[Combination of Sabal and Urtica extract vs. finasteride in benign prostatic hyperplasia (Aiken stages I to II). Comparison of therapeutic effectiveness in a one year double-blind study]. / Kombination aus Sabal- und Urticaextrakt vs. Finasterid bei BPH (Stad. I bis II nach Aiken). Vergleich der therapeutischen Wirksamkeit in einer einjährigen Doppelblindstudie.

Therapeutic equivalence should be demonstrated in a randomised, reference-controlled multicentric double blind clinical trial with PRO 160/120, a combination of Sabal- and Urtica-Extract, and Finasteride, respectively, in patients suffering from benign prostatic hyperplasia (BPH, Stage I to II according to Aiken). The study involved 543 patients, who were treated for 48 weeks with two capsules of PRO 160/120 or one capsule of Finasteride per day, in a double dummy design. Primary variable was the change of the maximum urinary flow after 24 weeks of therapy in comparison to therapy start. As secondary variables urodynamic parameters such as average urinary flow, miction volume and miction time were monitored. Urinary symptoms were recorded by the International-Prostate-Symptom-Score (I-PSS, Paris 1993). Additionally, the impacts of the symptoms on quality of life had been assessed by a quality of life questionnaire according to The American Urological Association Measurement Committee (1991). An increase of the urinary flow rate could be observed in both treatment groups (1.9 ml/s with PRO 160/ 120; 2.4 ml/s with Finasteride). During the trial, the average urinary flow increased, whereas the miction time decreased in both groups in a similar extent. The miction volume did not show any relevant differences after treatment with either PRO 160/120 or Finasteride. The I-PSS decreased from 11.3 at the therapy start to 8.2 after 24 weeks and 6.5 (week 48) under PRO 160/120 and from 11.8 to 8.0 and 6.2, under Finasteride, respectively. Accordingly, life quality improved between therapy start and therapy end from 7.5 to 4.3 with PRO 160/120 and from 7.7 to 4.1 with Finasteride. In terms of safety aspects less adverse events occurred with the Sabal/Urtica-Extract as with Finasteride. Especially less cases of diminished ejaculation volume, erectile dysfunction and headache have been reported.

Combined sabal and urtica extract compared with finasteride in men with benign prostatic hyperplasia: analysis of prostate volume and therapeutic outcome.

OBJECTIVE: To test the hypothesis that in patients with benign prostatic hyperplasia (BPH), the outcome of drug therapy with finasteride may be predictable from the baseline prostate volume and that positive clinical effects might be expected only in patients with prostate volumes of > 40 mL, using a subgroup analysis of results from a previously reported clinical trial of finasteride and phytotherapy. PATIENTS AND METHODS: A subgroup of 431 patients was analysed from a randomized, multicentre, double-blind clinical trial involving 543 patients with the early stages of BPH. Patients received a fixed combination of extracts of saw palmetto fruit (Serenoa repens) and nettle root (Urtica dioica) (PRO 160/120) or the synthetic 5alpha-reductase inhibitor finasteride. The patients assessed had valid ultrasonographic measurements and baseline prostate volumes of either 40 mL. All 516 patients were included in the safety analysis. The results of the original trial showed equivalent efficacy for both treatments. RESULTS: The mean (SD) maximum urinary flow (the main outcome variable) increased (from baseline values) after 24 weeks by 1.9 (5.6) mL/s with PRO 160/120 and by 2.4 (6.3) mL/s with finasteride. There were no statistically significant group differences (P = 0.52). The subgroups with small prostates ( 40 mL were similar, at 2.3 (6.1) and 2. 2 (5.3) mL/s, respectively. There were improvements in the International Prostate Symptom Score in both treatment groups, with no statistically significant differences. The subgroup analysis showed slightly better results for voiding symptoms in the patients with prostates of > 40 mL, but there were also improvements in the subgroup with smaller prostates. The safety analysis showed that more patients in the finasteride group reported adverse events and also there were more adverse events in this group than in patients treated with PRO 160/120. CONCLUSION: The present analysis showed that the efficacy of both PRO 160/120 and finasteride was equivalent and unrelated to prostate volume. However, PRO 160/120 had better tolerability than finasteride.

Electromyographical study on surgeons in urology. I. Influence of the operating technique on muscular strain.

An electromyographical field study was performed in the operating theatre on four surgeons during 15 urological operations. In the course of the operations two endoscopic techniques were applied alternately: (1) direct endoscopy, and (2) monitor endoscopy. During direct endoscopy the surgeon looks into the urethra and the bladder via an endoscope. In monitor endoscopy, by contrast, the operating area is observed via a video system consisting of a camera mounted on top of the endoscope and a monitor. During the operations surface electromyograms were derived from both trapezius muscles, the right deltoideus muscle and the left erector spinae muscle. An activity code describing the surgeons' activity was additionally recorded. Analysis of the activity recording reveals that the monitor endoscopic method is preferred in the first third of the operations, whereas preference is given to the direct method in the last third. The electromyographical measurements indicate that during monitor endoscopy the myoelectrical activity of both trapezius muscles and of the right deltoideus muscle is significantly reduced in comparison with the activity for the direct endoscopic technique. A significant influence of the surgical technique on the myoelectrical activity could not be established for the erector spinae muscle. The electromyographical findings reveal that the activity of the shoulder musculature required for the maintenance of the posture and the performance of the operation is significantly lower in monitor endoscopy than in direct endoscopy. Consequently, a clear reduction in muscular strain can be achieved during the performance of endoscopic operations in urology if a video system is employed.

Muscular strain and fatigue among urologists during transurethral resections using direct and monitor endoscopy.

OBJECTIVES: The aims of the study were to analyze muscular strain and fatigue of urologists during the performance of transurethral resections using direct and video endoscopy and to reduce the muscular effort by an ergonomic arrangement of the operation equipment. METHODS: The study was performed before, during and after the introduction of a video-guided resection method. Muscular strain and fatigue were studied by means of surface electromyograms derived from various shoulder and back muscles of surgeons. RESULTS: During direct endoscopy, muscular strain was found to be significantly higher for the shoulder muscles than during monitor endoscopy. The occurrence of muscular fatigue was established for at least one of the muscles under test in all operations during the application of direct endoscopy. A routine use of the video method was facilitated by arranging the operation equipment according to ergonomic principles. This results in a reduction in muscular fatigue, in particular for the trapezius muscle. For this muscle the number of operations accompanied with fatigue was lowered from about 80% before redesign to about 42% after redesign. CONCLUSION: Muscular strain and fatigue of urologists occurring during transurethral resections is reduced by applying video endoscopy instead of using direct endoscopy. The routine use of the video method requires an ergonomic arrangement of the operation equipment.

Electromyographical study on surgeons in urology. II. Determination of muscular fatigue.

An electromyographical fatigue analysis was performed in the operating theatre on four surgeons during 14 urological operations in which 'direct endoscopy' (cf. Luttmann et al. 1996, Part I) was applied. Surface electromyograms (EMG) were derived from the m. trapezius on both sides of the body, the right m. deltoideus, and the left m. erector spinae. The surgeons' activities were documented by simultaneously recording an electrical activity code signal parallel to the EMGs. The electrical activity (EA) was formed from the raw EMG by rectification and continuous averaging. For purposes of spectral analysis, the EMGs were digitized and converted to the frequency domain by Fast Fourier Transformation. During the performance of endoscopic surgery, an increase in EA, as well as a spectral shift towards lower frequencies, are observed for at least one of the muscles under test in all of the operations. This indicates the development of muscular fatigue in the course of the operations. The finding is confirmed by applying a newly developed method for the joint analysis of the spectrum and the amplitude of EMGs (JASA) which permits discrimination between fatigue-induced and force-related changes in the EMG. Utilizing this method, the development of fatigue was confirmed for 11 of the 14 operations in the case of the right m. trapezius. The right trapezius muscle therefore constitutes a bottleneck for the performance of the operations. The endurance time was estimated from the increase in EA and compared with the actual duration of the operations. Since both are of the same order of magnitude, it is concluded that the final part of an operation has to be performed when the muscles are already fatigued. Application of the newly available method known as 'monitor endoscopy' (cf. Part I) can lead to a reduction in muscular strain and fatigue. This, in turn, will enable operations to be performed at less risk to the patient.

Interferons modify in vitro proliferation of human bladder transitional cell carcinoma in the presence of doxorubicin and mitomycin C.

PURPOSE: The aim of the present study was to investigate whether interferons with their known antitumor activity modify the response of human bladder carcinoma cells to antitumor drugs. MATERIALS AND METHODS: We investigated the in vitro effect of doxorubicin, mitomycin C and the interferons alpha and gamma on cell proliferation in human bladder carcinoma cell lines as measured by 5-bromo-2'-deoxy-uridine (BrdU) incorporation. RESULTS: Exposure of RT 112 (but not EJ 28) cells for 2 hours to doxorubicin (500 ng./ml.) and mitomycin C (200 ng./ml.) reduced the proliferation rate to 85.9 +/- 3.3% (n = 4) and 89.3 +/- 4.0% (n = 4) of control. Treatment for 2 days with interferon alpha and gamma up to the highest concentration (200 U/ml.) showed no effect. The combination of 100 U/ml. interferon alpha and doxorubicin decreased proliferation significantly. At 50 ng./ml. the proliferation rate was decreased to 88.0 +/- 5.7% of control and at 500 ng./ml. to 67.7 +/- 3.1%. Thus interferon alpha seems to increase the sensitivity of the cells to doxorubicin. Cells treated with 20 ng./ml. mitomycin C after pretreatment with interferon alpha showed a dramatic decrease in cell proliferation (from 98.8 +/- 2.1% to 80.2 +/- 4.0% of control). This decrease was similar in the presence of 200 ng./ml. mitomycin C. Thus mitomycin C seems to render cells more sensitive to the antiproliferative action of interferon alpha. Interferon gamma had only minor effects on the response of the cells to doxorubicin or mitomycin C. CONCLUSIONS: These studies suggest that exposure to interferon alpha increases the efficacy of anticancer drugs in vitro, probably by several mechanisms. Potential consequences of this finding for the therapeutic regime employed for treatment of bladder carcinoma are discussed.

[Parasympathicolytic treatment of abnormal neurogenic bladder function: a urodynamic study (author's transl)]. / Parasympathikolytische Therapie neurogener Blasenfunktionsstörungen. Urodynamische Untersuchungen.

The effect of two parasympatholytic drugs, trospium chloride and hyoscine-N-butylbromide, was studied by urodynamic tests in 20 patients with spastic neurogenic bladder function. After intravenous injection of 0.6 mg trospium chloride or 60 mg hyoscine-N-butyl bromide bladder capacity increased significantly, while the degree of spasm and the response in the ice water test decreased significantly. Maximal sphincter pressure, resting bladder pressure, maximal bladder filling pressure and abdominal pressure remained unchanged.