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

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.

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Efficacy of Intracavernosal Injections of 50-Unit versus 100-Unit Doses of AbobotulinumtoxinA (Masport®) in Vasculogenic Erectile Dysfunction with Phosphodiesterase Type 5 Inhibitors Resistant

Nephro-Urology Monthly ◽

10.5812/numonthly.119131 ◽

2022 ◽

Vol In Press (In Press) ◽

Author(s):

Sajad Moradi ◽

Dinyar Khazaeli ◽

Mohammadreza Dadfar ◽

Nima Bakhtiari

Keyword(s):

Erectile Dysfunction ◽

Single Dose ◽

Unit Group ◽

P Value ◽

Phosphodiesterase Type 5 Inhibitors ◽

Systemic Complications ◽

Significant Difference ◽

Unit Dose ◽

Phosphodiesterase Type ◽

Intracavernosal Injections

Background: We aimed to evaluate the safety and efficacy of 50-unit dose against 100-unit dose of intracavernosal injection (ICI) of AbobotulinumtoxinA (BTX-A) (Masport®) in patients with vascular erectile dysfunction (ED) resistant to first-line therapies, including phosphodiesterase type 5 inhibitors (PDE5I). Methods: In this double-blind randomized controlled trial (RCT), 40 patients with ED resistant to PDE5I were randomly divided into two groups: ICI of a single dose of Masport® 50 units and single dose of 100 units. Peak systolic velocity (PSV) confirmed arterial insufficiency vascular disorder. For all patients, IIEF (International Index of Erectile Function), SHIM (Sexual Health Inventory for Men), and EHS (Erection Hardness Score) questionnaires were completed. Six weeks after the treatment, the subjects were re-examined. Results: Our results showed an acceptable clinical efficacy and safety of ICI of Masport® six weeks after injection. No systemic complications in patients were seen. Three patients complained of brief penile pain shortly after injection, but there were no other local complications. The increase in mean PSV in the 100-unit group due to treatment was significant (P-value < 0.0001). Also, there was a significant difference between the two groups of 50- and 100-unit (P-value < 0.0001). In addition, the increase in mean IIEF-EF, SHIM score, and EHS due to treatment was significant between the two groups. For the 100-unit group, P-value < 0.0001 and the difference between the two groups was also significant (P-value < 0.0001), which indicated a better response to treatment in the 100-unit group. The mean increase of IIEF score (EF domain) was 4.3 (mean IIEF: 9.4 and 13.7 after and before, respectively) in the 100-unit group and (mean IIEF: 8.1 and 9.1 after and before, respectively) in the 50-unit group. Conclusions: The results of this study showed that ICI of AbobotulinumtoxinA, especially at a dose of 100 units, in patients with refractory vasculogenic ED is safe and effective in improving sexual function and ultrasound indices.

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Prevalence and risk factors of erectile dysfunction in patients with hepatitis B virus or hepatitis C virus or chronic liver disease: results from a prospective study

Sexual Health ◽

10.1071/sh17168 ◽

2018 ◽

Vol 15 (5) ◽

pp. 408 ◽

Cited By ~ 1

Author(s):

Ivan Gentile ◽

Ferdinando Fusco ◽

Antonio Riccardo Buonomo ◽

Riccardo Scotto ◽

Emanuela Zappulo ◽

...

Keyword(s):

Diabetes Mellitus ◽

Risk Factors ◽

Erectile Dysfunction ◽

Hepatitis C Virus ◽

Liver Disease ◽

Hepatitis C ◽

Chronic Infection ◽

Phosphodiesterase Type 5 Inhibitors ◽

B Virus ◽

Phosphodiesterase Type

Background Approximately 300 million people are affected by hepatitis B virus (HBV) or hepatitis C virus (HCV) infection worldwide. Erectile dysfunction (ED) is a frequent condition that impairs the quality of life and can be associated with several chronic disorders (type 2 diabetes mellitus, atherosclerosis, depression). Few studies have evaluated the prevalence of ED in patients with HBV and HCV chronic infection. The aim of this study was to evaluate the prevalence and the risk factors of ED in a cohort of patients with HBV or HCV-related chronic liver diseases. Methods: Consecutive patients with HCV and HBV chronic infection were enrolled. Results: In total, 89 out (49 with cirrhosis, 21 with HBV and 68 with HCV infection) were included in this study. ED was diagnosed in 76.4% of patients. The use of phosphodiesterase type 5 inhibitors was reported by 21.3% of patients. Patients with ED were older and had a higher rate of cirrhosis and diabetes mellitus compared with patients without ED. At multivariate analysis, diabetes mellitus and stage of liver disease (cirrhosis vs chronic hepatitis) were the only independent predictors of ED. Conclusion: Due to the high rate of ED in outpatients with viral-related liver disease and the underuse of phosphodiesterase type 5 inhibitors, a larger study focussed on these patients is needed.

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Predictors of Erectile Dysfunction in Men with Type 2 Diabetes Mellitus Referred to a Tertiary Healthcare Centre

Advances in Endocrinology ◽

10.1155/2016/9753154 ◽

2016 ◽

Vol 2016 ◽

pp. 1-8 ◽

Cited By ~ 5

Author(s):

Theophilus Ugwu ◽

Ignatius Ezeani ◽

Samuel Onung ◽

Babatope Kolawole ◽

Rosemary Ikem

Keyword(s):

Diabetes Mellitus ◽

Risk Factors ◽

Erectile Dysfunction ◽

Glycemic Control ◽

Autonomic Neuropathy ◽

Erectile Function ◽

Poor Glycemic Control ◽

Testosterone Deficiency ◽

Tertiary Healthcare

Background. The frequency of erectile dysfunction (ED) complicating diabetes mellitus (DM) is reportedly high. However, its risk factors have not been well studied. Methods. This was a cross-sectional study of 160 male type 2 DM adults, aged 30–70 years, attending a tertiary healthcare clinic. Demographic and relevant clinical information was documented. Erectile function was assessed using an abridged version of the International Index of Erectile Function (IIEF-5). All subjects were evaluated for central obesity, glycemic control, peripheral arterial disease (PAD), autonomic neuropathy, dyslipidemia, and testosterone deficiency. Results. 152 (95%) patients with a mean age of 60.3 ± 8.8 years completed the study. 71.1% had varying degrees of ED, while 58.3% suffered from a moderate-to-severe form. Independent predictors of ED [presented as adjusted odds ratio (95% confidence interval)] were longer duration of DM, 1.14 (1.02–1.28), PAD, 3.87 (1.28–11.67), autonomic neuropathy, 3.51 (1.82–6.79), poor glycemic control, 7.12 (2.49–20.37), and testosterone deficiency, 6.63 (2.61–16.83). Conclusion. The prevalence of ED and its severe forms was high in this patient population. Poor glycemic control and testosterone deficiency were the strongest risk factors for ED, making it possibly a preventable condition.

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The Combined Use of Stem Cells and Platelet Lysate Plasma for the Treatment of Erectile Dysfunction: A Pilot Study–6 Months Results

Medicines ◽

10.3390/medicines7030014 ◽

2020 ◽

Vol 7 (3) ◽

pp. 14

Author(s):

Vassilis Protogerou ◽

Sara El Beshari ◽

Efstathios Michalopoulos ◽

Panagiotis Mallis ◽

Dimosthenis Chrysikos ◽

...

Keyword(s):

Stem Cells ◽

Stem Cell ◽

Erectile Dysfunction ◽

Side Effects ◽

Cell Therapy ◽

Stem Cell Therapy ◽

Erectile Function ◽

Peak Systolic Velocity ◽

Platelet Lysate ◽

Intracavernosal Injections

Background: The current treatment of Erectile Dysfunction (ED) is mainly based on the use of drugs that provide erections shortly after use but they do not really treat the problem. Stem cell therapy is a novel treatment with regenerative properties that can possibly treat erectile dysfunction. Methods: Five patients with erectile disease were treated with Adipose-Derived Stem Cells (ADSCs) and Platelet Lysate Plasma (PLP). ADSCs were obtained through abdominal liposuction and PLP was prepared after obtaining blood samples from peripheral veins. Erectile function was evaluated with the International Index of Erectile Function questionnaire (IIEF-5) questionnaire, penile triplex at the 1st, 3rd, 6th and 12th month post-treatment. A CT scan of the head, thorax and abdomen was done before treatment and at the 12th month. Results: IIEF-5 scores were improved in all patients at the 6th month although not in the same pattern in all patients. Peak Systolic Velocity (PSV) also improved at the 6th month in all patients but also with different patterns in each patient, while End Diastolic Velocity (EDV) was more variable. Two patients decreased the treatment they used in order to obtain erection (from Intracavernosal injections (ICI) they used PDE-5Is), two had unassisted erections and one had an initial improvement which decreased at the 6th month. There were no side effects noted. Conclusions: Stem cell therapy in combination with PLP appears to show some improvement in erectile function and has minimal side effects in the short term.

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Penile Low-Intensity Shock Wave Therapy for Erectile Dysfunction: Personal Experience

Klinička psihologija ◽

10.21465/2016-kp-p-0023 ◽

2016 ◽

Vol 9 (1) ◽

pp. 156-156

Author(s):

P. Letizia ◽

◽

G. Alei ◽

A. Rossi ◽

F. De Marco ◽

...

Keyword(s):

Shock Wave ◽

Blood Flow ◽

Erectile Dysfunction ◽

Shock Waves ◽

Endothelial Function ◽

Erectile Function ◽

Power Doppler ◽

Shock Wave Therapy ◽

Low Intensity ◽

Intracavernosal Injections

Objective: Penile extracorporeal low-intensity shock wave therapy (LIST) to the penis has recently emerged as a novel and promising modality in the treatment of erectile dysfunction. LIST can improve penile blood flow and endothelial function by stimulating angiogenesis in the penis. Design and Method: We applied LIST to patients with mild to moderate vasculogenic ED who responded well to the use of PDE5i. The treatment protocol consisted of one treatment sessions per week for 6 weeks, a 6 -week no-treatment interval. Each session comprised the application of 3000 shock waves (energy intensity of 4 mJ/mm3) to each penile shaft and 1000 shock waves for each crura. Results: The results showed that 6 weeks after treatment, erectile function improved in the 85% of the cases, good result was achieved in 10% and no results in 5% of the patients. The average increase in the IIEF-EF domain score was 8.8 points. Furthermore, erectile function and penile blood flow were measured using nocturnal penile tumescence (NPT) and color-power Doppler of the penis. All NPT parameters improved as recorded by significant increases in the duration of the erections and penile rigidity. Conclusions: The treatment options for ED have greatly expanded and include PDE5i, intracavernosal injections, and penile prostheses. Our experience presented here demonstrate that LIST of the corpora cavernosa is a novel therapeutic option for ED. LIST may have a fundamental effect on penile endothelial function, increasing penile blood flow, and improving erectile function and consequently sexual satisfaction.

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A prospective study of erectile dysfunction in men after pelvic surgical procedures and its association with non - modifiable risk factors

10.21203/rs.2.16681/v1 ◽

2019 ◽

Author(s):

Sofia Artemi ◽

Panteleimon Vassiliu ◽

Nikolaos Arkadopoulos ◽

Maria - Eleni Smyrnioti ◽

Pavlos Sarafis ◽

...

Keyword(s):

Risk Factors ◽

Erectile Dysfunction ◽

Erectile Function ◽

Pelvic Surgery ◽

Modifiable Risk Factors ◽

Analysis Model ◽

History Of ◽

Male Patients ◽

A Prospective Study

Abstract Objective: Erectile dysfunction can be caused iatrogenically, due to pelvic surgery. The purpose of this study was to evaluate sexual function at various times after pelvic surgery in male patients and to investigate the non-modifiable risk factors associated with the presence and intensity of sexuality in these patients. Results: The mean age of the participants was 66.16 ± 13.07 years old. Regarding comorbidity, 47.2% reported various cardiovascular problems, 20.8% hypertension, 9.4% diabetes mellitus and 5.7% depression. A history of colectomy was present in 36.8%, 18.9% had undergone sigmoidectomy, and 33% inguinal hernia repair. The percentage of severe erectile function increased from 38.7% before surgery to 48.1% (25% increase) after surgery, at the end of the follow-up period (p <0.05). In the multivariate analysis model, age emerged as an independent predictor of erectile function ( p <0.001). Age was the most important determinant of the IIEF score, which was aggravated by 25% from the first to the last assessment of patients.

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Prospectively collected baseline erectile function (EF) in 1,173 consecutive newly diagnosed prostate cancer patients referred for radiotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.6_suppl.89 ◽

2017 ◽

Vol 35 (6_suppl) ◽

pp. 89-89

Author(s):

Jill Nicholson ◽

Paul J. Kelly

Keyword(s):

Prostate Cancer ◽

Risk Factors ◽

Erectile Dysfunction ◽

Cancer Patients ◽

Erectile Function ◽

Smoking History ◽

Newly Diagnosed ◽

High Prevalence ◽

History Of ◽

Vascular Comorbidity

89 Background: Preservation of EF is a goal of care for many men with newly diagnosed prostate cancer. In order to accurately counsel patients regarding their likely treatment outcome, an assessment of baseline EF, and screening for known risk factors, should form part of the assessment of all prostate cancer patients. Methods: We performed a retrospective review of prospectively-collected data regarding baseline EF in men with prostate cancer referred for a radiotherapy opinion. 1173 consecutive patients referred over a 5.5 year period from 2011-16 were included. All patients were offered the opportunity to complete the International Index of Erectile Function (IIEF-5) questionnaire in privacy. Information on known risk factors such as age, vascular comorbidity, smoking and alcohol history, and cardiovascular risk factors was recorded. Results: Of the 1173 patients, 233 were excluded due to metastatic disease at referral. Of the remaining 940 with localised disease, 812 (86%) completed the questionnaire. 561 (69%) successfully filled the questionnaire yielding a score. A further 251 (31%) commented on the questionnaire without completing the score (see table). Median age was 66years (IQR 62-71). 574(61%) had known risk factors for erectile dysfunction such as hypertension or diabetes. 173 (18.5%) had a history of peripheral, cardiovascular, or cerebrovascular disease. Smoking and alcohol history was available for 645 patients, 353(60%) had a smoking history, and 450(70%) had a history of alcohol use. Conclusions: In this population, there is a high prevalence of baseline erectile dysfunction (IIEF-5 ≤16), 242/561 (43%). Additionally, significant numbers of patients were sexually inactive or unconcerned regarding ED. Known risk factors for erectile dysfunction were common in this population, many of which are modifiable. [Table: see text]

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Recent advances in the understanding and management of erectile dysfunction

F1000Research ◽

10.12688/f1000research.16576.1 ◽

2019 ◽

Vol 8 ◽

pp. 102 ◽

Cited By ~ 5

Author(s):

Sarah C Krzastek ◽

Justin Bopp ◽

Ryan P Smith ◽

Jason R Kovac

Keyword(s):

Erectile Dysfunction ◽

Platelet Rich Plasma ◽

Treatment Options ◽

Well Being ◽

Lifestyle Changes ◽

Phosphodiesterase Type 5 Inhibitors ◽

Prosthetic Devices ◽

Oral Medications ◽

Treatment Paradigm ◽

Intracavernosal Injections

Erectile dysfunction (ED) is important to a man’s well-being and health, since it not only affects the individual but also causes strain on a couple’s lifestyle and relationship. There are multiple non-invasive treatments that exist for ED including lifestyle changes, oral medications (phosphodiesterase type 5 inhibitors), vacuum-assisted erectile devices, and intraurethral suppositories. While lifestyle changes and oral medications are typically first-line treatments for ED, more-invasive treatments including intracavernosal injections and surgically implanted prosthetic devices may be required for the management of complex cases. Additionally, novel therapies are currently being developed, and future treatment options may include shock-wave therapy, external prosthetic devices, and injection of stem cells or platelet-rich plasma. The current manuscript seeks to highlight advances in management and may eventually alter the treatment paradigm to allow more-inclusive care pathways.

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Whether Adding Vitamin D to Tadalafil 5 mg Treatment Is Useful in Patients with Erectile Dysfunction and Vitamin D Deficiency?

Urologia Internationalis ◽

10.1159/000514056 ◽

2021 ◽

pp. 1-6

Author(s):

Aykut Demirci ◽

Murat Çakan ◽

Murat Topçuoğlu

Keyword(s):

Vitamin D ◽

Erectile Dysfunction ◽

Vitamin D Deficiency ◽

Sexual Desire ◽

Erectile Function ◽

Phosphodiesterase Type 5 Inhibitors ◽

Vitamin D Levels ◽

Group 2 ◽

Phosphodiesterase Type ◽

Group 1

Introduction: Numerous factors such as endothelial disease and hormonal disorder cause the development of erectile dysfunction (ED). However, the relationship between vitamin D deficiency (VDD) and ED is unclear. Moreover, the benefit of vitamin D replacement on ED patients with VDD is uncertain. As far as we know, there is no study yet in the literature regarding the addition of vitamin D to phosphodiesterase type 5 inhibitors in the treatment of ED patients with VDD. In this study, we investigated whether adding vitamin D to daily tadalafil treatment would be beneficial in ED patients with VDD. Methods: A total of 111 patients with VDD accompanying ED were retrospectively evaluated between January 2016 and December 2019. Patients were divided into 2 groups according to the treatment they received. Group 1 (n = 58) was treated with daily oral tadalafil 5 mg, while group 2 (n = 53) received oral tadalafil 5 mg and 4,000 IU vitamin D3. Total International Index of Erectile Function-15 (IIEF-15) scores and vitamin D levels of the groups were compared at the end of the study. Results: The mean vitamin D level was increased statistically significant in group 2, but no difference was seen in group 1 (p < 0.001 and p > 0.05, respectively). There was a significant increase in median erectile function, orgasmic function, sexual desire, sexual satisfaction, and overall satisfaction scores in both groups (p < 0.001). However, the increase in median erectile function and sexual desire scores was significantly higher in group 2 compared to group 1 at the end of the study (p = 0.01 and p < 0.001, respectively). Conclusion: We found that adding vitamin D to 5 mg oral daily tadalafil treatment may have an additional positive effect on erectile function and sexual desire in ED patients with VDD.

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A prospective study of erectile dysfunction in men after pelvic surgical procedures and its association with non - modifiable risk factors

10.21203/rs.2.16681/v3 ◽

2019 ◽

Author(s):

Sofia Artemi ◽

Panteleimon Vassiliu ◽

Nikolaos Arkadopoulos ◽

Maria - Eleni Smyrnioti ◽

Pavlos Sarafis ◽

...

Keyword(s):

Risk Factors ◽

Erectile Dysfunction ◽

Prospective Study ◽

Erectile Function ◽

Pelvic Surgery ◽

Control Group ◽

Modifiable Risk Factors ◽

Analysis Model ◽

Male Patients ◽

A Prospective Study

Abstract Objective: A pelvic surgery can cause erectile dysfunction. The purpose of this study was to evaluate erectile function at various times after pelvic surgery in male patients; to search the non-modifiable risk factors associated with the presence and intensity of sexuality in these patients. This prospective study used the erectile dysfunction IIEF scale. Results: The study population comprised of 106 male patients who had undergone minor pelvic surgery at least 9 months before and during the 2010–2016 period in the 4th Surgical Clinic. A control group of healthy males (N=106) who underwent no pelvic surgery matched for age was also used for reference values. The main age of the participants was 66.16 ±13.07 years old. A history of colectomy was present in 36.8%, 18.9% had undergone sigmoidectomy, and 33% inguinal hernia repair. The percentage of severe erectile function increased from 38.7% before surgery to 48.1% (25% increase) after surgery, at the end of the follow-up period (p<0.05). In the multivariate analysis model, age emerged as an independent predictor of erectile function (p<0.001). Age was the most important determinant of the IIEF score, which was aggravated by 25% from the first to the last assessment of patients.

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