standard CONSORT checklist and the extension CONSORT additional items for trials assessing nonpharmacologic treatments. RESULTS: Among 135 articles retrieved, 8 met the inclusion criteria and were assessed. Abstract scores ranged from 4.7-14.1. Standard scores were >10.0 out of 20 for most articles; the extension scores did not exceed 5.0 out of 10. Four reported trials were not identified as randomized in the title. The interventions were incompletely reported. Four articles reported whether blinding was achieved but lack of blinding was never discussed as a potential source of bias. Few articles reported the operators and centers characteristics and their impact on statistical analysis. The combination of the 3 checklists was considered a useful guideline to enhance and assess the reporting quality of a surgical trial. CONCLUSION: Our results support the further use of CONSORT criteria as a basic standardized tool in all stages of clinical evaluation for any prosthetic device in female pelvic surgery.

Fenoterol functionally activates the ß3-adrenoceptor in human urinary bladder, comparison with rat and mouse: implications for drug discovery.

Fenoterol has been reported to be a potent and selective ß(2)-adrenoceptor agonist and is currently used clinically to treat asthma. Electrical field stimulation (EFS) of isolated urinary bladder mimics the voiding contraction by stimulating parasympathetic nerves, resulting in neurogenic contractions. To determine if stimulation of ß(2)-adrenoceptors can inhibit this response, fenoterol was tested against EFS-induced contractions in human isolated urinary bladder and compared with mouse and rat. Bladder strips were mounted in organ baths and reproducible contractions induced by EFS. Fenoterol was added cumulatively in the presence of the ß(2)-adrenoceptor antagonist ICI118551 or the ß(3)-adrenoceptor antagonist L-748337. Fenoterol inhibited neurogenic contractions in all three species in a concentration-dependent manner with pEC(50) values of 6.66 ± 0.11, 6.86 ± 0.06 and 5.71 ± 0.1 in human, mouse and rat respectively. In human bladder strips ICI118551 (100 nM) did not affect responses to fenoterol, while L-748337 (0.3-3 µM) produced rightward shifts of the concentration-response curves with a pA(2) value of 8.10. In mouse bladder strips ICI118551 (30 nM) blocked the inhibitory effect of fenoterol (pA(2)=8.80), while L-748337 (10 µM) inhibited the response with a pA(2) of 5.79. In rat bladder ICI118551 (30 nM) was without effect, while L-748,337 (10 µM) inhibited the response to fenoterol with a pA(2) of 5.40. From these results it is clear that fenoterol potently activates ß(3)-adrenoceptors in human isolated urinary bladder to inhibit EFS-induced contractions. Fenoterol also activates ß(3)-adrenoceptors in rat, but ß(2)-adrenoceptors in mouse bladder to inhibit EFS-induced contractions.