FLOMAX - GENERIC
Generic name: tamsulosin

Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):164-9.
Prophylactic tamsulosin (Flomax) in patients undergoing prostate (125)I brachytherapy for prostate carcinoma: Final report of a double-blind placebo-controlled randomized study.
Elshaikh MA, Ulchaker JC, Reddy CA, Angermeier KW, Klein EA, Chehade N, Altman A, Ciezki JP.
Department of Radiation Oncology, Cleveland Clinic Foundation, Cleveland, OH, USA.

Purpose: To evaluate the effectiveness of prophylactic tamsulosin (Flomax) in reducing the urinary symptoms in patients undergoing (125)I prostate implantation (PI) for prostate adenocarcinoma. Methods and materials: This is a single-institution, double-blind, placebo-controlled, randomized trial for patients undergoing PI for prostate adenocarcinoma comparing prophylactic tamsulosin versus placebo. Eligibility criteria included patients not taking tamsulosin or other alpha-blockers treated with PI. The patients were randomly assigned to either tamsulosin (0.8 mg, orally once a day) or matched placebo. All patients started the medication 4 days before PI and continued for 60 days. The American Urologic Association (AUA) symptom index questionnaire was used to assess urinary symptoms. The AUA questionnaire was administered before PI for a baseline score and weekly for 8 weeks after PI. Patients were taken off the study if they developed urinary retention, had intolerable urinary symptoms, or wished to discontinue with the trial. Results: One hundred twenty-six patients were enrolled in this study from November 2001 to January 2003 (118 were evaluable: 58 in the tamsulosin arm and 60 in the placebo group). Pretreatment and treatment characteristics were comparably matched between the two groups. The urinary retention rate was 17% (10 patients) in the placebo group compared with 10% (6 patients) in the tamsulosin group (p = 0.3161). Eighty-eight percent (14 patients) of those who developed urinary retention experienced it within 2 weeks after the PI. Intolerable urinary symptoms were reported equally (10 patients in each group) with 70% occurring in the first 2 weeks after PI. There was a significant difference in mean AUA score in favor of tamsulosin at Week 5 after PI (p = 0.03). Conclusions: Prophylactic tamsulosin (0.8 mg/day) before prostate brachytherapy did not significantly affect urinary retention rates, but had a positive effect on urinary morbidity at Week 5 after PI.

Prostate Cancer Prostatic Dis. 2005 May 10;
Switch from phytotherapy to tamsulosin in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH).
Gross AJ, Busse M, Leonard J, Schumacher H.
1Marien Krankenhaus, Bergisch-Gladbach, Germany.

The aim of this observational prospective study was to evaluate the switch from phytotherapy to tamsulosin 0.4 mg once daily (o.d.) on efficacy, sexual function and tolerability in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) who have a poor response to at least 4 weeks of phytotherapy. The switch to tamsulosin 0.4 mg o.d. improves LUTS and related quality of life. Sexual function is also slightly improved. Tamsulosin is as well tolerated as phytotherapy and abnormal ejaculation appears to be no problem. Tamsulosin is perceived by both patients and urologists to be superior to preceding phytotherapy.Prostate Cancer and Prostatic Diseases advance online publication, 10 May 2005; doi:10.1038/sj.pcan.4500803.

Eur Urol. 2005 Mar;47(3):361-5. Epub 2004 Dec 16. Related Articles, Links
The utility of tamsulosin in the management of orgasm-associated pain: a pilot analysis.
Barnas J, Parker M, Guhring P, Mulhall JP.
Department of Urology, Weill Medical College of Cornell University, New York Presbyterian Hospital, 525 E 68th Street, Starr 900, NY 10021, USA.

INTRODUCTION:: Orgasmic pain is an infrequently reported but distressing problem for the patients who experience it. No consensus exists as to its etiology however bladder neck/pelvic floor spasm may play a role. This analysis was conducted to assess the effect of the alpha-blocking medication, tamsulosin on post-orgasmic pain. METHODS:: In a prospective, non-placebo controlled study, patients with orgasmic pain were interviewed and administered tamsulosin 0.4mg po qhs for at least 4 weeks. Outcome measures included libido, pain and continence and these were evaluated using the International Index of Erectile Function (IIEF), a visual analog scale (VAS) for pain and an incontinence scale respectively pre and post treatment. Patients were separated into groups based on etiology of the problem (radical prostatectomy, radiation therapy, and other) for statistical analysis. RESULTS:: 98 patients were enrolled. Pain was located predominantly in the penis (72%), with other sites including testis, rectum and abdomen. Most patients (52%) experienced pain for less than 5minutes post-orgasm. 76/98 (77%) patients reported significant improvement in pain (>/=2 points on pain VAS) and 12/98 (12%) noted complete resolution of their pain. The VAS for pain reflected a statistically significant decrease in pain for all groups in response to tamsulosin treatment. The entire group had a decrease of 2.7 points between pre and post-treatment phases. The IIEF libido domain increased significantly (mean of 2.4 points) for all treatment groups. CONCLUSION:: Tamsulosin decreases orgasmic pain intensity in patients with orgasmic pain. These data support the hypothesis that orgasmic pain is related to bladder neck and/or pelvic floor muscle spasm.

BJU Int. 2005 Feb;95(3):354-7. Related Articles, Links
Tamsulosin in the management of patients in acute urinary retention from benign prostatic hyperplasia.
Lucas MG, Stephenson TP, Nargund V.
Morriston Hospital, Swansea, UK. malcolm.lucas@swansea-tr.wales

OBJECTIVE: To evaluate the efficacy of tamsulosin compared to placebo for treating catheterized patients with acute urinary retention (AUR) caused by benign prostatic hyperplasia (BPH), by comparing the numbers of patients who voided successfully after removing their catheter. PATIENTS AND METHODS: This was a randomized, double-blind, placebo-controlled, parallel-group, multicentre study. Men with AUR secondary to BPH were catheterized and then, if they fulfilled the entry criteria, were randomly assigned to receive either 0.4 mg tamsulosin hydrochloride in a modified-release capsule once daily, or a placebo. After up to eight doses the catheter was removed and the ability to void unaided assessed. RESULTS: In all, 149 men (mean age 69.4 years) were randomly assigned to receive tamsulosin (75) or placebo (74); eight were not evaluable, so the intent-to-treat population was 141 men. Thirty-four men taking tamsulosin and 18 taking placebo did not require re-catheterization on the day of the trial without catheter (48% and 26% respectively, P = 0.011; odds ratio 2.47, 95% confidence interval, CI, 1.23-4.97). Success using free-flow variables was also higher in the men who received tamsulosin, at 37 (52%) vs 24 (34%) on placebo (P = 0.019; odds ratio 2.34, 95% CI 1.15-4.75). Withdrawals were high (120 men, 81%), mostly because of a need for re-catheterization (89 men, 60%). Dizziness and somnolence occurred in seven (10%) and four (6%) men who received tamsulosin, and two (3%) who received placebo, but overall the incidence of adverse events was similar in the two groups. One patient died from carcinomatosis. CONCLUSION: Men catheterized for AUR can void more successfully after catheter removal if treated with tamsulosin, and are less likely to need re-catheterization. The side-effect profile was similar for tamsulosin and placebo, and consistent with known pharmacology. From these results tamsulosin can be recommended for treating men after catheterization for AUR, and can reduce the likelihood of the need for re-catheterization.

Ann Intern Med. 2004 Oct 19;141(8):581-9.
Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial.
Alexander RB, Propert KJ, Schaeffer AJ, Landis JR, Nickel JC, O'Leary MP, Pontari MA, McNaughton-Collins M, Shoskes DA, Comiter CV, Datta NS, Fowler JE Jr, Nadler RB, Zeitlin SI, Knauss JS, Wang Y, Kusek JW, Nyberg LM Jr, Litwin MS; Chronic Prostatitis Collaborative Research Network.
Veterans Affairs Maryland Health Care System and University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. ralexander@smail.umaryland.edu

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in men is principally defined by pain in the pelvic region lasting more than 3 months. No cause of the disease has been established, and therapies are empirical and mostly untested. Antimicrobial agents and alpha-adrenergic receptor blockers are frequently used. OBJECTIVE: To determine whether 6-week therapy with ciprofloxacin or tamsulosin is more effective than placebo at improving symptoms in men with refractory, long-standing CP/CPPS. DESIGN: Randomized, double-blind trial with a 2 x 2 factorial design comparing 6 weeks of therapy with ciprofloxacin, tamsulosin, both drugs, or placebo. SETTING: Urology outpatient clinics at 10 tertiary care medical centers in North America. PATIENTS: Patients were identified from referral-based practices of urologists. One hundred ninety-six men with a National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 15 and a mean of 6.2 years of symptoms were enrolled. Patients had received substantial previous treatment. MEASUREMENTS: The authors evaluated NIH-CPSI total score and subscores, patient-reported global response assessment, a generic measure of quality of life, and adverse events. Interventions: Ciprofloxacin, 500 mg twice daily; tamsulosin, 0.4 mg once daily; a combination of the 2 drugs; or placebo. RESULTS: The NIH-CPSI total score decreased modestly in all treatment groups. No statistically significant difference in the primary outcome was seen for ciprofloxacin versus no ciprofloxacin (P = 0.15) or tamsulosin versus no tamsulosin (P > 0.2). Treatments also did not differ significantly for any of the secondary outcomes. LIMITATIONS: Treatment lasting longer than 6 weeks was not tested. Patients who had received less pretreatment may have responded differently. CONCLUSION: Ciprofloxacin and tamsulosin did not substantially reduce symptoms in men with long-standing CP/CPPS who had at least moderate symptoms.

Int J Urol. 2004 Oct;11(10):870-5.
Long-term treatment outcome of tamsulosin for benign prostatic hyperplasia.
Ichioka K, Ohara H, Terada N, Matsui Y, Yoshimura K, Terai A, Arai Y.
Department of Urology, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki 710-8602, Japan.

BACKGROUND: The present study assessed the long-term efficacy (>12 months) of tamsulosin in 123 patients with lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). METHODS: The patients received a starting dose of tamsulosin of 0.2 mg/day, with a further titration up to 0.4 mg/day until symptom relief. Subjective and objective clinical variables were assessed using the international prostate symptom score (IPSS), IPSS quality of life (QoL) score, BPH impact index score, peak urinary flow rate (Q(max)) and postvoid residual urine volume. RESULTS: Except for Q(max), all clinical variables showed significant sustained improvements from baseline throughout the study period (median follow up, 43 months). Thirty patients (24.4%) withdrew because of surgical interventions. The Cox proportional hazards model showed that a baseline IPSS total score >or=15 (HR [hazard ratio] 2.13; 95% CI 1.04-4.34) was predictive of failure for tamsulosin therapy. Furthermore, during the first 12 months, a lowest IPSS total score >or=13 (HR 2.34; 95% CI 1.12-4.89), a lowest IPSS QoL score >or=3 (HR 4.16; 95% CI 1.26-13.68), and a lowest BPH impact index score >or=4 (HR 3.54; 95% CI 1.62-7.75) were also predictive of failure for tamsulosin therapy. CONCLUSIONS: Tamsulosin treatment of BPH patients for more than 12 months showed a sustained, stable efficacy. Patients without short-term effects were prone to withdraw from tamsulosin therapy, but so did patients with a high baseline IPSS total score, even if therapy was effective for at least 12 months.

J Pharmacol Exp Ther. 2004 Oct 6;
Evaluation of tamsulosin and alfuzosin activity in the rat vas deferens: relevance to ejaculation delays.
Tambaro S, Ruiu S, Dessi C, Mongeau R, Marchese G, Pani L.
Neuroscienze-PharmaNess.

The effect of two alpha-adrenergic receptor antagonists widely employed in the therapy of benign prostatic hyperplasia, (-)-(R)-5-[2-[[2-(0-ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide (tamsulosin) and (+/-)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino]propyl] tetrahydro-2-furancarboxamide (alfuzosin), was investigated in the rat vas deferens. Because several clinical studies have shown that tamsulosin causes ejaculatory disorders, this study also evaluated the possible mechanisms implicated in these disorders by comparing the effect of tamsulosin with that of alfuzosin. Tamsulosin competitively antagonized the contractions induced by noradrenaline in vitro in the epididymal portion of the vas deferens with a potency, pA2 value, of 9.2 +/- 0.8. In the prostatic portion, tamsulosin increased the amplitude of intermittent spikes induced by exogenous noradrenaline (100-1000 microM). In both portions of the vas deferens, alfuzosin behaved as an alpha-adrenergic antagonist, blocking the contractions induced by exogenous noradrenaline without altering spikes. The administration of 3 microg/kg i.v. of tamsulosin significantly reduced the contractions evoked by electrical pulses in the epididymal portion, while it increased those produced in the prostatic portion. Intravenous tamsulosin antagonized the contraction produced by exogenous noradrenaline, while alfuzosin administration (10 microg/kg, i.v.) left unchanged the electrically-induced contractions in both portions of the rat vas deferens, and did not antagonize the contractions produced by exogenous noradrenaline. The fact that tamsulosin unusually enhances noradrenaline-induced intermittent spikes contractions and nerve-stimulation induced twitches in the prostatic portions might be linked to its greater propensity to cause sexual dysfunctions.

Arch Esp Urol. 2004 May;57(4):451-60.
Long-term study to assess the efficacy of tamsulosin in the control of symptoms and complications developed in patients with symptomatic benign prostatic hyperplasia (OMNICONTROL study): first-year follow-up report.
Palacio A, Hernandez C, Marques A, Prats J, Espinosa FJ.
Servicio de Urologia, H. Virgen de la Torre, Madrid, Spain.

OBJECTIVE: To evaluate: i. long-term efficacy of tamsulosin in the control of lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO) using the I-PSS questionnaire, ii. the frequency of complications related to the disease, and iii. short and long-term tolerability of tamsulosin. METHODS: A total of 2.921 patients with LUTS suggestive of BPO for more than 6 months and total IPSS > 7 treated with tamsulosin (Omnic) in real life practice conditions in Spain entered an observational prospective multicentre clinical study. Efficacy was primarily assessed by changes from baseline to endpoint in I-PSS symptoms score (total, irritative and obstructive), and secondarily by the appearance of disease complications, and urinary flow measurements. Safety was assessed recording every suspected adverse reaction, blood pressure changes and laboratory data on months 6 and 12. Evolution in time of free flow and sonographical evaluation of the prostate were also obtained in 663 (22.7%) and 1346 (46.1%) cases, respectively, and the use of previous and concomitant medication was also analysed. RESULTS: After 6 and 12 months total I-PSS, irritative, and obstructive symptoms were significantly reduced with the use of tamsulosin 0,4 mg once daily. At 1 year follow-up total I-PSS score, irritative symptoms, and obstructive symptoms were reduced in 8.2, 3.5 and 4.8 points 146%, 45% and 48% improvement), respectively (p < 0.0001). The proportion of patients seriously symptomatic (total I-PSS score 20-35) was reduced from 34.8% at the start of the study to 8% at 6 months and 2.9% at 12 months. Mean QoL also significantly improved after 6 and 12 months of treatment. Average score QoL index was reduced from 4.1 to 1.86 after 12 months (2.24 points, 55% improvement) (p < 0.0001). Qmax also significantly improved after 6 and 12 months of treatment (p < 0.0001). The good tolerability profile of tamsulosin has been confirmed after 6 and 12 months of treatment. CONCLUSIONS: Therapeutic intervention with tamsulosin 0,4 mg once daily is effective in all parameters analysed (I-PSS questionnaire and flow study), very well tolerated and safe in the short-term (6 and 12 months) in patients with LUTS suggestive of BPO. Long-term data specifically regarding the decrease in prostate volume and the evolution of the BPH condition will be welcome.

Int J Urol. 2003 Nov;10(11):587-94.
Usefulness of tamsulosin hydrochloride and naftopidil in patients with urinary disturbances caused by benign prostatic hyperplasia: a comparative, randomized, two-drug crossover study.
Ikemoto I, Kiyota H, Ohishi Y, Abe K, Goto H, Kishimoto K, Miki K.
Department of Urology, Jikei University School of Medicine, Nishi-Shinbashi, Tokyo, Japan. isao@jikei.ac.jp

BACKGROUND: The aim of the study presented here was to stratify drug therapy for patients with benign prostatic hyperplasia (BPH) displaying various voiding symptoms. METHODS: Two different alpha1-adrenoceptor antagonists; tamsulosin hydrochloride (Tam) and naftopidil (Naf ), were administered to 96 patients with BPH for 8 weeks in a crossover study. RESULTS: With the administration of both drugs, the International Prostate Symptom Score (I-PSS) significantly decreased and the maximum urinary flow significantly increased. Whereas Naf monotherapy decreased the I-PSS for storage symptoms, Tam monotherapy decreased the I-PSS for voiding symptoms. In both the Naf-to-Tam and Tam-to-Naf groups, crossover was effective when the initial drug was judged subjectively and objectively to have been ineffective. Compliance was acceptable with both drugs. CONCLUSION: Our results show that either Naf or Tam can be used to treat patients on the basis of objective and subjective assessment of voiding symptoms. Our findings should be helpful for patient guidance and treatment of BPH.

Expert Opin Pharmacother. 2004 Jan;5(1):151-60.
Efficacy and safety of tamsulosin in the treatment of urological diseases.
Michel MC, de la Rosette JJ.
Department of Pharmacology, and Pharmacotherapy, University of Amsterdam, The Netherlands. m.c.michel@amc.uva.nl

The alpha(1)-adrenoceptor antagonist, tamsulosin, is selective for alpha(1A)- and alpha(1D)- over alpha(1B)-adrenoceptors. Both placebo-controlled and comparative studies with other agents have demonstrated tamsulosin to be an effective treatment for patients with lower urinary symptoms suggestive of benign prostatic hyperplasia. Its effectiveness appears to be maintained over many years. Tamsulosin may also effectively reduce lower urinary tract symptoms in other urological diseases. A dose of tamsulosin 0.4 mg/day has a tolerability close to that of placebo and has little, if any, blood pressure lowering effects. Tolerability and lack of blood pressure lowering are maintained even in high-risk patients such as those with cardiovascular comorbidity and/or comedication. Apart from adrenoceptor subtype-selectivity, a smooth pharmacokinetic profile of its modified-release formulation and a selective accumulation in target tissues may contribute to an excellent efficacy:tolerability ratio.

Urologiia. 2004 Jul-Aug;(4):48-51.
[Tamsulosin in the treatment of detrusor-sphincter dyssynergia of the urinary bladder in patients with multiple sclerosis]
[Article in Russian]
[No authors listed]

Urination disorders occur in 80% patients with multiple sclerosis (MS). Most common of them is detrusor-sphincter dyssynergia (DSD). Alpha1-adrenoblockers can relax the neck of the urinary bladder (UB) and urethral sphincters, thus eliminating dynamic obstruction, reducing resistance to urine flow and facilitating voiding. Our study assessed feasibility of using a selective alpha1A/D-adrenoblocker tamsulosin in MS-associated DSD. The choice of this alpha-adrenoblocker was based on its high safety profile in relation to cardiovascular system. The trial enrolled 28 patients (20 females and 8 males) with verified diagnosis of DSD. They were given tamsulosin (omnik) in a dose 0.4 mg/day (1 capsule) for 2 months. To the end of the trial quality of life raised in 96% patients. Occurrence of pollakiuria, number of imperative micturate urges diminished, the IPSS score decreased by 54%, QL index improved by 58%. There was also a decrease in the volume of the residual urine, amplitude of involuntary detrusor contractions, an increase in maximal volumic speed of urine flow, cystometric volume of the UB, mean urine volume in urination. Side effects were not registered. Thus, tamsulosin has a positive effect in voiding disorders in the presence of DSD associated with MS. This considerably improves quality of life of MS patients.

Prog Urol. 2004 Jun;14(3):326-31.
[Evaluation of the clinical benefit of Permixon and tamsulosin in severe BPH patients--PERMAL study subset analysis]
[Article in French]
Debruyne F, Boyle P, Calais da Silva F, Gillenwater JG, Hamdy FC, Perrin P, Teillac P, Vela-Navarrete R, Raynaud JP, Schulman C.
Hopital Universitaire Saint Radboud, Nijmegen, Pays-Bas. f.debruyne@uro.ucm.nl

OBJECTIVE: To compare the efficacy of the lipido-sterolic extract of Serenoa repens, Permixon, to that of the a-blocker, tamsulosin, in the treatment of severe low urinary tract symptoms (LUTS) of benign prostatic hyperplasia (BPH). METHODS: In a 12-month, double-blind, randomized study that showed equivalent efficacy of Permixon 320 mg/day and tamsulosin 0.4 mg/day ("PERMAL study"), 685 BPH patients with IPSS > 10 had been analyzed for efficacy. Of these, the 124 patients with severe LUTS (IPSS > 19) at randomization were retained for this subset analysis. After a 4-week run-in period, 59 and 65 patients had been randomized to tamsulosin and Permixon groups, respectively. Both treatment groups were compared regarding the evolution from baseline of total IPSS and its irritative and obstructive subscores. LUTS-related QpL, prostate volume, Qmax and MSF-4 (sexual activity questionnaire) at different time points over 1 year An analysis of variance of changes from baseline to end point was performed for all the parameters. The over-time evolutions of total, irritative and obstructive IPSS were further compared using a variance analysis for repeated measurements. RESULTS: At 12 months, total IPSS decreased by 7.8 with Permixon and 5.8 with tamsulosin (p = 0.051); the irritative symptoms improved significantly more (p = 0.049) with Permixon (- 2.9 versus - 1.9 with tamsulosin). The superiority of Permixon in reducing irritative symptoms appeared as soon as month 3 and was maintained up to month 12 (p = 0.03). CONCLUSION: Permixon 320 mg/day was shown to be slightly superior to tamsulosin 0.4 mg/day in reducing LUTS in severe BPH patients after 3 months and up to 12 months of treatment.

Eur J Pharmacol. 2004 Aug 30;497(3):327-34.
Effects of tamsulosin on hypogastric nerve stimulation-induced intraurethral pressure elevation in male and female dogs under anesthesia.
Ohtake A, Sato S, Saitoh C, Yuyama H, Sasamata M, Miyata K.
Pharmacology Laboratories, Institute for Drug Discovery Research, Yamanouchi Pharmaceutical Co., Ltd., 21 Miyukigaoka, Tsukuba, Ibaraki 305-8585, Japan. ohtake@yamanouchi.co.jp

The aim of the present study was to investigate the effects of tamsulosin, an alpha(1)-adrenoceptor antagonist, on hypogastric nerve stimulation-induced intraurethral pressure elevation in anesthetized male and female dogs and to evaluate sex differences in these effects. Additionally, the effects of tamsulosin were also compared with those of other alpha(1)-adrenoceptor antagonists, namely prazosin, naftopidil and urapidil. Tamsulosin dose-dependently inhibited hypogastric nerve stimulation-induced intraurethral pressure elevation, with doses required to induce 50% inhibition of the elevation (ED(50) values) of 0.72 and 0.74 microg/kg i.v. in anesthetized male and female dogs, respectively. Mean arterial blood pressure slightly decreased after administration of tamsulosin at a dose which inhibited intraurethral pressure elevation almost completely. Prazosin, naftopidil and urapidil also inhibited increases in intraurethral pressure in a dose-dependent fashion, but caused decreases in mean arterial blood pressure at the same doses. The estimated rank order of inhibitory potency for urethral response was tamsulosin>prazosin>naftopidil=urapidil. In conclusion, tamsulosin dose-dependently inhibited increases in intraurethral pressure with little effect on mean arterial blood pressure in both male and female dogs, and these effects were almost equipotent. These results indicate that tamsulosin will be useful in the treatment of dysuria associated with lower urinary tract symptoms in women as well as men.

Eur Urol. 2004 Aug;46(2):235-40; discussion 240.
The effect of tamsulosin on the resting tone and the contractile behaviour of the female urethra: a functional urodynamic study in healthy women.
Reitz A, Haferkamp A, Kyburz T, Knapp PA, Wefer B, Schurch B.
Neuro-Urology, Swiss Paraplegic Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland. areitz@balgrist.unizh.ch

AIMS: The aim of this functional urodynamic experiment was to study the effect of the selective alpha1(A)-blocker tamsulosin on the urethral pressure in healthy human females and assessed first the resting urethral pressure and second the urethral contractility in response to magnetic stimulation of the sacral roots. METHODS: 11 healthy female subjects gave their written informed consent and were included. A microtip pressure transducer catheter was inserted into the bladder and three baseline urethral pressure profiles were obtained. Another three urethral pressure profiles were recorded while magnetic single pulse stimulation of the sacral roots was performed above the motor threshold of the pelvic floor to evoke reproducible urethral contractions. Then the subjects received 0.4 mg of tamsulosin and the entire protocol was repeated 6 hours after drug administration. Cardiovascular monitoring was obtained during the baseline and follow-up measurements. Mean and maximal urethral pressure values calculated over the entire urethra, mean pressure values calculated over the proximal, middle and distal third of the urethra and the pressure amplitudes to magnetic stimulation at baseline were statistically compared to the follow-up measurements with tamsulosin. RESULTS: The oral administration of tamsulosin did not change the systemic blood pressure, but did significantly reduce the mean and maximal urethral pressure acquired over the entire urethra. When the proximal, middle and distal third of the urethra were analysed separately, there was a significant pressure reduction in all three segments. Amplitudes of the urethral contractions evoked by sacral magnetic stimulation remained unchanged after tamsulosin. CONCLUSIONS: These data show a significant relaxing effect of tamsulosin on the resting urethral tone in healthy females in vivo. These results may suggest tamsulosin as a new pharmacological approach to treat urinary retention due to overactive or non-relaxing urethra in women.

Eur Urol. 2004 Jun;45(6):773-9; disucssion 779-80.
Evaluation of the clinical benefit of permixon and tamsulosin in severe BPH patients-PERMAL study subset analysis.
Debruyne F, Boyle P, Calais Da Silva F, Gillenwater JG, Hamdy FC, Perrin P, Teillac P, Vela-Navarrete R, Raynaud JP, Schulman CC.
Department of Urology, Academic Hospital Nijmegen, Geert Grooteplein Zuid 16, 426 Afdeling Urologie, 6500 HB Nijmegen, The Netherlands. f.debruyne@uro.umcn.nl

OBJECTIVE: To compare the efficacy of the lipido-sterolic extract of Serenoa repens, Permixon, to that of the alpha-blocker, tamsulosin, in the treatment of severe low urinary tract symptoms (LUTS) of benign prostatic hyperplasia (BPH). METHODS: In a 12-month, double-blind, randomized study that showed equivalent efficacy of Permixon 320 mg/day and tamsulosin 0.4 mg/day ("PERMAL study"), 685 BPH patients with IPSS > or =10 had been analyzed for efficacy. Of these, the 124 patients with severe LUTS (IPSS >19) at randomization were retained for this subset analysis. After a 4-week run-in period, 59 and 65 patients had been randomized to tamsulosin and Permixon groups, respectively. Both treatment groups were compared regarding the evolution from baseline of total IPSS and its irritative and obstructive subscores, LUTS-related QoL, prostate volume, Q(max) and MSF-4 (sexual activity questionnaire) at different time points over 1 year. An analysis of variance of changes from baseline to end point was performed for all the parameters. The over-time evolutions of total, irritative and obstructive IPSS were further compared using a variance analysis for repeated measurements. RESULTS: At 12 months, total IPSS decreased by 7.8 with Permixon and 5.8 with tamsulosin (p=0.051); the irritative symptoms improved significantly more (p=0.049) with Permixon (-2.9 versus -1.9 with tamsulosin). The superiority of Permixon in reducing irritative symptoms appeared as soon as month 3 and was maintained up to month 12 (p=0.03). CONCLUSION: Permixon 320 mg/day was shown to be slightly superior to tamsulosin 0.4 mg/day in reducing LUTS in severe BPH patients after 3 months and up to 12 months of treatment.

J Urol. 2004 Apr;171(4):1594-7.
Treatment of chronic prostatitis/chronic pelvic pain syndrome with tamsulosin: a randomized double blind trial.
Nickel JC, Narayan P, McKay J, Doyle C.
Queen's University, Kingston, Ontario, Canada. jcn@post.queensu.ca

PURPOSE: We compared the efficacy of tamsulosin with placebo for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). MATERIALS AND METHODS: In a double blind phase II trial, 58 patients 55 years old or younger with moderate to severe CP/CPPS were randomized to receive 0.4 mg tamsulosin or placebo for 6 weeks. Patients were assessed on days -14 and -1 during a 2-week washout, and on days 15 and 45. The primary end point was the change from baseline in total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score on day 45. Secondary end points were the change from baseline in total NIH-CPSI score on day 15 and the change from baseline in pain, urinary symptoms and quality of life/impact domains of the NIH-CPSI on days 15 and 45. Analyses of responders were performed post hoc. RESULTS: On day 45 the treatment effect (difference between treatment groups in change from baseline) was -3.6 (p = 0.04) in favor of tamsulosin. The overall effect of tamsulosin was a function of the baseline total NIH-CPSI score. Treatment effect increased significantly as the baseline score increased (for total NIH-CPSI p <0.01). Tamsulosin efficacy was superior to placebo at the 75th percentile of baseline score for the total NIH-CPSI score (-8.3, p <0.01), the pain domain (-2.9, p = 0.02), the urinary symptoms domain (-2.3, p <0.01) and the impact/quality of life domain (-2.1, p = 0.02). The efficacy of tamsulosin increased with time (no significant treatment difference at 15 days) and tamsulosin was well tolerated. CONCLUSIONS: Tamsulosin was superior to placebo in providing symptomatic relief in men with CP/CPPS, particularly in those with more severe symptoms.

Prostate Cancer Prostatic Dis. 2003;6(4):315-23.
A comparison of the efficacy and tolerability of tamsulosin and finasteride in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
Rigatti P, Brausi M, Scarpa RM, Porru D, Schumacher H, Rizzi CA; MICTUS Study Group.
Universita Vita-Salute S Raffaele, Milan, Italy. rigatti.patrizio@hsr.it

In this multicentre, double-blind study, patients with LUTS/BPH were randomised to 26 weeks with finasteride 5 mg once daily (n=204) or tamsulosin 0.4 mg once daily (n=199). Double-blind treatment was continued for another 26 weeks (total treatment duration: 1 y). The primary efficacy parameter was the difference in mean change in total Symptom Problem Index (SPI) from baseline to end point at week-26 in the intention-to-treat (ITT) and per protocol (PP) populations. Tamsulosin induced a greater improvement in total SPI (-5.2 points or -37%) compared to finasteride (-4.5 points or -31%) at week-26 (P=0.055 in ITT and P=0.032 in PP). Tamsulosin improved urinary symptoms (particularly the more bothersome storage symptoms) and flow more quickly than finasteride. The difference was statistically significant for the SPI from week-1 (reduction, respectively, -2.5 vs -1.8 points, P=0.043) to week-18 and for Qmax from week-1 (increase, respectively, 2.3 vs 0.7 ml/s, P=0.0007) to week-12. Both treatments were well tolerated with a comparable incidence of adverse events, including urinary retention.

J Urol. 2003 Dec;170(6 Pt 1):2202-5.
Efficacy of tamsulosin in the medical management of juxtavesical ureteral stones.
Dellabella M, Milanese G, Muzzonigro G.
Department of Urology, A. O. Umberto I-Torrette, University of Ancona, Italy.

PURPOSE: We evaluated the efficacy of the alpha1-adrenergic antagonist tamsulosin for conservative expulsive therapy in patients with ureteral colic due to juxtavesical stones. MATERIALS AND METHODS: A total of 60 consecutive symptomatic patients with stones located in the juxtavesical tract of the ureter were randomly divided into group 1--30 who received oral floroglucine-trimetossibenzene 3 times daily and group 2--30 who received 0.4 mg tamsulosin daily. The 2 groups received 30 mg deflazacort daily for 10 days plus cotrimoxazole 2 times daily for 8 days and 75 mg diclofenac injected intramuscularly on demand. Ultrasound followup and medical visits were performed weekly for 4 weeks. Stone passage rate and time, analgesic use, hospitalization and endoscopical intervention were evaluated. Statistical analysis was performed using the Student t test. RESULTS: The stone expulsion rate was 70% for group 1 and 100% for group 2. Mean stone size was 5.8 and 6.7 mm, respectively (p = 0.001). Mean expulsion time was 111.1 hours for group 1 and 65.7 hours for group 2 (p = 0.020). The mean number of diclofenac injections was 2.83 for group 1 and 0.13 for group 2 (p <0.0001). Ten group 1 patients were hospitalized, of whom 9 underwent ureteroscopy, compared with none in group 2 (p <0.0001 and 0.001, respectively). CONCLUSIONS: Tamsulosin used as a spasmolytic drug during renal colic due to juxtavesical calculi increased the stone expulsion rate and decreased expulsion time, the need for hospitalization and endoscopic procedures, and provided particularly good control of colic pain.

Int J Urol. 2003 Nov;10(11):576-81.
Urodynamic effects of alpha1-blocker tamsulosin on voiding dysfunction in patients with neurogenic bladder.
Kakizaki H, Ameda K, Kobayashi S, Tanaka H, Shibata T, Koyanagi T.
Department of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan. kaki@med.hokudai.ac.jp

BACKGROUND: The therapeutic role of alpha-blockers in the treatment of voiding disorders due to benign prostatic hyperplasia has been extensively examined. To investigate a possible effect of alpha1-blocker on urodynamic voiding parameters in patients with neurogenic bladder, we conducted a clinical trial using tamsulosin. METHODS: Twenty-four patients (14 men and 10 women) ranging from 24 to 82 years of age (mean age 61 years) with neurogenic bladder were analyzed. Urodynamic studies were performed before and after treatment with 0.4 mg tamsulosin daily for 4 weeks. RESULTS: On uroflowmetry, the average flow rate (from 4.6 +/- 3.3 to 6.7 +/- 3.0 mL/s, P = 0.04), maximum flow rate (from 9.4 +/- 6.8 to 14.1 +/- 7.0 mL/s, P = 0.016) and residual urine rate (from 46 +/- 29 to 32 +/- 21%, P = 0.02) improved significantly. In patients with detrusor contraction during voiding, detrusor opening pressure and detrusor pressure at maximum flow decreased significantly from 69.0 +/- 36.2 to 49.2 +/- 26.4 cmH2O (P = 0.046) and from 66.7 +/- 34.6 to 53.6 +/- 26.5 cmH2O (P = 0.007), respectively. On the other hand, in patients with detrusor areflexia, vesical opening pressure (from 78.2 +/- 23.4 to 61.6 +/- 25.2 cmH2O), or vesical pressure at maximum flow (from 68.6 +/- 23.2 to 62.9 +/- 25.2 cmH2O) did not change significantly after treatment. CONCLUSION: Tamsulosin reduces functional urethral resistance during voiding and improves flow rate in patients with neurogenic bladder. It has more beneficial urodynamic effects in patients with detrusor contraction during voiding than in patients with detrusor areflexia.

Zhonghua Nan Ke Xue. 2003 Oct;9(7):510-1.
[Tamsulosin in the treatment of benign prostatic hyperplasia patients with acute urinary retention]
[Article in Chinese]
Hua LX, Wu HF, Sui YG, Chen SG, Xu ZQ, Zhang W, Qian LX.
Department of Urology, First Affiliated Hospital, Nanjing Medical University, Nanjing, Jiangsu 210029, China.

OBJECTIVE: To evaluate the clinical efficacy of alpha-1 A adrenoceptor antagonist (tamsulosin) in the treatment of benign prostatic hyperplasia (BPH) patients with acute urinary retention. METHODS: Seventy-two BPH patients with acute retention of urine were randomly divided into treatment group and control group of 36 patients each. All the patients were treated with indwelling catheter, oral antibiotics and the patients in treatment group tamsulosin 0.4 mg once a day for 3 days. The catheter was removed after 72 hours of treatment. RESULTS: After removal of the catheter, 44% (32/72) of patients voided successfully. The effect rates were 61% (22/36) in the tamsulosin treatment group and 28% (10/36) in the control group(P < 0.01). CONCLUSIONS: Treatment with tamsulosin was effective in raising the success rate of voiding without catheter after an episode of acute urinary retention. The efficacy of treatment was not influenced by the volume of prostate.