Stefanie Petrou Binder, MD

A new comparative study showed that the use of intradetrusor injections of abobotulinum toxin A (Dysport) for urinary incontinence due to neurogenic detrusor overactivity (NDO) provided results that were similar to or superior to those seen with onabotulinum toxin A (Botox), depending on the dosage of the latter.

	Urinary incontinence due to NDO in adults who have an inadequate response to or are intolerant of anticholinergic therapy has been shown to be responsive to onabotulinum toxin A. Although an increasing number of reports support the efficacy of abobotulinum toxin A for urinary incontinence, few studies have compared the two in NDO patients.

	The current retrospective case-control study was carried out by first author Benoit Peyronnet, MD, a urologist at Rennes University Hospital in Rennes, France, and his team of specialists, and was presented at the European Association of Urology annual congress in Munich, Germany. It was subsequently published online in 

	The study included 211 NDO patients who were treated in three consecutives periods of time. The first time period extended from 2004 to 2006 and included the treatment of 80 patients who received onabotulinum toxin, 300 U; the second period was from 2007 to 2011 and included 78 patients who were treated with abobotulinum toxin, 750 U; and the third time period spanned the years 2011 to 2014 and studied 53 patients who received onabotulinum toxin, 200 U.

	Study authors compared urodynamic and clinical parameters among the three groups with regard to the first intradetrusor injections of three botulinum toxin formulations. The primary endpoint was the rate of success defined as the combination of urgency, urinary incontinence, and detrusor overactivity resolution.

	Dr. Peyronnet and his team noted that the success rates were similar-65.4% versus 55.6% 

=0.16)-when comparing combined urgency, urinary incontinence, and detrusor overactivity resolution among patients who received either abobotulinum toxin or onabotulinum toxin (any dose, 200 U or 300 U), respectively (n=133).

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	The patients who were treated with abobotulinum toxin, 750 U had a higher success rate when compared to the success rate seen in those patients receiving onabotulinum toxin, 200 U (65.4% vs. 41.5%; 

=.007). By contrast, there were similar success rates in the abobotulinum toxin, 750 U, and onabotulinum toxin, 300 U groups (65.4% vs. 65%; 

	However, the investigators noted a trend toward longer time intervals between the first and the second injections in the onabotulinum toxin, 300 U group compared to the abobotulinum toxin, 750 U group (12.4 vs. 9.3 months; 

=.09), suggesting a longer duration of action of onabotulinum toxin, 300 U.

	“Success rates of abobotulinum toxin 750 U and onabotulinum toxin 300 U were similar but interval between injections tended to be longer with onabotulinum toxin 300 U,” Dr. Peyronnet and colleagues wrote.

	Onabotulinum toxin, 200 U treatments were associated with higher complication rates than were seen in onabotulinum toxin, 300 U, and abobotulinum toxin, 750 U patients. These included seven cases of urinary tract infection (13.2%) and one case of fatigue in onabotulinum toxin 200 U patients. Complications in the other two groups affected under 4% of the study patients.

	The side effects of anticholinergic therapy have led to poor compliance with long-term use. Fortunately, patients with an unsatisfactory response to anticholinergic therapy no longer need to face invasive surgical interventions. The low complication rates observed in this study seem to bode well for long-term applications of botulinum toxin for NDO.

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A new comparative study showed that the use of intradetrusor injections of abobotulinum toxin A (Dysport) for urinary incontinence due to neurogenic detrusor overactivity provided results that were similar to or superior to those seen with onabotulinum toxin A (Botox), depending on the dosage of the latter.

Botulinum formulations show slight outcomes differences

Preliminary findings of a Swiss study revealed that the brain activity associated with the desire to void in response to the automated, repetitive filling and distention of the bladder with body warm saline differed greatly between healthy patients and patients with non-neurogenic overactive bladder (NNOAB).

Dr. WalterOAB is characterized by urinary urgency and frequency. Supraspinal control and specifically sensory processing become altered in patients with OAB, according to first author Matthias Walter, MD, research fellow in neuro-urology at the University of Zürich, Balgrist University Hospital, Zürich, Switzerland.

	The study, which was presented at the European Association of Urology annual congress in Munich, Germany, included 24 right-handed female participants, of whom 12 had a diagnosis of OAB and 12 were healthy subjects who were matched for age and gender. This was a block design functional magnetic resonance imaging (fMRI) study that acquired neuroimaging data with the use of a 3 Tesla MR scanner. The scan paradigm comprised automated, repetitive bladder filling of 100 mL body warm saline within 15 s.

	The patients were catheterized and their bladders were pre-filled until a persistent desire to void was reported from each subject. Using SPM8, the blood-oxygenation-level dependent signal change during bladder filling was compared to the level at rest; ie, the pre-filled bladder.

	Dr. Walter and his colleagues observed bilateral activation in the frontal and prefrontal areas in healthy subjects, including in the inferior frontal gyrus pars triangularis (BA45), pars orbitalis (BA47), and medial frontal gyrus (BA10 and 46).

	Activation patterns in NNOAB patients included the right hemisphere: insula, supramarginal gyrus (BA40), rolandic operculum (BA44), and the postcentral gyrus (primary somatosensory cortex); the left hemisphere: superior frontal gyrus (BA8), caudate, angular gyrus (BA39); and thalamus, as well as bilateral activation patterns: middle cingulate cortex (BA24).

Next: No group differences on whole-brain analysis

	No group differences on whole-brain analysis

	Furthermore, no group differences were detected on whole-brain analysis. The regions of interest (ROI) analyses revealed significantly stronger activations in the right posterior insula, left middle cingulate cortex, and left cerebellum for NNOAB patients compared to healthy subjects.

	“These differences might reflect the abnormal and unpleasant sensation of urinary urgency and fear of leakage, since both the right dorsal insula and the middle cingulate cortex have been associated with the processing of complex somatosensory information involving emotions and sensory discomfort,” Dr. Walter explained.

	The second-level random effects analysis included a sample t-test for each group. Within-group results are shown at a voxel-threshold at 

<.001 using the false discovery rate correction, with a strict cluster threshold correction of 

<.05 (cluster extend: k >42 voxels) to adjust for multiple comparisons using Monte Carlo simulations.

	For group comparisons, whole-brain analyses as well as ROI analyses were computed. The whole-brain analysis was conducted for a comprehensive overview. The ROI approach was performed to explore regional differences between both groups. Thus, the ROIs were included as a mask in order to restrict the voxel-by-voxel statistical analysis (including FEW correction) to pre-specified brain areas. ROIs were generated using the WFU Pickatlas.

	“fMRI is a powerful tool to investigate the supraspinal network of lower urinary tract control in response to distinct stimuli such as repetitive bladder filling,” Dr. Walter said.

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Preliminary findings of a Swiss study revealed that the brain activity associated with the desire to void in response to the automated, repetitive filling and distention of the bladder with body warm saline differed greatly between healthy patients and patients with non-neurogenic overactive bladder.

Brain activity in OAB patients characterized in study

A patient follow-up report shows promising mid-term results from five German urology centers that implemented the prostatic urethral lift (UroLift System, NeoTract, Inc.) to alleviate symptomatic 

 in patients suffering from mild, moderate, and even severe obstruction. 

READ: Urethral lift's efficacy, safety sustained at 2 years

	The outcomes reflect the benefits of PUL in patients with symptoms normally contraindicated in PUL clinical trials; previous studies included patients with mild to moderate obstruction only and no complications.

	The prostatic urethral lift (PUL) uses anchors that are placed in the prostate and on the inside of the urethra, which through gentle pulling action create a channel in the urethra that allows the patient to void. The advantage of the procedure over transurethral resection of the prostate lies in the absence of tissue ablation, eliminating the dreaded complication of retrograde ejaculation and preserving patients’ sexual function, researchers say.

Dr. Sievert“Men want to preserve their sexual activity, and one of the major complications of TURP, unfortunately, is retrograde ejaculation. Using UroLift, we matched the results seen in PUL clinical trials and did not see this complication. Thirty-seven percent of our more severely obstructed patients would have been denied PUL, since clinical trials exclude patients with prostates larger than 40 mL to 50 mL. We also included patients with retention, another trial contraindication,” said senior author Karl-Dietrich Sievert, MD, PhD, chair of urology at the University of Lübeck, Lübeck, Germany.

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	Dr. Sievert reported on the outcomes of 70 patients (age 38-85 years) from five German centers who underwent PUL instead of TURP following patient education. The prostate volume (PV) ranged from 17 mL to 111 mL (mean PV: 43±18.8 mL) and seven patients had a high post-void residual (PVR) of 250 mL or greater. He followed the patients for 0.5 to 18 months (mean follow-up, 9.05± 5.55 months) and evaluated them prior to and after surgery using maximum flow rate (Qmax), PVR, International Prostate Symptom Score, and quality of life.

NEXT: 96% of patients report immediate symptom relief

	A total of two to seven implants (average, four) were delivered under general or local anesthesia. Ninety-six percent of patients reported immediate symptom relief with significantly improved mean Qmax, PVR, IPSS, and QoL 

<.001) within the first month, which either remained unchanged or improved for up to 18 months. Sexual function including ejaculation was unchanged or even improved in those who reported sexual activity prior to surgery. Adverse events were negligible. Three patients (4%) had unsatisfactory results and subsequently underwent repeat PUL (one patient) with positive results, or TURP (two patients).

	Lift holds advantages for old, young patients

	“Further advantages of PUL include shorter surgery time, no intra-surgery bleeding, and an outpatient option (depending on the medical system). This new treatment is likely to be a particularly attractive option for young patients who do not want to face retrograde ejaculation or old patients with comorbidities who take anticoagulants and need to avoid major surgery that can induce bleeding,” Dr. Sievert said.

	Dr. Sievert explained that the study’s patient follow-up was unique because candidates were not excluded based on oral therapy for lower urinary tract symptoms, high PVR, PV, or history of urinary retention.

	“The only exclusion criteria were an obstructive median lobe or high entrance into the bladder,” Dr. Sievert said.

	“You cannot expect the flow or residual to be as good as when you remove tissue, but according to the IPSS score, patients value their QoL significantly and were very satisfied. The BPH-6 study that compares the UroLift system to TURP takes a better look at flow and residual and will be reported soon,” he added.

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A patient follow-up report shows promising mid-term results from five German urology centers that implemented the prostatic urethral lift (UroLift System, NeoTract, Inc.) to alleviate symptomatic BPH in patients suffering from mild, moderate, and even severe obstruction.

BPH technique efficacious even in severe obstruction

Photoselective vaporization of the prostate (PVP) is non-inferior to 

transurethral resection of the prostate (TURP)

 in men with benign prostatic obstruction (BPO), researchers reported at the European Association of Urology annual congress in Stockholm, Sweden.

	Study authors presented 1-year follow-up data of the Goliath Study, a large open-label, prospective, European, multicenter, randomized controlled trial that compared 

 (American Medical Systems, Minnetonka, MN) PVP and TURP in men with BPO over 6 months. The study’s primary targets were International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), and complication-free rate, with a follow-up time of 2 years.

	“An investigation comparing GL-XPS and TURP that included a lengthy follow-up period was vital to prove the safety and efficacy of the laser system and dispel any doubts concerning increased adverse events following XPS,” principal investigator and co-author Alexander Bachmann, MD, told 

	“We showed at 6 months and again at 1 year after surgery that side effects and complications of XPS laser were non-inferior-meaning comparable-to TURP. In fact, the questionnaires revealed that the re-intervention rate was higher after TURP, as was recovery, again substantiating that side effects are not higher with XPS,” said Dr. Bachmann, chair of urology and head of the Bladder-Kidney-Prostate Tumor Center at the University of Basel in Basel, Switzerland.

	The Goliath Study included 291 patients who were enrolled between April 2011 and September 2011 at 29 sites in nine European countries. A total of 281 were randomized and 269 received treatment. Non-inferiority was evaluated using one-sided tests at the 2.5% level of significance. An IPSS margin of 3 was deemed necessary to demonstrate non-inferiority. The trial was also powered to compare Qmax and the complication-free rate at 6 months, evaluated at the two-sided (5%) level.

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	At 6 months, the study demonstrated the non-inferiority of PVP to TURP in IPSS. An analysis of secondary endpoints demonstrated that length of catheterization, time until stable health, and length of stay were superior after PVP compared with TURP (

	The 1-year functional results, which included 95.5% of the patients (PVP, 130; TURP, 127), evaluated International Index of Erectile Dysfunction (IIEF-5), International Consultation on Incontinence Modular Questionnaire–Urinary Incontinence short form (ICIQ-UI SF), and overactive bladder quality of life questionnaire (OAB-q).

	The findings showed that IPSS was 7.0 in the PVP arm and 5.7 in the TURP arm (mean difference of 1.3, 95% confidence interval: 0.1–2.7). Qmax was 23.0 in the XPS arm and 24.7 in the TURP arm. The complication-free rate after 12 months was 84.6% for GreenLight XPS patients and 80.5% for TURP patients (

	IIEF-5, IPSS-QoL, post-void residual, prostate volume, and PSA revealed no significant difference between the two treatment arms at 12 months, while the results of OAB-q and ICIQ-UI SF slightly favored TURP statistically. Conversely, the proportion of subjects with adverse events requiring surgical or invasive interventions was 12.4% after PVP and 15.0% after TURP.

	The early postoperative re-intervention rate was three times higher after TURP compared with GreenLight XPS (

=.025); however, the overall postoperative re-intervention rates were not significantly different between treatment arms.

	Limitations to the study include a short follow-up time. A study design comprising a 2-year follow-up period was designed to address this.

	Dr. Bachmann maintained that these data clearly demonstrate that clinical assessments of efficacy and safety at 6 and 12 months are similar between GreenLight XPS and TURP, contradicting the view that the laser is less efficacious and associated with a higher rate of adverse events compared with TURP. The GreenLight XPS laser system using the MoXy fiber represents a significant improvement over previous GreenLight systems in terms of safety and efficacy, he said.

Photoselective vaporization of the prostate is non-inferior to transurethral resection of the prostate in men with benign prostatic obstruction, researchers reported at the European Association of Urology annual congress in Stockholm, Sweden.

Author | Stefanie Petrou Binder, MD

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Botulinum formulations show slight outcomes differences

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