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Abstract Introduction While adjuvant immunotherapy with Bacille Calmette Guérin (BCG) is effective in non-muscle-invasive bladder cancer (BC), adverse events (AEs) are considerable. Monocyte-derived activated killer cells (MAK) are discussed as essential in antitumoural immunoresponse, but their application may imply risks. The present trial compared autologous intravesical macrophage cell therapy (BEXIDEM®) to BCG in patients after transurethral resection (TURB) of BC. Materials and methods This open-label trial included 137 eligible patients with TaG1-3, T1G1-2 plurifocal or unifocal tumours and ≥ 2 occurrences within 24 months and was conducted from June 2004 to March 2007. Median follow-up for patients without recurrence was 12 months. Patients were randomized to BCG or mononuclear cells collected by apheresis after ex vivo cell processing and activation (BEXIDEM). Either arm treatment consisted of 6 weekly instillations and 2 cycles of 3 weekly instillations at months 3 and 6. Toxicity profile (primary endpoint) and prophylactic effects (secondary endpoint) were assessed. Results Patient characteristics were evenly distributed. Of 73 treated with BCG and 64 with BEXIDEM, 85% vs. 45% experienced AEs and 26% vs. 14% serious AEs (SAE), respectively (p < 0.001). Recurrence occurred significantly less frequent with BCG than with BEXIDEM (12% vs. 38%; p < 0.001). Discussion This initial report of autologous intravesical macrophage cell therapy in BC demonstrates BEXIDEM treatment to be safe. Recurrence rates were significantly lower with BCG however. As the efficacy of BEXIDEM remains uncertain, further data, e.g. marker lesions studies, are warranted. Trial registration The trial has been registered in the ISRCTN registry http://isrctn.org under the registration number ISRCTN35881130.

Background: Practice guidelines hardly recommend herbal extracts for male lower urinary tract symptoms (LUTS). However, many patients are unsatisfied with first-line synthetic drugs and often prefer herbal medicines because of good tolerability. To improve the decision-making process, which should consider the patients' expectations, it is crucial to reflect on the role of phytotherapy in the treatment of LUTS. We (panel experts) reflected on current guideline recommendations and real practice across various European countries and debated the potential role of plant extracts with a focus on pumpkin seed soft extract investigated over 12 months in two randomised placebo-controlled trials. Summary: Most guidelines give no clear recommendations on phytotherapy due to the heterogeneity of clinically investigated extracts. Nevertheless, plant extracts are prescribed to patients with mild-to-moderate LUTS. Also, self-medicating patients often handle their complaints with herbal products. Many patients aim to avoid synthetic drugs for fear of sexual functional side effects and a negative impact on their quality of life. For the elderly, vasoactive comedications might become an issue. When taking plant extracts, patients experience an acceptable symptomatic relief similar to that achieved with synthetics but without side effects. Key Messages: In shared decision-making for purely symptomatic treatment, a low risk of side effects takes priority. We propose to consider patient preferences in the treatment of mild-to-moderate LUTS in men with a low risk of disease progression. We found a consensus that pumpkin seed soft extract adds to the therapeutic armamentarium for patients who cannot or do not want to apply synthetic drugs. [ABSTRACT FROM AUTHOR]

Objective: To investigate the safety and efficacy of a special terpene combination in the treatment of patients with urolithiasis after extracorporeal shockwave lithotripsy (ESWL). Patients and Methods: 222 patients with clinically stable kidney or ureter stones of 0.3-2.0 cm undergoing complication-free ESWL were randomised to receive a special terpene combination (Rowatinex®; 3 × 2 capsules/day) or placebo. The study consisted of a 12-week active treatment phase and a 2-week follow-up phase. All patients had a physical examination, and diagnosis of kidney stones was made by X-ray, intravenous pyelogram or ultrasound at weeks 1, 4, 8 and 12 as well as after 2 weeks of follow-up. Stone-free status was defined as obviously successful expulsion of calculi/fragments, being without any stone. Results: In all, when compared to placebo, significantly more patients receiving the terpene combination treatment in the intent-to-treat (ITT) group [72 (67.9%) vs. 49 (50.0%); p = 0.0009] and the per-protocol (PP) group [69 (78.4%) vs. 48 (52.2%); p = 0.0004] were stone-free at the end of the study. Treatment with the terpene combination was also more effective when analysed with respect to the size of the treated stone. In addition, treatment with the terpene combination significantly reduced the median time to stone-free status from 85.0 to 56.0 days (p = 0.0061) and from 85.0 to 49.5 days (p = 0.0028) in the ITT and PP populations, respectively. Nine mild-to-moderate adverse events (AE; terpene combination group: 7 AE in 4 patients; placebo group: 2 AE in 2 patients) were assessed as drug-related. Conclusions: Treatment with the terpene combination is well tolerated and safe. The terpene combination was found to be an efficacious treatment in eliminating calculi fragments generated by ESWL as compared to placebo. The pharmacodynamic properties of the terpene combination (antilithogenic, antibacterial, antiinflammatory, spasmolytic and analgesic effects), which have been also confirmed in preclinical studies, represent a valuable alternative to the different drugs used in the treatment of urolithiasis. Copyright © 2010 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Abstract: Background: Extracorporeal shockwave lithotripsy (ESWL) is the first-choice treatment for most renal stones. Rowatinex®, a special terpene combination, has been used therapeutically in the supportive treatment of urolithiasis and for assistance in the expulsion of stones of the renal system for many years. Objective: The aim of the study was to investigate the safety and efficacy of Rowatinex® in the treatment of patients with urolithiasis after ESWL. Design, setting, and participants: In a randomized, double-blinded, placebo-controlled, multicenter trial, 222 patients with clinically unapparent kidney or ureter stones who had undergone complication-free ESWL were included between June 2003 and December 2006. The study consisted of a 12-wk active treatment phase and a 2-wk follow-up phase. All patients underwent physical examination, and diagnosis of kidney stones was made by x-ray, intravenous pyelogram (IVP), or ultrasound at weeks 1, 4, 8, and 12 as well as after 2 wk of follow-up. Intervention: Patients were randomized to receive either 3×2 Rowatinex® capsules per day or placebo. Measurements: The primary end point was the rate of stone-free patients (without any fragments) after 12 wk of treatment. Results and limitations: Significantly more patients treated with the terpene combination were stone free at the end of the study compared to placebo (intention-to-treat [ITT]—verum vs placebo: 72 patients [67.9%] vs 49 patients [50.0%]; p =0.0009; per-protocol [PP]—verum vs placebo: 69 patients [78.4%] vs 48 patients [52.2%]; p =0.0004). The treatment was even more effective when analyzed with respect to the size of the treated stone. In addition, the terpene combination treatment significantly reduced the median time to stone-free status (ITT—placebo vs verum: 85.0 d vs 56.0 d; p =0.0061; PP—placebo vs verum: 85.0 d vs. 49.5 d; p =0.0028). Tolerability was excellent. Conclusions: The terpene combination Rowatinex® was found to be an efficacious, well-tolerated, and safe treatment for eliminating calculi fragments generated by ESWL compared to placebo. [Copyright &y& Elsevier]

Introduction: While adjuvant immunotherapy with Bacille Calmette Guérin (BCG) is effective in non-muscle-invasive bladder cancer (BC), adverse events (AEs) are considerable. Monocyte-derived activated killer cells (MAK) are discussed as essential in antitumoural immunoresponse, but their application may imply risks. The present trial compared autologous intravesical macrophage cell therapy (BEXIDEM®) to BCG in patients after transurethral resection (TURB) of BC. Materials and methods: This open-label trial included 137 eligible patients with TaG1-3, T1G1-2 plurifocal or unifocal tumours and = 2 occurrences within 24 months and was conducted from June 2004 to March 2007. Median follow-up for patients without recurrence was 12 months. Patients were randomized to BCG or mononuclear cells collected by apheresis after ex vivo cell processing and activation (BEXIDEM). Either arm treatment consisted of 6 weekly instillations and 2 cycles of 3 weekly instillations at months 3 and 6. Toxicity profile (primary endpoint) and prophylactic effects (secondary endpoint) were assessed. Results: Patient characteristics were evenly distributed. Of 73 treated with BCG and 64 with BEXIDEM, 85% vs. 45% experienced AEs and 26% vs. 14% serious AEs (SAE), respectively (p < 0.001). Recurrence occurred significantly less frequent with BCG than with BEXIDEM (12% vs. 38%; p < 0.001). Discussion: This initial report of autologous intravesical macrophage cell therapy in BC demonstrates BEXIDEM treatment to be safe. Recurrence rates were significantly lower with BCG however. As the efficacy of BEXIDEM remains uncertain, further data, e.g. marker lesions studies, are warranted. Trial registration: The trial has been registered in the ISRCTN registry http://isrctn.org under the registration number ISRCTN35881130. [ABSTRACT FROM AUTHOR]

Introduction: Our aim was to identify the independent risk factors associated with urinary incontinence after radical retropubic prostatectomy (RRP). Materials and Methods: Using univariate and multivariate analyses, we examined several pre- and perioperative factors. One hundred and sixty-six patients were divided into three groups: patients who were immediately continent after catheter removal (group I), patients who became continent later (group II) and incontinent patients (group III). Results: There were 34 patients (20.5%) in group I, 111 (66.9%) in group II, and 21 (12.6%) in group III. The multivariate analysis between the continent and incontinent patients proved that the postoperatively measured total length of the posterior urethra (strongly associated with length of the sphincter, length of the urethral stump and the presence of anastomotic stricture) was the independent risk factor for permanent incontinence or delayed continence following RRP. The age of patients per se represented a risk factor only for delayed continence, but not for permanent incontinence. Conclusions: Postoperatively measured shorter posterior urethral length results in an increased risk of urinary incontinence and delays continence after RRP. It seems that older age only delays reaching continence. Copyright © 2007 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

The authors present the case of a 52-year-old man who had recurring scrotal abscesses resulting in oncotomy being carried out seven times within 2 years. Eventually, it was dissected out totally. Histology proved anaplastic cancer metastasis. The primary tumor was detected in the bronchia; moreover, metastases were found in other organs as well. The patient died 6 weeks after the first diagnosis. We intended to draw attention to frequently occurring scrotal inflammation and thus the underlying diseases. We emphasize the importance of histology examinations. Copyright © 2009 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]