Recommendations
Major Recommendations
Definitions of the strength of the recommendations (standard, recommendation, option) are defined at the end of the "Major Recommendations" field.
Initial Management and Discussion of Treatment Options with Patients
Recommended Therapies and Patient Information
Standard: The management of erectile dysfunction begins with the identification of organic comorbidities and psychosexual dysfunctions; both should be appropriately treated or their care triaged. The currently available therapies that should be considered for the treatment of erectile dysfunction include the following: oral phosphodiesterase type 5 (PDE5) inhibitors, intra-urethral alprostadil, intracavernous vasoactive drug injection, vacuum constriction devices, and penile prosthesis implantation. These appropriate treatment options should be applied in a stepwise fashion with increasing invasiveness and risk balanced against the likelihood of efficacy (based on review of data and Panel consensus).
Standard: The patient and, when possible, his partner should be informed of the relevant treatment options and their associated risks and benefits. The choice of treatment should be made jointly by the physician, patient, and partner, when possible, taking into consideration patient preferences and expectations and the experience and judgment of the physician (based on Panel consensus).
Treatment Guideline Statements
PDE5 Inhibitors
Standard: Oral PDE 5 inhibitors, unless contraindicated, should be offered as a first-line of therapy for erectile dysfunction (based on review of data and Panel consensus).
Standard: PDE5 inhibitors are contraindicated in patients who are taking organic nitrates (based on review of U.S. Food and Drug Administration [FDA]-approved product labeling and Panel consensus).
Recommendation: The monitoring of patients receiving continuing PDE5 inhibitor therapy should include a periodic follow-up of efficacy, side effects, and any significant change in health status including medications (based on Panel consensus).
Recommendation: Prior to proceeding to other therapies, patients reporting failure of PDE5 inhibitor therapy should be evaluated to determine whether the trial of PDE5 inhibition was adequate (based on Panel consensus).
Recommendation: Patients who have failed a trial with PDE5 inhibitor therapy should be informed of the benefits and risks of other therapies, including the use of a different PDE5 inhibitor, alprostadil intra-urethral suppositories, intracavernous drug injection, vacuum constriction devices, and penile prostheses (based on Panel consensus).
Alprostadil Intra-urethral Suppositories
Standard: The initial trial dose of alprostadil intra-urethral suppositories should be administered under healthcare provider supervision due to the risk of syncope (based on review of FDA-approved product labeling and Panel consensus).
Intracavernous Vasoactive Drug Injection Therapy
Standard: The initial trial dose of intracavernous injection therapy should be administered under healthcare provider supervision (based on Panel consensus).
Standard: Physicians who prescribe intracavernous injection therapy should (1) inform patients of the potential occurrence of prolonged erections, (2) have a plan for the urgent treatment of prolonged erections, and (3) inform the patient of the plan (See the National Guideline Clearinghouse [NGC] summary of the American Urological Association [AUA] guideline The Management of Priapism) (based on Panel consensus).
Vacuum Constriction Devices
Recommendation: Only vacuum constriction devices containing a vacuum limiter should be used whether purchased over-the-counter or procured with a prescription (based on Panel consensus).
Treatment Modalities With Limited Data
Trazodone
Recommendation: The use of trazodone in the treatment of erectile dysfunction is not recommended (based on review of the data and Panel consensus).
Testosterone
Recommendation: Testosterone therapy is not indicated for the treatment of erectile dysfunction in the patient with a normal serum testosterone level (based on Panel consensus).
Yohimbine
Recommendation: Yohimbine is not recommended for the treatment of erectile dysfunction (based on review of the data and Panel consensus).
Other Herbal Therapies
Recommendation: Herbal therapies are not recommended for the treatment of erectile dysfunction (based on review of the data and Panel consensus).
Surgical Therapies
Penile Prosthesis Implantation
Standard: The patient considering prosthesis implantation and, when possible, his partner should be informed of the following: types of prostheses available; possibility and consequences of infection and erosion, mechanical failure, and resulting reoperation; differences from the normal flaccid and erect penis, including penile shortening; and potential reduction of the effectiveness of other therapies if the device is subsequently removed (based on Panel consensus).
Standard: Prosthetic surgery should not be performed in the presence of systemic, cutaneous, or urinary tract infection (based on Panel consensus).
Standard: Antibiotics providing Gram-negative and Gram-positive coverage should be administered preoperatively (based on Panel consensus).
Vascular Surgery
Penile Venous Reconstructive Surgery
Recommendation: Surgeries performed with the intent to limit the venous outflow of the penis are not recommended (based on review of the data and Panel consensus).
Penile Arterial Reconstructive Surgery
Option: Arterial reconstructive surgery is a treatment option only in healthy individuals with recently acquired erectile dysfunction secondary to a focal arterial occlusion and in the absence of any evidence of generalized vascular disease (based on review of the data and Panel consensus).
Definitions:
Strength of Recommendations
Initial Management and Discussion of Treatment Options with Patients
Recommended Therapies and Patient Information
Standard: The management of erectile dysfunction begins with the identification of organic comorbidities and psychosexual dysfunctions; both should be appropriately treated or their care triaged. The currently available therapies that should be considered for the treatment of erectile dysfunction include the following: oral phosphodiesterase type 5 (PDE5) inhibitors, intra-urethral alprostadil, intracavernous vasoactive drug injection, vacuum constriction devices, and penile prosthesis implantation. These appropriate treatment options should be applied in a stepwise fashion with increasing invasiveness and risk balanced against the likelihood of efficacy (based on review of data and Panel consensus).
Standard: The patient and, when possible, his partner should be informed of the relevant treatment options and their associated risks and benefits. The choice of treatment should be made jointly by the physician, patient, and partner, when possible, taking into consideration patient preferences and expectations and the experience and judgment of the physician (based on Panel consensus).
Treatment Guideline Statements
PDE5 Inhibitors
Standard: Oral PDE 5 inhibitors, unless contraindicated, should be offered as a first-line of therapy for erectile dysfunction (based on review of data and Panel consensus).
Standard: PDE5 inhibitors are contraindicated in patients who are taking organic nitrates (based on review of U.S. Food and Drug Administration [FDA]-approved product labeling and Panel consensus).
Recommendation: The monitoring of patients receiving continuing PDE5 inhibitor therapy should include a periodic follow-up of efficacy, side effects, and any significant change in health status including medications (based on Panel consensus).
Recommendation: Prior to proceeding to other therapies, patients reporting failure of PDE5 inhibitor therapy should be evaluated to determine whether the trial of PDE5 inhibition was adequate (based on Panel consensus).
Recommendation: Patients who have failed a trial with PDE5 inhibitor therapy should be informed of the benefits and risks of other therapies, including the use of a different PDE5 inhibitor, alprostadil intra-urethral suppositories, intracavernous drug injection, vacuum constriction devices, and penile prostheses (based on Panel consensus).
Alprostadil Intra-urethral Suppositories
Standard: The initial trial dose of alprostadil intra-urethral suppositories should be administered under healthcare provider supervision due to the risk of syncope (based on review of FDA-approved product labeling and Panel consensus).
Intracavernous Vasoactive Drug Injection Therapy
Standard: The initial trial dose of intracavernous injection therapy should be administered under healthcare provider supervision (based on Panel consensus).
Standard: Physicians who prescribe intracavernous injection therapy should (1) inform patients of the potential occurrence of prolonged erections, (2) have a plan for the urgent treatment of prolonged erections, and (3) inform the patient of the plan (See the National Guideline Clearinghouse [NGC] summary of the American Urological Association [AUA] guideline The Management of Priapism) (based on Panel consensus).
Vacuum Constriction Devices
Recommendation: Only vacuum constriction devices containing a vacuum limiter should be used whether purchased over-the-counter or procured with a prescription (based on Panel consensus).
Treatment Modalities With Limited Data
Trazodone
Recommendation: The use of trazodone in the treatment of erectile dysfunction is not recommended (based on review of the data and Panel consensus).
Testosterone
Recommendation: Testosterone therapy is not indicated for the treatment of erectile dysfunction in the patient with a normal serum testosterone level (based on Panel consensus).
Yohimbine
Recommendation: Yohimbine is not recommended for the treatment of erectile dysfunction (based on review of the data and Panel consensus).
Other Herbal Therapies
Recommendation: Herbal therapies are not recommended for the treatment of erectile dysfunction (based on review of the data and Panel consensus).
Surgical Therapies
Penile Prosthesis Implantation
Standard: The patient considering prosthesis implantation and, when possible, his partner should be informed of the following: types of prostheses available; possibility and consequences of infection and erosion, mechanical failure, and resulting reoperation; differences from the normal flaccid and erect penis, including penile shortening; and potential reduction of the effectiveness of other therapies if the device is subsequently removed (based on Panel consensus).
Standard: Prosthetic surgery should not be performed in the presence of systemic, cutaneous, or urinary tract infection (based on Panel consensus).
Standard: Antibiotics providing Gram-negative and Gram-positive coverage should be administered preoperatively (based on Panel consensus).
Vascular Surgery
Penile Venous Reconstructive Surgery
Recommendation: Surgeries performed with the intent to limit the venous outflow of the penis are not recommended (based on review of the data and Panel consensus).
Penile Arterial Reconstructive Surgery
Option: Arterial reconstructive surgery is a treatment option only in healthy individuals with recently acquired erectile dysfunction secondary to a focal arterial occlusion and in the absence of any evidence of generalized vascular disease (based on review of the data and Panel consensus).
Definitions:
Strength of Recommendations
- Standard: A guideline statement is a standard if (1) the health outcomes of the alternative interventions are sufficiently well-known to permit meaningful decisions, and (2) there is virtual unanimity about which intervention is preferred.
- Recommendation: A guideline statement is a recommendation if (1) the health outcomes of the alternative intervention are sufficiently well-known to permit meaningful decisions and (2) an appreciable but not unanimous majority agrees on which intervention is preferred.
- Option: A guideline statement is an option if (1) the health outcomes of the interventions are not sufficiently well-known to permit meaningful decisions or (2) preferences are unknown or equivocal.
Clinical Algorithm(s)
None provided
Evidence Supporting the Recommendations
Type of Evidence Supporting the Recommendations
The recommendations are based on current professional literature, clinical experience, and expert opinion.
Benefits/Harms of Implementing the Guideline Recommendations
Potential Benefits
Overall Potential Benefit
Appropriate management and effective treatment of organic erectile dysfunction
Appropriate management and effective treatment of organic erectile dysfunction
Potential Harms
- Sildenafil, tadalafil, and vardenafil have side effects due to peripheral vasodilation such as facial flushing, nasal congestion, headache, and dyspepsia. Both sildenafil and vardenafil, but not tadalafil, have some cross-reactivity with phosphodiesterase type 6 (PDE6) and thus may produce visual side effects. Tadalafil exhibits some cross-reactivity with PDE11, but there are no known side effects due to PDE11 inhibition at this time. Back pain has been reported in a limited number of patients, especially those taking tadalafil, and the pathophysiology of this adverse effect is unknown. A mild prolongation of the QT interval has been observed with vardenafil. The Food and Drug Administration (FDA)-approved product labeling for vardenafil recommends that caution be used when prescribing vardenafil in patients with a known history of QT prolongation or in patients who are receiving agents that prolong the QT interval.
- When considering PDE5 inhibitors for the management of erectile dysfunction (ED), physicians should be aware that even healthy volunteers may experience mild transient systemic vasodilation; this effect may be aggravated by alpha-blocking therapies.
- Hypotension has been reported to occur in approximately 3% of patients after the first dose of alprostadil.
- A healthcare provider should be present to instruct patients on the proper technique of intracavernous drug administration, to determine an effective dose, and to monitor patients for side effects, especially prolonged erection.
- In addition to mechanical failure, inflatable penile prostheses are associated with complications such as pump displacement and auto-inflation.
- Infection is a devastating complication of any prosthetic surgery. Currently available inflatable prostheses have been modified in an attempt to reduce the risk of infection.
Contraindications
Contraindications
- Phosphodiesterase type 5 inhibitors are contraindicated in patients who are taking organic nitrates.
- Magnetic resonance imaging (MRI) is contraindicated in patients with a ferromagnetic implant because of the risks associated with movement, dislodgement, induction of electrical current, excessive heating, and/or misinterpretation artifacts.
- Prosthetic surgery should not be performed in the presence of systemic, cutaneous, or urinary tract infection.
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Erectile dysfunction (impotence) occurs when a man can no longer get or keep an erection firm enough for sexual intercourse.
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