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Vacuum Constriction Device for Management of Erectile Impotence
0022-534 7/89 /1412-0320$2.00/0 THE JOURNAL OF UROLOGY
Vol. 141, February
Copyright© 1989 by The Williams & Wilkins Co.
Printed in U.S.A.
VACUUM CONSTRICTION DEVICE FOR MANAGEMENT OF ERECTILE IMPOTENCE ROY WITHERINGTON From the Section of Urology, The Medical College of Georgia School of Medicine, Augusta, Georgia ABSTRACT
A mechanical device for treatment of impotence based on the concept of entrapment of blood in the penis following vacuum-assisted tumescence is described and more than 15,000 units have been marketed. A total of 1,517 users who acquired the device between 1974 and 1987 completed a questionnaire concerning the system. Of these patients 92 per cent either achieved an erection or an erection-like state that was satisfactory for intercourse and 77 per cent had intercourse at least every 2 weeks. No serious ill effect from use of the device has been reported and it is particularly effective in the management of partial impotence. In selected patients the device is an alternative to either surgical placement of a penile prosthesis, intracavernous injection of vasoactive drugs or sexual abstinence. (J. Ural., 141: 320-322, 1989) Increased sexual expectations and an aging population have resulted in an immense upsurge of interest in the management of impotence. Various medications, including hormones and intracavernosally injected vasoactive drugs, often are effective and penile prostheses generally have met with remarkable success. 1- 5 However, a reversible noninvasive form of treatment for this troublesome affliction appears to be ideal and the quest for such has resulted in the development of some ingenious external devices. Some have been effective but most have been cumbersome and less than satisfactory. The concept of an external device capable of producing an erection-like state by use of vacuum suction and penile constriction is not new. The vacuum constriction device has been commercially available for more than a decade but until recently it has received scant attention. The device consists of a plastic cylinder, vacuum pump, plastic tube and elastic constriction bands (fig. 1). The cylinder is large enough to fit over the erect penis and the base is open. The opposite end is closed except for a nipple to which the vacuum pump is attached by the tube. A constriction band is placed around the base of the cylinder before the latter is placed over the flaccid penis (fig. 2, A). Pump suction then creates negative pressure within the cylinder, which either augments an inadequate erection or produces an erection-like state (fig. 2, B). After adequate penile engorgement the band is guided from the cylinder to the base of the penis. The cylinder then is removed and the erection or erection-like state is maintained long enough to permit intercourse (fig. 2, C). The system is patented, sale is permitted by the United States Food and Drug Administration, and it is available by prescription only. More than 15,000 units have been marketed.
months to 10 years and 80 per cent were unable to have a perceptible erection. The interval that the device was in use averaged 8.6 months (range less than 6 months to 10 years). Of the users 92 per cent could achieve an erection-like state that was adequate for satisfactory intercourse and 77 per cent stated that they had intercourse at least every 2 weeks. Also, 25 per cent of the subjects occasionally were able to have sexual intercourse without using the device and 58 per cent indicated great improvement in self-image. Penile ecchymosis and pain or discomfort when the device initially was used occurred in 37 per cent of the patients but with time these nuances disappeared in the majority. Practice time required for successful use of the device averaged 1 week (range 1 day to more than 6 weeks). An average of 4 practice sessions (range 1 to more than 12) was required before successful use. The average time required to obtain usable penile engorgement was 2.5 minutes (range 30 seconds to more than 7 minutes). Orgasm was considered to be pleasant by 57 per cent of the patients but 9 per cent had pain. Twelve per cent were unable to ejaculate and this usually reflected the underlying cause of impotence. Despite absence of ejaculation, most users described the sex act as pleasant. Of the users 83 per cent indicated a solid relationship with their sexual partners and 92 per cent indicated that they would recommend the system to others. Seventy per cent of the devices were prescribed by urologists.
MATERIAL AND METHODS
A total of 1,700 users who obtained the system between 1974 and 1987 agreed to participate in a survey and were furnished detailed questionnaires by the distributor of the device. Among these users 1,517 responses were received. The questions dealt with appropriate medical history, mechanics of the device and outcome from its use. RESULTS
For brevity, only responses to major questions will be addressed. The average age of the user was 64 years (range 25 to 90 years) and the perceived causes of impotence include all known etiologies. Participants had been sexually inactive for 6 Accepted for publication June 6, 1988.
FIG. 1. Assembled vacuum constriction device. Note 2 types of constriction bands. Also note insert that can be introduced into base of cylinder to narrow aperture if penis is small. 320
321
SUCTION DEVICE TREATMENT OF IMPOTENCE
A
C
B Suction
!IG. ~-
A, cylinder with constri~ti~n bands aro~nd base place_d over flaccid penis. B, suction applied creating negative pressure within cylinder an pemle _engorg1;ment. Ci c~mstrict10n bands guided from cylmder to base of penis. Penile tumescence is maintained producing erection-like state. Reprmted with perm1ss1on. 9 DISCUSSION
Nadig and associates recently reported use of a vacuum constriction device in 35 men with proved organic impotence. 6 They applied the device and for the next 30 minutes monitored vacuum pressures, penile arterial blood flow, skin temperature, longitudinal rigidity and circumference. Of the patients 27 (77 per cent) achieved a penile longitudinal rigidity of more than 454 gm. buckling force, the minimum considered adequate by sleep laboratories. The amount of vacuum applied ranged from 175 to 380 mm. Hg. Strain gauge plethysmography confirmed continued blood flow in all patients and skin temperature decreased an average of 0.96C. After removal of constriction the penis returned to its normal flaccid state. The penile brachial index did not change in 9 of the subjects studied before and after 6 to 22 months of use. Of the men 24 (69 per cent) were satisfied with the device and used it regularly. It is noteworthy that 4 of their 5 patients who had a penile longitudinal rigidity of less than 454 gm. of buckling force still used the device regularly and were pleased with it. Wiles recently reported highly satisfactory results from use of this device in 10 impotent diabetic men. 7 Nelson recently described use of the device as a viable alternative to operative management of impotence in selected patients. 8 Additionally, successful management of impotence with the device, particularly in men with partial impotence, has been reported recently. 9 • 10 Unfortunately, the majority of respondents to the current survey had had little if any systemic evaluation before beginning use of the system. However, available data indicate that many were partially impotent but some were totally impotent. A strong point favoring use of this device is that sophisticated pre-treatment evaluation is not really necessary. Since it is a completely reversible and noninvasive method of management, it is not crucial that either the exact etiology or the degree of impotence be proved before use of the device. That one-fourth of the users occasionally were able to have sexual intercourse without the device indicates that a large number had partial impotence, an expected finding. Spontaneously acquired impotence is at first a partial type and with time, particularly in the absence of effective treatment, it progresses to complete impotence. Consequently, suction and constriction therapy may be of particular benefit to a large segment of the impotent population. The major drawbacks to the device are that it is
cumbersome, and requires time and patience to learn to use properly. In men with total impotence use of the device causes tumescence distal to the point of constriction only and the proximal fixed part of the penis remains flaccid. This proximal flaccidity may make sexual intercourse difficult. Despite this finding many men with total impotence described satisfactory sexual function. Urethral occlusion by the constriction band prevents normal emission of semen and concomitant distension of the bulbous urethra. Because of this fact ejaculation may be painful. However, surprisingly few users actually described pain on ejaculation. If painful ejaculation is encountered use of a quick release type of constriction band is recommended, since it can be unfastened just before ejaculation. It currently is recommended that the period of penile constriction should not exceed 30 minut~s .. If a longer perio_d of tumescence should be required, constr1ct10n should be discontinued for a few minutes and tumescence repeated. C:ontraindications to use of the device are few. Any man on anticoagulants or who has a blood dyscrasia should use the device with caution. To date, no serious ill effects have been r~ported. Specifically, corporeal fibrosis, urethral stricture, pemle gangrene and penile skin necrosis have not been described. In the management of impotence there is occasional reluctance by the patient and/or physician to proceed with insertion of a penile prosthesis. When such reluctance is encountered use of the vacuum constriction device may help to determine the ability of the patient and partner to cope with a usable erection. If the device should result in a usable erection and both are pleased the likelihood of a satisfactory result from insertion of a prosthesis appears to be good. However, if the device results in a usable erection and either the patient or his se~ual ~artner is displeased insertion of a prosthesis may termmate m an unhappy outcome even with a superior anatomical and potentially functional postoperative result. REFERENCES
1. Montague, D. K.: Impotence: 1950-1983. J. Urol., 131: 526, 1984. 2. Zorgniotti, A. W_. and Lefleur, R. S.: Auto-injection of the corpus cavernosum with a vasoactive drug combination for vasculogenic impotence. J. Urol., 133: 39, 1985.
322
WITHERINGTON
3. Morales, A., Surridge, D. H. C., Marshall, P. G. and Fenemore, J.: Nonhormonal pharmacological treatment of organic impotence. J. Urol., 128: 45, 1982. 4. Malloy, T. R., Wein, A. J. and Carpiniello, V. L.: Comparison of the inflatable penile and the Small-Carrion prostheses in the surgical treatment of erectile impotence. J. Urol., 123: 678, 1980. 5. Beutler, L. E., Scott, F. B., Karacan, I., Baer, P. E., Rogers, R. R., Jr. and Morris, J.: Women's satisfaction with partners' penile implant. Inflatable vs noninflatable prosthesis. Urology, 24: 552, 1984. 6. Nadig, P. W., Ware, J.C. and Blumoff, R.: Noninvasive device to produce and maintain an erection-like state. Urology, 27: 126, 1986. 7. Wiles, P. G.: Successful non-invasive management of erectile impotence in diabetic men. Brit. Med. J., 296: 161, 1988. 8. Nelson, R. P.: Nonoperative management of impotence. J. Urol., 139: 2, 1988. 9. Witherington, R.: External aids for treatment of impotence. J. Urol. Nursing, 6: 10, 1987. 10. Witherington, R.: Suction device therapy in the management of erectile impotence. Urol. Clin. N. Amer., 15: 123, 1988.
EDITORIAL COMMENT With data derived from retrospective patient surveys this study attempts to define patient satisfaction with an externally applied vacuum constriction device in the management of erectile impotence. The survey examines less than 11 per cent (1,517 of 15,000) of the patients who have purchased the device. This statistic, combined with the admission that the survey was generated and interpreted by a marketing company rather than by a medical institution, raises the question of bias. How were the 1,700 patients to be surveyed selected? Were the questions over preferentially sent to patients who previously corresponded with the company or to those who had a particular type of problem and so forth? Another objection to this report is the lack of pre-treatment evaluation to differentiate organic versus psychogenic impotence. The author states that "since it is a completely reversible and noninvasive method
of management, it is not crucial that either the exact etiology or the degree of impotence be proved before use of the device". This statement overlooks patient cost considerations, and also the time and frustration spent with a potentially inadequate form of therapy. Pre-treatment evaluation data with tumescence testing as well as subdivision of the organically impotent patients into neurogenic, arterial or corporovenous leak categories should be presented to help one select patients most likely to benefit from thi's device. It is difficult to accept that a nonphysiological erection predicated upon trapping blood in the penis with proximal crutal flaccidity, urethral compression hindering ejaculation and a general cooling of the phallus should elicit such a high favorable response rate. Perhaps lack of complete patient satisfaction is underscored by the fact that although 92 per cent of them claim satisfactory erections only half reported a pleasant orgasm. The potential for adverse effects secondary to use of this device also must be addressed. While no complications are reported 37 per cent of the patients initially described penile pain and ecchymosis. The potential for penile and urethral injury from abuse of the constricting band, especially in patients with compromised penile arterial systems, must be considered. While this device may prove to have application for part of the impotent population in the future, I remain concerned that patients most likely to benefit have not been accurately targeted scientifically.
Ralph C. Benson Department of Urology Mayo Clinic Jacksonville Jacksonville, Florida REPLY BY AUTHOR Bias in such a study cannot be ruled out; however, the users who responded to the survey had agreed to participate before they ever used the device. Use of such a device at first glance appears unscientific. This causes many of our colleagues to refuse to accept it and to not offer it to their patients. I shared these concerns for several years and only after interviewing several satisfied users was I willing to prescnoe it. Since then I have seen many satisfied users. The device is no panacea but it has a place in our therapeutic armamentarium.
Vol. 141, February
Copyright© 1989 by The Williams & Wilkins Co.
Printed in U.S.A.
VACUUM CONSTRICTION DEVICE FOR MANAGEMENT OF ERECTILE IMPOTENCE ROY WITHERINGTON From the Section of Urology, The Medical College of Georgia School of Medicine, Augusta, Georgia ABSTRACT
A mechanical device for treatment of impotence based on the concept of entrapment of blood in the penis following vacuum-assisted tumescence is described and more than 15,000 units have been marketed. A total of 1,517 users who acquired the device between 1974 and 1987 completed a questionnaire concerning the system. Of these patients 92 per cent either achieved an erection or an erection-like state that was satisfactory for intercourse and 77 per cent had intercourse at least every 2 weeks. No serious ill effect from use of the device has been reported and it is particularly effective in the management of partial impotence. In selected patients the device is an alternative to either surgical placement of a penile prosthesis, intracavernous injection of vasoactive drugs or sexual abstinence. (J. Ural., 141: 320-322, 1989) Increased sexual expectations and an aging population have resulted in an immense upsurge of interest in the management of impotence. Various medications, including hormones and intracavernosally injected vasoactive drugs, often are effective and penile prostheses generally have met with remarkable success. 1- 5 However, a reversible noninvasive form of treatment for this troublesome affliction appears to be ideal and the quest for such has resulted in the development of some ingenious external devices. Some have been effective but most have been cumbersome and less than satisfactory. The concept of an external device capable of producing an erection-like state by use of vacuum suction and penile constriction is not new. The vacuum constriction device has been commercially available for more than a decade but until recently it has received scant attention. The device consists of a plastic cylinder, vacuum pump, plastic tube and elastic constriction bands (fig. 1). The cylinder is large enough to fit over the erect penis and the base is open. The opposite end is closed except for a nipple to which the vacuum pump is attached by the tube. A constriction band is placed around the base of the cylinder before the latter is placed over the flaccid penis (fig. 2, A). Pump suction then creates negative pressure within the cylinder, which either augments an inadequate erection or produces an erection-like state (fig. 2, B). After adequate penile engorgement the band is guided from the cylinder to the base of the penis. The cylinder then is removed and the erection or erection-like state is maintained long enough to permit intercourse (fig. 2, C). The system is patented, sale is permitted by the United States Food and Drug Administration, and it is available by prescription only. More than 15,000 units have been marketed.
months to 10 years and 80 per cent were unable to have a perceptible erection. The interval that the device was in use averaged 8.6 months (range less than 6 months to 10 years). Of the users 92 per cent could achieve an erection-like state that was adequate for satisfactory intercourse and 77 per cent stated that they had intercourse at least every 2 weeks. Also, 25 per cent of the subjects occasionally were able to have sexual intercourse without using the device and 58 per cent indicated great improvement in self-image. Penile ecchymosis and pain or discomfort when the device initially was used occurred in 37 per cent of the patients but with time these nuances disappeared in the majority. Practice time required for successful use of the device averaged 1 week (range 1 day to more than 6 weeks). An average of 4 practice sessions (range 1 to more than 12) was required before successful use. The average time required to obtain usable penile engorgement was 2.5 minutes (range 30 seconds to more than 7 minutes). Orgasm was considered to be pleasant by 57 per cent of the patients but 9 per cent had pain. Twelve per cent were unable to ejaculate and this usually reflected the underlying cause of impotence. Despite absence of ejaculation, most users described the sex act as pleasant. Of the users 83 per cent indicated a solid relationship with their sexual partners and 92 per cent indicated that they would recommend the system to others. Seventy per cent of the devices were prescribed by urologists.
MATERIAL AND METHODS
A total of 1,700 users who obtained the system between 1974 and 1987 agreed to participate in a survey and were furnished detailed questionnaires by the distributor of the device. Among these users 1,517 responses were received. The questions dealt with appropriate medical history, mechanics of the device and outcome from its use. RESULTS
For brevity, only responses to major questions will be addressed. The average age of the user was 64 years (range 25 to 90 years) and the perceived causes of impotence include all known etiologies. Participants had been sexually inactive for 6 Accepted for publication June 6, 1988.
FIG. 1. Assembled vacuum constriction device. Note 2 types of constriction bands. Also note insert that can be introduced into base of cylinder to narrow aperture if penis is small. 320
321
SUCTION DEVICE TREATMENT OF IMPOTENCE
A
C
B Suction
!IG. ~-
A, cylinder with constri~ti~n bands aro~nd base place_d over flaccid penis. B, suction applied creating negative pressure within cylinder an pemle _engorg1;ment. Ci c~mstrict10n bands guided from cylmder to base of penis. Penile tumescence is maintained producing erection-like state. Reprmted with perm1ss1on. 9 DISCUSSION
Nadig and associates recently reported use of a vacuum constriction device in 35 men with proved organic impotence. 6 They applied the device and for the next 30 minutes monitored vacuum pressures, penile arterial blood flow, skin temperature, longitudinal rigidity and circumference. Of the patients 27 (77 per cent) achieved a penile longitudinal rigidity of more than 454 gm. buckling force, the minimum considered adequate by sleep laboratories. The amount of vacuum applied ranged from 175 to 380 mm. Hg. Strain gauge plethysmography confirmed continued blood flow in all patients and skin temperature decreased an average of 0.96C. After removal of constriction the penis returned to its normal flaccid state. The penile brachial index did not change in 9 of the subjects studied before and after 6 to 22 months of use. Of the men 24 (69 per cent) were satisfied with the device and used it regularly. It is noteworthy that 4 of their 5 patients who had a penile longitudinal rigidity of less than 454 gm. of buckling force still used the device regularly and were pleased with it. Wiles recently reported highly satisfactory results from use of this device in 10 impotent diabetic men. 7 Nelson recently described use of the device as a viable alternative to operative management of impotence in selected patients. 8 Additionally, successful management of impotence with the device, particularly in men with partial impotence, has been reported recently. 9 • 10 Unfortunately, the majority of respondents to the current survey had had little if any systemic evaluation before beginning use of the system. However, available data indicate that many were partially impotent but some were totally impotent. A strong point favoring use of this device is that sophisticated pre-treatment evaluation is not really necessary. Since it is a completely reversible and noninvasive method of management, it is not crucial that either the exact etiology or the degree of impotence be proved before use of the device. That one-fourth of the users occasionally were able to have sexual intercourse without the device indicates that a large number had partial impotence, an expected finding. Spontaneously acquired impotence is at first a partial type and with time, particularly in the absence of effective treatment, it progresses to complete impotence. Consequently, suction and constriction therapy may be of particular benefit to a large segment of the impotent population. The major drawbacks to the device are that it is
cumbersome, and requires time and patience to learn to use properly. In men with total impotence use of the device causes tumescence distal to the point of constriction only and the proximal fixed part of the penis remains flaccid. This proximal flaccidity may make sexual intercourse difficult. Despite this finding many men with total impotence described satisfactory sexual function. Urethral occlusion by the constriction band prevents normal emission of semen and concomitant distension of the bulbous urethra. Because of this fact ejaculation may be painful. However, surprisingly few users actually described pain on ejaculation. If painful ejaculation is encountered use of a quick release type of constriction band is recommended, since it can be unfastened just before ejaculation. It currently is recommended that the period of penile constriction should not exceed 30 minut~s .. If a longer perio_d of tumescence should be required, constr1ct10n should be discontinued for a few minutes and tumescence repeated. C:ontraindications to use of the device are few. Any man on anticoagulants or who has a blood dyscrasia should use the device with caution. To date, no serious ill effects have been r~ported. Specifically, corporeal fibrosis, urethral stricture, pemle gangrene and penile skin necrosis have not been described. In the management of impotence there is occasional reluctance by the patient and/or physician to proceed with insertion of a penile prosthesis. When such reluctance is encountered use of the vacuum constriction device may help to determine the ability of the patient and partner to cope with a usable erection. If the device should result in a usable erection and both are pleased the likelihood of a satisfactory result from insertion of a prosthesis appears to be good. However, if the device results in a usable erection and either the patient or his se~ual ~artner is displeased insertion of a prosthesis may termmate m an unhappy outcome even with a superior anatomical and potentially functional postoperative result. REFERENCES
1. Montague, D. K.: Impotence: 1950-1983. J. Urol., 131: 526, 1984. 2. Zorgniotti, A. W_. and Lefleur, R. S.: Auto-injection of the corpus cavernosum with a vasoactive drug combination for vasculogenic impotence. J. Urol., 133: 39, 1985.
322
WITHERINGTON
3. Morales, A., Surridge, D. H. C., Marshall, P. G. and Fenemore, J.: Nonhormonal pharmacological treatment of organic impotence. J. Urol., 128: 45, 1982. 4. Malloy, T. R., Wein, A. J. and Carpiniello, V. L.: Comparison of the inflatable penile and the Small-Carrion prostheses in the surgical treatment of erectile impotence. J. Urol., 123: 678, 1980. 5. Beutler, L. E., Scott, F. B., Karacan, I., Baer, P. E., Rogers, R. R., Jr. and Morris, J.: Women's satisfaction with partners' penile implant. Inflatable vs noninflatable prosthesis. Urology, 24: 552, 1984. 6. Nadig, P. W., Ware, J.C. and Blumoff, R.: Noninvasive device to produce and maintain an erection-like state. Urology, 27: 126, 1986. 7. Wiles, P. G.: Successful non-invasive management of erectile impotence in diabetic men. Brit. Med. J., 296: 161, 1988. 8. Nelson, R. P.: Nonoperative management of impotence. J. Urol., 139: 2, 1988. 9. Witherington, R.: External aids for treatment of impotence. J. Urol. Nursing, 6: 10, 1987. 10. Witherington, R.: Suction device therapy in the management of erectile impotence. Urol. Clin. N. Amer., 15: 123, 1988.
EDITORIAL COMMENT With data derived from retrospective patient surveys this study attempts to define patient satisfaction with an externally applied vacuum constriction device in the management of erectile impotence. The survey examines less than 11 per cent (1,517 of 15,000) of the patients who have purchased the device. This statistic, combined with the admission that the survey was generated and interpreted by a marketing company rather than by a medical institution, raises the question of bias. How were the 1,700 patients to be surveyed selected? Were the questions over preferentially sent to patients who previously corresponded with the company or to those who had a particular type of problem and so forth? Another objection to this report is the lack of pre-treatment evaluation to differentiate organic versus psychogenic impotence. The author states that "since it is a completely reversible and noninvasive method
of management, it is not crucial that either the exact etiology or the degree of impotence be proved before use of the device". This statement overlooks patient cost considerations, and also the time and frustration spent with a potentially inadequate form of therapy. Pre-treatment evaluation data with tumescence testing as well as subdivision of the organically impotent patients into neurogenic, arterial or corporovenous leak categories should be presented to help one select patients most likely to benefit from thi's device. It is difficult to accept that a nonphysiological erection predicated upon trapping blood in the penis with proximal crutal flaccidity, urethral compression hindering ejaculation and a general cooling of the phallus should elicit such a high favorable response rate. Perhaps lack of complete patient satisfaction is underscored by the fact that although 92 per cent of them claim satisfactory erections only half reported a pleasant orgasm. The potential for adverse effects secondary to use of this device also must be addressed. While no complications are reported 37 per cent of the patients initially described penile pain and ecchymosis. The potential for penile and urethral injury from abuse of the constricting band, especially in patients with compromised penile arterial systems, must be considered. While this device may prove to have application for part of the impotent population in the future, I remain concerned that patients most likely to benefit have not been accurately targeted scientifically.
Ralph C. Benson Department of Urology Mayo Clinic Jacksonville Jacksonville, Florida REPLY BY AUTHOR Bias in such a study cannot be ruled out; however, the users who responded to the survey had agreed to participate before they ever used the device. Use of such a device at first glance appears unscientific. This causes many of our colleagues to refuse to accept it and to not offer it to their patients. I shared these concerns for several years and only after interviewing several satisfied users was I willing to prescnoe it. Since then I have seen many satisfied users. The device is no panacea but it has a place in our therapeutic armamentarium.