Since the international rise of masculology research in the 1970s, many men’s sexual dysfunction disorders have been effectively treated. However, there are still some cases of erectile dysfunction (ED) with complex etiology or difficult psychological ED that cannot be solved fundamentally at present. Therefore, the search for an effective mechanical treatment device has become the goal of many scholars’ research. From November 1998 to March 2005, we applied the comprehensive negative pressure suction device JY86-10A male sexual function rehabilitation treatment instrument to treat various types of male sexual dysfunction and counted 870 cases, and achieved certain clinical results, which are summarized as follows.
1. Data and method
1.1, clinical data
The total number of 870 cases in this group, including 375 cases of erectile dysfunction (ED) group in group 1, aged 23-68; 120 cases of premature ejaculation group in group 2, aged 24-51; 65 cases of non-ejaculation group in group 3, aged 26-43; 310 cases of short penis group in group 4, aged 21-52.
1.2. Evaluation criteria of therapeutic effect
At the end of the treatment course.
Group 1 patients’ International Questionnaire of Erectile Function (IIEF-5) scores improved from severe (5-7) to moderate (8-11) or an overall improvement of 3 was considered effective; from severe improvement to mild (12-21) or an overall improvement of 6 was considered effective; IIEF-5 scores of 21 or more after treatment were considered cured; IIEF-5 scores without improvement were considered ineffective.
Group 2 patients with prolonged intercourse time to more than 3 min or more than 30% of the frequency of the spouse during sex can be satisfied as effective; significantly prolonged intercourse time or can control the ejaculation time at will as cured; no prolonged intercourse time as ineffective.
Group 3 patients can occasionally ejaculate during sexual intercourse as effective; regular sexual intercourse can ejaculate every time as cured; sexual intercourse still cannot ejaculate or even “ejaculate” as ineffective.
Group 4 patients with penis lengthening 1M is effective; penis lengthening more than 2M is effective; no significant lengthening is ineffective.
1.3, treatment methods
Shanghai Kejian Medical Equipment Company JY86-10A male function treatment instrument (patent number: 22845), each treatment time 20min, once a day, 15 times for a course of treatment. Each treatment was 1~7 courses of treatment. Other medications were stopped during the treatment and observation period.
The patient sits, first fixes the electromagnetic wave treatment head in the lumbosacral area, places the penis into the glass receiver, injects the corresponding disease treatment solution (kidney tonic, aphrodisiac, blood activation, sperm fixation type of Chinese medicine extract), starts the instrument and then the patient controls the adjustment valve, gradually raises the negative pressure, after the penis is sucked to erection, adjusts the negative pressure 10 times in sequence, controls the negative pressure between 20kpa ~ 40kpa; pulse electromagnetic wave The intensity of pulsed electromagnetic wave was generally adjusted at 48V, and the waveform was selected as II shape; the patient was instructed to make 10 anal lifting movements during the low pressure period. During each treatment, the color of the glans penis, erection time, erection angle and length were observed and measured, and the intensity of negative pressure was registered. During the treatment period, sexual intercourse was moderated to observe the efficacy. At the end of the treatment, the sexual life condition and patient satisfaction were followed up.
2. Results
The results of the treatment of sexual dysfunction in men of various categories are shown in Table 1.
Table 1 The effect of treatment of sexual dysfunction in men
Type of disease Number of cases Course of treatment Effective (%) Effective (%) Cured (%) Ineffective (%) Total effective rate
E D 375 1~5 60（16） 82（22） 154（41） 79（21） 79 ％
Premature ejaculation 120 1~4 47 (39) 41 (34) 32 (27) 73%
Non-ejaculation 65 1~2 6 (9) 37 (57) 22 (34) 66%
Short penis 310 1~13 189(61) 31(10) 99(29) 71%
Total 870 72%
All treated patients had no complications except for a few cases of glans mucosal blistering, ecchymosis and foreskin edema due to over-regulation of negative pressure. The patients with sexual dysfunction recovered stably and were satisfied with the treatment effect at the follow-up of three months; some of the patients with short penis lengthening effect had retracted.
3. Discussion
Human beings have been looking for effective methods to improve or enhance male sexual function by applying devices. As early as 1917, the American Lederer designed a vacuum erection device, but did not attract attention until 1960 when Geddings Osbon designed and developed the Vacuum Constriction Device VCD and was approved by the FDA for use in 1982.
The hemodynamics of VCD-induced erections differ from those of normal erections in that there is no active relaxation of the cavernous body or vascular smooth muscle. Animal tests have shown that arterial blood flow does not increase after VCD use, but venous return is significantly reduced, and blood filling of the cavernous body and penile skin leads to penile enlargement, and its intracavernosal pressure can reach the level after poppy booster injection. 216 patients, with a satisfaction rate of 84% and 89% for each other. Althof et al. described the results of psychometric tests for spouses of 47 patients treated with injection therapy or VCD, and about 60% of patients opted for VCD after one year (3). We have been clinically applying the manual type “male helper” since 1988, and the satisfaction rate of patients is only about 75%. The main disadvantages are: inconvenient operation, the penis is still drooping after enlargement; the woman feels the penis is cold; a few patients have pain, ejaculation difficulties, skin ecchymosis and injury, etc.
At present, the types of negative pressure suction devices commonly used are ①Osbon erection aid device: VCD is of this type, consisting of a transparent plastic vacuum cylinder, vacuum pump, connecting tube and narrowing ring. After the penis swells to an erect state, the narrowing ring is placed on the root of the penis to block the venous return and maintain the erection. ②Synergist erection aid device: Vacuum penis sleeve (Vacuum entrapment) belongs to this category, a kind of external support device similar to penis sleeve, made of soft transparent silicone, characterized by penis expansion without the narrowing ring, the external support is still fixed on the penis during sexual intercourse. ③ negative pressure applicable device: the male function treatment instrument we use belongs to this kind of negative pressure applicable comprehensive device, is the improved type of VCD, in addition to the narrowing ring on the compression of venous return, and the use of continuous negative pressure to help erection principle of men’s rehabilitation device, with negative pressure, temperature-controlled water massage, electromagnetic pulse oscillation and ion introduction and other effects, combined with Chinese medicine treatment solution comprehensive treatment.
The use-aid effect of VCD on ED has been recognized, but scholars still have different views on the therapeutic effect of the integrated negative pressure device. Men with normal erectile function are known to have an average of more than three (3-5) nocturnal penile tumescence (NPT) per night for a total duration of approximately 100 min, with a partial pressure of oxygen in the cavernous body (PO peal) similar to arterial blood during full erection (4). Previously, the physiological significance of spontaneous erection in men was inconclusive. Nowadays, some scholars believe that it is the process of “self-oxygenation” of the penis, and we believe from long-term clinical observation that this oxygenation process is very important to maintain the high-intensity blood flow state of the penis in erection. Erection is the result of hemodynamic changes in the cavernous body and smooth muscle of the penis, and the diastole of cavernous smooth muscle mediated by nitric oxide (NO) and cyclic guanosine monophosphate (cGMP) is the key; if local collagen synthesis increases, it will cause fibrosis of the cavernous endothelium and smooth muscle. Prostaglandin 1 (PGE1) and prostaglandin 2 (PGE2) activate G protein-coupled receptors in cavernous smooth muscle cell membranes and activate adenylyl cyclase (AC), which increases cGMP synthesis and inhibits collagen synthesis, whereas the synthesis of PGE1, PGE2, and NO are all dependent on elevated partial pressure of oxygen in the tissue (5). Most ED patients do not have spontaneous erections for more than 3-6 months, with atrophy of the cavernous vascular sinuses and decreased elasticity. The General Hospital of the People’s Liberation Army used transmission electron microscopy to observe the cellular ultrastructure of penile cavernous tissue in ED patients and found that their specimens had increased interstitial tissue, occlusion of microvascular lumen, atrophy of smooth muscle cells, and obvious pathological changes in organelles (6).
The treatment mechanism of the negative pressure device is: 1, negative pressure: through repeated negative pressure attraction to fill the cavernous body, increase the partial pressure of oxygen and restore “self-oxygenation”; restore the elasticity of the white membrane of the cavernous body; 2, traditional Chinese medicine: the introduction of kidney tonic and aphrodisiac blood-boosting drugs and the stimulating effect of electromagnetic waves on the sympathetic and parasympathetic ganglia of the thoracolumbosacral vertebrae, helping to restore erection function; different herbal treatment solutions also have a therapeutic effect on premature ejaculation and non-ejaculation; 3, psychological: treatment to witness the full erection of the penis plays a good biofeedback treatment effect on the patient’s psychological disorder (7); 4, soft tissue expansion: soft tissue expansion has been used for a long time in human history and has become one of the conventional treatments in plastic surgery (8); stimulation of tissue growth is achieved through mechanical traction (9). Repeated negative pressure attraction can result in some growth in penile length and circumference through soft tissue expansion effect, but circumferential expansion seems to be more pronounced (10). Our treatment of patients with severe penile shortening using penile lengthening surgery followed by negative pressure apparatus is more ideal (11).
In conclusion, the negative pressure suction applicable device has the advantages of non-invasiveness, few complications, low cost and high acceptability of use for all types of ED, even for those who have failed surgical treatment for prosthesis removal. Indications include: ① patients who refuse interventional therapy for erectile dysfunction; ② adjuvant therapy for patients with psychological erectile dysfunction; ③ prior treatment before ICI or prosthesis implantation; ④ adjuvant therapy to enhance the efficacy of oral medication or ICI if the efficacy is unsatisfactory; ⑤ adjuvant therapy for penile vascular surgery; ⑥ adjuvant therapy for premature ejaculation or non-ejaculation; ⑦ patients with small penis (12). We believe that each type of negative pressure applicable device, as the recognized first-line treatment instrument, has a clear mechanism and good effect. However, the fineness of the instruments must be improved; basic research must be strengthened to further elucidate the ultrastructural changes of the cavernous body before and after negative pressure treatment; the optimal negative pressure regulation parameters must be clarified; and they have important application significance in uro-male clinical practice.