Botox for Erectile Dysfunction

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madman

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Botox for Erectile Dysfunction (2022)
Engy Habashy MD, Tobias S.Köhler MD


To understand the theoretical pharmacologic effect of BoNT A on erectile function, one must first understand normal erectile physiology. Multiple organ systems play a role in achieving a rigid erection, including the cardiovascular, central nervous, peripheral nervous, endocrine, and psychological systems. Normal psychogenic erections require the input of erotic visual or auditory stimuli. That input is then transmitted from the central nervous system through the spinal cord as neural signals to the peripheral pelvic nerves, which prompt the release of nitric oxide (NO). NO plays a role as a local intrapenile neurotransmitter that facilitates the relaxation of intracavernosal smooth muscle, allowing for increased blood flow into the corpora cavernosa. The expansion of the corpora cavernosa leads to increased pressure on the surrounding emissary veins, thereby decreasing the venous blood outflow. The synergy of increased arterial inflow and decreased venous outflow allows a man to attain and maintain a firm erection.14 Detumescence occurs with the metabolism of cyclic GMP by intracavernosal type 5 cyclic GMP phosphodiesterase. Cyclic GMP is needed to maintain nitric oxide-induced dilation of the intracavernosal smooth muscle tissue.

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The hypothesis behind BoNT A's potential erectogenic effect lies in the idea of an existing balance between sympathetic and parasympathetic influences that maintain flaccidity and rigidity in the penile tissue, respectively. It is believed that BoNT A inhibits the exocytosis of norepinephrine synaptic vesicles at the postganglionic sympathetic neurons in the erectile tissue.
The blunting of the sympathetic tone allows NO, which diffuses freely, to be the dominant neurotransmitter within the erectile tissue, thus increasing the overall parasympathetic tone.11 Additional unknown mechanisms are also thought to play a physiologic role in the efficacy of BoNT A on ED, as studies showed objectively improved erectile function after BoNT A ICI in patients who failed ICI con training sympatholytic agents.5,15 The onset of BoNT A occurs within days of exposure, with maximal effect expected within weeks. The effect on muscle tissue begins to subside at 2 months, and baseline function returns at 3 months.16

Despite the theoretical increased risk of systemic side effects when injecting a neurotoxin into a vascular organ like the penis, no reports of priapism or systemic toxicities have been reported in the 2 animal and 2 human studies conducted to date in this research space.9,10,12,13
In Giuliano's retrospective review, one patient reported mild penile pain during the injection, and another reported mild penile pain during the 3 days following the injection.12 In Abdelrahman's prospective trial, no local or systemic complications occurred in the treatment or the control group during the period of the study.13 Unlike intracavernosal collagenase clostridium histolyticum injections, which may be associated with pain, bruising, or hematomas, BoNT A lacks significant local adverse effects and is well tolerated, similarly to PGE1 ICI. Long-term follow-up after multiple BoNT A ICI is currently lacking. Therefore, long-term safety data and possible sequelae (ie, corporal fibrosis, diminished therapeutic effect, etc.) can't be elucidated at this time.




In conclusion, intracavernosal BoNT A injections have demonstrated safety in many urologic and non-urologic pathologies. The therapeutic potential of its use in the treatment of ED holds some potential but has not seen widespread adoption. A limitation of BoNT A injections includes its limited efficacy duration (months), requiring repeat injection. High-level evidence to support its wide clinical utilization for the treatment of ED is currently scarce. Large multicenter double-blinded randomized controlled trials with extended follow-up are needed to determine the long-term safety and optimal dose of BoNT A in ED treatment. Penile doppler hemodynamics and patient-reported outcomes questionnaires (IIEF/SHIM) can be utilized as objective efficacy metrics in future studies. Given the multitude of treatment options currently available for the management of ED (PDE5i, VED, IU alprostadil, ICI, prostheses) and the many treatment options currently under investigation (LiSWT, SCT, PRP), a substantial advantage of BoNT A use would need to be demonstrated to warrant its inclusion in the treatment algorithms.
 
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madman

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*Multiple organ systems play a role in achieving a rigid erection, including the cardiovascular, central nervous, peripheral nervous, endocrine, and psychological systems
 

madman

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madman

Super Moderator
Again a point that needs to be stressed!

Everyone is so caught up on hormones T, estradiol, DHT, and prolactin.

Erectile function/libido are complex and multifactorial.



*Testosterone replacement therapy can improve several aspects of sexual life, including erection, only in hypogonadal subjects but its contribution alone is clinically effective only in milder forms of erectile dysfunction
 

madman

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madman

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EAU Guidelines on Sexual and Reproductive Health 2023


5.6 Treatment of erectile dysfunction

5.6.2.8 Other treatments

5.6.2.8.1 Botulinum Neurotoxin


Botulinum Neurotoxin A (BoNT-A) is the most commonly used toxin serotype in everyday clinical practice work-up for the management of musculoskeletal, integumentary and urological disorders. Over thst decade BoNT-A has also been investigated also as a possible treatment of ED [595]. On the one hand, this effect is due to the relaxation of the cavernosal smooth muscle secondary to the inhibition of noradrenaline release by the adrenergic neurons which reduces the overall sympathetic tone and facilitates the occurrence of erection after stimulation [596]. On the other, BoNT-A is able to block also the release of acetylcholine from parasympathetic neurons which is crucial for the subendothelial increase of nitric oxide responsible for the erection; as such, it has been proposed that the dilatation of sinusoids at the level of the corpora will be sustained only by the nitric oxide released after stimulation by the non-adrenergic non-cholinergic neurons [596]. Two double-blind placebo-controlled RCTs have investigated the effect of BoNT-A for the treatment of patients with ED who were non-responders to PDE5is or ICI of pro-erectile drugs [597, 598]. One RCT randomized 70 patients with ED refractory to PDE5Is to receive a single ICI of 100 UI of BoNT-A or saline [597]. Patients in both groups were instructed to keep using on-demand high-dose PDE5Is. The RCT showed an improvement in EHS and PSV at two weeks post-treatment. At six weeks the treatment group showed a 5 points improvement in the SHIM score vs. no improvement in the placebo group, with 53% of patients reporting an erection hard enough for vaginal penetration [597]. The second RCT randomized 176 patients, all non-responders to PDE5Is or ICI trimix, to three treatment groups: BoNT-A 100 UI; BoNT-A 50 UI; or placebo [598]. A significant improvement in SHIM, EHS and SEP scores was reported in both treatment groups with a maximum response rate being reacted three months after treatment. Overall, the RCT showed that up to 40% of patients were able to resume satisfactory sexual activity after treatment [598]. Both trials reported only mild local side-effects with no systemic complications.

Other single-arm, non-controlled studies have confirmed these findings [599, 600]; therefore, showing a promising role for BoNT-A in the treatment of patients who are non-responders to well-established ED therapies.
At present, the Guidelines panel considers that no recommendations can be provided, since larger trials are needed to confirm these findings and define the efficacy and safety of BoNT-A for ED.
 
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