A Novel Incisionless Disposable Vaginal Device for Female Stress Urinary Incontinence: Efficacy and Quality of Life

Purpose This clinical study sought to evaluate the possible clinical effectiveness and practicality of URINO, an innovative, incisionless, and disposable intravaginal device, designed for patients suffering from stress urinary incontinence. Methods A prospective, multicenter, single-arm clinical trial was carried out, involving women diagnosed with stress urinary incontinence who used a self-inserted, disposable intravaginal pessary device. Comparisons were made between the results of the 20-minute pad-weight gain (PWG) test at baseline and visit 3, where the device was applied. After 1 week of device usage, compliance, satisfaction, the sensation of a foreign body, and adverse events were assessed. Results Out of 45 participants, 39 completed the trial and expressed satisfaction within the modified intention-to-treat group. The average 20-minute PWG of participants was 17.2±33.6 g at baseline and significantly dropped to 5.3±16.2 g at visit 3 with device application. A total of 87.2% of participants exhibited a reduction ratio of PWG by 50% or more, surpassing the clinical trial success benchmark of 76%. The mean compliance was recorded as 76.6%±26.6%, the average visual analogue scale score for patient satisfaction was 6.4±2.6, and the sensation of a foreign body, measured on a 5-point Likert scale, was 3.1±1.2 after 1 week of device use. No serious adverse events were reported; there was 1 instance of microscopic hematuria and 2 cases of pyuria, all of which recovered. Conclusions The investigated device demonstrated significant clinical effectiveness and safety for patients with stress urinary incontinence. It was easy to use, showing favorable patient compliance. We propose that these disposable intravaginal pessaries could potentially be an alternative treatment for patients with stress urinary incontinence who are seeking nonsurgical options or are unable to undergo surgery. Trial Registration The study was registered as a clinical trial (KCT0008369)

Increased Expression of Neuregulin 1 and erbB2 Tyrosine Kinase in the Bladder of Rats With Cyclophosphamide-Induced Interstitial Cystitis

Purpose: The aim of this study was to evaluate changes in expressions of neuregulin (NRG)1 and erbB2 tyrosine kinase (ErbB2) in bladders of rats with cyclophosphamide (CYP)-induced interstitial cystitis (IC). Methods: Twenty-four Sprague-Dawley rats were divided into the IC group (n=16) and the control group (n=8). After inducing IC with intraperitoneal CYP injection, expressions of NRG1 and ErbB2 were analyzed using western blotting and reverse transcriptase-polymerase chain reaction. Results: In Western blotting, relative intensities and distributions of both NRG1 and ErbB2 were approximately 1.5- and 3.2-fold higher, respectively, in the IC group than in the control group (mean±standard deviation: 1.42±0.09 vs. 0.93±0.15 and 0.93±0.16 vs. 0.29±0.08, P<0.05). In the rat bladder samples, mRNA expression levels of NRG1 and ErbB2 were higher in the IC group than in the control group (P<0.05). Conclusions: Our study has demonstrated significant changes in mRNA expression and immunoreactivity of NRG1 and ErbB2 receptors in the urinary bladder after CYP-induced IC. These results suggest that the up-regulated NRG1 may play a role in inducing an overactive bladder and promoting regeneration in the inflammatory bladder with CYP-induced IC

Is endoscopic resection an alternative to surgery for early low-risk submucosal gastric cancers: analysis of a large surgical database

Background: Although endoscopic resection (ER) for early gastric cancers (EGCs) has become popular with the development of endoscopic instruments and skillful endoscopists, the risk of lymph node metastasis (LNM) is still an obstacle in performing ER. In this study, we aimed to identify the risk factors of LNM and validated the expanded criteria, with the goal of suggesting modified criteria for ER in submucosal EGCs. Methods: Of patients who underwent gastrectomy with LN dissection and were diagnosed as EGCs with depth of invasion such as sm1, sm2 or ≤500 μm from 1999 to 2008, 318 EGCs with submucosal invasion ≤500 μm were enrolled through pathologic evaluations. To identify the risk factors of LNM, a multivariate analysis of clinicopathologic factors was performed. By combining the independent risk factors of LNM, the risk of LNM was analyzed. Result: LNM were detected in 35 cases (11.0 %). Tumors >30 mm in size and with lymphatic invasion were identified as an independent risk factor for LNM in EGCs with depth of invasion ≤500 μm. Among 94 cases meeting the expanded criteria, two cases (2.1 %) were found to have LNM. Based on the submucosal invasion <300 μm, there was no LNM in EGCs with a size ≤30 mm and no lymphovascular invasion, regardless of differentiation grade. Conclusion: To exclude the possibility of LNM, applying the modified criteria based on the submucosal invasion <300 μm in performing ER might be worthwhile