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

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.

Sexual dysfunction and rehabilitation of patients with spinal cord injury

In the rehabilitation of patients with spinal cord injuries, sexual rehabilitation is a pertinent issue that should not be ignored. Although they may not openly discuss sexual issues with their doctor at first, patients consider these issues to be very important. Therefore, doctors should ask their patients about their sexual problems in order to provide them with consultation and treatment. For males with spinal cord injuries, erectile dysfunction is the most significant problem. Patients are looking for a doctor who can help them to solve their problem of erectile dysfunction. Fortunately, there are a variety of effective methods that can help with erectile dysfunction in patients with spinal cord injuries. Oral medications, such as sildenafil, are very effective. However, if medications prove ineffective, intracavernosal injections may be considered. Couples with spinal cord injury are, of course, still capable of sexual intercourse. A couple in which the patient is a male may use the woman-on-top position. If the aim is conception, women with spinal cord injuries should be informed that their fertility is likely unaffected. Doctors may recommend that males with spinal cord injuries be treated in a fertility clinic. Hospitals with full-time sexual rehabilitation personnel and sexual rehabilitation programs can be of great help to patients with spinal cord injuries. The scope of such sexual rehabilitation should include not only medical help but also strategies for restoring sexual life, eliminating conflicts, and ensuring the happiness of couples.

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

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.

Smooth Muscle Progenitor Cells Preserve the Erectile Function by Reducing Corporal Smooth Muscle Cell Apoptosis after Bilateral Cavernous Nerve Crush Injury in Rats

Radical prostatectomy causes erectile dysfunction (ED) and irreversible morphologic changes, including induction of endothelial and smooth muscle cell (SMC) apoptosis in the corpus cavernosum (CC). The injection of smooth muscle progenitor cells (SPCs) thickens the vascular intima and has demonstrated therapeutic benefit in cardiovascular disease animal. Herein, we investigated the effect of SPCs on the recovery of erectile function (EF) in rat models with bilateral cavernous nerve (CN) injury. Twenty-four male Sprague-Dawley rats were randomized into sham, vehicle only, or SPC treatment groups. Rats in the SPC treatment and vehicle groups were subjected to bilateral CN injury before intracavernosal injection. Intracavernosal injections of SPCs increased all EF parameters at day 28 after injury and simultaneously reduced apoptosis of the SMCs. Ultrastructural analysis revealed that SPCs maintained the integrity of the CC by preserving the structure of the adherens junctions. Tracking transplanted SPCs labeled with EdU showed that transplanted SPCs remained in the CC 28 days after treatment. Intracavernosal SPC injection restored EF after bilateral CN injury by reducing SMC apoptosis, which favored the maintenance of the structure of adherens junctions and regulated the stability of corporal vessels. These findings demonstrate the therapeutic potential of SPCs for treating ED in humans.

How much do people know about male sexual problems? A survey in a selected population sample

Objectives: Our purpose has been to investigate by an ad hoc questionnaire the knowledge of several aspects of male sexual dysfunction in a significant sample of men and women (largely not physicians) attending an International Health Care Exhibition, held in Italy. Materials and methods: The survey took place during Exposanità, 2018 edition, aimed at medical and non-medical professionals. We devised as investigation tool an ad hoc anonymous questionnaire in two versions, one for each sex. Object of this report are questions addressing subject’s knowledge of prevalence of erectile dysfunction (ED), ED causes, ED as early sign of coronary heart disease/myocardial infarction, available ED treatments and attitudes towards penile prosthesis, and reimbursement of ED treatments. Results: As many as 1094 Convention attendees (495 men, 599 women) participated to the survey (about 4% of total attendees). Mean sample age was 40.5 years in men and 39.9 years in women. Forty-three percent of the sample worked in healthrelated professions, 5.9% being physicians. Respondents globally over-estimated the prevalence of ED. Both responding men and women rated psychologic and lifestyle factors as the most frequent ED causes. The majority of responders did not regard ED as a possible predictor of cardiovascular events. Oral pills resulted the most known ED treatment by both men (77.2%) and women (79.1%). Psychotherapy ranked as the second most known treatment approach. Other effective ED treatments (intracavernosal injections, vacuum erection device, penile prostheses) were known by a minority of men (22.2-27.9%) and women (19.2-20.2%). Roughly half of the sample (50.7% of men and 48.4% of women) were willing to choose (men) or to support (women) the penile prosthesis option in cases of severe ED; majority of both sexes (71.3% of men and 76.3% of women) expressed no resistances to the perspective of penile prosthesis use. Vast majority of men (80.3%) and women (80.4%) considered that coverage for ED treatments should be provided by the National Health System.Conclusions: The outcomes of our survey show both an elevated prevalence of misconceptions on the role of organic factors in the etiology of ED, and ignorance of the implications of ED on cardiovascular health. Knowledge of available second level ED treatments resulted scanty. Nonetheless, when confronted with the most aggressive treatment, penile prosthesis, majority of both genders responders would undergo/support this surgery, should it be the only way to solve the erectile problem. In this perspective, population appears ready and overall keen to a treatment option that too often is not addressed by majority of the medical community when counseling men with severe ED not responsive to conservative approach.

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.