Heinrich Schulte-Baukloh

Botulinum toxin was approved by the Food and Drug Administration in 2011 for neurogenic bladder and in 2013 for idiopathic overactive bladder (OAB)

Introduction: Botulinum toxin A detrusor injection (BoNT/A-DI) is used in patients with overactive bladder (OAB) or neurogenic bladder due to multiple sclerosis (MS) or after spinal cord injury. The procedure is generally performed under local anaesthesia. We examined the influence of BoNT/A-DI on blood pressure, the most important autonomic parameter in awake patients, as a potential risk factor for cardiovascular events. Material & Methods: Patients with OAB or spontaneous voiding with neurogenic detrusor overactivity (NDO) due to MS in whom BoNT/A-DI was planned under local anaesthesia, vital parameters (systolic, diastolic, and mean blood pressure; heart rate; and rate pressure product [RPP]) were recorded before, during, and after the procedure. Participants with and without previously known hypertension were compared, along with those with initial versus repeat injections, with a focus on the high-risk group, which comprised the 20% of patients with the highest baseline blood pressure values. Results: Seventy patients were included (mean age: 64.0, median age: 66, range: 27–86 years), and two were excluded because their initial blood pressure values were too high. Sixty patients had OAB, and eight had NDO due to MS; twenty-two patients had a history of hypertension. A total of 40 patients received the first injection, and 28 received a repeat injection. Systolic blood pressure increased significantly by an average of 9.8 mmHg. However, in the hypertensive patients, systolic blood pressure rose by an average of 19.4 mmHg; isolated peak systolic values rose by up to 232 mmHg, and peak diastolic values rose by up to 128 mmHg. Cardiac stress (measured by rate pressure product [RPP]) in these patients increased significantly (RPP = 17.6 versus 7.2 in the non-hypertensive group). In the 20% of patients with the highest resting blood pressure values, systolic blood pressure rose to an average of 187.4 mmHg (15.1 mmHg compared with resting blood pressure), and cardiac workload increased by 17. No significant differences were observed between patients who received initial and repeat injections. Conclusions: Clinicians who administer BoNT/A-DI should monitor blood pressure during the procedure and be aware of the risk of potentially significantly elevated blood pressure values during BoNT/A DI, especially in patients with a medical history of hypertension. Significantly elevated pre-interventional blood pressure values should receive an internal medicine consultation timely before the intervention to prevent cardiovascular risks.

Background: According to the European Association of Urology guidelines, the limit for monopolar, transurethral resection (M-TURP) in BPH- therapy is a volume of 80 g. However, whether larger prostates can also be resected transurethrally might also depend on the experience of the surgeon and especially the resected volume and speed of the resection. Little is known about the latter, and this paper aims to these factors. Methods: This study included 540 patients who received a single-stage M-TURP. Based on the postoperative resection weight, these were divided into four groups: group 1 with 10 to 59.9 g, group 2 with 60 to 79.9 g, group 3 with 80 to 99.9 g, and group 4 with ≥ 100 g. We examined patient age, the ASA-score, the IPSS, quality of life, resection weight, time and speed, pre- and postoperative hemoglobin and serum sodium values, complications, and surgeon experience. Results: The mean resection weight was 41.6 g, and the mean values for resection time and speed were 61.3 min and 0.7 g/min, respectively. The resection speed increased significantly with resection weight (from 0.7 to 1.3 g/min) as well as with the surgeon’s level of experience (from 0.4 to 0.9 g/min). The number of serious complications (Clavien–Dindo ≥ IIIb) increased significantly from a resection volume of 59.5 g (cut-off value). Summary: The resection speed of M-TURP increased significantly with the resection weight and the surgeon's level of experience. Regardless of speed, resection weight of more than 60 g might increase the risk of severe complications.

Background: The onabotulinumtoxinA detrusor injection (OnabotA DI) was approved a decade ago for the treatment of patients with idiopathic overactive bladder (iOAB) or neurogenic detrusor overactivity (nDO) dysfunction who had not been treated successfully otherwise. The procedure is usually performed under local anesthesia (LA), and various approaches have been investigated to make the procedure as painless as possible. We examined the level of anxiety and pain experienced by patients who wanted to have the procedure performed under LA or general anesthesia (GA). Material and Methods: Patients scheduled for OnabotA DI were able to choose the anesthesia procedure (LA or GA). The Amsterdam Preoperative Anxiety and Information Scale (APAIS) was used to grade anxiety before anesthesia or before the procedure itself. Intra- and postoperative pain was determined using the Visual Analogue Scale (VAS). Various established questionnaires (including the Urinary Distress Inventory UDI-6), as well as a postoperative satisfaction questionnaire, were used to evaluate the success of the therapy. Results: In total, 104 patients (93 F, 11 M; age 64.0 (22–89) years; 80× iOAB, 24× nDO) were evaluated. OnabotA-DI was performed with LA in 72 patients and GA in 32. Stratified by first versus repeat injection in the LA group, there was a significant decrease in the Anxiety Score in the first vs. repeat injection group (p = 0.038). The LA group showed higher concerns in the anesthesia questions of the Amsterdam Preoperative Anxiety and Information Scale (APAIS) than the GA group (OR: 0.29, 95%CI: 0.02–1.74). The VAS Pain Score during the procedure was significantly lower in the GA group compared to the LA group (LA: 3.3 ± 2.2, GA group 1.5 ± 1.5; p < 0.001). There were no differences in the success of therapy. Despite the fear and pain, patients preferred LA to GA. Conclusions: This study shows that the anxiety and pain burden of patients undergoing OnabotA-DI under LA is significant in comparison to GA during the first injection, but insignificant for following injections. Overall, LA is favored over GA.

Overactive bladder (OAB) has a significant impact on the quality of life; thus, it requires treatment that can be adhered to over a long period without undue side effects. The current treatment which uses an anticholinergic or β-3 agonist may fail to improve symptoms and has side effects, leading to high discontinuation rates. OnabotulinumtoxinA (OnabotA) detrusor injection has been approved for idiopathic OAB as a second-line treatment with good effectiveness and tolerability. This study used a visual analog scale (VAS) to assess the impact of the type of needle used for OnabotA detrusor injections under local anesthesia on the pain levels after each injection. This study included 68 female patients. We used three different needles with thicknesses ranging from 22 to 27 gauge, lengths between 4 and 5 mm, and different cuts. The sensation of pain was rated at each standardized injection location. Regardless of the needle used, the patients’ perceptions of pain at the beginning of the procedure were rated as being less than the subsequent injections. Most pain sensations were rated as low to moderate. The mean pain sensation on the VAS was 2.5 ± 0.3 overall, i.e., for all patients and needles used. Statistically significant differences in pain sensation were rated only at some locations of the bladder (on the back wall and the right side of the bladder). The single needles averaged the following pain scores: 2.8 ± 0.3 for needle A (20 G, 4 mm), 2.1 ± 0.3 for needle B (27 G, 5 mm), and 2.6 ± 0.4 for needle C (20 G, 4 mm, sharp cut 15°). The 27-gauge needle caused significantly less pain, and it had no negative impact due to its length, which was 1 mm longer than the other needles. Thus, the needle thickness was a decisive factor in the patients’ perceptions of pain.

Introduction: Detrusor injection with onabotulinumtoxin A (OnabotA-DI) is an established therapy for overactive bladder (OAB). Little is known about the exact onset and course of the effect in the days after the injection therapy. By using a new type of app-controlled automated diary pod, for the first time, the precise onset of the effect of OnabotA-DI can be documented in real time. Materials and methods: Patients due for OnabotA-DI were asked to document voiding 3 days before and up to 3 weeks after therapy using the Diary Pod app. The detrusor injection was performed with onabotulinumtoxin A (Botox^®), 100 units, at 20 sites of the detrusor muscle in a standardized manner. Voiding on the injection day itself was not documented. Results: A total of 17 patients (15 women, 2 men; aged 33–83 (mean 64.6; median 70) years) were included in the study. The handling of the Diary Pod app was user-friendly, and elderly patients did not encounter technical problems. The results of patients with reliably documented micturitions showed a continuous reduction in micturition frequency every day from the first day and significantly from day 5. For 24 h voiding, from 12.83 ± 5.54 in the 3 days before injection, the following mean values were found with significant (p < 0.05) changes after the intervention: 9.17 ± 3.19 on day 5, 8.75 ± 3.69 on day 10, 7.17 ± 2.04 on day 15, and 5.75 ± 0.5 on day 20. These changes were in similar proportions during the daytime and nighttime. Conclusions: Contrary to previous knowledge, the effect of the OnabotA-DI set in from the first postoperative days and was reflected a similar extent in day and night micturition. This study is the first to document the onset of action of OnabotA-DI in real time.

Zusammenfassung: Hintergrund OnabotulinumtoxinA (Botox) ist in Deutschland seit 2013 nach Versagen einer anticholinergen Therapie für die Second-line Behandlung der idiopathischen überaktiven Harnblase als Detrusorinjektion (OnabotA-DI) zugelassen. Bis 2018 führten jedoch abrechnungstechnische Hürden dazu, dass die Anwendung weit hinter dem Bedarf zurückblieb. Seit Anfang 2018 gibt es nun in Deutschland eine EBM-Zulassungsziffer für die transurethrale Anwendung von Botox in der Urologie. Fragestellung Ziel einer Umfrage 2019 unter Kursteilnehmern regelmäßig stattfindender Injektions-Workshops (WS-T) in unserer Institution war es zu evaluieren, ob die Abrechenbarkeit das Anwenderverhalten in Deutschland bedarfsgerecht verändert hat. Eine gleiche Umfrage 2021 sollte Entwicklungen der vergangenen zwei Jahre aufzeigen. Material und Methoden 88 konsekutive TeilnehmerInnen eines seit 2013 regelmäßig stattfindenden Anwender- Workshops wurden im Jahre 2019 per Fragebogen anonym bzgl. der bei ihnen durchgeführten Praxis der OnabotA-DI befragt. Die Befragung wurde 2021 nochmals in einer anonymisierten Online-Umfrage bei 55 Kursteilnehmern wiederholt, um Veränderungen des Anwenderverhaltens der vergangenen zwei Jahre zu evaluieren. Ergebnisse Evaluation 2019: Rücklaufquote 35/88 der Fragebögen (39,8%); eine große Mehrheit (82%) der WS-T hatten erst NACH der Einrichtung der EBM-Ziffer den Workshop besucht. Ldgl. 54,5% der WS-T führten nach dem Workshop zwei oder mehr (12% mehr als zehn) OnabotA-DI pro Quartal durch. Die meisten der Anwender (85%) führten den Eingriff immer oder weit überwiegend ambulant, 63% immer oder weit überwiegend in Lokalanästhesie durch. Die Mehrheit (84%) verabreichte keine oder lediglich eine perioperative Antibiose, 13% über eine Woche. 89% gaben an, dass mind. 70% ihrer PatientInnen keine oder nur leichte Beschwerden unter der LA hatten. In der Evaluation 2021 führten die Anwender den Eingriff tendenziell häufiger ambulant und in LA sowie häufiger ganz ohne Antibiotikagaben durch. Schlussfolgerungen Die Ergebnisse unserer Anwenderumfrage deuten darauf hin, dass die Durchführung der OnabotA-DI seit der EBM-Zulassung in Deutschland im Januar 2018 wesentlichen Aufwind gewonnen hat. Der Eingriff lässt sich in der überwiegenden Zahl unkompliziert ambulant in Lokalanästhesie durchführen.

Die neurogene Detrusorhyperaktivität und die nicht-neurogene. sog. idiopathische überaktive Blase (engl. Overactive Bladder OAB) sind gekennzeichnet durch einen imperativen Harndrang mit oder ohne Harninkontinenz, eine deutlich erhöhte Miktionsfrequenz, und sie sind häufig begleitet von einer Nykturie. Als second-line Therapie nach Versagen einer anticholinergen Behandlung dieser Erkrankungen hat sich die OnabotulinumtoxinA Detrusorinjektion fest etabliert. Der Eingriff ist sowohl im stationären als auch im ambulanten Setting und unter Allgemein- oder Lokalanästhesie durchführbar. Nebenwirkungen betreffen hauptsächlich das Auftreten von Harnwegsinfekten sowie – insbesondere bei neurogen bedingten Funktionsstörungen – den Harnverhalt. Wenn der Neurologe Hinweise auf eine Detrusorhyperaktivität hat und bisherige medikamentöse Therapieversuche nicht zu dem gewünschten Erfolg führen, empfiehlt sich somit eine Vorstellung beim Urologen zur Frage der OnabotulinumtoxinA-Detrusorinjektion. Dieser Artikel beschränkt sich auf die zugelassenen Indikationen der OnabotulinumtoxinA Detrusorinjektionen und fasst ihre aktuelle Datenlage zusammen. An overactive neurogenic detrusor and an non-neurogenic overactive bladder both exhibit symptoms such as urgency and frequency, both with and without urinary incontinence, and are often accompanied by nocturia. OnabotulinumtoxinA-Detrusorinjection has become well established as a second line therapy in cases where anticholinergic medication has failed. The procedure can be performed under general or local anesthesia, in both in- and outpatient settings. The side effects of the procedure are primarily urinary tract infections and – especially in neurogenic bladder patients – urinary retention. This article focuses on the approved indications and summarizes the current scientific data.