Beyond Pills: Understanding the Full Spectrum of ED Options in the 2018 AUA Guideline

Oral medication is the most widely advertised and most frequently prescribed treatment for erectile dysfunction, and many men assume it is the only option available.

The 2018 American Urological Association (AUA) Erectile Dysfunction Guideline covers considerably more. Approximately twenty of its numbered statements concern treatment, and a minority of these address oral medication. The remainder cover devices, injections, surgery, lifestyle modification, psychological support, and an assessment of therapies the panel judged unproven.

This is the final article in our series on the AUA Erectile Dysfunction Guideline. The first explained what the guideline is, the second covered venous leak and surgery, the third examined shared decision-making, and the fourth distinguished arterial from venous causes. This article sets out the full range of options the guideline presents.

Background: what the AUA Guideline is

The Erectile Dysfunction: AUA Guideline (2018) is the primary evidence-based document guiding how urologists in the United States evaluate and treat ED. Each statement carries a designation: Strong, Moderate, or Conditional Recommendation with an evidence grade, or Clinical Principle or Expert Opinion where professional consensus exceeds the published evidence. The guideline asks clinicians to present all options that are not medically contraindicated, and holds that a man may begin with any of them regardless of invasiveness. See our overview of the guideline and our article on shared decision-making.

Lifestyle and mental health

Statement 7 (Moderate Recommendation; Evidence Level: Grade C) asks clinicians to counsel men whose comorbidities affect erectile function that lifestyle modification, specifically dietary change and increased physical activity, improves overall health and may improve erectile function. The guideline uses "may" rather than "will". Lifestyle change is worthwhile and is not usually sufficient on its own.

Statement 6 (Moderate Recommendation; Evidence Level: Grade C) advises that referral to a mental health professional should be considered, to promote treatment adherence, reduce performance anxiety, and integrate treatment into a sexual relationship. Adherence is a recognized problem in ED care: a treatment that is effective but not used consistently does not produce results.

Oral medication

Statement 8 (Strong Recommendation; Evidence Level: Grade B) is the guideline's strongest treatment recommendation: men with ED should be informed about FDA-approved oral PDE5 inhibitors unless contraindicated.

Two subsequent statements address a common cause of apparent treatment failure. Statement 9 (Strong Recommendation; Evidence Level: Grade C) requires that instructions be provided to maximize efficacy, covering timing relative to food and to sexual activity, and the fact that these medications require sexual stimulation to produce an effect. Statement 10 (Strong Recommendation; Evidence Level: Grade B) requires that the dose be titrated for optimal effect. A single dose at the lowest strength, taken with food and without adequate stimulation, does not constitute an adequate trial.

Two further statements refine the picture. Statement 12 (Moderate Recommendation) notes that in men with testosterone deficiency, a PDE5 inhibitor may be more effective when combined with testosterone therapy. Statement 11 (Moderate Recommendation; Evidence Level: Grade C) advises that men hoping to preserve erectile function after prostate cancer treatment should be told that early PDE5 inhibitor use may not improve spontaneous, unassisted erectile function.

Vacuum erection devices

Statement 13 (Moderate Recommendation; Evidence Level: Grade C) covers vacuum erection devices. A VED draws blood into the penis using negative pressure rather than pharmacological action, which makes it suitable for men who cannot take medication or who prefer to avoid it.

A VED has two components. The pump produces the erection, and a constriction ring at the base retains the blood once the vacuum is released. For men whose difficulty is retention rather than filling, the ring performs the therapeutic function, and its fit and stability affect the result more than the pump does.

If you use a constriction ring, observe the standard safe-use limits: a maximum of 30 minutes of continuous wear, removal before sleeping, and immediate removal if numbness, coldness, discolouration, or pain occurs. Men taking anticoagulants, men with sickle cell disease, and men with reduced penile sensation should consult a physician before use.

Intraurethral and injectable therapy

Statement 14 (Conditional Recommendation; Evidence Level: Grade C) covers intraurethral alprostadil, a pellet inserted into the urethra. Statement 16 (Moderate Recommendation; Evidence Level: Grade C) covers intracavernosal injections of alprostadil or combination formulations, administered directly into the erectile tissue.

Injections act on the erectile tissue directly rather than depending on the nerve signalling that oral medication requires. For this reason they are often effective when oral medication is not, including following nerve-sparing prostate surgery.

The guideline attaches a safeguard to each. Statements 15 and 17 are both Clinical Principles requiring an in-office test dose before a man self-administers at home. The test dose establishes the appropriate dose, confirms that the technique can be performed correctly, and provides the opportunity to explain what to do in the event of a prolonged erection.

If an injection produces an adequate erection that then diminishes faster than expected, the pattern is more consistent with an outflow problem than with insufficient dosing. See our article on venous leak and erectile dysfunction.

Penile prosthesis

Statement 18 (Strong Recommendation; Evidence Level: Grade C) states that men with ED should be informed about penile prosthesis implantation. The Strong Recommendation applies to informing the patient, consistent with the guideline's position that treatments need not be attempted in order of invasiveness. An implant is a legitimate option to discuss at any stage.

Reported satisfaction rates are high. The procedure is irreversible: implantation destroys the erectile tissue, so natural erections and most other treatments are not available afterwards. Statement 19 (Clinical Principle) requires counselling on post-operative expectations, and Statement 20 (Clinical Principle) states that the surgery should not be performed in the presence of systemic, cutaneous, or urinary tract infection.

Vascular surgery

Statement 21 (Conditional Recommendation; Evidence Level: Grade C) permits penile arterial reconstruction for young men with focal pelvic or penile arterial occlusion and without generalized vascular disease or veno-occlusive dysfunction. Statement 22 (Moderate Recommendation; Evidence Level: Grade C) states that penile venous surgery is not recommended.

The reasoning is covered in part two of this series, and the arterial-versus-venous distinction in part four.

Therapies classed as unproven

The panel addressed several therapies that are actively marketed but not supported by adequate evidence.

• Statement 23 (Conditional Recommendation; Evidence Level: Grade C): low-intensity extracorporeal shock wave therapy should be considered investigational.
• Statement 24 (Conditional Recommendation; Evidence Level: Grade C): intracavernosal stem cell therapy should be considered investigational.
• Statement 25 (Expert Opinion): platelet-rich plasma therapy should be considered experimental.

These designations indicate that the evidence available at the time of review did not support presenting these therapies as established treatment. They are frequently offered at substantial cost. If one is recommended to you, asking what evidence supports the specific claim being made is appropriate.

Where the list is incomplete

Oral medication, intraurethral therapy, intracavernosal injections, and vacuum pumps all work primarily by increasing blood flow into the penis. Penile prosthesis replaces the vascular mechanism. Arterial reconstruction repairs inflow.

For a man whose primary problem is retention rather than inflow, most of the listed options address a different mechanism, and the guideline does not recommend the surgical procedure directed at his. The remaining approaches are those that improve retention: constriction devices used alone or in place of the ring supplied with a pump, pelvic floor training in milder cases, and combinations pairing an inflow treatment with an outflow treatment.

This reflects the state of the evidence in 2017, when the literature review closed. The practical consequence is that a man with significant veno-occlusive dysfunction who works through the list in the conventional order may spend considerable time on treatments directed at a mechanism that is not his limiting factor.

Practical points

• Ask to hear the full range of options. The guideline expects every non-contraindicated option to be discussed.
• Before concluding that oral medication has failed, confirm you have had an adequate trial: correct instructions and a properly titrated dose (Statements 9 and 10).
• If you use a pump, note that the constriction ring performs the retention function.
• Request an in-office test dose before starting injections or intraurethral therapy. The guideline requires it.
• Treat implantation as an irreversible decision, and one you are entitled to discuss at any stage.
• Ask what evidence supports shock wave, stem cell, or PRP therapy before agreeing to it.
• If your problem is outflow, say so, and ask about approaches that address retention.

Summary

• The 2018 guideline presents a wide range of options, of which oral medication is a minority of the treatment statements.
• PDE5 inhibitors carry the strongest recommendation (Statement 8). Two further Strong Recommendations on instruction and dose titration indicate that many apparent failures are inadequate trials.
• Vacuum devices, intraurethral alprostadil, injections, and penile prosthesis each have their own statements. In-office test doses are required before self-administered therapies.
• Vascular surgery is narrowly permitted for arterial disease in young men and is not recommended for venous disease.
• Shock wave, stem cell, and PRP therapies are classed as investigational or experimental.
• Most listed options address inflow. Men whose primary problem is retention often require approaches directed at outflow, alone or combined with inflow therapies.

This concludes the five-part series. If you have comments or questions, please don't hesitate to contact us at hello@xialla.com.

References

• Burnett AL, Nehra A, Breau RH, et al. Erectile Dysfunction: AUA Guideline. Journal of Urology. 2018;200(3):633–641. https://www.auajournals.org/doi/10.1016/j.juro.2018.05.004
• American Urological Association. Erectile Dysfunction: AUA Guideline (2018) — unabridged version, including Statements 6 through 25 covering lifestyle, mental health referral, PDE5 inhibitors, vacuum erection devices, intraurethral alprostadil, intracavernosal injections, penile prosthesis, vascular surgery, and investigational therapies. AUA Guidelines page
• Claes H, et al. Pelvic floor exercise versus surgery in the treatment of impotence. British Journal of Urology. 1993.