Botulinum neurotoxin serotype-A (BoNT-A) as a new therapy to treat Erectile Disfunction (ED). Our experience

==inizio objective==

This study evaluated the efficacy of Botulinum neurotoxin serotype-A (BoNT-A) to treat vasculogenic erectile dysfunction (ED) not responding to phosphodiesterase inhibitors type 5 (PDE5i) at high dosages.

==fine objective==

==inizio methodsresults==

The BoNT-A used in our study was Botox® (onabotulinumtoxin A; Allergan) due to robust randomized controlled trial data supporting its efficacy and safety in the treatment of a variety of medical pathologies [1]. In urology, intradetrusor BoNT-A injection has revolutionized the treatment landscape for patients with neurogenic bladder because has proven its efficacy in reducing intravesical pressure and in reducing incontinence episodes [2].
At our Andrology department, after obtaining a specific informed consent, 11 men aged between 52 to 61 affected by vasculogenic ED unresponsive to any PDE5i at maximum possible dosage were treated with an only one-time intracavernosal injection (ICI) of Botox® 50 U. All patients answered “no” to questions 2 and 3 of the Sexual Encounter Profile (SEP). Patients with an history of radical pelvic surgery, spinal cord injury, preexisting neuromuscular disorders (such as myasthenia gravis or amyotrophic lateral sclerosis), presence of hormonal or anatomical abnormalities were exclude from study. During the study the patients could not use any oral or injectable medications for ED.

==fine methodsresults==

==inizio results==

Only one patient had priapism occurred about an hour after the injection which resolved by ICI of ephedrine. Two patients had reported pain after injection that was managed with oral analgesics. No systemic side effects were noted. At follow-up visit, three months after ICI of BoNT-A, 10 patients answered “yes” to questions 2 and 3 of SEP. Only one patient reported penile erections sufficient to permit a satisfactory sexual performance using in addition on-demand Tadalafil 5 mg.

==fine results==

==inizio discussions==

BoNT-A inhibits sympathetic adrenergic or cholinergic vasoconstriction, sensory nerves, endothelial exocytosis of endothelin 1, which are involved in the pathophysiology of ED [3]. The muscle relaxing capacity of BoNT-A could be used within the corpora cavernosa to enhance valid erections, thus introducing a possible new line of safe and effective treatment for erectile dysfunction (ED) not responding to phosphodiesterase inhibitors type 5 (PDE5i) at high dosages.

==fine discussions==

==inizio conclusion==

BoNT-A could be a viable and safe therapy for vasculogenic ED unresponsive to any PDE5i, compared to self-administered intracavernosal injection of Prostaglandin E1 (PGE1). Further studies are needed to confirm the validity of this therapeutic choice and to determine how long the action of BoNT-A lasts.

==fine conclusion==

==inizio reference==

Reddy AG, Dick BP, Natale C, Akula KP, Yousif A, Hellstrom WJG. Application of Botulinum Neurotoxin in Male Sexual Dysfunction: Where Are We Now? Sex Med Rev. 2021 Apr;9(2):320-330. doi: 10.1016/j.sxmr.2020.05.004. Epub 2020 Jul 5. PMID: 32641225.
Linsenmeyer TA. Use of botulinum toxin in individuals with neurogenic detrusor overactivity: state of the art review. J Spinal Cord Med. 2013 Sep;36(5):402-19. doi: 10.1179/2045772313Y.0000000116. PMID: 23941788; PMCID: PMC3739890.
El-Shaer W, Ghanem H, Diab T, Abo-Taleb A, Kandeel W. Intra-cavernous injection of BOTOX® (50 and 100 Units) for treatment of vasculogenic erectile dysfunction: Randomized controlled trial. Andrology. 2021 Jul;9(4):1166-1175. doi: 10.1111/andr.13010. Epub 2021 Apr 20. PMID: 33784020.

==fine reference==

Vacuum Erection Device for erectile function rehabilitation after radical prostatectomy: which is the correct schedule? Results from a systematic review

==inizio objective==

Vacuum erection device (VED), for its capacity to improve the peak flow and elasticity of cavernous arteries, is a well-known tool to improve recovery of erectile function (EF) after radical prostatectomy (RP). Aim of this study is to compare the different therapeutic schemes proposed in literature to find the most effective timing for VED treatment and to evaluate its efficacy alone or associated with phosphodiesterase 5 inhibitors (PDE5i).

==fine objective==

==inizio methodsresults==

A systematic review of Literature was performed on October 2022 using MEDLINE, EMBASE, and Cochrane Central Controlled Register of Trials to retrieve all articles dealing with EF rehabilitation after RP (excluding non-English papers or meeting abstracts). Patients were divided among those receiving VED alone or combined with other treatments. Study outcomes were compared dividing them between those with follow-up shorter or longer than 12 months

==fine methodsresults==

==inizio results==

The literature search retrieved 496 papers. 144 duplicate studies were automatically excluded. After title and abstract screening of the remaining 352 unique references, 207 records were excluded because they were irrelevant to this study’s aim. There were left 145 full texts which were assessed for eligibility. Finally, 16 papers were accepted and included [1-16].
Among them, 7 were randomized-controlled trials (RCT), 5 were prospective observational studies and 4 were retrospective. VED alone was evaluated in 8 articles, while 6 papers evaluated the combination of VED with 5PDEi. Regarding VED therapeutic protocol, most of studies used it daily (8/16). Rehabilitation protocol lasted less than one year in 6 studies, up to 12 months in 5 studies and more than 1 year in 4 studies. 11/16 studies had a comparison treatment arm.

==fine results==

==inizio discussions==

Even if combination therapy appeared to increase EF outcomes, no significative improvements were noted for patients who underwent the treatment over 12 months. VED results appear to increase when patients were addressed to VED-dedicated programs to enhance their compliance to the device. Continuative use of VED after RP was also useful to prevent penile shrinkage and deformities such as Peyronie disease who can often occur after RP.

==fine discussions==

==inizio conclusion==

VED application for the first 12 months after RP appear to significantly improve EF recovery and conservation of penile length especially when associated to oral 5PDEi treatment. Dedicated VED education programs should be promoted to increase patients’ understanding and compliance to the treatment.

==fine conclusion==

==inizio reference==

1. Albaugh J, Adamic B, Chang C, et al: Adherence and barriers to penile rehabilitation over 2 years following radical prostatectomy. BMC Urol. 2019; 19: 89.
2. Baniel J, Israilov S, Segenreich E, et al: Comparative evaluation of treatments for erectile dysfunction in patients with prostate cancer after radical retropubic prostatectomy. BJU Int. 2001; 88: 58–62.
3. Osadchiy V, Eleswarapu S V, Mills SA, et al: Efficacy of a preprostatectomy multi-modal penile rehabilitation regimen on recovery of postoperative erectile function. Int. J. Impot. Res. 2020; 32: 323–328.
4. Raina R, Agarwal A, Ausmundson S, et al: Early use of vacuum constriction device following radical prostatectomy facilitates early sexual activity and potentially earlier return of erectile function. Int. J. Impot. Res. 2006; 18: 77–81.
5. Raina R, Agarwal A, Allamaneni SSR, et al: Sildenafil citrate and vacuum constriction device combination enhances sexual satisfaction in erectile dysfunction after radical prostatectomy. Urology 2005; 65: 360–364.
6. Raina R, Pahlajani G, Agarwal A, et al: Long-term potency after early use of a vacuum erection device following radical prostatectomy. BJU Int. 2010; 106: 1719–1722.
7. Rujinithiwat S, Usawachintachit M, Panumatrassamee K, et al: Early penile rehabilitation with a vacuum erectile device in patients undergoing robotic-assisted radical prostatectomy: A randomized trial. Urol. Sci. 2021; 32: 77–82.
8. Zhang M, Che J-Z, Liu Y-D, et al: A prospective randomized controlled study on scheduled PDE5i and vacuum erectile devices in the treatment of erectile dysfunction after nerve sparing prostatectomy. Asian J. Androl. 2022; 24: 473–477.
9. Basal S, Wambi C, Acikel C, et al: Optimal strategy for penile rehabilitation after robot-assisted radical prostatectomy based on preoperative erectile function. BJU Int. 2013; 111: 658–665.
10. Dalkin BL and Christopher BA: Preservation of penile length after radical prostatectomy: Early intervention with a vacuum erection device. Int. J. Impot. Res. 2007; 19: 501–504.
11. Engel JD: Effect on sexual function of a vacuum erection device post-prostatectomy. Can. J. Urol. 2011; 18: 5721–5725.
12. Gontero P, Fontana F, Zitella A, et al: A prospective evaluation of efficacy and compliance with a multistep treatment approach for erectile dysfunction in patients after non-nerve sparing radical prostatectomy. BJU Int. 2005; 95: 359–365.
13. Jones P, Sandoval Barba H, Johnson MI, et al: Erectile dysfunction after robotic radical prostatectomy: Real-life impact of vacuum erection device clinic. J. Clin. Urol. 2021; 14: 325–331.
14. Kimura M, Caso JR, Bañez LL, et al: Predicting participation in and successful outcome of a penile rehabilitation programme using a phosphodiesterase type 5 inhibitor with a vacuum erection device after radical prostatectomy. BJU Int. 2012; 110: E931-8.
15. Köhler TS, Pedro R, Hendlin K, et al: A pilot study on the early use of the vacuum erection device after radical retropubic prostatectomy. BJU Int. 2007; 100: 858–862.
16. Nason GJ, McNamara F, Twyford M, et al: Efficacy of vacuum erectile devices (VEDs) after radical prostatectomy: the initial Irish experience of a dedicated VED clinic. Int. J. Impot. Res. 2016; 28: 205–208.

==fine reference==