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Safety and Efficacy of Intracavernosal Injections of AbobotulinumtoxinA (Dysport®) as Add on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 for Erectile Dysfunction-Case Studies.

ABSTRACT: Erectile dysfunction (ED) is a highly prevalent condition with a variety of possible risk factors and/or etiologies. Despite significant advances regarding ED pharmacological management, there are still insufficient responders to existing pharmacological treatments e.g., approximately 30% of patients are insufficient responders to phosphodiesterase type 5 inhibitors (PDE5-Is). It has been recently proposed that botulinum toxin A intracavernosally (IC) delivered could be effective in these patients. Data from a retrospective uncontrolled single center study of 47 ED patients, consecutively recruited, insufficient responders to existing pharmacological treatments e.g., PDE5-Is or IC PGE1 injections treated with IC abobotulinumtoxinA 250 or 500 U as free combination with their existing treatment have been analyzed. Response rate, according to the International Index of Erectile Function-Erectile Function domain score, 6 weeks following IC abobotulinumtoxinA in combination with prior pharmacological treatment, was 54%. Two patients have reported mild penile pain on injection or during the 3 days following injection. Therapeutic efficacy did not seem to be influenced by the etiologies and/or risk factors for ED. Conversely, the less severe ED, the higher the response rate. Preliminary evidence for the therapeutical potential with acceptable safety of IC abobotulinumtoxinA as add-on therapy for ED not sufficiently responsive to standard therapy should be confirmed in randomized clinical trials.

SUBMITTER: Giuliano F

PROVIDER: S-EPMC6563248 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Safety and Efficacy of Intracavernosal Injections of AbobotulinumtoxinA (Dysport<sup>®</sup>) as Add on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 for Erectile Dysfunction-Case Studies.

Giuliano Francois F Joussain Charles C Denys Pierre P

Toxins 20190521 5

Erectile dysfunction (ED) is a highly prevalent condition with a variety of possible risk factors and/or etiologies. Despite significant advances regarding ED pharmacological management, there are still insufficient responders to existing pharmacological treatments e.g., approximately 30% of patients are insufficient responders to phosphodiesterase type 5 inhibitors (PDE5-Is). It has been recently proposed that botulinum toxin A intracavernosally (IC) delivered could be effective in these patien ...[more]

PMID: 31117236

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Project description:BackgroundBotulinum toxin (BoNT) injections were shown to improve muscle tone of limbs in patients with spasticity. However, limited data are available regarding the effects of repeated BoNT injections on walking ability.ObjectiveTo assess changes in walking velocity (WV), step length, and cadence under different test conditions after repeated treatment with abobotulinumtoxinA (aboBoNT-A; Dysport) in spastic lower limb muscles.DesignSecondary analysis of an open-label, multiple-cycle extension (National Clinical Trials number NCT01251367) to a phase III, double-blind, randomized, placebo-controlled, single-treatment cycle study, in adults with chronic hemiparesis (NCT01249404).SettingFifty-two centers across Australia, Belgium, the Czech Republic, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia, and the United States.Patients352 Ambulatory adults (18-80 years) with spastic hemiparesis and gait dysfunction caused by stroke or traumatic brain injury, with a comfortable barefoot WV of 0.1 to 0.8 m/s.InterventionsUp to four aboBoNT-A treatment cycles, administered to spastic lower limb muscles.Main outcome measurementsChanges from baseline in comfortable and maximal barefoot and with shoes WV (m/s), step length (m/step), and cadence (steps/minutes).ResultsAt Week 12 after four injections, WV improved by 0.08 to 0.10 m/s, step length by 0.03 to 0.04 m/step, and cadence by 3.9 to 6.2 steps/minutes depending on test condition (all P < .0001 to .0003 vs baseline). More patients (7% to 17%) became unlimited community ambulators (WV ≥0.8 m/s) across test conditions compared with baseline, with 39% of 151 patients classified as unlimited community ambulators in at least one test condition and 17% in all four test conditions.ConclusionsClinically meaningful and statistically significant improvements in WV, step length, and cadence under all four test conditions were observed in patients with spastic hemiparesis after each aboBoNT-A treatment cycle.

Project description:BackgroundThe recognition of the erectile dysfunction pathogenesis is essential to identify the appropriate erectile dysfunction management. As vascular erectile dysfunction could be a manifestation of a systemic arterial damage, the watershed in the erectile dysfunction diagnostic framework is the discrimination between psychological erectile dysfunction and vascular erectile dysfunction. However, reliable tools to directly diagnose psychological erectile dysfunction are currently lacking.ObjectiveTo identify which parameters could predict psychological erectile dysfunction. Moreover, we suggest a new intracavernosal injection procedure to optimize the erectile dysfunction diagnostic workup.Materials and methodsA retrospective, real-world analysis was carried out including all men who underwent intracavernosal injection procedure at the Modena Andrology Unit from 2018 to 2021. A first intracavernosal injection procedure with 5 µg of prostaglandin E-1 (PGE-1) was performed. In the absence of a full drug-induced erection (immediate or delayed), an echo-color Doppler penile evaluation after administration of PGE-1 10 µg was conducted, measuring intracavernosal blood flows, to document a possible vascular etiology. Hormonal evaluations were performed.ResultsOut of 179 enrolled patients, 70.4% showed psychological erectile dysfunction, 21.7% vascular erectile dysfunction, and 7.8% hormonal genesis. Multinomial logistic regression analysis identified absence of cardiovascular disease (p = 0.017), presence of spontaneous morning erections (p = 0.018), and normal penile erections with masturbation (p = 0.035) as predictors of psychological erectile dysfunction. Clinically, normal intracavernosal injection test response was detected in 86 patients and abnormal response in 93 subjects. Among the latter, 54 patients experienced a delayed response. The combination of intracavernosal injection test with late penile erections evaluation was able to diagnose psychological erectile dysfunction (sensitivity 97%, specificity 100%), avoiding unnecessary retesting.DiscussionWe propose a two-step intracavernosal injection procedure that allows to recognize psychological erectile dysfunction with a high sensitivity/specificity, saving costs and time, and limiting adverse events. Moreover, the presence of spontaneous morning erections and valid penile erections after masturbation could guide the diagnostic workup, indirectly identifying those patients deserving of a deeper evaluation of vascular health.

Project description:BackgroundFollowing metoidioplasty, transmen (TM) experience sexual function challenges including erectile dysfunction, which is typically treated in cisgender men with phosphodiesterase-5 inhibitors (PDE5i) and intracavernosal injections (ICI).AimWe aim to evaluate sexual function post-metoidioplasty and explore attitudes toward using PDE5i and ICI as potential erectile aids METHODS: All patients who had metoidioplasty completed at the Gender Surgery Program in Vancouver, British Columbia were contacted. Participants completed an electronically accessible self-constructed questionnaire consisting of 39 items on erectile function, orgasm, and penetrative intercourse which also captured Erection Hardness Scores (EHS). Data were analyzed via t-test and 1-way ANOVA.OutcomesOur outcomes were the importance of erectile function, ability to orgasm, penetrative intercourse, and attitudes towards using PDE5i and ICI post-metoidioplasty.ResultsFifteen out of 22 patients completed the survey (median age 32 years). Most had metoidioplasty within the past 2 years. The participants ranked the ability to orgasm and to achieve or maintain erections significantly higher than penetrative intercourse (P <.001, P =.005 respectively). Most participants reported facing challenges with penetrative intercourse (87%) and erectile function (80%). In contrast, a smaller proportion reported challenges with orgasm (33%). With regards to EHS, 83% of participants described their erections as either "larger but not hard," or "hard but not hard enough for penetration." A total of 47% of the participants had previously tried PDE5i, but none had used ICI. Although 87% were willing to use PDE5i, only 40% were willing to try ICI to improve their erections. Patients reported lack of knowledge and understanding among primary care physicians as barriers to accessing treatment for sexual dysfunction.Clinical translationThe results of this study can facilitate decision making for TM undergoing genital gender-affirmation surgery and provide potential options for improving erectile function post surgery.Strengths & limitationsThis study represents the first assessment of sexual function and use of erectile aids in post-metoidioplasty patients. The results of this study are limited by the small sample size and enrolment from a single surgical center.ConclusionMetoidioplasty patients surveyed fail to achieve a fully rigid erection without treatment, typically retain the ability to orgasm, and are generally willing to try PDE5i. Khorrami A, Kumar S, Bertin E, et al. The Sexual Goals of Metoidioplasty Patients and Their Attitudes Toward Using PDE5 Inhibitors and Intracavernosal Injections as Erectile Aids. Sex Med 2022;10:100505.

Project description:BackgroundAlthough the short- and long-term effectiveness of abobotulinumtoxinA (Dysport®/Azzalure®) for glabellar line (GL) treatment is well established, reporting of subject satisfaction over repeat treatment cycles is limited. The APPEAL study aimed to assess subject satisfaction with long-term GL treatment with abobotulinumtoxinA in a real-life setting.MethodsAPPEAL was a noninterventional, prospective, longitudinal study in subjects administered ≥ 3 abobotulinumtoxinA injection cycles for moderate-to-severe GL, according to routine clinical practice. Subjects completed a satisfaction questionnaire at 3 weeks (± 7 days) after each cycle. Primary endpoint included subjects' overall satisfaction with GL after three injection cycles. Secondary endpoints included satisfaction after Cycles 1 and 2 and factors associated with satisfaction after each cycle. Physician satisfaction was also assessed after Cycles 1 and 3.ResultsOf 150 subjects enrolled, 135 completed the overall subject satisfaction questionnaire after Cycle 3. At 3 weeks after Cycle 3, 99.3% of subjects were 'very satisfied' (74.1%) or 'satisfied' (25.2%) with GL. Levels of subject satisfaction and associated factors after Cycles 1 and 2 were as large and significant as after Cycle 3 (83-100%, depending on question). Physicians' satisfaction with GL appearance, facial expression, and overall satisfaction was almost complete after the first injection (≥ 97.4%) and unanimous after the third (100%).ConclusionsIn the APPEAL study, overall satisfaction was high after three abobotulinumtoxinA injection cycles for GL based on both subjects' (99.3%) and physicians' (100.0%) assessments. High levels of subject satisfaction reported after Cycle 1 were maintained with repeated injections. No new safety signals were observed.Level of evidence ivThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . Trial registration NCT02353897.

Project description:PurposeIntracorporeal injections have low use rates and high discontinuation rates. We examined factors associated with intracorporeal injection use, long-term satisfaction with intracorporeal injection and reasons for discontinuation in men treated with radical prostatectomy.Materials and methodsBetween October 2000 and September 2003, 731 men who underwent open radical retropubic prostatectomy were enrolled in a prospective outcomes study. The 8-year followup evaluation included the UCLA-PCI, and a survey capturing intracorporeal injection use, satisfaction and reasons for discontinuation. Logistic regression was used to determine associations between intracorporeal injection use and preoperative variables.ResultsThe 8-year self-assessment was completed by 368 (50.4%) men. Of these men 140 (38%) indicated prior or current intracorporeal injection use, with only 34 using intracorporeal injection at 8 years. Overall, 44% of the men were satisfied with intracorporeal injections. Reasons for discontinuation included dislike (47%), pain (33%), return of erection (19%), inefficacy (14%) and no partner (6%). Men trying intracorporeal injections had greater preoperative UCLA-PCI sexual function scores (75.2 vs 65.62, p = 0.00005) as well as greater decreases in this score at 3 months (p = 0.0002) and 2 years (p = 0.003). Higher preoperative sexual function scores were independently associated with the use of intracorporeal injections in a model adjusted for age, marital status, nerve sparing status and body mass index (OR 1.021, 95% CI 1.008-1.035).ConclusionsMen pursuing intracorporeal injections have better baseline erectile function and experience greater deterioration in erectile function during the early postoperative period. Despite the high efficacy of injections, many men discontinue intracorporeal injections due to dislike or discomfort. Satisfaction rates for intracorporeal injections indicate their long-term role in restoring sexual function in men with post-prostatectomy erectile dysfunction.

Dataset Information

Safety and Efficacy of Intracavernosal Injections of AbobotulinumtoxinA (Dysport®) as Add on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 for Erectile Dysfunction-Case Studies.

Publications

Safety and Efficacy of Intracavernosal Injections of AbobotulinumtoxinA (Dysport<sup>®</sup>) as Add on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 for Erectile Dysfunction-Case Studies.

Similar Datasets

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