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Ultimately, PDE5i have had a significant impact on the treatment of ED in men with SCI. The ease of use and tolerability of the medication has also led to improved satisfaction and quality of life that had been previously affected by SD.

Head to head trials evaluating specific PDE5i within

the

PDE5i should be considered first line therapy, however men with high thoracic and cervical lesions should be warned about an increased chance of dizziness with sildenafil and possibly other PDE5i use.

Parkinson’s disease (PD) PDE5i use in PD has not been well studied; however its benefits have been shown. Raffaele performed an open label, prospective study evaluating the efficacy of sildenafil 50 mg on demand and depressive symptoms experienced by the PD patient (73).

Erections were improved in approximately 85% of men and 75% noted improvements in their depressive symptoms as well. Sildenafil was well tolerated without significant side effects.

, performed a shorter study showing improvements in erectile function but no change in depression and parkinsonisms after ED treatment (74).

Iatrogenic hypotension can occur in men in neurodegenerative disease using sildenafil (49). placed men with PD and MSA on sildenafil and recorded blood pressure before and after.

Half of the 12 MSA patients developed postural hypotension, while none of the twelve PD patients did.

Since MSA can be difficult to distinguished diagnostically from PD, baseline blood pressure measurements prior to prescribing the medication and seeking medical assistance if symptomatic hypotension occurred was recommended for viagra 100mg online shopping all patients with PD, and MSA.

Of note, none of the men with MSA who developed hypotension discontinued sildenafil use due to its effectiveness at improving their erections. Multiple sclerosis (MS) PDE5i for ED in patients with MS can be considered as reasonably effective and safe. performed a randomized, multicenter, double-blind, flexible dose trial with open label extensions comparing sildenafil to placebo (75).

A nearly 4-fold increase in effective erections was noted in the treatment arm, 96% vs.

Sexual satisfaction and overall satisfaction were also improved in the treatment group based on IIEF scores, and quality of life assessments. Seventy eight percent of the men responded with improved erections, better quality of life with regards to sexual function, partner relationship and family life.

Just less than half the men who responded to the tadalafil did so at the lower dosage of 10 mg.

Subjects in either studies did not have any significant adverse side effects beyond flushing, and headache with PDE5i use.

Spina bifida (SB) One study by Palmer and colleagues evaluated sildenafil use in SB males with thoracic lesions (76).

A prospective, blinded, randomized, placebo-controlled, dose-escalation, crossover study in 17 patients with SB and ED was performed.

All study participates took sets of tablet in groups, two sets of placebo, one of 25 mg, and the last 50 mg. Overall response to the tablet sets was measured by IIEF response and self-report of erectile rigidity.

Patients reported that taking 50 mg of sildenafil led to improved erections, duration of erections, frequency of erections and level of confidence compared to sildenafil 25 mg and more significantly compared to placebo.

Of the five patients who reported side effects, two experienced

mild

Sildenafil has been previously suggested as a treatment option for ED in men with epilepsy (77,78). warned that PDE5i are potentially pro-convulsant and should be used with walgreens viagra price great caution in men with epilepsy (79). Animal studies in rat and mice overwhelmingly suggest PDE5i can reduce seizure threshold.

PDE5i exerted their proconvulsive effect by lower seizure threshold possibly by worsening sleep or obstructive sleep apnea, causing cardiovascular changes, or leading to EEG changes specifically with tadalafil use.

Apomorphine is a non-selective D1/D2 receptor agonist with moderate efficacy and good tolerability in the treatment of mild ED (80). Apomorphine can be administered via subcutaneous injection or sublingually.

However, studies have shows a lower efficacy for apomorphine compared to oral sildenafil (81,82).

Apomorphine has a set role in the management of PD for non-motor symptoms, and has been reported to cause spontaneous erections and possible hypersexuality in PD men (83,84).

Its role in the management of ED has been postulated for men with PD but should be considered as an alternative to sildenafil.

Intracavernosal injections (ICI) Intracavenosal therapy involves injection of a vasoactive agent into the corpora cavernosa to effect smooth muscle relaxation and tumescence.

In 1983, Brindley injected the corpora of several SCI men with phentolamine (85). Two out of the three men had a sufficient erection produced.

Since then multiple reports on the efficacy of intracavernosal therapy have been published using, phentolamine, papaverine, prostaglandin, vasoactive intestinal peptide (VIP), and these medications in combination (86-90).

These medications have been found to be extremely effective for neurogenic ED due to their ability act locally and essentially bypassing neuronal pathways.

Local therapies are usually considered second-line after PDE5i fail to elicit a desired response which can occur in about 25–30% of men with ED, in general (91). Furthermore, the locally delivered medications can be quite dangerous if not used appropriately as priapism and significant pain with injections can occur.

These specific occurrences have been suggested as a reason for high discontinuation rates with intracavernosal therapy (92).

Papaverine is an opium alkaloid that acts as a non-specific PDEi that increases intracellular cAMP and cGMP leading corporal smooth muscle relaxation (93).

Intracavernosal papaverine injection was the first clinically effective pharmacological therapy for ED and led to a full erection in at least half of the patient in early studies (94,95). Alprostadil is a potent vasodilator and smooth muscle relaxant identical to the naturally occurring PGE1. PGE1 binds with specific receptors on smooth muscle cells and activates intracellular adenylate cyclase to produce cAMP, which in turn induces tissue relaxation through a second messenger system (96). PGE1 is the only FDA approved form of intracavernosal therapy and is available commercailly as EDEX, or Caverject. Its efficacy was demonstrated in several clinical trials where the rate of responders ranged from 40% to 80% (97,98). The most common adverse event is penile pain, which is not related to the injection of

the

Vasoactive intestinal peptide (VIP) VIP is a neurotransmitter with regulatory actions on blood flow, secretion and muscle tone with intracorporal adenylate cyclase activation and smooth muscle relaxation. VIP has been shown to elevate cAMP intracellular concentrations without affecting cGMP levels.

However, when VIP is given alone it may not induce erection and requires combination with phentolamine or papaverine for it to be effective (88).

Common associated adverse effects were facial flushing and headache.

VIP in combination with phentolamine is currently being used in the UK and Europe and is seeking regulatory approval for use in the United States. Phentolamine blocks post synaptic adrenergic ?1 receptors preventing smooth muscle contraction. However, it also may interfere with prejunctional ?2 receptors, which may counteract the process (100). Consequently, this may be a reason phentolamine is not prescribed as monotherapy, and frequently is combined with papaverine, alprostadil or VIP.

Multiple combinations of intracavernosal therapy exist and the effectiveness of them varies based on patient characteristics and varying dosing strength ( Table 1 ). Combination therapy have been extremely effective in the SCI population, and have several advantages including a reduction in cost per dose and side effects base on the lowered dose of each component (101,102).

Effectiveness of combination therapy in the spinal cord population is well established, but no specific dose recommendations can be made based on the data (103-106).

The use of combination therapy on other forms of neurogenic ED have not been well studied, but there use can be trialed as second-line therapy, or for populations were the side effects of PDE5i may preclude use such as in MSA due to

hypotension

This form of therapy has been trialed in SCI men with intermediate success (108).

Bodner trialed MUSE dose escalation in SCI men and found 1,000 ?g to be the most effective dose. Several men had hypotension when a constriction ring was not used in conjunction with the MUSE therapy. Vacuum erection devices (VED) VED involved placing the penis in a clear plastic tube where negative pressure created by the vacuum pump leads to penile engorgement and tumescence. Usually a constriction ring can be placed on the base of penis following penile engorgement.

Some men complain of bruising, a “cold” penis and pain associated with the constriction ring; however, in some men with NED sensation may not be intact mitigating the side effects of walgreens viagra price VEDs. VEDs have reported effectiveness up to 90% in certain ED populations and it remains a non-invasive means to achieve and erection. (109) compared VEDs with papaverine injections in 18 males with SCI.

The injections and pumps were equally effective in inducing erections and no adverse effects from the treatments were reported.

Treatment arms were crossed over, subsequently seven men chose the VED and seven men walgreens viagra price chose the papavarine highlighting equal efficacy in this population. In another treatment arm topical minoxidil was applied without any effective erections achieved by the study subjects.

VEDs in general have great success in the neurogenic population.

Limitations that may affect use are limited manual dexterity, cost due to non-insurance coverage, lack of spontaneity, artificiality of erection, obesity/buried penis, and anticoagulant use. Prior to the introduction of PDE5i in 1998, intracavernosal vasoactive medications and penile implant surgery were the mainstays of treatment. Penile implant surgery involves placement of inflatable or malleable rods within the corpora cavernosa to provide

rigidity

Choice of which implant to place usually depends upon manual dexterity and function of the patient, patient anatomy, physician preference and surgical

approach

performed penile implant surgery in 245 men with neurolgic impairment caused by spinal cord injury, CNS neoplasm, CNS infection, MS and SB (110). Mean follow-up time of 7.2 years was achieved in 195 patients, 50 patients were excluded for lost to follow-up or death from nonurological causes.

Interestingly, 135 patients underwent penile implantation to assist with management of urinary incontinence and improve ability for condom/intermittent catheterization.

Ninety-two patients patient underwent implantation for ED.

Eighty

two

After adopting an infrapubic approach the perforation rates dropped substantially. Since the advent of PDE5i, many other selective and non-selective peripheral acting compounds have been developed or are in development.

Avanafil has shown promising results in treating ED in post-prostatectomy patients with suspected cavernous nerve injury (111).

Other

experimental

It is suspected that the side effects of apomorphine relate to its D2 receptor affinity. D4 receptor agonists, such as ABT-724 and azulenylmethylpiperazines, may not have the same associated side effects and show potent pro-erectile effects in animal models compared to apomorphine (32,119).

Melanocortin receptor agonists were found to induce erections serendipitously. A study investigating the dermatologic use of Melanotan-II (MT-II) was found to generate erections unexpectedly leading to the development of MTII derivatives for ED treatment (120).

MT-II was initially used to induce pigment changes in the skin for artificial tanning but has been suspected to induce melanoma, however (121).

Finally, gene therapy and stem cell research has widened the frontier of ED treatment proposed as possibility to even reverse ED.

Specifically, gene therapy pertains to repairing the cause of ED by restoring defective gene function and/or altering the expression of the mutant gene (32). Most of the available data on gene therapy are in the animal model. However, a phase I clinical trial walgreens viagra price in men with ED undergoing intracavernous injection with a DNA plasmid carrying the alpha-subunit of the corporal smooth muscle Maxi-K channel showed promise in increased erectile function based on IIEF assessment sustained throughout the 3-month study period (122).

Recently, several advances in the uses of stem cells have bet met with great anticipation.

Stem cells have the ability to differentiate into different cell lines based on the cellular signaling they receive. Bone marrow mononuclear cells in particular have been used for the treatment of ED in animal models. recently delivered bone marrow-mononuclear cells (BM-MNC) into the intracavernous smooth muscle of post radical prostatectomy men (123). The open label, dose escalation phase I/II trial showed improvements in IIEF-15 assessment as well as increased vascularization of the corpora based on penile Doppler arterial velocity measurements.