Aim To compare the effects of additional educational material on treatment satisfaction of overactive bladder (OAB) patients treated with a muscarinic receptor antagonist. Methods In an observational study of OAB patients being treated by their physician with fesoterodine for 4 months (FAKTEN study), sites were randomised to providing standard treatment or additional educational material including the SAGA tool. Patient satisfaction was assessed by three validated patient-reported outcomes including the Treatment Satisfaction Question. Because of premature discontinuation of the study, descriptive statistical analysis was performed. Results A total of 431 and 342 patients received standard treatment or additional educational material, respectively. At study end, 76.1% [95% CI = 71.3, 80.4] of patients with standard care and 79.6% [95% CI = 74.4, 84.1] with additional SAGA tool were satisfied with treatment (primary end-point). Comparable outcomes with and without the additional educational material were also found in various patient subgroups, at the 1-month time point, and for the other patient-reported outcomes. A notable exception was the subgroup of treatment-naïve patients in which the percentage of satisfied patients was 77.2% vs. 89.5% with standard treatment and additional SAGA tool, respectively (post hoc analysis). Discussion and conclusions In an observational study, most overactive bladder patients were satisfied with fesoterodine treatment. Because of the small sample size, the study does not support or refute the hypothesis that adding the SAGA tool will improve patient satisfaction with treatment. The potential effect of additional educational material in treatment-naïve patients warrants further dedicated studies.
AIMS:To systematically review dose-escalation data from flexible-dose studies of fesoterodine and summarise factors associated with dose-escalation decisions. METHODS:A PubMed search was conducted using the terms (fesoterodine AND flexible dose), with no limits. Articles were included if they contained fesoterodine dose-escalation data for efficacy or safety outcomes or factors associated with dose-escalation decisions. RESULTS:Of 13 articles identified by the search, 10 articles (six clinical studies) met inclusion criteria. In flexible-dose trials of fesoterodine, 51-63% of subjects initially receiving fesoterodine 4 mg opted for dose escalation to fesoterodine 8 mg. Escalators generally reported significantly more severe overactive bladder (OAB) symptoms, greater OAB symptom bother and worse health-related quality of life at baseline than non-escalators. Escalators demonstrated less treatment benefit with fesoterodine 4 mg than non-escalators. Non-escalators generally had a higher rate of dry mouth and constipation with fesoterodine 4 mg than escalators. The decision to escalate appeared to be determined by the efficacy/tolerability responses; fesoterodine escalators demonstrated a lower sensitivity (less efficacy and fewer adverse events) before their decision to escalate. By study end (8-11 weeks after escalation decision), the efficacy and tolerability profiles were similar in escalators and non-escalators. CONCLUSIONS:Data from flexible-dose studies provide strong evidence that fesoterodine provides treatment benefit to individual subjects with OAB because of its true dose-response effect. In clinical practice, it can be worthwhile to escalate to fesoterodine 8 mg in individual subjects who require additional efficacy benefit.
Female and male OAB-patients were enrolled in this non-interventional study if they fulfilled the following inclusion criteria: age ≥70 years and no treatment of OAB with anticholinergics within 4 weeks prior to study inclusion. Mini Mental State Examination (MMSE) test and Patient Perception of Bladder Condition (PPBC) questionnaire were completed at baseline and after 12 weeks of treatment with propiverine ER 30 mg QD. Post-void residual urine (PVR) and number of pads/24 h were recorded before and after 4 and 12 weeks of treatment with propiverine ER 30 mg QD. PVR and patient-reported adverse drug reaction (ADR) were monitored as safety parameters.
AIMS:To compare the efficacy and tolerability of a muscarinic receptor antagonist, darifenacin, in the treatment of overactive bladder (OAB) patients with concomitant diabetes as compared with those without comorbidities.METHODS:Post hoc exploratory analysis of a published, large, non-interventional study in OAB patients treated with darifenacin including 532 diabetics and 1315 controls. Associations of diabetes with treatment responses were evaluated by multiple regression models.RESULTS:Diabetics (largely type 2 patients) and controls differed in baseline age, body weight, duration of OAB symptoms and presence of co-medications. However, they exhibited similar OAB symptom episode frequency and problem rating and received similar starting doses of darifenacin. Presence of diabetes was associated with a significantly smaller reduction of OAB symptoms, but the effect attributable to diabetes was small relative to the overall treatment response. The presence of diabetes was not associated with differences in tolerability.DISCUSSION AND CONCLUSIONS:We conclude that a muscarinic receptor antagonist has comparable efficacy and tolerability in the treatment of OAB patients with and without concomitant diabetes.
Eine eindeutige Empfehlung zur Feststellung des Zeitpunktes einer Urinextravasation nach radikaler retropubischer Prostatektomie (RRP) gibt es in der Literatur nicht. In den letzten 10 Jahren haben wir für unsere Klinik ein standardisiertes Untersuchungsverfahren entwickelt, bei dem die Farbe des Katheterurins richtungweisend zur Überprüfung der vesikourethralen Anastomose ist.
P>Aims:Gender, age, obesity, smoking and alcohol or caffeine intake have been shown or proposed to be risk factors for the prevalence and/or severity of the overactive bladder symptom complex (OAB) or related parameters. We have explored whether any of these factors affect the therapeutic response to a muscarinic receptor antagonist during routine clinical use.Methods:Data were analysed from 3766 OAB patients (77.1% woman, age 62.6 +/- 12.8 years) participating in an observational, open-label postmarketing surveillance study of the safety and efficacy of darifenacin. Multiple logistic regression models were applied to explore the effect of potential OAB risk factors on the darifenacin treatment-associated improvement of OAB symptoms, patient's subjective rating of bladder problems and global efficacy and tolerability.Results:Age and (less consistently) gender were statistically significantly correlated with efficacy parameters, but the extent of their impact was judged to be too small to be clinically relevant. Except for a very small effect of body mass index on urgency episode improvement, none of the lifestyle-associated factors had significant effects on the efficacy of darifenacin. Except for a very small age effect, none of the potential risk factors had significant effects on global tolerability.Discussion and conclusions:We conclude that the efficacy and tolerability of a muscarinic receptor antagonist, such as darifenacin is largely independent of potential OAB risk factors, such as gender, age, obesity, smoking and alcohol or caffeine intake.
PURPOSE:Through the introduction of ureterorenoscopy (URS) and extracorporal shock wave lithotripsy (ESWL) into stone treatment, the Zeiss-loop procedure has lost more and more its importance. Current guidelines recommend on the level of an expert-opinion, that stone extraction without endoscopic-visual control should not be performed anymore. Nevertheless, stone extraction using the Zeiss-loop is still being performed in our clinic and therefore we wanted to determine its position in stone treatment in the age of URS and ESWL.METHODS:The data of 253 patients with ureter stones, who were treated with the Zeiss-loop were evaluated. The loop is always pulled through completely under radiological control.RESULTS:In 221 cases, the concrement was located in the distal ureter. All concrements have been maximally 10 mm in size. Independently of size and position, in 219 patients the loop extraction resulted in a complete stone removal. Complication rates are low. No complete tear-off of the ureter occurred. The overall success rates of loop extraction were superior to those of ESWL in ureter stones but worse than URS. Referring to distal stones, success rates are similar, but stones treated by URS have been bigger.CONCLUSIONS:Therefore, in our opinion, immediate stone extraction under fluoroscopic control with the Zeiss-loop, is still a possible treatment alternative for small distal stones (<10 mm). Being aware of these first "new" data of an old procedure, the Zeiss-loop will still play a role in endoscopic stone treatment in our department and should not be completely abandoned due to its bad reputation.
After radical prostatectomy, urinary extravasation at the anastomosis is common. Nevertheless, no data exist regarding the optimal time for catheter removal at the time of expected complete healing of the leakage. Therefore, over the last 10 years we have developed a standardized way to check the healing of the anastomosis. From 1999 to 2008, 1,479 radical prostatectomies were performed. Of those, 752 could be evaluated using the standardized method of checking the anastomosis for complete healing. All patients were postoperatively evaluated by cystogram. The date for checking the anastomosis/extravasation was determined by the color of the urine (cloudy, clear, or bloody). In the 752 evaluated patients (mean age 64 years), urinary extravasation was detected 2-8 days postoperatively in 41%, 9-12 days postoperatively in 16%, and in no patient 21 days postoperatively. The measured volume of urinary extravasation after 2-8 days postoperatively was 15 ml (3-49 ml) using cystogram evaluation. After 9-12 days, the volume was determined by cystogram to be 9 ml (3-24 ml). Macroscopic evaluation of the urinary color correlated very well with the likelihood of extravasation still being present. When the urine was cloudy or colored by old blood, extravasation was present in 86% of the patients (predictive value 0.99, specificity 97%). Microscopic evaluation of the urine on the same day showed that significant leukocyturia or hematuria correlated with persistent extravasation in 49% of the patients (sensitivity 98%, specificity 34%). The transurethral catheter remained in place for a mean of 7.9 days (4-31 days). After radical prostatectomy, the macroscopic color of the urine is evaluated as a single criterion for determining the time for assessing for possible persisting leakage of the anastomosis. Microscopic urine evaluation is less effective.
The urological practice setting in Germany has changed tremendously over the last years. Group practices with two or more urologists working together are becoming more and more popular. At the same time, marketing has become essential even for urologists. To evaluate the patient flow to our group practice, we asked all new patients to fill out a questionnaire (n=2112). We also evaluated the efficacy of our recall system.The analysis showed that patients were 18-93 years old (mean 57 years), 68% being male and 32% female. The largest age group consisted of 41-50-year-olds. The most important reasons for choosing our practice were recommendations by general practitioners in 38%, recommendations by specialists in 11%, and recommendations by friends and relatives in 27%. Five percent of the patients chose the practice because of the Internet home page and 10% because of entries in various phone books. Three percent of the patients came because of newspaper articles about the practice owners, and <1% had attended patient presentations. The Internet was used mainly by 31-40-year-old patients. Our recall system showed an efficacy of 59%.In summary, a good reputation in the medical society as well as in the neighbourhood is still the best advertising for a urological practice. Phone books are increasingly becoming less important, and the Internet is increasingly attractive to the younger population. Recall systems can also be useful for urological practices.
Anticholinergic therapy is the first-line therapy for overactive bladder (OAB) syndrome. Especially in the last years, the number of available substances has increased because of the launch of solifenacin, darifenacin, and fesoterodine. Additionally, slow-release and transdermal formulations have led to a large variety of available treatment options. The efficacy of all substances has been proven in randomised, double-blind studies, and reviews and meta-analyses have also underlined the efficacy of all available anticholinergics and have been updated regularly. All available drugs are efficacious for OAB treatment, and clinically relevant differences among them have not been proven consistently. Moreover, age, gender, and the type of OAB (dry vs. wet) seem to lack clinically relevant impact on the efficacy of OAB treatment. The various drugs are similar in tolerability, with the exception of more dry mouth and central nervous effects with slow-release oxybutynin. Knowledge of pharmacokinetic properties of the individual substances is important in order to choose the right therapy for each patient.
Osteoporosis is a systemic disease of the bones with increasing incidence in the elderly. Over the age of 50 years bone mineral density continuously decreases resulting in osteoporotic fracture. Osteoporosis is positively correlated with late-onset hypogonadism and increases under androgen deprivation therapy. The evaluation of osteoporosis should be done in cooperation with an endocrinologist. Measurement of bone mineral density is recommended before starting androgen deprivation therapy. Patients with fracture and/or decreased bone mineral density 2.5 or more standard deviations below normal peak bone mass of young men should be treated. The appropriate treatment is calcium and vitamin D substitution combined with oral or i.v. administration of bisphosphonates.
Bulking agents belong to the treatment options of stress urinary incontinence in both genders for a long time, but early injection of bulking agents following radical prostatectomy to improve early continence is a new treatment modality and the results of the first years will be presented in this study. From 1996 to 2001, 55 incontinent patients, of whom 44 suffered from post-prostatectomy incontinence (PPI), have been treated by bulking agents in our clinic and evaluated later on, using a semistandardized questionnaire. Mean age was 65.5 years and the mean follow-up was 32 months. Of 44 patients with PPI, 29 suffered from incontinence of the third, 10 from incontinence of the second and 5 from incontinence of the first degree. We examined the influence of transurethral injection of bulking agents on direct postoperative continence (short-term results) and on continence at the time of follow-up (long-term results) (mean 32 month). An improved early continence (short-term result) was achieved in 30 patients. At follow-up, 19 patients were completely dry, 18 reported an improved continence. Especially the time of treatment, referring to radical prostatectomy, had a significant influence on treatment results with better results in the subgroup of 34 patients that have been treated early (mean 23 days) compared to 10 patients that received delayed treatment (mean 26 months) following radical prostatectomy. The preoperative degree of incontinence had a significant influence on short-term results, and not on long-term results. The amount of bulking material and the number of injections had no significant influence on short-term results, but repeated injections resulted in statistically worse long-term results. In summary, early transurethral injection of bulking agents is an effective and minimal invasive therapy option to improve early continence in patients with PPI. Time to improved continence due to training of the sphincter externus muscle cannot be shortened, but the quality of life during this time can be improved. In case of a severe lesion of the sphincteric muscle, continence cannot be improved for a longer period and the results are poor. In these cases, procedures like implantation of an artificial urinary sphincter may be required.
PURPOSE Essential arterial hypertension is a frequent condition. Spontaneously hypertensive rats (SHRs) show bladder dysfunction similar to that seen in patients with overactive bladder. Since muscarinic receptors and rho-kinase have a key role in the regulation of bladder contractility, we determined whether alterations of either one might contribute to hypertension associated bladder dysfunction. MATERIALS AND METHODS The bladders of SHRs and normotensive Wistar Kyoto rats (WKYs) were compared in in vitro radioligand binding and contractility studies. RESULTS The mean total number of muscarinic receptors +/- SEM (181 +/- 14 vs 191 +/- 22 fmol/mg protein) and the relative roles of their subtypes were similar in SHRs and WKYs. Contractile responses to the muscarinic agonist carbachol (maximum effect 2.04 +/- 0.24 vs 2.05 +/- 0.14 mN/mm strip length and -log EC50 5.61 +/- 0.07 vs 5.64 +/- 0.04) and to KCl in a receptor independent manner were similar in the 2 strains. The M3 selective antagonist darifenacin inhibited carbachol responses much more potently than the M2 selective antagonist methoctramine but the potency of the 2 drugs was similar in each strain. The rho-kinase inhibitor Y27,632 attenuated carbachol induced contraction in a quantitatively similar manner in SHRs and WKYs. CONCLUSIONS An altered function of muscarinic receptor subtypes or rho-kinase does not appear to contribute to bladder dysfunction in SHRs.
Die Phytotherapie des BPS hat in Deutschland eine lange Tradition. Insgesamt sind die zu den einzelnen Präparaten erhobenen Daten spärlich, wenn überhaupt vorhanden. Daher wurde eine randomisierte, doppelblinde, placebokontrollierte Multicenterstudie über 1 Jahr mit Bazoton® uno (459 mg Brennnesselwurzeltrockenextrakt) an 246 Patienten durchgeführt. Die Hauptzielvariable IPSS verbesserte sich im Mittel (Daten normal verteilt) von 18,7±0,3 auf 13,0±0,5 und zeigte damit eine statistisch signifikante Überlegenheit im Vergleich zu Placebo (18,5±0,3 auf 13,8±0,5, p=0,0233). Der Lebensqualitätsindex zeigte am Ende der Therapie mit 65% verbesserten Patienten unter Bazoton® uno im Vergleich zu 62% unter Placebo ebenfalls eine positive Tendenz, diese war aber nicht statistisch signifikant (p=0,69).