Treating Erectile Dysfunction with a Vacuum Tumescence Device:
A Retrospective Analysis of Acceptance and Satisfaction
S. Baltaci, M.D. Urologist, K. Aydos, M.D. Urologist, A. Koser, M.D. Urologist, K. Anafarta. M.D. Professor of Urology Correspondence: Dr. S. Baltaci. Kavacik Subayevleri
British Journal of Urology (1995), 76.757-760
Medical study stating that 88% of participants who used a Vacuum Therapy Device, reported a erection rigid enough for intercourse and an improvement in their natural, spontaneous erections.
Introduction
Objectives: To evaluate the quality of erections, ability to perform sexual intercourse, incidence of complications and satisfaction of patients using an external vacuum erection device in the treatment of erectile failure. Patients and methods. Of the 61 impotent men who participated in this clinical trial, 49 used the device and were surveyed. The mean follow-up period was 12.8 months. A subjective rating scale from 1 to 10 was used to assess to patients satisfaction with the device where 1 indicated dissatisfied and 10 indicated very satisfied. Results. The ease of using the device, satisfaction with quality of erections and ability to perform intercourse were given scores>5 by 88.84 and 82% of the patients, respectively. Sixteen (33%) of the men withdrew for the trial, primarily because they were unable to achieve and maintain a full erection, suffered conflicts in their relationship, or for reasons not related to the device.
Overall, the effectiveness rate was 67%. Of 32patients with arteriogenic impotence, 28 (88%) had satisfactory results and had an improvement in their capability for spontaneous erections with the device. The most frequent adverse effects were blocked ejaculation, bruising or the development of ecchymosus-discomfort during pumping and discomfort from using the constriction bands.
Conclusion. These results suggest that the vacuum device is an effective and safe treatment for impotence of various aetiologies, especially for those patients with arteriogenic impotence.
Despite considerable therapeutic advances in the management of impotence, e.g. the advent of effective penile protheses, self-injection of vasoactive drugs and effective vascular surgical procedures, one reversible non-invasive form of treatment, i.e. the vacuum device appears to be ideal. Vacuum constriction devices provide a mechanical, non-surgical and reversible means of inducing and maintaining an erection and appear to be an attractive alternative to either no treatment or other treatment modalities. Several studies have demonstrated that external vacuum devices can produce erections sufficient for intercourse in 89-100% of men with erection problems of various aetiologies.
The use of these devices for the treatment of impotence is gradually gaining acceptance among patients and urologists. In the last decade, vacuum devices have become available in Turkey and are being increasingly used in the therapy for those unwilling to enter self injection programs or to undergo surgical procedures. We initiated a study using an external vacuum erection device to determine whether it is effective in restoring erectile function and coital capacity.
Patients and methods
A total of 61 patients with erectile difficulty participated in a clinical trial of an external vacuum device. Of the 61 men who began the clinical trial, 12 were lost to follow-up and this report concerns the 49 men who used the device and were surveyed. The evaluation of patients included a thorough medical and sexual history and physical examination, nocturnal penile tumescence testing (NPT), endocrine studies, an intracavernosal papaverine test, and color Doppler flow ultrasonography (CDFU) in addition to cavernosometry, cavernosography, sacral latency-time testing psychiatric evaluation when needed. For the papaverine test 60 mg of papaverine hydrochloride was injected intracavernosally.
If a good erection was produced within 10 min. and maintained for 30 min. the patient was considered to have to cavernosal vascular pathology. The CDFU examination was performed after and injection with 60 mg of papaverine-HCI, when arterial and venous functions were assessed as described previously. A peak systolic velocity in the cavernosal arteries of <25cm/s and a diameter increase of these arteries of <75% were considered as indicating arterial dysfunction. However, enddiastolic velocities of cavernosal arteries of <5 cm/s indicated venous pathology.
The cavernosometric study was performed in the radiology suite. Measurements were made 10 min. after an injection with 60mg papaverine. A maintenance flow rate of>30mL/min to maintain intracorporeal pressure at>90mmHg and a drop in intracorporeal pressure from 150 mmHg to <100mmhg at 30.s and to <60mmhg at 5 min. after stopping infusion was considered as indication corporeal veno-occlusive dysfunction. The parameters used to indicate arterial dilation amd a peal velocity of <25 cm/s by CDFU.
The age of the patients ranged from 23 to 67 years, with mean age of 48 years. The mean duration of impotence was 2.8 years (range 6 months-10 years.) Of the 49 subjects, 40 were diagnosed as having organic erectile difficulties (arteriogenic in 32, venogenic in six and neurogenic in two), while seven had erectile failure of mixed aetiology and two had psychogenic erectile problems. After the various options for the treatment of impotence were discussed, these patients elected to use the vacuum erection device. The men were instructed on the use of the device by verbal explanation and the individual demonstration sessions were also performed. The men were instructed to begin their use with the largest constriction band, but to use a smaller band only if his erection could not be maintained. The men returned to the clinic for follow-up evaluations after 2 and 4 weeks of use. A physical examination was performed to detect symptoms and signs of complications and they were interviewed regarding complications, side effects and their satisfaction with the device. After the first two visits further information was obtained by direct questioning of patients during follow-up visits or in a telephone survey, or by letters with standardized questionnaires.
The ease of use, quality of the erection achieved and the ability to perform sexual intercourse were used to assess satisfaction, employing a subjective rating scale of 1 to 10 where 1 indicated dissatisfied and 10 indicated very satisfied.
Results
Follow-up of the 49 patients ranged from 2 to 32 months (mean 12.8) during which they received no additional therapy. Overall, the rate of effectiveness was 67%. Of the 49 men, four (8%) had an improvement in spontaneous erections after a mean of 2 months of use and had periodic sexual activity, consisting primarily of manual stimulation with using the device, and they had discontinued its use. These four patients had borderline arteriogenic impotence before treatment. Of the remaining 45 patients, 29 (64%) were still using the device successfully a mean 6.1 times per month and experienced an improvement in their capacity for spontaneous erection.
These 29 men were also asked to rate the quality of the device and 17 (59%) of them experienced a significant improvement in the quality and frequency of erections. The patients’ degree of satisfaction with the device is presented in Table 2. The case of using he device, satisfaction with the erection quality and ability to perform intercourse were given scores of>5 by 88.84 and 82% of the men, respectively. The frequency of sexual desire or masturbation was increased in five patients, whereas in two it was decreased.
Of the 49 men who entered the program 16 (33%) withdrew between 1 and 3 months after the start. Two men left for reasons unrelated to the device, one because of poor health (gastric cancer) and the other with marital problems. Reasons for withdrawal are presented in Table 3. Throughout the trial, 12 patients reported discomfort during pumping and 22 reported discomfort from the use of the constriction bands. However, with time these effects disappeared in the majority and only one patient stopped using the device. Thirteen men (27%) with normal ejaculatory ability reported blocked ejaculation with the constriction bands in place. Bruising or development of echymosis occurred on 19 patients 939%) during the trial. One man had a haematoma and stopped using the device.
Two other men experienced dizziness during pumping. The majority of these complications occurred during the first month of use. Follow-up physical examinations revealed no penile abnormalities such as fibrosis, intracorporeal induration or skin changes.
Discussion
Although intracavernosal injections of vasoactive drugs and improved penile prosthesis have been used successfully by many patients, they are not without adverse affects. However, a reversible non-invasive form of treatment of impotence appears to be ideal and this led to renewed interest in external vacuum devices. Indeed, the concept of vacuum-included erections is at least 75 years old.
Erections of sufficient quality for penetration and intercourse induced by external vacuum devices were reported in 68-100 % of men with erection problems of various aetiologies. The rate of effectiveness in the present study (67%) although lower than many other reports, was similar to that found in some previous studies. The men tended to increase their satisfaction score by improving the rate of pumping and by proper selection of ring size for the vacuum cylinder. In previous reports, no relationship was found between the quality of spontaneous erectile capacity of subjects in the organic, mixed and psychogenic erectile failure groups. However, in the present study of 32 patients with arteriogenic impotence, four had spontaneous erections after a mean of 2 months and subsequently did not need the vacuum device. Additionally, 24 patients with arteriogenic impotence experienced improvements in their capacity for spontaneous erections.
Overall, 28 of 32 (88%) patients with arteriogenic impotence had satisfactory results and improvements in the capacity for spontaneous erections with the external vacuum device. Although unproven, repeated application of the vacuum device may lead to improvement in the intracavernosal sinusoidal distension which possibly explains the satisfactory result in those with aeteriogenic impotence. Bosshardt et al (17) recently reported improvements in the duration and extend to nocturnal penile tumescence and rigidity after patients used the vacuum device for 2 weeks at home. Patients who reported having spontaneous morning erections showed significant improvements in total erection time, erection phase and plateau-phase duration, effective rigidity and tumescence increase. Bosshardt et al concluded that the increase in penile volume during the application of the device was caused not only by arterial inflow, but also by venous backflow.
In the present study, discomfort during the application of pressure was experienced in 12 patients (25%), but only one was severe enough to discontinue use. Discomfort from the use of the constriction bands was however reported in 22 patients (45%) but these problems disappeared with time. The incidence of both problems was similar to that in other studies. Skin bruising and ecchymosis occurred in 19 (395) patients who had experienced haematoma stopped using the device. In other studies, ecchymosis and skin bruising occurred in 21-37 % of the patients. Absence of ejaculatory fluid occurred in 27% of patients in the present study in previous studies. The reported incidence of blocked ejaculation was between 12 and 39%. Although most users did not describe blocked ejaculation to be a problem, this finding also indicates that vacuum devices need not me discarded as a treatment alternative in couples who are trying to conceive.
The most common reasons for discontinuation of the device in the present study were poor quality of the erections achieved and conflicts in personal relationships. Several investigators have also reported the difficulties that patients and partners encounter with these devices. These factors should be considered in planning programs for the education of patients and a short course of therapy for couples is often needed for them to become completely familiar with the device and adapt to its use. In summary, the external vacuum device is an effective and attractive treatment alternative for impotence of various aetiologies, especially for arteriogenic impotence. Limitations of the therapy include inability to achieve and maintain a full erection, conflicts in relationships and change in ejaculatory pattern
http://rejoynme dical.com/artic … ysfunction.html