Long-term use of tamsulosin to treat lower urinary tract symptoms/benign prostatic hyperplasia.

PURPOSE: The long-term efficacy and safety of 0.4 mg. tamsulosin once daily were assessed in patients with lower urinary tract symptoms/benign prostatic hyperplasia treated for up to 4 years. MATERIALS AND METHODS: A total of 516 patients were enrolled from 2 European open label studies that were extensions of 3 double-blind controlled studies. RESULTS: Significant improvement in maximum urine flow and total Boyarsky symptom score during the controlled trials was sustained throughout the extension study for up to 4 years in patients who remained on therapy. The increase in mean maximum urine flow from baseline was 1.2 to 2.2 ml. per second (p <0.001) and it remained 11.5 to 12 ml. per second during followup. Total Boyarsky symptom score was decreased from baseline by 4.1 to 4.7 points (p <0.001). The incidence of treatment responders, defined as a 25% or greater decrease in total symptom score, remained stable throughout the 4-year period. Increasing the dose of tamsulosin from 0.4 to 0.8 mg. seemed to have no substantial additional benefit. During the 4 years of treatment 26% of patients had side effects that were considered possibly or probably drug related. However, only 5% of patients discontinued treatment because of drug related side effects. No clinically significant changes in blood pressure or pulse rate occurred during the study. CONCLUSIONS: Long-term treatment with tamsulosin is safe and well tolerated in patients with lower urinary tract symptoms/benign prostatic hyperplasia. Improved efficacy was sustained during 4 years of followup.

Results of a European comparative randomized study comparing oral bropirimine versus intravesical BCG treatment in BCG-naive patients with carcinoma in situ of the urinary bladder. European Bropirimine Study Group.

OBJECTIVES: This European phase III clinical trial was part of an intercontinental study which was closed prematurely by the sponsor. The study was designed to compare the effects of oral bropirimine with intravesical BCG, the current standard treatment in patients with newly diagnosed bladder carcinoma in situ (CIS). METHODS: A total of 55 BCG-naive patients with bladder CIS were randomized to receive bropirimine (n = 27) or BCG (n = 28). Bropirimine was orally administered at a dose of 3 g/day for 3 consecutive days with a 4-day drug-free interval for up to 1 year. BCG-Tice instillations were administered weekly for 2 x 6 weeks. Both biopsies and cytology had to be negative for the patient to be considered a complete responder (CR). RESULTS: The percentage of dropouts for all of the adverse events was 4% for bropirimine and 14% for BCG. The most frequently reported local events in the bropirimine- versus the BCG-treated group were irritative complaints, 64 vs. 89% (p = 0.03) and hematuria, 24 vs. 61% (p < 0.01). The most frequently reported systemic events in the bropirimine- versus the BCG-treated group were fever 4 vs. 21%, flu syndrome 24 vs. 7%, headache 28 vs. 11% and nausea 24 vs. 11% (all p > 0.05). A total of 92% of the patients treated with bropirimine had a CR with a mean duration of 12.6 months (95% CI 9.2-15.9). In the BCG group, all of the patients had a CR with a mean of 12.3 months (95% CI 8.5-16.0). CONCLUSIONS: This study shows that bropirimine, an orally administered drug that can be self-administered to outpatients with more acceptable local toxicity compared to BCG, could be an effective first-line therapy in patients with CIS of the urinary bladder. Continued investigation of bropirimine is warranted to increase its clinical utility.

Tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist. A meta-analysis of two randomized, placebo-controlled, multicentre studies in patients with benign prostatic obstruction (symptomatic BPH). European Tamsulosin Study Group.

OBJECTIVE: This meta-analysis of two European studies evaluated the efficacy and safety of modified-release tamsulosin 0.4 mg once daily compared with placebo in patients with benign prostatic enlargement, lower urinary tract symptoms and prostatic obstruction (symptomatic BPH). METHODS: Patients entered a 2-week placebo run-in period, followed by randomization to treatment with tamsulosin (382 patients) or placebo (193 patients) once daily for 12 weeks. RESULTS: Maximum urinary flow rate improved to a greater extent in the tamsulosin group (1.6 ml/s, 16%) than the placebo group (0.6 ml/s, 6%) (p = 0.002). Total Boyarsky symptom score also improved to a greater extent in the tamsulosin group (3.3 points, 35.1% reduction) than the placebo group (2.4 points, 25.5% reduction) (p = 0.002). Significantly more tamsulosin patients (66%) than placebo patients (49%) had a > or = 25% decrease in total symptom score at endpoint (p < 0.001). Twelve weeks of treatment with tamsulosin also produced significant improvements in average urinary flow rate (p = 0.005) and voiding or "obstructive" (p = 0.008) and storage or "irritative' (p = 0.017) symptom scores. The incidence of drug-related adverse events was comparable for the tamsulosin and placebo groups (13 and 12% respectively, p = 0.802). The same applies to the incidence of adverse events commonly attributed to alpha 1-adrenoceptor antagonists, such as dizziness, headache, postural hypotension, syncope, asthenia, somnolence and rhinitis. There were no clinically significant changes in blood pressure or pulse rate in tamsulosin patients compared with placebo patients both in hypertensive and normotensive BPH patients. CONCLUSION: Tamsulosin 0.4 mg once daily is safe, well-tolerated and improves both the symptoms and urinary flow rate in patients with benign prostatic obstruction (symptomatic BPH).

[Microsurgical, neuroprotective plaque isolation in plastic penile induration]. / Mikrochirurgische, neuroprotektive Plaqueisolation bei Induratio penis plastica.

Conservative therapy of Peyronie's disease has not given very encouraging results. This means operative treatment strategies are the only effective therapy form that appears to be successful. Another treatment form, which often leads to a non-acceptable shorting of the penis, is the technique used in the Schröder-Essed and Nesbit procedures. Removal of the plaque, followed by a tissue transplant to cover the excision area, enables a correction of the deviation and maintenance of the original length of the penis. Because of the periodically described, possibly fatal results of postoperative perception disorders of the glans penis, preparation of the dorsal neurovascular bundle is performed under microsurgical conditions. Because of the certainty with which optical identification of nerves and vessels is achieved, it is possible to keep the nerves protected and to have atraumatic isolation of the plaque. After the first encouraging surgical results, we present the operative procedure under microsurgical conditions.

[Long-term follow-up of nephrectomy for hypernephroma in 442 patients]. / Analyse der Langzeitergebnisse nach Nephrektomie wegen Hypernephrom anhand von 442 Fällen.

The long-term-results of 442 patients with nephrectomy because of hypernephroma are analysed with regard to preoperative findings, surgical technique and postoperative therapy. Until 1971 conventional nephrectomy was performed, since then a modification with a long incision carried medially and "blind" manual preparation of the renal pedicle has been performed. This led to better long-term-results. A table of preoperative findings of all patients who survived more than 5 years or less the 6 months respectively may predict the prognosis of the individual patient. In our series postoperative radiotherapy shows very poor results and will be abandoned. The negative influence on the immuno resistance may be one reason for this.

[Experience with tumors in solitary kidneys without hypothermia nor extracorporal surgery (author's transl)]. / Erfahrungen mit Tumoren in Einzelnieren - ohne Hypothermie und extracorporale Chirurgie.

Our experience with carcinoma in solitary kidney is presented. We prefer the enucleation of the tumor or the partial resection of the kidney in normothermic ischemia. Two patients underwent total nephrectomy and hemodialysis. 5 patients with carcinoma in a solitary kidney survived an average of 20 months (max. 6 years), 5 patients died on an average of 21 months (1 week - 5 1/2 years). 2 out of 5 patients with simultaneous bilateral kidney tumors died 1 and 33 months after the operation, the 3 others survived 2-44 months till now. Enucleation and partial resection as therapy for tumors in solitary kidney can be recommended. The results are good concerning survival and renal function. The histology of bilateral kidney-tumors (consecutive or simultaneous) shows the criteria of primary carcinoma.

[Complete subpelvine rupture of ureter as the only sequela of a trauma (case report and references) (author's transl)]. / Subpelvine komplette Ureterruptur als alleinige Unfallfolge (Kasuistik und Literaturübersicht).

A complete subpelvine rupture of the right ureter of a nine year old girl is presented. After a short review of literature, the mechanism of the trauma and the resulting facts of this rare injury are being discussed. The excretion urography is the most important part of diagnosis. With early detection of the lesion, a restoration by different operative procedures is possible.

[A simple apparatus to facilitate epididymectomy (author's transl)]. / Durchleuchtungsteller zur Vereinfachung der Epididymektomie.

A simple apparatus is introduced which facilitates the preparation of testicular vessels in epididymectomy using diaphania. The applicability of this apparatus is being tested in other fields of surgery.

[Results of pyeloplasty in children (author's transl)]. / Ergebnisse der Nierenbeckenplastik beim Kind.

The results of 47 surgically corrected cases of stenosis of the pyelo-ureteral junction in children are presented. The method of Anderson-Hynes is preferred because of the removal of the functionally and morphologically damaged ureter-segment. In 80% of the cases the postoperative x-ray demonstrated a good result. Some of the other patients required a secondary nephrectomy. In 10 patients the technique of Culp-de Weerd was used. Six patients showed good results. Postoperatively the urine was sterile in 2/3 of the examined children. In some of the patients the postoperative follow-up was insufficient Etiology. Diagnostic procedure and indication for surgery are discussed.

[Operative correction of primary megaureter in children (author's transl)]. / Operative Korrektur des primären Megaureters beim Kind.

Sixty-seven children with congenital megaureter were treated by surgically. Nephroureterectomy was performed in 12 cases (17.9%). Fifty-five children were selected for surgical correction. In 23 patients, a bilateral ureteroneocystostomy with submucosal tunneling was performed. These latter patients were examined in the postoperative period for the following criteria: unobstructed flow urine, improved or stable renal function and absence of infection, 69.23% of these patients met these criteria. Because the primary goal is conservation of the kidney the indication for surgical correction is quite liberal. Thirty percent were failures partially due to previous surgery. The need for detailed preoperative study and long-term follow-up is stressed.

[In vitro perfusion of so-called endoprothesis. An experimental study of incrustations on internal splinting plastic tubes (author's transl)]. / In vitro Urin--Perfusion von Endoprothesen. Eine Studie zu Inkrustationstendenzen in Kunststoffschläuchen.

We have used the method of internal splinting of the ureter (endoprothesis) for the past ten years. Because we observed partial obstruction of the lumen by incrustations and/or fibrin coagula in cases in which the splints had been in place for long periods, we conducted in vitro experiments into the problem. Under constant and variable conditions, urine was perfused through plastic tubes of different materials. Organic and inorganic urine substances and urine pH were analyzed. The materials used were examined with special scanning electron microscopic techniques, and various depositions, especially in comparisons of in vivo and in vitro conditions, were found.

[Ureterlesion in laparoscopic sterilisation of the Fallopian tube (author's transl)]. / Harnleiterläsion bei laparoskopischer Tubensterilisation.

A case of severe ureterlesion following sterilisation of the Fallopian tube is presented. Since 28 days elapsed before operative relief of the kidney was attempted reconstructive surgery of the ureter at a later date proved to be unsuccessful. A secondary nephrectomy had to be performed.

PIP: A 36-year-old woman who underwent laparoscopic electrocoagulation of the Fallopian tubes developed a urethral-intestinal fistula affecting the right kidney. The condition was not diagnosed until 28 days after the operation. Reconstructive surgery was performed but was unsuccessful; 4-1/2 months later a nephrectomy was performed.

[Treatment of renal hypertension by nephrectomy in persons over 40 years of age]. / Nephrektomie bei einseitig renalbedingter Hypertonie im höheren Lebensalter

42 patients aged over 40 years at the time of nephrectomy (between 1961 and 1972) for unilateral renal disease and arterial hypertension were re-investigated. The WHO criteria for normotensive and hypertensive blood pressure levels were used. Systolic and diastolic pressures returned to normal after nephrectomy in 15 patients, systolic pressure alone in nine. Systolic and diastolic pressures remained unchanged in twelve. When grouped by histological criteria, only patients with small pyelonephritis kidney improved significantly, while those with pyelonephritis, arteriolosclerosis and renal-artery stenosis did not. It is concluded that patients aged over 40 years who have hypertension associated with unilateral renal disease may benefit from nephrectomy, especially if they have a small pyelonephritic kidney.

[An enzymatic method for the isolation of tubules and cells from human kidney cortex]. / Eine enzymatische Methode zur Isolierung von Tubuli und Zellen aus menschlicher Nierenrinde

The isolation of tubules and cells from human kidney cortex was realized by an enzymatic method. Tubules and cells were released from slices of kidney cortex by collagenase. The yield amounted to 80 % of the wet weight of incubated cortex slices. Thus numerous experiments with isolated tubules from one organ could be performed. Glucose production from different substrates was measured in order to test the biochemical integrity of the isolated cells. The highest rates of glucose formation were obtained with fructose as precursor. Glucose production was higher from lactate than from pyruvate. With proline and glutamine as substrates only small amounts of glucose were produced. Glucose formation from 10 mmol/1 pyruvate was linear with time up to 80 minutes. Ado-3':5'-P stimulated glucose formation at 10 mumolar concentration and inhibited gluconeogenesis at 1 mmolar, 0.1 mmolar and 1 mumolar concentrations.