Botox rechallenge-An additional tool in the management of an incompletely emptying bladder and inadequate overactive symptom control following sacral neuromodulation.

Two female patients aged 70 and 72 with video-urodynamics-confirmed detrusor overactivity and detrusor underactivity (DO-DU) were treated. Patients were refractory to medical therapies and had previously failed intravesical botulinum toxin type A (BoNT-A) at other centers secondary to urinary retention and difficulty with self-catheterization. Placement of an Interstim II device (Medtronic, Minneapolis, Minnesota) for sacral neuromodulation (SNM) as alternative third-line treatment partially improved overactive bladder (OAB) symptoms while significantly improving voiding symptoms. Postvoid residual (PVR) of patients improved from a median of 118 mL (110-125 mL) to 20 mL (18-26 mL) and 213 mL (195-230 mL) to 70 mL (60-73 mL), respectively. Addition of medical therapies post SNM failed to modify OAB symptoms further and a rechallenge with dose-reduced BoNT-A was undertaken.OAB symptoms were significantly improved by addition of BoNT-A, while urinary retention was avoided (median PVR post BoNT-A 38 mL [34-40 mL] and 185 mL [150-205 mL], respectively). Reduction in incontinence pad use as well as resolution of nighttime incontinence in both patients and daytime incontinence in one patient was achieved. DO-DU patients treated by SNM who have improved bladder emptying (PVR <100 mL) but incomplete resolution of OAB symptoms should be trialed on adjunct medical therapies to improve OAB symptoms. If OAB symptoms are still inadequately controlled, consideration of a rechallenge with BoNT-A, particularly with dose reduction, appears to be efficacious and avoids symptomatic retention in this challenging cohort.

[The use of alfuzosin in the treatment of patients with acute urinary retention].

AIM: To study the efficiency of using alfuzosin 10 mg (Alfuprost MR, SUN Pharma) in routine clinical practice in order to predict its feasibility for treating acute urinary retention. MATERIALS AND METHODS: A total of 47 patients, aged from 54 to 88 years old (mean 68.5+/-5.6) with acute urinary retention due to benign prostatic hyperplasia were treated at the urology department of City clinical hospital named after D.D. Pletnev from September to December 2019. 14 patients were excluded from the study since they had chronic urinary retention. In all cases, urethral catheter was put and left in place for 24-72 hours (mean 44+/-12). All 33 patients were prescribed alfuzosin 10 mg. After removal of the urethral catheter, spontaneous voiding was restored in 19 patients. Transurethral resection of the prostate was consequently performed in three patients. In one patient, the urethral catheter was changed to cystostomy tube due to the urethritis. Recurrent urinary retention occurred in 10 men, and 8 patients underwent cystostomy. In other two cases, spontaneous voiding was restored after repeated removal of the urethral catheter. RESULTS: the efficiency of conservative therapy was 63.6% (21/33). According to our results, history of severe lower urinary tract symptoms, the prostate volume more than 50 cc and intravesical protrusion of more than 1 cm have a significant influence on the outcome of conservative therapy in patients with acute urinary retention. CONCLUSIONS: Based on a prospective study, a high efficiency and safety of the Alfuprost MP 10 mg/day in patients with acute urinary retention was established.

[Ningmitai Capsules relieve lower urinary tract symptoms in patients with benign prostatic hyperplasia : A short-term clinical observation].

OBJECTIVE: To observe the clinical effect and safety of the Chinese patent medicine Ningmitai Capsules (NMT) in relieving lower urinary tract symptoms (LUTS) in the patient with benign prostatic hyperplasia (BPH). METHODS: We randomly assigned 40 BPH patients to an experimental and a control group of equal number to receive oral administration of NMT at 4 capsules tid and terazosin hydrochloride tablets at 2 mg qd, respectively, both for 14 days. At 7 and 14 days after medication, we recorded and compared the International Prostate Symptoms Score (IPSS), maximum urinary flow rate (Qmax), quality of life (QoL) scores, results of urinalysis and blood routine examination, and indexes of hepatic and renal function. RESULTS: Both NMT and terazosin significantly improved the total IPSS score, the IPSS scores in the storage and voiding phases, increased Qmax and urine output, reduced post-void residual urine (PVR), and improved the QoL of the patients. The patients of the NMT group showed a better relief of incomplete bladder emptying, more improved QoL and fewer adverse reactions, while those treated with terazosin achieved a better attenuation of weak urine stream and PVR. CONCLUSIONS: NMT is safe and effective in relieving LUTS in BPH patients. Each of NMT and terazosin has its own advantages in attenuating urinary tract irritation and obstruction, but whether their combination may produce a better effect on LUTS and the specific mechanisms of NMT improving acute symptoms of BPH are yet to be further studied.

Low-Pressure, Low-Flow Voiding Dysfunction in an Elderly Male Treated Through Ayurveda: A Case Report.

INTRODUCTION: Neurogenic bladder is a common urological condition among elderly. It results in incontinence or retention of the urine depending on the synergy of bladder smooth muscles and urethral sphincter. There can also be a condition where retention causes overflow incontinence. Retention of urine in this condition is caused by relative lack of contractility of bladder smooth muscles in response to the stretch reflex. As a result, there is no urge and therefore the bladder remains over-distended causing retention of urine. Currently, there are no absolute ways to deal with such a situation except that the patients are advised for self-help techniques of regularly evacuating the bladder. Pharmacotherapy for such condition is not promising. As the patients of neurogenic bladder are often healthy otherwise (with manageable conditions such as diabetes), a bladder dysfunction is considered as a disability that they do not want to share. In this state, any approach that offers a regeneration of bladder reflex and restoration of its functions is more than one can expect for. METHODS: An elderly male suffering with chronic urinary retention recommended for indwelling catheterization after the failure of voiding trial following the possible conventional pharmacotherapy was treated with Ayurvedic therapy. RESULTS: There was a complete symptom reversal after about 45 days of Ayurvedic therapy. The changes were stable after 3-month follow-up of the patient. CONCLUSION: This case report presents the complete symptom reversal in a case of chronic urine retention as an outcome of Ayurvedic therapy. Seeing the importance of this clinical condition and unavailability of sufficient means in conventional medicine, it requires a serious note and enquiry into its applicability in similar cases.

WITHDRAWN: Tamsulosin for benign prostatic hyperplasia.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate which can result in bothersome lower urinary tract symptoms. The treatment goal for men with BPH is to relieve these bothersome symptoms. OBJECTIVES: This systematic review assessed the effects of tamsulosin in the treatment of lower urinary tract symptoms (LUTS) compatible with BPH. SEARCH STRATEGY: Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library), by checking bibliographies, and by contacting manufacturers and researchers. SELECTION CRITERIA: Trials were eligible if they (1) randomized men with BPH to receive tamsulosin in comparison with placebo, other BPH medications or surgical interventions and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements, and (3) had a treatment duration of 30 days or longer. Eligibility was assessed by at least two independent observers. DATA COLLECTION AND ANALYSIS: Information on patients, interventions, and outcomes were extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of tamsulosin with placebo, medical or surgical interventions was the change in urologic symptom scale scores. Secondary outcomes included changes in urinary flow measures (peak urine flow rate). The main outcome measure for adverse effects was the number of men reporting adverse effects. MAIN RESULTS: Fourteen studies involving 4122 subjects met inclusion criteria. Study duration ranged from 4 to 26 weeks, and no placebo-controlled study lasted longer than 13 weeks. The mean age of subjects was 64 years. Baseline symptom scores and urine flow rates demonstrated that men had moderate LUTS. Tamsulosin improved symptoms and peak urine flow relative to placebo. The weighted mean differences (WMD) for mean change from baseline for the Boyarsky symptom score for 0.4 mg and 0.8 mg doses of tamsulosin relative to placebo were -1.1 points (95% CI = -1.49 to -0.72; 12% improvement) and -1.6 points (95% CI = -2.3 to -1.0; 16% improvement), respectively. The WMD for mean change from baseline in peak urine flow were 1.1 mL/sec (95% CI = 0.59 to 1.51) and 1.1 mL/sec (95% CI= 0.65 to 1.48) for 0.4 mg and 0.8 mg, respectively. Tamsulosin (0.2 mg to 0.4 mg) was as effective as other alpha antagonists and the phytotherapeutic agent Permixon® in improving symptoms and flow rates though the doses of all alpha-antagonists studied may not have been optimal. Discontinuations from treatment for any reason and discontinuations "due to adverse events" were similar in the low dose tamsulosin (0.2 mg) and placebo groups but increased to 16% in trials utilizing a 0.8 mg dose of tamsulosin. Low dose tamsulosin was generally well tolerated although not all the trials reported specific adverse events. The most frequently reported adverse events that were significantly greater than placebo included dizziness, rhinitis and abnormal ejaculation. Adverse effects increased markedly as tamsulosin dosing increased, and were reported in 75% of men receiving the 0.8 mg dose. Men receiving a 0.2 mg dose tamsulosin were less likely to discontinue treatment compared to men receiving terazosin. AUTHORS' CONCLUSIONS: Tamsulosin provided a small to moderate improvement in urinary symptoms and flow compared to men receiving placebo in men with BPH. Effectiveness was similar to other alpha antagonists and increased only slightly with higher doses. Long term effectiveness and ability to reduce complications due to BPH progression could not be determined. Adverse effects were generally mild but their frequency, including withdrawals, increased substantially with the higher doses that are generally available for treatment.

Benign prostatic hyperplasia and male lower urinary tract symptoms (LUTS).

INTRODUCTION: Lower urinary tract symptoms related to benign prostatic hyperplasia (BPH) and bladder outlet obstruction may affect up to 30% of men in their early 70s. Symptoms can improve without treatment, but the usual course is a slow progression of symptoms, with acute urinary retention occurring in 1% to 2% of men with BPH per year. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of medical, herbal, and surgical treatments? We searched: Medline, Embase, The Cochrane Library, and other important databases up to July 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found 63 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: 5 alpha-reductase inhibitors, alpha-blockers, beta-sitosterol plant extract, Pygeum africanum, rye grass pollen extract, saw palmetto plant extracts, transurethral electrovaporisation, transurethral Holmium laser enucleation of the prostate, transurethral microwave thermotherapy, transurethral needle ablation, and transurethral resection (including transurethral resection versus transurethral incision, and transurethral resection versus visual laser ablation/laser vaporisation).

[One-week effects of Tamsulosin on benign prostatic hyperplasia assessed with a daily symptom score].

The early effects of Tamsulosin within one week of administration on lower urinary tract symptoms in patients with benign prostatic hyperplasia (BPH) were investigated. Patients with newly diagnosed BPH were randomized into a Tamsulosin group and a Eviprostat group. Changes in subjective symptoms daily for 7 days after the start of administration and in the 4th week (8 times in total) were evaluated using seven symptoms in the International Prostate Symptom Score (IPSS) and the quality of life (QOL) index entered in a self-scoring diary kept by the patients daily. In the Tamsulosin group, the IPSS total score showed significant improvements. Significant improvements were observed in the incomplete emptying and frequency scores from the day after the start of administration, in the intermittence and straining scores from day 2, in the urgency and weak stream scores from day 3 and in the nocturia score from day 5. The QOL index significantly improved on day 7. In comparison with Eviprostat, Tamsulosin showed a stronger improvement tendency in the total IPSS, voiding symptoms score and incomplete emptying score and the difference was significant. The difference between the two groups was especially marked for the intermittence and weak stream scores and Tamsulosin showed significantly better early effects. Tamsulosin also showed significantly better early effects than Eviprostat in the QOL index. In conclusion, it was clear that Tamsulosin caused significant improvement in lower urinary tract symptoms associated with BPH as a whole from a very early stage within one week after administration.

Results of double-blind placebo-controlled crossover study of sildenafil citrate (Viagra) in women suffering from obstructed voiding or retention associated with the primary disorder of sphincter relaxation (Fowler's Syndrome).

OBJECTIVES: Women with the primary disorder of sphincter relaxation find voiding difficult. Studies have identified neuronal nitric oxide synthase in the female urethral sphincter, and nitric oxide donors have been shown to decrease sphincter pressures. The aim of our study was to determine if sildenafil could improve sphincter relaxation and thereby increase flow rates and improve bladder emptying. METHODS: Twenty women with complete (5), partial retention or obstructed voiding (15) with a maximum flow rate (Qmax) of less than 15 ml/min with an elevated maximal urethral closure pressure (92--age cm H(2)O) and sphincter volume (>1.6 cm(3)) were included in the study. The study was a double-blind, randomised, placebo-control, crossover design, with patients taking sildenafil or placebo, and with measurement of flow rate and residual volume at baseline and after each treatment phase. Voiding diary, quality of life, and International Prostate Symptom Score (IPSS) data were also collected. RESULTS: No statistical significant difference was seen in any voiding parameters and diaries when sildenafil citrate was compared with placebo. There was a significant mean decrease in IPSS of 3.64 between baseline and the sildenafil phase (p=0.0083), but not when compared with placebo. In the subgroup of women with partial retention and obstructed voiding (15/20), there was a statistically significant increase in Qmax of 4.7 ml/sec (p=0.025) between sildenafil and baseline; however this difference was not seen when compared with placebo. CONCLUSIONS: This is the first study looking at sildenafil in voiding dysfunction in women. Clinical improvements with sildenafil were not significant when compared with placebo. Sildenafil was not effective as a therapeutic pharmacologic agent in this group of patients.

[Drug therapy for benign prostatic syndrome (BPS)]. / Medikamentöse Therapie des benignen Prostatasyndroms (BPS).

Alpha1-receptor blockers (alfuzosin, doxazosin, tamsulosin and terazosin), 5alpha-reductase inhibitors (dutasteride and finasteride) and combinations thereof are used in the drug treatment of benign prostatic syndrome. As before, there is still no evidence supporting the use of plant extracts, the use of anticholinergic substances alone or in combination with other BPS drugs is currently under investigation and should not be attempted outside of clinical trials. For all drugs the placebo effect is considerable. Accordingly, deviations from the recommended doses are rapidly associated with an activity loss over that of placebo. alpha1-Receptor blockers show a rapid onset of action and are slightly superior to 5alpha-reductase inhibitors with regard to the relief of symptoms. All alpha1-receptor blockers are similarly effective at adequate doses, however, quantitative differences are seen in the side effect profiles. 5alpha-reductase inhibitors also provide relief from BPS-associated symptoms with the relief being volume-dependent. Prostate volume-dependent complications of BPS (operation risk and risk of acute urine retention) can be reduced by 5alpha-reductase inhibitors. Long-term drug studies have demonstrated the superiority of combination therapies over monotherapies with alpha1-receptor blockers and 5alpha-reductase inhibitors in patients with a high risk for progression. This superiority is accompanied by a combination of the respective side-effect profiles and their absolute increase. Besides poorer tolerability, combination therapies also result in higher costs. Thus, it is important to decide at an early stage which patients are to be treated with drugs and which by surgery.

Repetitive prostatic massage and drug therapy as an alternative to transurethral resection of the prostate.

We describe 5 men with urinary retention and indwelling urethral catheters who were treated with repetitive prostatic massage, antimicrobials, alpha blockers, and--in 2 cases--finasteride. We retrospectively reviewed the charts of all patients presenting to the genitourinary clinic with indwelling urinary catheters during a 1-year period. Five men (mean age, 70 years; range, 64-76; SD 4.47) presented to the Manila Genitourinary Clinic (Cebu Branch), Cebu, Philippines, wearing indwelling urinary catheters placed for acute urinary retention. Urologists had told all 5 men that they needed to undergo transurethral resection of the prostate (TURP). The Cebu genitourinary physician removed the catheters, instituted repetitive prostatic massage, and diagnosed all 5 patients with prostatitis. All 5 patients received repetitive prostatic massage, alpha-blocker medication, and antibiotic therapy, whereas finasteride was given to 2 patients. During treatment, statistically significant improvements occurred in global symptom severity scores, urethral white blood cell (WBC) counts, WBC counts of the expressed prostatic secretions (EPS), EPS red blood cell (RBC) counts, urinary WBC counts, and urinary RBC counts. Fluorescing Chlamydia elementary bodies disappeared in 3 of the 4 positive patients by the end of treatment. (One patient was not available for retesting.) Repetitive prostatic massage, antimicrobial therapy, alpha-blocker therapy, and--in 2 cases--finasteride enabled catheter removal in all 5 men (100%) as well as successful urination in all 5 men (100%). TURP has been prevented for a mean of 2.53 years (range, 16-38 months).

Long term follow up of men with Alfuzosin who voided successfully following acute urinary retention*.

INTRODUCTION: Acute urinary retention (AUR) is one of the commonest causes of admission in urology ward and successful voiding with alpha-blockers has been reported. However, long-term efficacy of Alfuzosin, following an episode of AUR is lacking. This is a continuation of our earlier reported study. We report the results of a 4 year follow-up on patients who were on Alfuzosin SR 5 mg BD, following resumption of voiding after an episode of AUR. PATIENTS AND METHODS: A total of 33 patients voided successfully following AUR in our original study. These patients continued on Alfuzosin SR 5 mg BD and were assessed at 2 and 4 years. Symptomatic assessment was performed with IPSS and QOL symptom score and objective assessment was with urinary flow rate and post void residual volume. Patients who continued to deteriorate symptomatically and objectively or developed further AUR were listed for surgery. RESULTS: Out of 33 patients, 28 patients were followed up at 2 years (three patients died due to various medical reasons and two did not attend for follow-up). Nineteen patients (68%) underwent transurethral resection of prostate (TURP) for severe lower urinary tract symptom (LUTS) . The mean peak flow rate at 2 years was 8.4 ml/s and the mean residual volume was 112 ml. Ten patients attended for follow up at 4 years. The mean flow rate was 5.17 ml/s and the mean post-void residual volume was 101 ml. Four patients underwent TURP for severe outflow symptoms. At 4 years follow up 24 out of 30 patients (80%) on Alfuzosin needed TURP. CONCLUSIONS: These data do not support the long term use of alpha-blockers in patients who voided successfully after acute urinary retention.

Can alpha-blocker therapy be an alternative to biofeedback for dysfunctional voiding and urinary retention? A prospective study.

PURPOSE: Traditional treatment of dysfunctional voiding in children with urinary retention involves retraining the pelvic floor muscles using biofeedback. Alpha-blockers are reported to also be effective in children with urinary retention and dysfunctional voiding. We compared the efficacy of biofeedback and alpha-blockers for dysfunctional voiding and urinary retention in terms of residual urine volume and urge incontinence episodes, mean flow rates and urinary tract infections. MATERIALS AND METHODS: A total of 28 patients with a mean age of 6.25 years (range 4 to 10) presented with symptoms of urinary incontinence, urgency and urinary tract infections without anatomic and neurogenic causes of urinary retention. All patients had increased post-void residual (PVR) urine volume (mean 59 ml, 32% of age expected capacity [AEC]). The biofeedback group consisted of 16 children (mean age 6.5 years) and the alpha-blocker group consisted of 12 children (mean age 5.9 years). Both groups were also on continued timed voiding, constipation treatment and anticholinergics, which had been used for at least the last 6 months. Biofeedback (median 10, range 6 to 16 sessions) and doxazosin (0.5 to 2 mg) were administered. At 3 and 6 months incontinence episodes, urinary tract infections, mean urinary flow rates, PVR and parental satisfaction grades (1 to 10) were reevaluated. Six refractory cases were started on alpha-blockers and biofeedback, and reevaluated after 1 month and 3 months. RESULTS: Pretreatment mean PVR was 54 ml (30% of AEC), and mean posttreatment PVR was 21 ml (12% of AEC) and 9 ml (5% of AEC) at 3 and 6 months in the biofeedback group (p <0.05). Pretreatment mean PVR was 64 ml (38% of AEC), and posttreatment mean PVR was 17 ml (12% of AEC) and 13 ml (8% of AEC) at 3 and 6 months in the alpha-blocker group (p <0.05). There was no statistical difference in posttreatment PVR between the 2 groups (p >0.05). High PVR persisted in 4 (25%) biofeedback cases and in 2 (16%) alpha-blocker cases. Complete improvement in urge incontinence episodes occurred in 10 (62.5%) and 7 (70%) children in the biofeedback and alpha-blocker groups, respectively. In therapy responsive children parental satisfaction was higher with alpha-blocker than with biofeedback (9.2 vs 7.9, p <0.05). Refractory high PVR decreased significantly after combination treatment with biofeedback and alpha-blocker in 5 of 6 children (mean 80 ml, 35% of AEC vs mean 15 ml, 7% of AEC). No drug related side effect was reported in the alpha-blocker group. CONCLUSIONS: Alpha-blocker therapy seems to be a viable alternative to biofeedback in dysfunctional voiding in children with urinary retention to improve bladder emptying. Combination treatment (biofeedback and alpha-blockers) can be used as additional therapy in refractory cases.

Pharmacological therapy of benign prostatic hyperplasia/lower urinary tract symptoms: an overview for the practising clinician.

Less than 10 years ago surgery and watchful-waiting were the only widely accepted management options for lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) and benign prostatic obstruction (BPO). There has been an enormous decline in the popularity of surgery and it is now apparent that medication is the most frequently used treatment for BPH/LUTS; this has arguably therefore been the most major change in urological clinical practice in the last decade. Currently alpha(1)-adrenoceptor antagonists are the commonest medical therapy, and are thought to act by relaxing prostatic smooth muscle, the neural or so-called 'dynamic' component of BPO. 5alpha-reductase inhibitors (finasteride, dutasteride) are another option for BPH/LUTS, which reduce prostatic mass and therefore the mechanical or 'static' component of BPO. In the last 10 years there have been four direct comparative studies between alpha(1)-adrenoceptor antagonists and finasteride, including their combination, the results of which, and their implications for therapy, are discussed. Another group of agents are the phytotherapeutic extracts, which act via various mechanisms, many as yet poorly defined. This review critically assesses existing publications relating to the medical management of BPH/LUTS.

The role of a lipido-sterolic extract of Serenoa repens in the management of lower urinary tract symptoms associated with benign prostatic hyperplasia.

OBJECTIVE To examine the clinical profile of medication derived from a lipido-sterolic extract of Serenoa repens (saw palmetto) for managing lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS We reviewed clinical trials involving extracts of S. repens, focusing on the benefit/risk ratio in patients with BPH. RESULTS S. repens extract significantly reduces the symptoms of BPH, increases urinary flow, improves the quality of life and is well tolerated. CONCLUSION Analysis of the overall clinical database indicates that extract of S. repens may be considered a viable first-line therapy for treating LUTS.

Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial.

OBJECTIVE: To compare the effect of a Serenoa repens extract with placebo for symptoms of benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: In a double-blind placebo-controlled randomized trial between January 1999 and March 2000, 100 men with symptoms of BPH, aged < 80 years, with a maximum urinary flow rate of 5-15 mL/s for a voiding volume of 150 mL, were randomly and equally allocated to 320 mg S. repens extract or placebo (paraffin oil). The main outcome measures were the International Prostate Symptom Score (IPSS), peak urinary flow rate, and the Rosen International Index of Erectile Function (IIEF) questionnaire. RESULTS: There was no significant difference between the treatments over the 12 weeks of the study in the IPSS, peak urinary flow rate or for the IIEF questionnaire. CONCLUSIONS: During the trial all participants had some improvement in their symptoms of BPH but there was no significant beneficial effect of this S. repens extract over placebo in this 12-week trial.

Managing lower urinary tract symptoms in men.

Over one-quarter of men aged 40 years or over in the UK have lower urinary tract symptoms. These symptoms, which may seriously disrupt day-to-day activity, include frequency, urgency, hesitancy, reduced flow, dribbling, nocturia, incontinence and incomplete emptying of the bladder. Here, we review non-surgical measures that may help men with such symptoms.

The effect of supplemental beam radiation on prostate brachytherapy-related morbidity: morbidity outcomes from two prospective randomized multicenter trials.

PURPOSE: To detail the effect of supplemental beam radiation on prostate brachytherapy-related morbidity. METHODS AND MATERIALS: The 220 patients reported here were a subgroup randomized on two treatment protocols, with a planned total accrual of 1200. Low-risk patients, with Gleason Grade 2-6, prostate-specific antigen (PSA) 4-10 ng/mL, were randomized to implantation with I-125 (144 Gy, TG-43) vs. Pd-103 (125 Gy, NIST-99). Intermediate-risk patients, with Gleason Grade 7 or higher or PSA of 10-20 ng/mL, were randomized to implantation with Pd-103, delivering 90 vs. 115 Gy (NIST-1999), with 44 vs. 20 Gy external beam irradiation (EBRT), respectively. Beam radiation was delivered with a four-field arrangement, designed to cover the prostate and seminal vesicles with a 2-cm margin (reduced to 1.0 cm posteriorly). Treatment-related morbidity was monitored by mailed questionnaires, using standard American Urologic Association (AUA) and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months. Use of alpha-blockers to relieve obstructive symptoms was not controlled for, but was noted at each follow-up time. RESULTS: AUA score increases were highest at 1 month in the patients treated with higher prescription doses of Pd-103 (125 Gy Pd-103 alone or 115 Gy Pd-103 with 20 Gy EBRT), consistent with prior reports. By 6 months, most Pd-103 patients had returned to baseline, whereas I-125 patient scores were still declining. Patients treated with lower dose Pd-103 combined with EBRT had lesser elevations of their AUA scores at 1 and 6 months, but differences between those receiving 20 vs. 44 Gy beam radiation were inconsistent. At no point did beam radiation significantly affect postimplant AUA scores or urinary morbidity scores. Rectal morbidity scores were remarkably similar between groups, apart from higher scores at 1 month in patients treated with full dose Pd-103. Rectal morbidity consisted primarily of increased frequency and mucous passage. There have been no instances of rectal ulceration or fistula. The addition of beam radiation significantly increased postimplant rectal morbidity scores only at the 1-month time point. CONCLUSION: The addition of supplemental beam radiation had little effect on morbidity. We do not believe that morbidity per se should influence the decision of whether or not to use supplemental beam radiation.