An Electrophysiological Technique to Accurately Diagnose and Treat Erectile Dysfunction

Summary

Here we describe an appropriate electrophysiological technique to diagnose and treat patients with erectile dysfunction.

Abstract

Erectile dysfunction (ED) is a common disease in males. In the past, the first-line treatment of ED was mainly noninvasive-psychotherapy and oral phosphodiesterase 5 (PDE5) inhibitors. Oral PDE5 inhibitors often need to be used before sexual intercourse and do not repair the pathological damage; hence, the therapeutic effect for secondary ED caused by neurological or endocrine disorders is poor. Second-line treatments mainly include penile corpus cavernosum injection of alprostadil, transurethral administration, vacuum negative pressure devices, and other methods, with obvious side effects such as local pain.

The third-line treatment mainly refers to penile prosthesis implantation. Indications of this treatment are strict, complications such as mechanical failure and infection may occur after operation, and it is expensive. Other treatments such as stem cell therapy and gene therapy are still in the experimental research stage and have not been used in clinics. A new treatment based on an electrophysiological technique combines a medical infrared thermal imager with low-frequency (20-50 Hz) neuromuscular electrical stimulation, which has achieved good results in the prevention and treatment of female pelvic floor dysfunction.

Male generative organs are located in the pelvic floor area, and their normal function not only depends on the integrity of the structure and function of the male generative organs, but is also closely related to the blood vessels, nerves, muscles, and other pelvic floor organs. Therefore, this electrophysiological technique was applied to male ED, focusing on the observation of the penis, groin, and hypogastrium for accurate diagnosis and treatment. This demonstrated effective improvement in the conscious erectile status and erectile function scores of patients suffering from ED.

Introduction

Erectile dysfunction (ED) refers to the male inability to achieve and/or maintain a satisfactory erection during sexual behavior¹. The common etiologies of ED are psychological, neurotic, anatomical, vascular, and drug-induced. Worldwide, the prevalence of ED in men is high and increases with age². ED can affect a patient's self-confidence, quality of life, and the stability of family relations. In addition, research shows that ED increases the risk of cardiovascular disease in patients in the future³. Therefore, once ED is diagnosed, it should be treated as soon as possible. At present, the main therapies for ED are oral PDE5 inhibitors and surgeries. Studies show that PDE5 inhibitors are ineffective in up to 35% of patients suffering from ED⁴, resulting in a discontinuation rate between 35% and 45%⁵. The reasons for the discontinuation of PDE5 inhibitors include concerns about possible side effects and high drug costs⁶. Additionally, surgical treatment could cause complications such as infection and pain. However, electrophysiological technology can be used to analyze the temperature of patients in different positions under different movements by using medical infrared thermal imaging visual thermography to identify the abnormal parts of the human body, and then patients can be treated with low-frequency (20-50 Hz) neuromuscular electrical stimulation.

The low-frequency nerve and muscle electrical stimulator is a continuous activation instrument with simple and effective operation and a wide range of indications, which has been widely used in obstetrics and gynecology⁷, cardiovascular diseases⁸, and perioperative rapid rehabilitation⁹. In particular, it has achieved good results in the prevention and treatment of female pelvic floor dysfunction diseases and female pelvic floor discipline construction¹⁰. It is noteworthy that this electrophysiological technology has not yet been applied in andrology. The medical infrared thermal imager can produce infrared wave images emitted by humans. As a part of the temperature regulation process, the intensity can be changed according to the health status of the patients¹¹, and the physiological and pathological reactions of diseases can be studied from the cell metabolism and human functional changes to provide a specific auxiliary diagnostic method for clinical research. There are temperature differences between individuals due to the differences in human anatomy, tissue metabolism, blood circulation, nerve function, and blood states.

Moreover, different images can be formed by medical infrared thermal image scanning. Comparisons of the similarities and differences between the images of the normal state of the body and abnormal states can help diagnose the nature and degree of the disease in combination with clinical diagnosis. These comparisons can also help accomplish accurate diagnoses of related diseases under the infrared visible state by combining these data with the low-frequency (20-50 Hz) neuromuscular therapy instrument. Accurate electrophysiological diagnosis and treatment parameters, including treatment sites, blood vessels, muscles, and nerves, are determined using computer software supporting the low-frequency neuromuscular therapy instrument, and individualized treatment plans are formulated to achieve immediate and precise treatment. Moreover, related parameters can be seen simultaneously, and it is convenient for the observation and evaluation of the curative effect.

Male pelvic floor muscles can promote erection and ejaculation¹². By monitoring intracavernous pressure, spontaneous contraction and electrical stimulation increase muscle strength in the sciatic cavernous body¹³. Although patients suffering from ED have potential pelvic floor muscle dysfunction, the treatment of ED is still based on drug treatment and lifestyle improvement. In this study, electrophysiological technology, including medical infrared thermal imaging and low-frequency neuromuscular electrical stimulation, provides a new method for the treatment of ED patients through the diagnosis and treatment of nerves, muscles, and blood vessels in abnormal parts of patients suffering from ED.

Protocol

All the procedures in the following protocol were reviewed and approved by the Institutional Review Board of The Northern Jiangsu People's Hospital for application on November 11, 2020. In this study, the process is explained to the patients in detail and the patients' consent is obtained before using electrophysiological technology for diagnosis and treatment.

1. Patient selection

1. Set the following inclusion criteria:
   1. Select patients who score <22 points on the International Erectile Function Questionnaire-5 (IIEF-5).
   2. Ensure that the selected patients are generally in good health, married or have a fixed sexual partner, and can maintain normal sexual intercourse at least once a week from the beginning to the end of the study.
   3. Ensure that patients do not and have not taken any drugs to improve erectile function in the first 4 weeks.
   4. Select patients whose reproductive hormone examination results are normal.
   5. Select patients who voluntarily agree to participate in this study and give their signed, informed consent.
2. Set the following exclusion criteria:
   1. Exclude patients suffering from ED caused by hormones, nerves, or psychological factors.
   2. Exclude patients with organic abnormalities in the penis (abnormal development of genitalia or abnormal palpation of the bilateral testis, epididymis, or spermatic cord).
   3. Exclude patients with severe cardiovascular and cerebrovascular diseases who cannot have normal sex lives.
   4. Exclude patients with a pacemaker implantation.
   5. Exclude patients with poor blood pressure control (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg after treatment) and patients with poor glycemic control whose fasting plasma glucose is >7.0 mmol or 126 mg/dL after treatment.
   6. Exclude patients with drug, alcohol, or other substance abuse history in the past 6 months.
   7. Exclude patients with radical prostatectomy or pelvic surgery and those who have participated in any other medical device or drug clinical research studies in the past 3 months.

2. Diagnosis and treatment process

1. Preparation before inspection
   1. Maintain the ambient temperature of the infrared thermal imaging inspection chamber at 24 ± 2 °C and ambient humidity at 40% to 60%.
   2. Prohibit the examinee from drinking alcohol, taking vasodilator and vasoconstrictor drugs, and eating food at temperatures over 40 °C (or any spicy food), 24 h before examination.
   3. Fully expose the test area during the examination, removing bandages 2 h before the examination.
   4. Prohibit the examinee from being exposed to high temperature, a strong cold environment, or being directly in the airflow from an air conditioner or fan 1 h before inspection. Loosen the pants belt, and remove watches, necklaces, and other items 15 min in advance.
   5. Let the examinee stand or sit quietly in the waiting area for 10 min.
2. Locate the outliers.
   1. Let the patient enter the medical infrared camera inspection chamber, take off all their clothes, and face the scanning head.
   2. Click the motion capture bar button after posing, click freeze, and save each action (Figure 1).
   3. Analyze the temperatures of different positions of patients under different movements, especially the penis, groin, and lower abdomen.
      1. Consider the penis position to be abnormal if the penis temperature is lower than 33.5 °C or higher than 34.5 °C (see Figure 2).
      2. Consider the groin position to be abnormal if the groin temperature is lower than 33.5 °C or higher than 34.5 °C (see Figure 2).
      3. Consider the lower abdomen position to be abnormal if the lower abdomen temperature is lower than 33 °C or higher than 34 °C (see Figure 2).
3. Analyze and determine the diagnosis and treatment plan.
   1. Analyze the treatment plan of the abnormal points on the computer equipment of the low-frequency neuromuscular therapy instrument and download it to the diagnosis equipment of the low-frequency neuromuscular therapy instrument after detecting the abnormal point.
   2. Determine the abnormal points where the temperature anomaly was detected before, affix the electrodes one by one to the corresponding sites on the patient, and connect them to the computer equipment of the low-frequency (20-50 Hz) neuromuscular therapy instrument, as shown in Figure 3, Figure 4, and Figure 5.
   3. Observe the real-time temperature change of each program acting on the abnormal point under infrared thermal imaging.
   4. Select the fastest program that can be seen on the infrared imager for the temperature of the abnormal part to return to normal and determine the corresponding frequency and pulse width on the equipment of the low-frequency neuromuscular therapy instrument.
4. Precision electrophysiological therapy
   1. Find the corresponding plan on the Bluetooth equipment of the low-frequency neuromuscular therapy instrument.
   2. Use the Bluetooth equipment of the low-frequency neuromuscular therapy instrument to connect the patient's own mobile phone for treatment. Select a value at which the patient feels comfortable within the allowable frequency (20-50 Hz) and pulse width (0.02-0.3 ms) range once a day, for 12 stimulations as a course, and evaluate the effect after a course of treatment.

Discussion

During sex, penile erection is largely dependent upon sufficient blood flow into the corpus cavernosum, which requires the coordination of arterial endothelium-dependent vasodilation and sinus endothelium-dependent cavernous smooth muscle relaxation¹⁴. Nitric oxide (NO) is the primary neurotransmitter of the peripheral erectile-promoting nerves, released by parasympathetic autonomic nerves and sinus endothelium to produce cyclic guanosine monophosphate (cGMP). This cGMP relaxes the cavernous smooth muscle, resulting in increased pressure in the cavernous body to achieve erection¹⁵. By monitoring the formation of NO and cGMP, it was confirmed that electrical stimulation could lead to the formation of NO and cGMP in the penile cavernous smooth muscle¹⁶.

From the perspective of anatomical structure, male reproductive organs are located in the pelvic floor-related areas, and their normal function depends not only on their structural and functional integrity but also on the blood vessels, nerves, muscles, and other organs associated with the pelvic floor. Studies have shown that contraction of the superficial pelvic floor musculature can increase intracavernous pressure by restricting venous return to the base of the penis to produce an erection¹⁷. In addition, neural, endocrine, immune regulatory networks, and psychophysiological factors also play important roles. Problems in any one or more of the above areas will promote the occurrence and development of male diseases. Previous studies have shown that male pelvic floor muscle training, including electrical stimulation, can improve stress urinary incontinence, overactive bladder, ED, premature ejaculation, lower urinary tract syndrome, and muscle-related pelvic pain¹². Further, physical exercise therapy and electrical stimulation can effectively treat premature ejaculation with an effective rate of 64%¹⁸.

Although functional electrical stimulation therapy is widely used in sexual dysfunction¹⁹, there are few studies on the treatment of ED. There are many advantages of the described electrophysiological technique; it is suitable for a variety of diseases caused by nerve and muscle damage, including pelvic floor dysfunction diseases, motor system injury diseases, nervous system diseases, digestive system diseases, and endocrine diseases. Additionally, it has no side effects, is easy for patients to accept, and has been used in clinical practice for many years because of its stable, safe, and reliable features.

This study draws lessons from this electrophysiological technique that has achieved good results in the prevention and treatment of female pelvic floor dysfunction. Medical thermal imaging is used to detect, before low-frequency neuromuscular electrical stimulation is used to accurately treat, abnormal sites through blood vessels, muscles, and nerves.

We use a medical thermal imager to find the abnormal parts and then treat them with low-frequency neuromuscular current stimulated by blood vessels, muscles, and nerves, which provides a new method for the diagnosis and treatment of patients suffering from ED. However, due to the short duration of this study and the small number of samples, we will continue to increase the number of cases to observe the recovery of patients suffering from ED treated with this electrophysiological technique. In addition, compared with the current ED treatment methods, this method has the disadvantages of a slow effect and long therapeutic time.

Materials

Name	Company	Catalog Number	Comments
Low-frequency nerve and muscle electrical stimulator	Foshan Shanshan Datang Medical Technology Company	20182260716
RigiScan Plus Monitor	GOTOP Medical	20162211942