Long-term experience of hyperbaric oxygen therapy for refractory radio- or chemotherapy-induced haemorrhagic cystitis.

BACKGROUND: Radiotherapy and cyclophosphamide-induced haemorrhagic cystitis are rare but severe complications occurring in 3-6% of patients. Hyperbaric oxygen treatment (HBOT) has been demonstrated to be an effective treatment for haematuria not responding to conventional management. Only very few data exist for long-term follow-up after HBOT. METHODS: We retrospectively reviewed 15 patients referred for HBOT for haemorrhagic cystitis (HC). HBOT was performed for 130 min/day at a pressure of 2.4 atmospheres. We evaluated patient demographics, type of radio- and chemotherapy and characteristics of haematuria. The effect of HBOT was defined as complete or partial resolution of hematuria according to the RTOG/EORTC grade and Gray score. RESULTS: A total of 15 patients (12 after radiotherapy, two after chemotherapy and one patient with a combination of both) were treated with a median of 34 HBO treatments. Radiotherapy patients received primary, adjuvant, salvage and HDR radiotherapy (60 - 78 Gy) for prostate, colon or cervical cancer. The patient with combination therapy and both of the chemotherapy patients were treated with cyclophosphamide. First episodes of haematuria occurred at a median of 48 months after completion of initial therapy. The first HBOT was performed at a median of 11 months after the first episode of hematuria. After a median of a 68-month follow-up after HBOT, 80% experienced a complete resolution and two patients suffered a singular new minor haematuria (p < 0.00001). A salvage-cystectomy was necessary in one patient. No adverse effects were documented. CONCLUSIONS: Our experience indicate that HBOT is a safe and effective therapeutic option for treatment-resistant radiogenic and chemotherapy-induced haemorrhagic cystitis. For a better evaluation prospective clinical trials are required.

Effects of a 15-Month Supervised Exercise Program on Physical and Psychological Outcomes in Prostate Cancer Patients Following Prostatectomy: The ProRehab Study.

PURPOSE: Despite advanced medical treatment options, many prostate cancer patients are still confronted with unfavorable physical and psychological burdens. Physical exercise has proven to be beneficial for prostate cancer patients, yet specific exercise offers are rare. The ProRehab Study aimed to evaluate the exercise program offered in rehabilitative prostate cancer sports groups in Germany and determine whether it is beneficial for patients following prostatectomy. METHODS: Eighty-five prostate cancer patients were recruited for a multicenter, 2-armed, nonrandomized controlled trial 6 to 12 weeks after prostatectomy. The intervention group (n = 56) took part in a 15-month supervised multimodal exercise program. Exercise sessions took place once a week for 60 minutes at a moderate intensity (3.84-4.84 MET-hour). The control group (n = 29) received no intervention. Outcomes included aerobic fitness, activity levels, quality of life, disease- and treatment-related adverse effects, such as urinary incontinence and erectile dysfunction, and relapse-relevant blood values. Intention-to-treat analysis was performed. RESULTS: A significant between-group difference was observed in the urinary symptom score (P = .027). Physical fitness, urinary incontinence, physical, role, emotional, and social functioning, as well as further disease- and treatment-related side effects (dyspnea, urinary, and bowel symptoms) significantly improved within the intervention group. Erectile dysfunction and physical activity levels improved similarly in both groups. CONCLUSIONS: The presented data hint at the potential of rehabilitative sports groups for prostate cancer patients. However, according to the current state of the art, exercise intensity and volume may need to be increased to enhance the effects. A number of shorter studies (8-24 weeks) have proven significant between-group differences in quality of life, incontinence, and fitness outcomes when patients exercised 2 to 3 times per week. This is the first exercise intervention study with prostate cancer patients that was conducted over 15 months. Further studies are necessary to investigate whether prostate cancer patients recover sooner when receiving a supervised exercise program.

Assessment criteria for compensation of occupational bladder cancer.

In Germany, more than 100 bladder tumor cases are annually recognized as occupational disease and compensated, given that medical experts regard exposure to carcinogenic aromatic amines as a likely cause of cancer. The amount of compensation is initially based on the tumor staging and grading at the time of initial diagnosis ("basic MdE") (MdE--reduction of earning capacity) and is adapted after a recurrence-free period of 2 and 5 years, respectively. In the event of treatment or tumor-related secondary conditions, the monthly compensation increases based on the severity of the objectified functional disorder. In the following article, medical experts specializing in this field provide a complete list of all known disorders, including treatment-related loss of a kidney or erectile dysfunction. In addition, the weighting of medical criteria in the assessment and calculation of the compensation is analyzed in greater detail. Since the given criteria are based on comprehensible experiences of urologists with their patients, they also provide medical experts in other countries with valuable points of reference for the calculation of the compensation.

Implementation and scientific evaluation of rehabilitative sports groups for prostate cancer patients: study protocol of the ProRehab Study.

BACKGROUND: Although treatment regimen have improved in the last few years, prostate cancer patients following a radical prostatectomy still experience severe disease- and treatment-related side effects, including urinary incontinence, erectile dysfunction and psychological issues. Despite high incidence rates and the common adverse effects there is a lack of supportive measures for male patients and specific physical exercise recommendations for prostate cancer patients during rehabilitation or in the aftercare are still missing. METHODS/DESIGN: The ProRehab Project aims to establish rehabilitative sports groups particularly for prostate cancer patients and to evaluate the effects of the offered exercise program. Starting 8-12 weeks after prostatectomy or combination therapy, prostate cancer patients will exercise for 15 months within a patient preference randomized controlled trial. One exercise session will be conducted within a pre-established rehabilitative sports group, while the other will be completed independently. Patients in the control group will not participate in the intervention. The main outcomes of the study include aerobic fitness, quality of life, incontinence and erectile dysfunction. DISCUSSION: By combining science, practice, and public relations the first rehabilitative sports groups for prostate cancer patients in Germany have been set up and thus contribute to the care structure for prostate cancer patients. By offering a 15-month physical exercise intervention that is conducted in supervised group sessions, long-term lifestyle changes and therefore improvements in quality of life in prostate cancer patients can be expected. TRIAL REGISTRATION: German Clinical Trials Register DRKS00004184.

Bladder cancer in crack testers applying azo dye-based sprays to metal bodies.

Bladder cancer may be produced by azo dyes due to the presence of carcinogenic aromatic amines. Nine cases of suspected occupational bladder cancer that were exposed to different crack test sprays in metal-related jobs were examined. A detailed occupational history was taken and, if possible, the N-acetyltransferase 2 (NAT2) status was determined. The first exposure to crack test sprays ranged from 1957 to 1986. Age at first exposure was between 14 and 33 yr. Age at first diagnosis of bladder cancer varied from 35 to 64 yr. Latency periods were between 17 and 45 yr. The maximal reported exposure period was 29 yr. Four of six genotyped cases were slow NAT2 acetylators. The handling of the crack test spray included spraying the red dye-containing matter on the metal body and washing off the spray with a rag. Thus, workers were exposed by dermal contact as well as by inhalation. The crack test spray, which makes the cracks visible after washing off the red testing spray compounds and applying an additional white spray, contained dyes such as solvent red 19 (Sudan red 7B, N-ethyl-1[[4-(phenylazo)phenyl]azo]-2-naphthylamine) or a mixture of p-phenylazoaniline-N-ethyl-2-naphthylamine and p-phenylazoaniline-N-ethyl-1-naphthylamine. The aromatic amine 2-naphthylamine is classified as human carcinogen by IARC and the national authorities and has been banned in many countries since the mid 1950s. Bladder cancer patients with metal-related jobs need to be explicitly asked about the use of crack test sprays.

The Real-Life Safety and Efficacy of vardenafil (REALISE) study: results in men from Europe and overseas with erectile dysfunction and cardiovascular or metabolic conditions.

INTRODUCTION: The Real-Life Safety and Efficacy of vardenafil study is an international, open-label, prospective, noncomparative, noninterventional study in men with erectile dysfunction (ED). AIM: To determine the safety and efficacy of vardenafil in a large international pool of men with ED (aged ≥ 18 years) and associated underlying conditions (N=73,946), in a real-life setting. METHODS: Patients attended an initial physician visit and one to two follow-up visits. Data were acquired by physician interviews and patient diaries and recorded in case report forms (CRFs). Data were pooled from 47 countries in Europe, Asia-Pacific, Latin America, and the rest of the world (excluding the United States and Japan for methodological reasons). Results were stratified by baseline ED severity, body mass index (BMI), and the presence of hypertension, diabetes, lipid metabolism disorder, or cardiovascular disease (CVD). MAIN OUTCOME MEASURES: CRFs and patient questionnaires containing questions on overall improvement of erection, satisfaction with efficacy, and desire to continue vardenafil use. RESULTS: Many participants had hypertension (32.0%), diabetes (22.1%), lipid metabolism disorder (14.6%), or CVD (42.2%). High percentages of patients reported improvements in erectile function, irrespective of baseline ED severity (mild, 97.0%; moderate, 96.2%; severe, 85.5%), BMI (<25, 94.1%; ≥ 25 and <30, 94.6%; ≥ 30, 92.9%), or the presence of hypertension (93.6%), diabetes (92.6%), lipid metabolism disorder (94.7%), or CVD (93.3%). Over 90% of patients, including those with underlying conditions, reported being "satisfied" or "very satisfied" with vardenafil efficacy, and stated their intention to continue vardenafil use after the end of the study period. The incidence of adverse events was low, and 97.0% of patients were either "satisfied" or "very satisfied" with vardenafil tolerability. CONCLUSIONS: These data from a worldwide population of men with ED and associated underlying conditions show that vardenafil is effective and well-tolerated for the treatment of ED in a real-life setting, supporting its use as a first-line ED therapy.

Obturator and thigh abscess after transobturator tape implantation for stress urinary incontinence.

We report a case of obturator and thigh abscess 2 years after transobturator tape implantation (TVT-O) for stress urinary incontinence. Fifteen months after sling implantation repeated incisions and drainages of multiple recurrent thigh abscesses were performed. The source of infection, an eroded TVT-O, was only identified on readmission 9 months later when vaginal discharge was reported by the patient. Magnetic resonance imaging was performed because of tenderness and pain in the leg which revealed a large obturator and thigh abscess. The TVT-O was completely excised and the abscesses drained. Further follow-up was uneventful. This new technique of sling placement via the obturator route may be associated with novel infectious complications. Symptoms and signs as well as imaging modalities and conservative versus surgical management are discussed and the literature reviewed.

Comparable efficacy of once-daily versus on-demand vardenafil in men with mild-to-moderate erectile dysfunction: findings of the RESTORE study.

BACKGROUND: Phosphodiesterase (type) 5 (PDE5) inhibitors are currently administered on demand for treatment of erectile dysfunction (ED). Once-daily dosing has been suggested to benefit patients. OBJECTIVE: To determine whether daily vardenafil use provides added clinical benefits to patients compared with on-demand dosing. DESIGN, SETTING, AND PARTICIPANTS: In this placebo-controlled, double-blind, multicentre parallel-group study, men with mild-to-moderate ED were randomised to 24 wk of treatment, followed by a 4-wk washout. INTERVENTION: Patients were randomised to receive once-daily vardenafil 10mg plus on-demand placebo for 12 or 24 wk, or once-daily placebo plus on-demand vardenafil 10mg for 24 wk. MEASUREMENTS: Primary efficacy variable was the between-group difference in change in International Index of Erectile Function-Erectile Function domain (IIEF-EF) score from baseline to end of washout. Secondary variables included change from baseline in proportion of positive respondents to Sexual Encounter Profile questions and in satisfaction with treatment as assessed with the Treatment Satisfaction Scale (TSS). RESULTS AND LIMITATIONS: LS mean changes from baseline in IIEF-EF scores were 2.02, 2.29, and 2.63 for vardenafil 12 wk once daily, 24 wk once daily, and 24 wk on demand, respectively. After washout, the trend was towards improved IIEF-EF scores in the on-demand group (20.58 [+/-0.96]) versus both once-daily groups (12 wk, 19.88 [+/-0.93]; 24 wk, 20.11 [+/-0.94]). Furthermore, there were no significant between-group differences in the percentage of patients with "normal" erectile function. TSS analyses demonstrated no significant differences between treatment groups. This study recruited patients with mild-to-moderate ED; therefore, the results may not be the same as in patients with severe ED. CONCLUSIONS: Once-daily vardenafil did not produce greater sustained effects on EF than on-demand vardenafil in men with mild-to-moderate ED, suggesting that daily dosing of PDE5 inhibitors does not produce sustained clinical benefits beyond cessation of treatment above those observed with on-demand administration.

Infection reduction using antibiotic-coated inflatable penile prosthesis.

OBJECTIVES: Inflatable penile prosthesis (IPP) infection remains a devastating surgical complication. American Medical Systems recently introduced an IPP with a coating of minocycline HCL and rifampin (InhibiZone). We report our experience with this coating and compare the rate of infection with our historical rate. METHODS: A total of 467 patients receiving InhibiZone-coated IPPs were followed up for infection. The patients were stratified into four groups: nondiabetic, first-time (virgin) implants; diabetic, virgin implants; revision without washout; and revision with antiseptic solution washout. All patients were observed for longer than 1 year. The infection rates were compared with our published data of noncoated IPPs. RESULTS: No infections developed among the 223 virgin implants in nondiabetic patients. Of the 83 diabetic patients with virgin implants, 1 developed an infection (1%). Of the 39 revision patients without washout, 4 (10%) had infections. When an antiseptic washout was used in patients requiring revision, the infection rate dropped to 3% (4 of 123). Compared with our previous publications of infection rates with noncoated implants, InhibiZone-coated IPPs showed a statistically significant reduction in infection in virgin nondiabetic, virgin diabetic, and revision with washout implants. No reduction in the infection rate occurred among revision patients without washout. CONCLUSIONS: Antibiotic-coated implants become infected less often in virgin, nondiabetic and virgin, diabetic patients than in our historical experience with noncoated implants. However, antibiotic-coated implants used in revision surgery did not reduce the infection rate unless adjunctive antiseptic solution washout was also used.

Laparoscopic radical prostatectomy--the experience of the German Laparoscopic Working Group.

PURPOSE: To present the current status of laparoscopic radical prostatectomy (LRP) in Germany, Austria and Switzerland with respect to transferability, learning curve, and outcome. MATERIAL AND METHODS: The data of 5824 patients who underwent LRP in 18 centers by 50 urologists from March 1999 to August 2004 were analyzed retrospectively. Three centers performed more than 500, and six more than 250 cases. A transperitoneal descending technique with was used in 2701, a transperitoneal ascending in 1234, an extraperitoneal descending in 1814, and an extraperitoneal ascending modification in 75 cases. Specimen showed pT2 in 3535, pT3a in 1555, pT3b in 623, and pT4 in 111 cases. RESULTS: Mean operating time averaged 211 (131-292) minutes, with shorter duration of the extraperitoneal descending technique. Conversion to open surgery averaged 2.4 (0-14.1) %. Re-intervention rate amounted to 2.7 (0.3-7.7) %. Complication rate averaged 8.9 (1.8-10.8) % including bleeding (0.3-2.5%) and rectal lesion (1.5-2.5%). The rate of positive margins was 10.6 (3.2-18) % for pT2- and 32.7 (20-38.5) % for pT3a-tumors Continence after 12 months was 84.9 (72-94) %. Data about potency (7 centers) revealed 52.5 (35-67) % full erections following bilateral nerve preservation. 5 year-PSA recurrence rate (3 centers) was 8.6 (4-15.3) % for pT2-tumors and 17.5 (15-20.6) % for pT3a-stages. CONCLUSIONS: The results confirm the efficacy of the training program with safe transfer of LRP (i.e. low complication rate), however including all known problems of a retrospective study.

Laparoscopic radical prostatectomy: prospective evaluation of the learning curve.

OBJECTIVE: We prospectively evaluated the learning curve (LC) of laparoscopic radical prostatectomy (L-RPE) regarding the improvements in operative times (OT) and technical difficulty in one-operator-practice as it compares with open RPE. METHODS: Over 18 months, 50 L-RPE were performed by an inexperienced surgeon in laparoscopy but skilled in open surgery. Difficulty scores were obtained at the completion of each L-RPE comparing L-RPE to open RPE. OT, estimated blood loss (EBL), length of stay, and catheterization time were also obtained. RESULTS: In the ablative part of L-RPE the median difficulty score was significantly higher (p<0.001) for the first 10 cases, decreased dramatically by case 11 becoming equivalent (p=0.3) to open RPE and by case 31 the L-RPE becomes significantly easier than open RPE (p=0.002). The difficulty scores for the urethrovesical anastomosis performance is always uniformly higher for the whole patient series (p<0.001). Median OT decreased significantly from 293 minutes in the first 10 cases to 114 minutes in the last 10 cases (p<0.001). Catheterization time and length of hospitalization, decreased significantly with the progression of the LC. EBL remained stable throughout the patient cases. Obesity, prior surgery, and extension of the procedure (lymphadenectomy, nerve-sparing) significantly increased the OT. CONCLUSION: Although the ablative part of L-RPE has a relatively short LC for a skilled open surgeon reflected by the rapid decrease in difficulty scores and OT by case 21, the performance of anastomosis shows a longer LC. Intensive training on anastomosis may be necessary to master this skill.