Erectile Dysfunction: Clinical Guidelines

List of Abbreviations

AH – arterial hypertension

CHD – coronary heart disease

mg – milligram

ICD-10 – International Statistical Classification of Diseases and Related Health Problems (10th Revision)

min – minutes

cm – centimeter

sec – second

TG – triglycerides

LH – luteinizing hormone

PDE-5 – phosphodiesterase-5

PDE-5 inhibitors – according to the ATC classification, drugs for the treatment of erectile dysfunction

FC – functional class

HDL-C – high-density lipoprotein cholesterol

LDL-C – low-density lipoprotein cholesterol

ED – erectile dysfunction

IIEF – International Index of Erectile Function

IIEF-5 – abbreviated version of the IIEF questionnaire

IIEF – International index of erectile function

LIWPT – low-intensity shockwave therapy

NMU — nomenclature of medical services

SHBG – sex hormone-binding globulin

Terms and Definitions

Erectile dysfunction (ED) is the persistent inability to achieve and maintain an erection sufficient for satisfactory sexual performance [1].

1. Brief information on the disease or condition

Erection is a complex physiological process based on the interaction between neurogenic, vascular, and endocrine components, involving arterial dilatation, relaxation of the smooth trabecular musculature, and activation of the veno-occlusive mechanism.

1.1 Definition of the disease or condition

Erectile dysfunction (ED) is the persistent inability to achieve and maintain an erection sufficient for satisfactory sexual performance [1].

1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)

Risk factors for ED [2]: age, diabetes mellitus, cardiovascular diseases, dyslipidemia, smoking, alcoholism, metabolic syndrome, hyperthyroidism, vitamin D and folic acid deficiency, depression and anxiety disorders, chronic kidney disease, inflammatory bowel disease, chronic obstructive pulmonary disease, adverse external factors – radiation, electromagnetic radiation, osteoporosis, physical inactivity, hyperuricemia, substance abuse, chronic pelvic pain syndrome/interstitial cystitis, prior surgical interventions (urethroplasty, prostate hyperplasia surgery), history of COVID-19 [3].

The pathophysiology of ED can be vasculogenic, neurogenic, anatomical, hormonal, drug-induced, and/or psychogenic. In most cases, multiple pathophysiological processes exert a combined negative impact on erectile function.

Causal factors for ED development:

1. Psychogenic factors cause psychogenic erection disorders, coded in the International Classification of Diseases 10th Revision (ICD-10) as F52.2 failure of genital response, not due to organic factors.

- generalized (e.g., lack of sexual arousal, phobic neuroses, etc.)

- situational (partner factors, guilt, etc.)

2. Organic factors, coded in ICD-10 as N48.4 – organic impotence

• Vasculogenic

- cardiovascular pathology (arterial hypertension, coronary artery disease, peripheral vascular disease – atherosclerosis, iliac artery occlusions, and veno-occlusive disorders)

- smoking

- diabetes mellitus

- hyperlipidemia

- surgical interventions (radical prostatectomy, etc.) or pelvic and retroperitoneal radiation therapy

- metabolic syndrome

- hyperhomocysteinemia

- lack of regular physical exercise

• Neurogenic

- neurodegenerative diseases (multiple sclerosis, Parkinson's disease, etc.)

- spinal cord trauma and diseases

- stroke

- central nervous system neoplasms

- intervertebral disc disorders

- peripheral neuropathies due to diabetes mellitus, chronic renal and hepatic failure, alcoholism

- polyneuropathies

- surgical interventions (radical prostatectomy, etc.) or pelvic and retroperitoneal radiation therapy

- urethral surgery

• Structural (anatomical)

- micropenis

- hypospadias, epispadias

- phimosis

- Peyronie's disease and congenital penile curvature

- fibrosclerotic changes due to cavernositis or priapism

- penile tumors

- penile trauma (penile fracture)

• Hormonal

- hyperprolactinemia

- hyperthyroidism

- panhypopituitarism

- hyper- and hypocorticism

- hypogonadism

- metabolic syndrome

- diabetes mellitus

• Drug-induced

- antidepressants (tricyclics (non-selective monoamine reuptake inhibitors), selective serotonin reuptake inhibitors)

- antihypertensive drugs (thiazide diuretics, non-selective beta-blockers)

- antiandrogens (testosterone 5-alpha-reductase inhibitors, gonadotropin-releasing hormone agonists, and antigonadotropin-releasing hormone agents)

- antipsychotics

- narcotic drugs

- anabolic steroids

• Mixed

- chronic systemic diseases (chronic obstructive pulmonary disease, diabetes mellitus, rheumatic diseases, chronic kidney and liver diseases, inflammatory bowel disease, psoriasis, gout, etc.)

- open-angle glaucoma

- obstructive sleep apnea syndrome

- allergic rhinitis

- chronic fatigue syndrome

• Iatrogenic

- pelvic surgery and prostate cancer treatment, including external beam and focal radiation therapy, brachytherapy, high-intensity focused ultrasound therapy, and cryotherapy

- penile surgery

- prostate biopsy

1.3 Epidemiology of the Disease or Condition

Epidemiological data indicate a high global prevalence and incidence of ED [4]. The Massachusetts Male Aging Study (MMAS) showed that the overall prevalence of ED among untreated men aged 40–70 years was 52%, of which mild ED accounted for 17.2%, moderate ED for 25.2%, and severe ED for 9.6%, respectively [4].

In the Cologne study of men aged 30–80 years, the prevalence of ED was 19.2% and correlated with age, reflected by an increase in rates from 2.3% to 53.4% [5].

In a cross-sectional study of men seeking care for ED for the first time, every fourth patient was younger than 40 years, and nearly 50% of young men suffered from severe ED. ED is a common condition in the Russian Federation, affecting 48.9% of men aged 20–77 years. Mild ED occurs in 34.6% of men, moderate ED in 7.2%, and severe ED in 7.1% [6].

1.4 Features of Coding the Disease or Condition

F52.2 – Nonorganic sexual arousal dysfunction

N48.4 – Male erectile dysfunction of organic origin

1.5 Classification of the disease or condition

Classification of ED by severity:

• mild

• moderate

• moderate

• severe

Pathogenetic classification of ED:

• psychogenic – approx. 40% of cases;

• organic – 29% of cases;

• mixed (combination of psychological and organic factors) – 25% of cases;

• unspecified genesis – 6% of cases [7].

Criteria for differentiating psychogenic and organic ED are presented in Table 4 of Appendix A.

1.6 Clinical presentation of the disease or condition

ED manifests either as an insufficient degree of initial penile rigidity and/or its spontaneous subsidence [5, 7].

2. Diagnostics, medical indications and contraindications for diagnostic methods

The primary criterion for establishing a diagnosis of ED is the presence of complaints regarding erectile dysfunction.

Diagnostic measures in patients presenting with ED are aimed at:

• confirming the presence of ED;

• determining its severity;

• identifying the causes of this disorder and its potential association with other types of sexual dysfunction (decreased libido, ejaculation and orgasm disorders) [8].

2.1 Complaints and Anamnesis

Comments: It is necessary to obtain information about the nature of the relationship with the sexual partner, previous consultations, therapeutic interventions, and their efficacy. The specific nature of the disorder, its duration, stability, and the influence of individual factors and circumstances should be clarified. It is important to discuss in detail with the patient the quality of adequate and spontaneous erections, characterize sexual desire, the duration of the friction phase of intercourse, and orgasm. A discussion with the patient's sexual partner is highly desirable and important both to clarify the nature and severity of the disorder and for the success of the planned therapy [9].

The Erection Hardness Score should be used in studies and for the clinical assessment of penile rigidity [10].

Patients should also be screened for decreased libido, fatigue, decreased performance, and other potential symptoms of hypogonadism [11].

Comments: Analysis of the data obtained allows for a high degree of confidence in determining the nature of ED. A situational, selective, and transient nature of the disorder, as well as the presence of spontaneous erections, indicate a psychogenic etiology. A quantitative conclusion regarding the severity of ED can be made based on the results of the patient-completed IIEF-5 questionnaire (Appendix G1).

Comments: It is necessary to determine whether the patient suffers from diabetes mellitus, hypogonadism, or metabolic syndrome [14-19].

2.2 Physical Examination

Comments: Physical examination may reveal occult conditions, such as premalignant or malignant genital lesions, Peyronie's disease, prostatic enlargement or pathological heterogeneity, and signs and symptoms indicative of hypogonadism.

Comments: Given the high prevalence of cardiovascular disease and metabolic syndrome, the scope of examination must be sufficient to conclude that sexual activity is permissible and that there are no contraindications to ED therapy. To standardize medical recommendations regarding sexual activity in the presence of cardiac risk, an international conference (Princeton, 2012) developed guidelines for managing sexual dysfunction in patients with cardiovascular disease [23]. According to the Princeton consensus, patients are categorized into low-, intermediate-, and high-risk groups (Table 5). At low risk, sexual activity or ED treatment is considered safe. At intermediate risk, a stress test is required (sexual activity is equivalent to 4 minutes on the Bruce protocol treadmill test). If the stress test is failed or the patient is at high risk, further evaluation by a cardiologist is required.

2.3 Laboratory Diagnostics

Comments: Blood glucose testing should be performed in a fasting state. When indicated, the levels of bioavailable or free testosterone in the blood (calculated using the appropriate formula based on total testosterone, albumin, and SHBG) are determined [24]. If relevant symptoms are detected, additional laboratory tests are indicated, such as PSA levels (A09.05.130 Determination of total prostate-specific antigen in blood) [25], prolactin levels, and LH levels (A09.05.131 Determination of luteinizing hormone in blood serum) [26].

2.4 Instrumental Diagnostics

In most cases, analysis of data obtained from a thorough medical history, a completed validated questionnaire, and a physical examination allows for an accurate diagnosis and treatment plan. However, specific diagnostic tests may be required in certain cases.

Comments: Duplex Doppler ultrasound of the penile vessels (pharmacological penile Doppler ultrasound) is most commonly used to diagnose ED, especially when a vascular etiology is suspected [28,29]. This method is more informative when the examination is performed in the flaccid state of the penis and after induced erection with #Alprostadil** (ATX code: G04BE01), administered intracavernously at a dose of 10 µg, followed by a comparison of the results. The main quantitative parameters in Doppler ultrasound (pharmacological penile Doppler ultrasound) are peak systolic velocity and end-diastolic velocity. The resistivity index is calculated from absolute values using standard formulas. Normally, the peak systolic velocity is greater than 30 cm/s, the end-diastolic velocity is <3 cm/s, and the resistivity index is greater than 0.8 [27-31]. Dynamic infusion cavernosography and pelvic arteriography (A06.12.013) are used only in patients scheduled for reconstructive vascular surgery [32].

2.5 Other Procedures

3. Treatment, including drug and non-drug therapies, diet therapy, and pain management

Comments: corrective measures and therapy aimed at normalizing blood pressure, cholesterol, glucose, and total testosterone levels in the blood, discontinuation and replacement (in collaboration with related specialists) of medications that negatively affect erection (see 1.2). Normalization of diet, body weight, and regular physical activity can lead to improved erectile function even without specific treatment or enhance the efficacy of therapeutic interventions [34].

Comments: The step-by-step approach to ED treatment involves the sequential use of therapeutic methods with increasing invasiveness, ranging from pharmacotherapy with phosphodiesterase type 5 inhibitors (according to ATX: Drugs for the treatment of erectile dysfunction) (an alternative to which may be vacuum therapy of the penis ( A17.30.010) and low-intensity shockwave therapy of the penis), to intracavernous injections of #Alprostadil** at a dose of 5–20 µg and phalloplasty with prosthetics (A16.21.019.001 Phalloplasty with single-piece prosthesis implantation, A16.21.019.002 Phalloplasty with three-piece inflatable prosthesis implantation). Treatment is stepped up when the current step is ineffective or unacceptable to the patient [35, 36].

However, currently, based on literature data and consensuses of working groups from various specialized associations, there is a trend toward developing an individualized, structured treatment strategy depending on efficacy, safety, invasiveness, cost, and the patient's own preferences and expectations.

A systematic review demonstrated interesting data on comparable rates of patient discontinuation across all available treatment modalities. This highlights the importance of understanding the patient's perspective on ED treatment—including efficacy, adverse events, quality of intimate relationships, and financial costs—which serves as a major barrier to the implementation of various therapeutic modalities [37].

3.1 Conservative pharmacotherapy

Comments: A distinctive feature of PDE5 inhibitors is their efficacy in all forms of ED and good tolerability. Drugs of this group are used on an as-needed (on-demand) basis a certain time before sexual intercourse, and sexual stimulation is required for the drug effect to occur. Doses are selected individually. PDE5 inhibition leads to smooth muscle relaxation, vasodilation, and erection. The side effect profile of vardenafil, sildenafil, and tadalafil is similar to placebo [40, 41, 42]. The effect of sildenafil can last for up to 12 hours. After 24 weeks of its use, improvement in erectile function was observed in 56, 77, and 84% of men taking 25, 50, and 100 mg of sildenafil, respectively, compared to 25% improvement in patients receiving placebo. In patients with diabetes mellitus, the use of sildenafil resulted in 66.6% improvement in erection and 63% successful intercourse attempts compared to 28.6% and 33% in men receiving placebo, respectively [41, 43]. A principal difference of tadalafil is its long duration of action: 36 hours. In premarketing studies after 12 weeks of tadalafil use, erection improvement was observed in 67 and 81% of men taking 10 and 20 mg, respectively, compared to 35% of men taking placebo [42]. After 12 weeks of vardenafil use, erection improvement was noted in 66, 76, and 80% of cases with 5, 10, and 20 mg, respectively, versus 31% of men taking placebo. When taking vardenafil in combination with diabetes mellitus, 78% of patients confirmed a positive change in erectile function, versus 13% of patients receiving placebo [41]. Studies have shown that daily use of tadalafil leads to greater improvement in sexual function than taking the drug on demand. Therefore, this drug has also become available in tablet form with a 5 mg dosage intended for daily use. It was found that long-term use of tadalafil improves endothelial function, and this effect persists after discontinuation of the drug [43]. Udenafil at a dosage of 100 mg has shown efficacy in a meta-analysis in patients with ED. Its administration demonstrated a statistically significant increase in the IIEF score by 5.65 points, which was significantly better than placebo (p<0.0001). The most frequent side effects associated with udenafil administration were facial flushing and headache (udenafil vs. placebo, 5.6% vs. 1.8% and 3.1% vs. 0%, respectively) [44]. None of the PDE5 inhibitors negatively affects exercise duration or time to ischemia onset during testing in patients with stable angina. The drugs may even improve the results of these tests. When PDE5 inhibitors are combined with antihypertensive agents and alpha-blockers, there is a tendency toward hypotension. The use of alpha-blockers in combination with PDE5 inhibitors can lead to orthostatic hypotension [45]. A comparison of pharmacokinetics, clinical efficacy, and adverse events of PDE5 inhibitors is presented in Tables 1, 2, and 3 of Appendix A. PDE5 inhibitors must not be taken concurrently with organic nitrates due to potentiation of the hypotensive effect. According to American Heart Association guidelines, organic nitrates can be used no earlier than 24 hours after taking short-acting PDE5 inhibitors and no earlier than 48 hours after taking tadalafil. When using PDE5 inhibitors, one should consider the potential risk of complications associated with sexual activity within 90 days after a myocardial infarction; in unstable angina or angina occurring during sexual intercourse; in heart failure of functional class II or higher developed within the last 6 months according to NYHA, uncontrolled heart rhythm disorders, arterial hypotension (BP below 90/50 mm Hg) or uncontrolled arterial hypertension, as well as within 6 months after a stroke [46]. The combination of PDE5 inhibitors with other medicinal products is possible.

Comments: intracavernous injections may be used when oral medications are ineffective.

This therapy is contraindicated in patients:

- with hypersensitivity to the drug used;

- at risk of developing priapism;

- with severe anatomical defects of the penis.

Adverse effects include:

- prolonged erection;

- priapism;

- penile pain;

- development of cavernosal fibrosis.

The patient should be warned to seek medical attention if the erection persists for more than 4 hours [48].

3.2 Conservative non-pharmacotherapy

Comments: The essence of the method is that the penis is placed in a special cylinder, where negative pressure is created using a vacuum pump. This increases blood flow to the corpora cavernosa, causing an erection, which is maintained by placing a special constriction ring at the base of the penis to limit venous outflow. The resulting erection is non-physiological. Indications for vacuum devices include contraindications to or ineffectiveness of drug therapy, as well as patient preference. Older men with low sexual activity are more inclined toward this type of therapy. The efficacy and satisfaction rate of the method range from 27% to 94%. Approximately 30% of patients discontinue the use of vacuum devices due to pain, subcutaneous bruising, difficult ejaculation, and decreased sensitivity of the glans penis [50].

Comments: Low-intensity shockwave therapy for ED is based on applying weak acoustic waves to the penile cavernous tissue. It is hypothesized that as acoustic waves pass through biological tissues of varying density, they induce shear stress, which increases the levels of complex chemical compounds and nitric oxide, stimulating neovascularization in the corpora cavernosa [55].

3.3 Innovative conservative therapy

A number of prospective and retrospective studies have been conducted to investigate the efficacy in ED therapy of: platelet-rich plasma [56,57,58]; stem cells [59]; botulinum neurotoxin (Botulinum toxin type A-hemagglutinin complex**) [60].

The use of platelet-rich plasma in patients with ED has been studied most extensively. The regenerative properties of plasma are likely related to the high concentration of platelets containing various growth factors, including vascular endothelial growth factor. These factors stimulate angiogenesis and stem cell migration [56,57,58].

However, despite promising results, the data are too heterogeneous across studies regarding timing, dosing regimens, qualitative and quantitative composition of growth factors and cytokines, and there is still no consensus on the optimal activation method and platelet concentration for each injection. Accordingly, this method can currently be used only within clinical trials, and further larger multicenter studies in this direction are needed [58].

The remaining aforementioned treatment methods cannot be recommended either, as there is insufficient data and larger studies are needed to evaluate their efficacy and safety in the treatment of ED.

3.4 Surgical treatment

Comments: when conservative ED therapy is ineffective—manifested by a lack of positive clinical dynamics and score increases on repeated IIEF or IIEF-5 questionnaires—as well as at the patient's request, the optimal treatment is to perform phalloplasty with single-piece or three-piece prosthesis implantation. There are two types of penile prostheses: rigid and three-piece inflatable. Most patients prefer the three-piece inflatable penile prosthesis because it achieves a more natural erection. Over 90% of operated patients and their partners report sexual satisfaction after implantation.

The rigid penile prosthesis provides constant axial rigidity of the organ.

Phalloplasty with single-component or three-piece prosthesis is performed via 2 main surgical approaches: scrotal and subpubic. The scrotal approach provides good visualization, allows access to the proximal part of the penile crura if necessary while avoiding damage to the dorsal nerves, and enables pump placement under direct vision. In the case of concomitant severe urinary incontinence, an artificial urinary sphincter can be implanted simultaneously through the same approach. However, with this approach, the reservoir is placed in the retropubic space without visual control, which may lead to potential damage to the urinary bladder and iliac vessels in patients with a history of major pelvic surgery (radical prostatectomy or cystectomy). In such situations, it is safer to resort to ectopic submuscular placement of the reservoir above the transversalis fascia through the primary skin incision.

The subpubic approach offers the advantage of placing the reservoir under direct vision; however, there is a risk of injury to the dorsal nerves of the penis, and pump implantation is somewhat more difficult.

In some cases, when ED is combined with severe penile deformity (in Peyronie's disease) to perform simultaneous corporoplasty (A16.21.014 Reconstructive surgery on the penis, A16.21.014.001 Restoration and plastic surgery on the penis. Plication corporoplasty, A16.21.014.002 Restoration and plastic surgery on the penis. Patch corporoplasty), as well as in pronounced distal cavernosal fibrosis when adequate access to the corpora cavernosa is required, a subcoronal surgical approach may be used.

The most severe complication of phalloplasty with a single-component or three-piece prosthesis is periprosthetic infection. Its incidence is significantly lower among high-volume urological surgeons. Antibiotic-coated penile prostheses help reduce the likelihood of this complication from 5% to 2%.

The functional lifespan of modern prostheses exceeds 15 years. In the event of mechanical failure, reimplantation of a new penile prosthesis is performed [61, 62, 63, 64].

4. Medical Rehabilitation and Sanatorium-Resort Treatment

Comments: penile rehabilitation should be carried out at early stages to protect the cavernosal tissue until the period of neurapraxia resolves. Achieving the required level of penile oxygenation in the postoperative period helps prevent the development of irreversible pathological processes leading to cavernosal fibrosis. If one of the ED prevention methods is ineffective, a combined approach is used (e.g., PDE5 inhibitors combined with vacuum therapy, etc.). If there is no positive response after 12 months, the issue of phalloplasty with a single-component or three-piece prosthesis should be discussed. In cases where non-nerve-sparing prostatectomy is performed, earlier phalloplasty with a single-component or three-piece prosthesis may be considered [65, 66, 67].

5. Prevention and Dispensary Observation

Comments: ED prevention measures include lifestyle normalization, adequate physical activity, smoking cessation, limitation of alcohol consumption, control and correction of body weight, blood glucose and lipid levels, as well as regular sexual activity (at least 3 times a week) [68, 69].

6. Organization of Medical Care

The criterion for the efficacy of conservative ED therapy is an increase in scores on repeated assessment using the IIEF-5 questionnaire.

Indications for elective hospitalization:

1) phalloplasty with a single-component or three-piece prosthesis

Indications for emergency hospitalization:

1) not applicable

Indications for discharging the patient from the hospital:

1) absence of complications after phalloplasty with a single-component or three-piece prosthesis

7. Additional Information

Absent

Criteria for Evaluating the Quality of Medical Care

References

Appendix A1. Working Group Composition

1. Badri R. Gvasaliya – D.Sc. in Medicine, Professor at the Department of Urology, Russian University of Medicine of the Ministry of Health of the Russian Federation

2. Safar I. Gamidov – D.Sc. in Medicine, Professor, Head of the Andrology and Urology Department, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of the Russian Federation

3. Alexander N. Bernikov – Ph.D. in Medicine, Associate Professor at the Department of Urology, Russian University of Medicine of the Ministry of Health of the Russian Federation

4. Kharchilava Revaz Revazovich – PhD in Medicine, Director of the Praxi Medica Medical Practice Training Center at the Federal State Autonomous Educational Institution of Higher Education "I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation"

Conflict of interest:

All members of the Working Group have confirmed that they have no financial support or conflicts of interest to disclose.

Appendix A2. Methodology for Developing Clinical Guidelines

Target audience for these clinical guidelines:

1. Urologist

2. Obstetrician-gynecologist

3. Medical students, residents, postgraduate students

In these clinical guidelines, all information is ranked by the level of reliability (evidence) depending on the quantity and quality of clinical studies on the issue

Table 1. Levels of Evidence (LoE) grading scale for diagnostic methods (diagnostic interventions)

Table 2. Scale for assessing levels of evidence (LE) for methods of prevention, treatment, and medical rehabilitation, including those based on natural therapeutic factors (preventive, therapeutic, and rehabilitation interventions)

Table 3. Scale for assessing the grades of recommendation (GR) for prevention, diagnostic, treatment, and medical rehabilitation methods, including those based on natural therapeutic factors (preventive, diagnostic, therapeutic, and rehabilitative interventions)

Procedure for updating clinical guidelines.

The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data on the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.

Appendix A3. Reference Materials

These clinical guidelines have been developed taking into account the following regulatory and legal documents:

1. Healthcare standard for erectile dysfunction (Order of the Ministry of Health of the Russian Federation No. 224n dated May 12, 2023, "On approval of the standard of medical care for adults with erectile dysfunction (diagnosis and treatment)").

2. European Association of Urology Guidelines 2024.

Table 1 – Main pharmacokinetic parameters of PDE-5 inhibitors

Table 2 – Clinical efficacy of PDE-5 inhibitors

Table 3 – Adverse effects of PDE-5 inhibitors

Table 4 – Differences between organic and psychogenic erectile dysfunction

Table 5 - Princeton Consensus Panel on cardiovascular risk stratification among men with erectile dysfunction

NYHA – New York Heart Association

Appendix B. Physician Action Algorithms

Appendix C. Patient Information

Erectile dysfunction (ED) is the persistent inability to achieve and maintain an erection sufficient for successful sexual intercourse.

What are the causes of erectile dysfunction?

Several factors are known to increase the risk of ED: age, diabetes mellitus, cardiovascular disease, dyslipidemia, smoking, alcoholism, metabolic syndrome, vitamin D and folic acid deficiency, depression and anxiety disorders, chronic kidney disease, inflammatory bowel disease, chronic obstructive pulmonary disease, adverse environmental factors (radiation, electromagnetic radiation), osteoporosis, physical inactivity, substance abuse, history of pelvic surgery, and history of COVID-19.

Eliminating lifestyle-related risk factors helps reduce the risk of ED. Specifically, increasing physical activity reduces its probability in middle-aged men by 70% over 8 years of regular exercise.

The causes of ED are divided into psychogenic (psychological disturbances leading to erectile function disorders) and organic (various diseases/pathological conditions of the body that cause ED at a structural, organic level). In addition, erectile dysfunction can be caused by certain medications: thiazide diuretics, non-selective beta-blockers, antiandrogens, psycholeptics, and opioids.

How common is erectile dysfunction?

ED is a prevalent condition in the Russian Federation, affecting 48.9% of men aged 20–77 years. Among smokers, ED occurs 15–20% more frequently than among non-smoking men.

How is erectile dysfunction diagnosed?

The diagnosis of erectile dysfunction is based on the patient's complaints of a persistent inability to achieve or maintain an erection sufficient for sexual intercourse.

To objectify complaints and clarify the severity of the disease, special questionnaires are used. The most widely used questionnaire is the abridged version of the International Index of Erectile Function (IIEF-5).

A physical examination of the patient is performed to identify concomitant cardiovascular, endocrine, and reproductive system disorders, of which ED may be the first manifestation.

The nature and scope of laboratory tests are determined individually based on complaints, history, and examination, depending on objective necessity and patient preference. Basic laboratory tests performed during the workup include: blood glucose level; lipid profile; total testosterone level in a morning blood sample.

A number of special instrumental studies (most commonly, assessment of penile blood flow using penile duplex Doppler ultrasound with pharmacologic agents) are performed when indicated.

What treatment methods exist for erectile dysfunction?

Lifestyle modification

Before starting treatment, it is necessary to eliminate risk factors for ED as much as possible (depression, physical inactivity, obesity, smoking, opioid use, alcohol abuse), and normalize lifestyle, sexual activity schedule, sleep, and rest. The possibility of discontinuing or substituting medications taken by the patient that may negatively affect erection should be considered.

Conservative treatment

If erectile function is not restored after lifestyle normalization, the doctor will offer several conservative treatment options, which include: oral medications, vacuum therapy, penile injections, and low-intensity shockwave therapy of the penis. Based on personal preferences and after a detailed discussion with the doctor explaining the pros and cons of each method, a treatment method is chosen individually. If ineffective, alternative treatment options from this list or their combination can be considered until the desired result is achieved.

Oral medications that enhance blood flow to the penis are most commonly used as the first line of therapy for ED. They are characterized by suitability for all forms of ED and good tolerability. They can be used either daily or episodically (on demand) a certain time before sexual intercourse, and sexual stimulation is required for the drug to work. Doses are selected individually.

If prescribing the above medications is impossible or the patient is unwilling to use them, treatment with negative pressure therapy (vacuum erection devices) or low-dose penile shockwave therapy is recommended as an alternative.

If the above therapy is ineffective, intracavernosal injection therapy into the penis may be recommended. Most commonly, this therapy is administered on an "on-demand" basis, i.e., immediately before sexual intercourse. Prior to this, the doctor instructs the patient on the correct autoinjection technique.

Surgical treatment

If all conservative treatment methods fail and the patient insists on a definitive solution to their problem, phalloplasty is performed with insertion of a rigid or 3-piece inflatable penile prosthesis. Three-piece inflatable penile prostheses best mimic natural erection, and the satisfaction rate among patients undergoing this type of phalloplasty exceeds 90%.

Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools

Appendix G1. Template for including a scale, questionnaire, or other validated methods for assessing patient status, predicting the risk of complications, and disease prognosis

Russian title: International Index of Erectile Function (IIEF-5)

Original title: 5-item version of the International Index of Erectile Function (IIEF-5)

Source: Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Peña BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec; 11(6):319-26.

Type: - scale

- index

- questionnaire

- other

Purpose: identification and assessment of the severity of ED

Content:

Rate your erectile function over the past 6 months by answering the 5 questions below

Key:

22–25 points – No ED

17–21 points – Mild ED

12–16 points – Mild-to-moderate ED

8–11 points – Moderate ED

5–7 points – Severe ED

Notes: Patients answer the 5 questions by selecting one of the 5 provided options. Each answer corresponds to a specified score. Upon completing the questionnaire, the scores for the answers are summed up and interpreted using the key. IIEF-5 allows confirming or ruling out ED, as well as determining its severity.