Prophylactic Tamsulosin Research Articles

Preventing Postoperative Urinary Retention (POUR) in Patients Undergoing Elective Lumbar Surgery: A Quality Improvement Project.

Postoperative urinary retention (POUR) is associated with significant morbidity. Our institution's POUR rate was elevated among patients undergoing elective lumbar spinal surgery. We sought to demonstrate that our quality improvement (QI) intervention would significantly lower our POUR rate and length of stay (LOS). A resident-led QI intervention was implemented from October 2017 to 2018 on 422 patients in an academically affiliated community teaching hospital. This consisted of standardized intraoperative indwelling catheter utilization, postoperative catheterization protocol, prophylactic tamsulosin, and early ambulation after surgery. Baseline data on 277 patients were collected retrospectively from October 2015 to September 2016. Primary outcomes were POUR and LOS. The focus, analyze, develop, execute, and evaluate (FADE) model was used. Multivariable analyses were used. P value <.05 was considered significant. We analyzed 699 patients (277 pre-intervention vs 422 post-intervention). The POUR rate (6.9% vs 2.6%, Δ confidence interval [CI] 1.15-8.08, P = .007) and mean LOS (2.94 ± 1.87 days vs 2.56 ± 2.2 days, Δ CI 0.066-0.68, P = .017) were significantly improved following our intervention. Logistic regression demonstrated that the intervention was independently associated with significantly decreased odds for developing POUR (odds ratio [OR] = 0.38, CI 0.17-0.83, P = .015). Diabetes (OR = 2.25, CI 1.03-4.92, P = .04) and longer surgery duration (OR = 1.006, CI 1.002-1.01, P = .002) were independently associated with increased odds of developing POUR. After implementing our POUR QI project for patients undergoing elective lumbar spine surgery, the institutional POUR rate significantly decreased by 4.3% (62% reduction) and LOS, by 0.37 days. We demonstrated that a standardized POUR care bundle was independently associated with a significant decrease in the odds of developing POUR.

Can prophylactic tamsulosin reduce the risk of urinary retention after surgery? A systematic review and meta-analysis of randomized control trials.

The meta-analysis aimed to integrate the evidence of randomized control trials to estimate the efficacy of prophylactic tamsulosin on postoperative urinary retention (POUR). The PubMed, Embase, Web of Science, and Cochrane Library databases were searched through 1 March 2022 using predetermined keywords. Randomized control trials reporting the preventive efficacy of prophylactic tamsulosin against POUR were identified according to the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guideline. Pooled risk ratios (RRs) were calculated using a random-effects model or a fixed-effects model based on the results of heterogeneity assessment. A meta-regression analysis was performed to explore the potential sources of heterogeneity. There were 14 studies with 1102 patients in the Tamsulosin group and 1119 patients in the Control group. The risk of POUR was significantly lower in the Tamsulosin group (156/1102 [14.2%] vs. 238/1119 [21.3%]; RR=0.65; 95% CI: 0.50-0.86; P =0.002; Heterogeneity: I2 =51%; P =0.01). Tamsulosin administration was associated with a higher risk of adverse events (65/614 [10.6%] vs. 39/626 [6.2%]; RR=1.72; 95% CI: 1.19-2.48; P =0.004; Heterogeneity: I2 =0%; P =0.70). The meta-regression identified the mean age of patients as the only potential source of heterogeneity. Subgroup analysis showed that the younger patients (age <50 years) might benefit more from tamsulosin intake (RR=0.36; 95% CI: 0.19-0.70; P =0.003; Heterogeneity: I2 =49%; P =0.14). The current meta-analysis suggested that prophylactic tamsulosin contributed to the prevention of POUR, and younger patients (<50 years) might benefit more from this preventive regimen. Tamsulosin was also associated with a higher risk of adverse events.

Prophylactic tamsulosin can reduce the risk of urinary retention after surgery in male patients: A systematic review and meta-analysis

The meta-analysis aimed to estimate the efficacy of prophylactic tamsulosin on postoperative urinary retention (POUR) in male patients. Papers were searched in the PubMed, Embase, Web of Science, and Cochrane Library databases with predetermined keywords up to March 1, 2022. The studies reporting the preventive efficacy of prophylactic tamsulosin on POUR among men were identified. Pooled risk ratios (RRs) were calculated based on the random-effects model. Meta-regression was performed to explore potential sources of heterogeneity. There were 11 studies with 1,046 patients in the tamsulosin group and 1,113 patients in the control group. The risk of POUR was significantly lower in the tamsulosin group (123/1,046 [11.8%] vs. 238/1,119 [19.0%]; RR = 0.61; 95% confidence interval [CI] 0.43 to 0.87; P = 0.006; heterogeneity: I 2 = 57%; P = 0.009). Administration of tamsulosin was related to higher risk of adverse events (57/688 [8.3%] vs. 33/624 [5.3%]; RR = 1.68; 95% CI: 1.13 to 2.48; P = 0.010; heterogeneity: I 2 = 33%; P = 0.20). The level of evidence and mean age of the included patients were identified as the potential sources of heterogeneity. The present meta-analysis indicated that prophylactic tamsulosin helps in preventing POUR and younger patients might benefit more from this preventive regimen. Administrating tamsulosin was also associated with a possibly higher risk of adverse events.

Does tamsulosin decrease postoperative urinary retention in spine surgery? A double-blind, randomized controlled trial.

The authors' objective was to determine whether preoperative administration of tamsulosin decreases postoperative urinary retention after spine surgery. In this randomized, double-blind, placebo-controlled clinical trial performed at a single institution between 2016 and 2019, eligible males aged 50 to 85 years were administered tamsulosin or placebo for 5 days prior to elective spine surgery. Patients were excluded if they were taking alpha adrenergic blocking drugs; were allergic to tamsulosin, lactose, or sulfa drugs; had a preexisting indwelling urinary catheter, orthostatic hypotension, history of urological surgery, or renal failure; or were scheduled for cataract surgery within 2 weeks. Screening identified 1051 eligible patients (140 declined participation, 150 did not meet the inclusion criteria, and 151 did not enroll for other reasons). A total of 610 patients were randomly assigned to receive 0.4 mg oral tamsulosin or an identical placebo capsule for 5 days preoperatively and 2 days postoperatively. A total of 497 patients were included in the final statistical analysis. The overall rate of postoperative urinary retention was 9.7%, and tamsulosin had no observed effect on reducing the rate of postoperative urinary retention as compared with placebo (9.4% vs 9.9%, p = 0.96). There were no significant differences in the reported adverse events between groups. Multivariate logistic regression was performed to model the effects of patient, surgical, and anesthetic factors on postoperative urinary retention, and the study drug remained an insignificant factor. This study did not detect an effect of perioperative tamsulosin on reducing the rate of postoperative urinary retention in male patients aged 50 to 85 years who underwent elective spine surgery. This study does not support the routine use of tamsulosin to reduce postoperative urinary retention in patients without a previous prescription. It is unknown if subpopulations exist for which prophylactic tamsulosin may reduce postoperative urinary retention.

Prophylactic tamsulosin and urinary retention rates following elective colorectal surgery: a retrospective cohort study.

Postoperative urinary retention (POUR) is a known morbidity after colorectal surgery. This study investigated the effect of prophylactic tamsulosin on urinary retention rates after colorectal surgery. A retrospective cohort study of male patients 50years or older undergoing elective colonic and rectal resections from May 2014 to November 2019 was performed. The intervention assessed was prophylactic tamsulosin use. POUR, defined by requiring intermittent or reinsertion of urinary catheter, was compared using chi-squared analysis. A total of 332 patients were included, 131 received no tamsulosin, and 201 received prophylactic tamsulosin. Overall POUR was significantly reduced (16.8% vs. 9.5%, p = 0.047). Subgroup analysis for age 50-59 revealed no difference (9.1% vs. 9.4%, p = 0.96), but POUR risk was significantly lower in age 60 and older (20.7% vs. 9.5%, p = 0.02). No significant difference was found in rectal resections alone (18.2% vs. 13.2%, p = 0.34). Prophylactic tamsulosin reduced POUR after colorectal surgery with the greatest effect in men 60years or older and colonic resections.

The AAHKS Clinical Research Award: Prophylactic Tamsulosin Does Not Reduce the Risk of Urinary Retention Following Lower Extremity Arthroplasty: A Double-Blinded Randomized Controlled Trial

BackgroundPostoperative urinary retention (POUR) is common. Selective alpha-1 adrenergic antagonists, such as tamsulosin, are effective for treating urinary retention. The purpose of this study is to determine whether perioperative prophylactic tamsulosin reduces the incidence of POUR following total hip and knee arthroplasty. MethodsMale patients 35 years of age and older undergoing primary total hip or knee arthroplasty at a single center from 2015 to 2018 were eligible for inclusion. Patients were randomized to receive tamsulosin 0.4 mg or placebo daily for 5 days preoperatively, the morning of surgery, and the first postoperative day. The incidence of POUR was determined during the postoperative hospitalization. ResultsA total of 176 patients were enrolled in the study. Two patients were withdrawn prior to randomization. The remaining 174 were randomized to tamsulosin (n = 87) or placebo (n = 87). After an additional 43 patients were withdrawn prior to surgery, 131 patients completed the study (tamsulosin, n = 64; placebo, n = 67). A total of 42 patients (32.1%) developed POUR, with 18 cases (28.1%) in the tamsulosin group and 24 cases (35.8%) in the placebo group (P = .345), resulting in an odds ratio of 0.701 and a risk difference of 7.69%. ConclusionProphylactic tamsulosin did not reduce the incidence of POUR after hip and knee arthroplasty compared to placebo. The odds ratio indicates an approximately 30% decreased odds of developing POUR in the tamsulosin group, albeit not statistically significant. Tamsulosin does not appear to be effective as a prophylactic measure for reducing POUR in male hip and knee arthroplasty patients.

Evaluation the efficacy of prophylactic tamsulosin in preventing acute urinary retention and other obstructive urinary symptoms following colporrhaphy surgery.

Background and Aim:Postoperative urinary retention (POUR) is defined as a disability in urinary excision after surgery. There are several strategies to prevent POUR, such as tamsulosin, which is a selective antagonist at alpha-1A and alpha-1B-adrenoceptors which reduces the bladder outlet resistance. The aim of this study was to investigate the efficacy of prophylactic tamsulosin in preventing acute urinary retention and other obstructive urinary symptoms following colporrhaphy surgery.Materials and Methods:This study was a randomized, double-blind clinical trial. A total of 130 patients who were candidates for colporrhaphy were divided into two groups: the intervention group (65 subjects received 0.4 mg tamsulosin in a single dose at the time of sleeping) and the control group (65 subjects received placebo at the same time as the intervention group). The incidence of acute urinary retention and other obstructive urethral symptoms and the mean urination volume after catheterization were recorded 24 h after operation. Patients’ demographic and clinical data were analyzed using SPSS version 20 software using Chi-square and Fisher's tests.Results:There was a significant difference in the incidence of acute urinary retention, decrease in urine flow diameter, and the mean residual urine volume Post Void Residual (PVR) in the bladder, and the incidence of these symptoms decreased in the tamsulosin recipient group. The incidence of other symptoms of acute urinary retention was not significantly different when compared between both the groups.Conclusion:It seems that the use of prophylactic tamsulosin is more effective in decreasing the incidence of acute urinary retention, decreasing the PVR in the bladder, and decreasing the diameter of the urine flow in patients after colporrhaphy.

Tamsulosin to Prevent Postoperative Urinary Retention After Female Pelvic Reconstructive Surgery.

This study aimed to determine the effect of tamsulosin on postoperative urinary retention in female patients after pelvic reconstructive surgery. Data were obtained from a retrospective, matched cohort of female patients who were admitted after pelvic reconstructive surgery at a single academic institution. Patients who received tamsulosin were compared with those who did not at a 1:4 ratio, matched by surgical procedure. Patients were excluded if they were discharged on the day of surgery or if an intraoperative complication necessitated prolonged postoperative bladder drainage. Information on demographics, preoperative diagnoses, prolapse stage, preoperative voiding dysfunction, urodynamic findings, intraoperative details, postoperative complications, and voiding outcomes up to 6 weeks after surgery was gathered. The primary outcome was postoperative urinary retention, defined by failure of an active voiding trial. Patients underwent surgery between January 2016 and March 2018. We identified 35 patients who received tamsulosin and matched to 140 controls. Patients in the tamsulosin group were younger; groups were otherwise similar. Patients who received tamsulosin after surgery were less likely to develop postoperative urinary retention (2.9% vs 24.3%, P = 0.004). After controlling for confounders, multivariable logistic regression identified tamsulosin use as the only independent predictor of postoperative urinary retention with a significant protective effect (odds ratio, 0.09; 95% confidence interval, 0.01-0.67; P = 0.03). Prophylactic tamsulosin use may be effective in preventing postoperative urinary retention in female patients undergoing pelvic reconstructive surgery.

Urinary retention in early urinary catheter removal after colorectal surgery

BackgroundHigh urinary infection (UTI) rate (12%) for our rectal surgery prompted practice change to early catheter removal (postoperative day 2) and prophylactic tamsulosin. Here we report urinary retention (UR) and UTI after this change. MethodsRetrospective cohort study in male patients 50+ years undergoing elective colorectal surgery from July 2015 to July 2017. Multivariate regression was used to determine risk factors for urinary retention. Results157 patients, 57 without and 100 with tamsulosin had UR 11.46% and UTI 5.13%. Of all potential risk factors, ileus (OR 5.50, 95% CI: 1.86–16.24) was an independent risk factor for urinary retention. ConclusionsUrinary retention of 11% after colorectal resection is within literature range and associated with post-operative ileus. Tamsulosin did not affect UR in our small study sample. Early catheter removal was associated with decreased UTI rate.

Prophylactic effects of alpha-blockers, Tamsulosin and Alfuzosin, on postoperative urinary retention in male patients undergoing urologic surgery under spinal anaesthesia.

ABSTRACTPurpose Postoperative urinary retention (POUR) is one of the most common complications after surgical procedures under spinal anaesthesia. Recent studies have shown the beneficial effects of alpha-adrenergic blockers in preventing POUR. The aim of this prospective study was to investigate and compare the prophylactic effects of tamsulosin and alfuzosin on POUR after urologic surgical procedures under spinal anaesthesia.Materials and Methods A total of 180 males who underwent elective urologic surgery were included in this study. The patients were randomly allocated into three Groups. The Group I received placebo. Patients in Group II were given 0.4mg of tamsulosin orally 14 and 2 hours before surgery. Patients in Group III were given 10mg of alfuzosin ER orally 10 and 2 hours before surgery. All patients were closely followed for 24 hours postoperatively and their episodes of urinary retentions were recorded.Results There were 60 patients in each Group. Their mean age was 35.95±15.16 years. Fifteen patients in Group I (25%), 3 patients in Group II (5%) and 4 patients in Group III (6.7%) required catheterization because of urinary retention. In tamsulosin group and alfuzosin group, there were a significantly lower proportion of patients with POUR compared with the placebo Group (p=0.002 and p=0.006). The beneficial effects of tamsulosin and alfuzosin on POUR were similar between both Groups (p=0.697).Conclusion This study suggests that the use of prophylactic tamsulosin or alfuzosin can reduce the incidence of urinary retention and the need for catheterization after urologic surgical procedures under spinal anaesthesia.

Prophylactic tamsulosin (Flomax) in patients undergoing prostate 125I 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

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 α-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.

Prophylactic tamsulosin (Flomax) in patients undergoing prostate 125I brachytherapy for prostate carcinoma: Final report of a double-blind placebo-controlled randomized study

To evaluate the effectiveness of prophylactic tamsulosin (Flomax) in reducing the urinary symptoms in patients undergoing 125I prostate implantation (PI) for prostate adenocarcinoma. 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. 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). 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.

Brachytherapy‐related dysuria

To evaluate the incidence and temporal resolution of dysuria after permanent prostate brachytherapy, and to identify predictors of brachytherapy-related dysuria. The study included 130 patients with no history of transurethral resection of the prostate before treatment, who had brachytherapy on one of two prospective randomized trials, with explicitly planned and executed urethral-sparing techniques (100-150% minimum peripheral dose) using either 103Pd or 125I for clinical T1c-T2c prostate cancer. The median follow-up was 22.6 months. An alpha-blocker was initiated either prophylactically 2 weeks before implantation and continued at least until the International Prostate Symptom Score (IPSS) returned to normal, or withheld until the onset of significant brachytherapy-related urinary morbidity. Dysuria was evaluated on a 0-10 scale, before brachytherapy and then at 1, 3, 6 and 12 months afterward, with a median of four dysuria questionnaires per patient. Clinical, treatment and dosimetric variables evaluated included alpha-blocker, age, IPSS before and the maximum after treatment, prostate volume on ultrasonography, hormonal status, supplemental radiotherapy, isotope, urethral dose, V(100/200), D90, and time to obtaining a normal IPSS. The maximum incidence of dysuria was 85% at 1 month after brachytherapy, with subsequent resolution over time. The use of prophylactic tamsulosin resulted in a statistically lower dysuria severity score (difference of 2.7 vs 4.2, P < 0.005) at 1 month, with no discernible differences at 3, 6, 12 and 18 months. Patients with dysuria had a statistically higher IPSS. The dysuria resolved faster in patients implanted with 103Pd but was unaffected by the use of supplemental radiotherapy and/or androgen deprivation therapy. In multivariate analysis, prophylactic alpha-blockers resulted in statistically lower maximum dysuria scores, while the maximum IPSS after implantation and isotope type (but only at 6 months) were the best predictors of the resolution of dysuria. Dysuria is common after brachytherapy but is typically mild. Prophylactic alpha-blockers gave significantly lower maximum dysuria scores but did not affect the time to the resolution of dysuria. The maximum IPSS after the implant was the best predictor of the resolution of dysuria.

The role of prophylactic Tamsulosin ± dexamethasone in patients undergoing prostate 125I seed implants for prostate carcinoma. A randomized double-blind study

Introduction: In this study, we aimed to evaluate the effectiveness of prophylactic dexamethasone added to tamsulosin (Flomax®) in reducing urinary symptoms after I 125 prostate brachytherapy (PI) for prostate adenocarcinoma. Materials and Methods: A single institution, randomized, double blind, placebo controlled trial of patients undergoing PI for prostate adenocarcinoma comparing the use of prophylactic dexamethasone plus tamsulosin before PI versus placebo plus tamsulosin was conducted. Patients undergoing permanent PI, who were not taking tamsulosin or other alpha-blockers prior to PI were eligible for the trial. All patients were given tamsulosin (0.8 mg, orally once a day) and were randomized to receive either placebo or dexamethasone (4 mg per day for the first 10 days after PI and then 2 mg per day for 4 additional days). Tamsulosin use was started four days prior to PI and continued for 60 days. Urinary symptoms were assessed with the American Urologic Association (AUA) symptom index score. The questionnaire was administered prior to PI and then on a weekly basis for the first eight weeks after PI and again at weeks 10 and 12 after PI. The primary endpoint of the trial was change in the AUA score from baseline. Patients were taken off of the study if they developed urinary retention, had intolerable urinary symptoms, or wished to discontinue with the trial. Results: One-hundred patients were enrolled in the study. Ninety-four patients started the study and 72 completed all 12 weeks. Patients were evenly matched according to pre-treatment and post-treatment characteristics except with regard to pre-treatment AUA score: the dexamethasone group had a median score of 3 while the placebo group had a median score of 5 (p=0.0023). When comparisons were made between the groups relative to percent change in overall AUA score from baseline, there was a significant difference in favor of the placebo group (p=0.0030). Conclusion: The combination of prophylactic dexamethasone and tamsulosin yields worse post-operative

The role of prophylactic Tamsulosin ± dexamethasone in patients undergoing prostate 125I seed implants for prostate carcinoma. A randomized double-blind study

To evaluate the effectiveness of dexamethasone in reducing the peak AUA urinary symptom scores and rate of intermittent self-catheterization (ISC) for patients with prostate adenocarcinoma treated with prophylactic Tamsulosin and prostate 125I seed implant.

The role of prophylactic tamsulosin (Flomax®) on obstructive and irritative urinary symptoms in patients undergoing prostate 125i seed implants for prostate carcinoma: a single institution double-blind randomized study

Materials/Methods: A double-blind, placebo controlled, randomized trial for patients undergoing 125I prostate implant (PI) comparing prophylactic tamsulosin vs placebo was performed. Eligibility criteria included patients undergoing PI, who were not taking tamsulosin or other alpha-blockers prior to PI. Patients received either placebo or tamsulosin (0.8 mg to be taken PO once a day). All patients started the medication 4 days prior to prostate implant and continued for a duration of 60 days. Patients were taken off the study if they developed urinary retention, had intolerable urinary symptoms, or wished to discontinue the trial. The American Urologic Association (AUA) symptom index questionnaire was used at baseline and on a weekly basis for 8 weeks to assess the irritative and obstructive urinary symptoms after PI. Irritative urinary symptoms included nocturia, urgency, and daytime urinary frequency. Obstructive urinary symptoms included the force of urinary stream, hesitancy, feeling of bladder emptiness, and straining to start urination. Irritative and obstructive symptoms were evaluated for the entire study period utilizing repeated measures analysis of variance (ANOVA) and unpaired t-tests for week by week comparisons.

The role of prophylactic tamsulosin (Flomax) in patients undergoing prostate 125-I seed implants for prostate carcinoma: final report of double-blind placebo-controlled randomized study

Materials/Methods: A single institution, double blind, placebo controlled, randomized trial for patients undergoing 125I prostate implant (PI) comparing prophylactic Tamsulosin (Flomax) vs. placebo. Eligibility criteria include patients undergoing PI, who were not taking Tamsulosin (Flomax) or other alpha-blockers prior to PI. The patients received either placebo or Tamsulosin (Flomax)(0.8 mg) to be taken PO once a day). All patients started the medication 4 days prior to prostate implant for duration of 60 days after PI. The American Urologic Association (AUA) symptom index questionnaire was used at baseline and on a weekly basis for 8 weeks to assess the severity of urinary symptoms after PI. For quality assurance purpose, all AUA questionnaires were conducted by one physician (ME). Patients were taken off the study if they developed urinary retention, had intolerable urinary symptoms, or did not wish to continue with the trial. Repeated measures analysis of variance (ANOVA) was done to see if there was a difference in AUA scores between the two treatment arms over the duration of the study period. Unpaired t-tests were done to compare AUA score between the two arms on a week by week basis.