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Snap-gauge band vs multidisciplinary evaluation in impotence assessment
SNAP-GAUGE
BAND VS MULTIDISCIPLINARY
EVALUATION
IN IMPOTENCE
JAMES
ALLEN.
DAVID
J. ELLIS,
JANELL
M.D.
MICKI
M.D.
L. CARROLL,
ASSESSMENT R. BALTISH,
DEMETRIUS PH.D.
R.N.
H. BAGLEY,
M.D.
JEFFERSON SEXUAL FUNCTION CEIVTI;H*
From the Department of Urology, Jefferson of Thomas Jefferson University, Philadelphia,
Medical College Pennsylvania
ABSTRACTThis study compares thefindings of multidisciplinary evaluation to the two-night use of the Snap-Guage band in 100 impotent men. An organic etiology was diagnosed in 52 percent of those evaluated. The Snap-Gauge band proved accurate as a screening devicefor organic disease. If no elements were broken over the two-night period, this finding correlated with multisystemic diagnosis of organic etiology in 86 percent of cases. Among the 52 patients in whom an organic etiology was diagnosed, 32 broke no elements for a 62 percent sensitivity. When ,more than one element was broken, the predictive value as to etiology of the erectile dysfunction diminished.
The multidisciplinary approach to the evaluation of erectile dysfunction is the time-honored method to differentiate psychogenic from organic impotence. 1.2 This thorough process, however, is both time-consuming and costly. Therefore a simplified and inexpensive approach for initial screening would be desirable. Documentation of the presence or absence of nocturnal erections has been a valuable tool in differentiating between organic and psychologic bases for impotence. However, serial overnight evaluation in a sleep laboratory is prohibitively expensive to be used as an initial screening device. Therefore, a simple method for detecting nocturnal tumescence is needed. The Snap-Gauge1 band is a device which addresses this issue. It is a Velcro-fastened band worn on the penis during sleep. Incorporated into the band are three plastic elements which break sequentially as greater radial force is applied with penile tumescence.3 Thus, a patient
*Members: D.H.Bagley, M.D.; S. Cohen, M.D.: R. Fishkin, D.O.; A. Goldman, M.A.; S. Jacobs, M.D.; K. Doghramji, M.D. TDacomed, 1701 East 79th Street. Suite 17, Minneapolis, Minrwota 55320.
can break from zero to three elements in one night’s use depending on the cross-sectional rigidity obtained. The device is inexpensive, but its accuracy is not well documented in clinical series. The present study compares the use of the Snap-Gauge with multidisciplinary evaluation to define the effectiveness of this device. Although it cannot replace multisystemic evaluation, the Snap-Gauge band can augment the evaluation and perhaps serve as a valuable screening device. Material
and Methods
The patient population consisted of 105 impotent men seen in the Jefferson Sexual Function Center over a six-month period. Each patient underwent evaluation by a urologist, an endocrinologist, and a psychiatrist or psychologist. Routine hematologic and biochemical reproductive hormone levels. and screening, penile arterial Doppler examinations were performed on all patients. Additional studies, such as nocturnal penile tumescence monitoring, repeat hormonal analinjection of papaverine, ysis, intracorporeal
3 patients 0 - 1 elements Organic
3 patients 2 - 4 elements
(7)
5 - 6 elements
1 patient
I 4 elements broken
(1)
Psychogenic
6 elements broken
Invalid NPT 2O ApneaFIGURE
2.
Sleep laboratory
evaluations
,14
19
ELEMENTS
t BROKEN
FIGURE 1. Relationship ken elements and organic
IN TWO NIGHTS
between number of broor psychologic disease. 22
and pudendal and bulbocavernosus electromyography were performed as indicated. Each patient also underwent a two-night evaluation wearing the Snap-Gauge band at home. Patients were instructed on placement of the device at the initial office visit and given a selfaddressed stamped envelope in which to return them. Following this evaluation a roundtable discussion was held on each patient and a working diagnosis as to the etiology of the erectile dysfunction was made. These diagnoses could be updated as additional testing was completed and those results became available. The SnapGauge results were not available to the group in arriving at a diagnosis. Results Of the 105 patients studied, three failed to return the bands, one experienced a mechanical failure with one device, and one failed to complete his one-day initial evaluation. Results are therefore based on 100 patients. An overall incidence of organic etiology was diagnosed in 52 percent of patients. This corresponds with the relative percentage of organic and psychogenic disease reported elsewhere.4 The relationship between the number of broken elements and organic or psychologic disease is presented in Figure 1. Thirty-seven patients broke no elements in two nights, and 32 patients were diagnosed with an organic cause for their erectile dysfunction. Therefore, the failure to break any bands on two consecutive
198
non-rigid
/ erections
1
(n = 9).
pts
O-l
element
broken
pts
2-4
elements
broker
\ 0 pts
5-6
elements
broken
2
pts
O-l
element
1
Pt
2-4
elements
broken
0
pts
5-6
elements
broken
5
Injections C
/
\ \
3 rigid erections
t
\ FIGURE 3.
Evaluation
broken
of papaverine
injections
(n
= 22).
nights was 86 percent accurate in diagnosing organic erectile failure. If those patients who break one band are included, 37 of 47 (79%) were found to be organic causes. If those patients who broke 4 or less bands are examined, then 48 of 83 (57 %) were organic causes. Thus, as increasing numbers of elements are broken, the overall incidence of 52 percent organic causes is approached. The predictive value of other higher numbers of broken bands is less valuable. The percentage of psychogenic to organic etiology varied little whether 2 or 6 bands were broken. In each instance, a psychogenic etiology was more likely, but occurred in approximately 70 percent of patients. Nine patients also had formal nocturnal penile tumescence monitoring in a sleep laboratory. The results of these studies are compared with the Snap-Gauge findings (Fig. 2). In 22 patients erectile function was evaluated by the intracorporeal injection of 30 mg of papaverine. Only 3 of these patients achieved rigid erections: The results of the Snap-Gauge study are compared for the two groups in Figure 3.
UROLOGY
L
/ OCTOBER
1989
Comment Recent advances in the diagnosis and treatment of erectile dysfunction have expanded interest in this field.” An aging society, increasingly effective medical therapy, and improved surgical prosthetics have been responsible for more patients than ever presenting for evaluation of complaints of erectile failure. The burden of accurate diagnosis weighs heavily on the urologist. Impotence is a disease not well suited for definition by objective parameters, and this makes diagnosis most challenging. Urologists therefore are continually seeking methods to better assess the problem objectively. The traditional approach to evaluation recluires a multidisciplinary examination of the patient. This process inspects each of the systems required to achieve an erection to detect any pathology therein. A primary goal has been to differentiate those with organic disease from those tvith psychogenic etiology.” The present results indicate the value of the Snap-Gauge as a screening device. If no elements wrere broken in our two-night study, correlation with organic disease was high. If one or more elements were broken, there was a higher incidence of psychogenic disease, regardless of the number of elements broken. From our study approximately one third of patients with an organic etiolo&T will break a variable number of elements. Therefore, one must rely more heavily on standard evaluations to distinguish etiologies in those who do break some elements. Among the 22 patients studied by intracorporeal injection of papaverine, 19 did not achieve sllfficientl!, rigid erections while three rigid erections were produced (Fig. 3). The 3 patients who did respond fully were diabetics in whom impotence was associated with neuropathic disease. Of these 22 patients with arterial or neurogenie etiologies, 14 (64 % ) broke no bands on two nights of tssting. This correlates well with the sensitivity of the Snap-Gauge observed in our study as a whole (32 of 52 [61.5 % ] patients with an organic etiology broke no elements). In the small group of patients who under\\rent formal three-night nocturnal penile tumescence monitoring in the sleep laboratory, no patient who failed to break any elements achieved sufficiently rigid nocturnal erections by NPT (Fig. 1). Patients with organic sleep laboratory results, however, do at times break variable numbers of elements. The 1 patient who did have adequate tumescence on NPT did break multiple elements on his two-night Snap-
Gauge test. Previous studies in our laboratory7 and other centers8 have noted a high but not perfect correlation between re:sults with the Snap-Gauge and formal NPT monitoring which has many advantages including evaluation of the quality and duration of erection and monitoring of the patient’s sleep pattern. There are several potential sources of error in the diagnostic use of the Snap-Gauge band to evaluate erectile failure. The most obvious is that the study is done by the patient at home and is therefore subject to manipulation, Accidental breakage of the bands ma\- also occur. The potential for tumescence without adequate axial rigidity but sufficient radial force to break the bands must also be considered as an unlikel) source of error. As this study demonstrates, the accuracy of the Snap-Gauge test is greatest when no bands are broken, thus suggesting the errors which can occur wit-h accidental breakage. It is considerably less accurate when any bands are broken. Our results confirm the near11 equal number of impotent men with psychogenic and organic causes in this referred population. The SnapGauge when used in this study context appears to be cost-effective and has a high patient compliance for use and return (97 % ) . The most useful information developed when no elements were broken; this was 86 percent specific for organic disease. If one or more elements were broken, approximately 70 percent \vere diagnosed as psychogenic. The Snap-Gauge. when used as a screening device, can aid in the process of diagnosing the cause of erectile ~d>~~flmctiim. Philadelphia.
Penryl~~ania 19107 rDR. HAGLEY)
1. Jacobs 1.4. cat (11: .4 nlrlltidisciplinar\ approach tion and managrment of male sexual dy\fllnvtloll.
to the w alua-
I I’rol 129:3.5
,1983). 2. Shrom SH, ct ul: Clinical profile ot rxperitvrcr x\ith 130 cow wcutive cases of impotent men, Urolo&~ 13: J I 1 (I X9). .3. Ek A. Bradley WE, and Kranr RI.: Snap-( :auge baud: neu concept in measuring penile rigidity, L’rology 21: 63 (1983). 4. Collins WE, c,t al: Multidisciplinary survq of twctil(~ impstcnce. Can Med ASOC J 128: 1395 (19X3). Ti. Montague DK: Impotence: 1950- IWI. tditcuial. J Ural 131: 526 (19X-1). 6. Van Arsdalen K. ct al: Erectilc Ph!xiol(qq; D>sfunctton and Evaluation. Part II: Etiology and Evaluation of Errctile Dysfunction, Stame! T (Ed): Monographs 111I’rolop?, \ol 3. no 5, Sept, Ott, 19x3. 7. Ellis DJ, Doghramji K, Bagley DH: Snap-Gauge hand versus penile rigidity in impotence asswment, J Ural 140: 61 (1988). 8. Condra M, rf ~1: Screening assessment #IFpenile tumesccncc and rigidity: clinical test of Snap-Caugc, Urologv 29: 254 (1987).
BAND VS MULTIDISCIPLINARY
EVALUATION
IN IMPOTENCE
JAMES
ALLEN.
DAVID
J. ELLIS,
JANELL
M.D.
MICKI
M.D.
L. CARROLL,
ASSESSMENT R. BALTISH,
DEMETRIUS PH.D.
R.N.
H. BAGLEY,
M.D.
JEFFERSON SEXUAL FUNCTION CEIVTI;H*
From the Department of Urology, Jefferson of Thomas Jefferson University, Philadelphia,
Medical College Pennsylvania
ABSTRACTThis study compares thefindings of multidisciplinary evaluation to the two-night use of the Snap-Guage band in 100 impotent men. An organic etiology was diagnosed in 52 percent of those evaluated. The Snap-Gauge band proved accurate as a screening devicefor organic disease. If no elements were broken over the two-night period, this finding correlated with multisystemic diagnosis of organic etiology in 86 percent of cases. Among the 52 patients in whom an organic etiology was diagnosed, 32 broke no elements for a 62 percent sensitivity. When ,more than one element was broken, the predictive value as to etiology of the erectile dysfunction diminished.
The multidisciplinary approach to the evaluation of erectile dysfunction is the time-honored method to differentiate psychogenic from organic impotence. 1.2 This thorough process, however, is both time-consuming and costly. Therefore a simplified and inexpensive approach for initial screening would be desirable. Documentation of the presence or absence of nocturnal erections has been a valuable tool in differentiating between organic and psychologic bases for impotence. However, serial overnight evaluation in a sleep laboratory is prohibitively expensive to be used as an initial screening device. Therefore, a simple method for detecting nocturnal tumescence is needed. The Snap-Gauge1 band is a device which addresses this issue. It is a Velcro-fastened band worn on the penis during sleep. Incorporated into the band are three plastic elements which break sequentially as greater radial force is applied with penile tumescence.3 Thus, a patient
*Members: D.H.Bagley, M.D.; S. Cohen, M.D.: R. Fishkin, D.O.; A. Goldman, M.A.; S. Jacobs, M.D.; K. Doghramji, M.D. TDacomed, 1701 East 79th Street. Suite 17, Minneapolis, Minrwota 55320.
can break from zero to three elements in one night’s use depending on the cross-sectional rigidity obtained. The device is inexpensive, but its accuracy is not well documented in clinical series. The present study compares the use of the Snap-Gauge with multidisciplinary evaluation to define the effectiveness of this device. Although it cannot replace multisystemic evaluation, the Snap-Gauge band can augment the evaluation and perhaps serve as a valuable screening device. Material
and Methods
The patient population consisted of 105 impotent men seen in the Jefferson Sexual Function Center over a six-month period. Each patient underwent evaluation by a urologist, an endocrinologist, and a psychiatrist or psychologist. Routine hematologic and biochemical reproductive hormone levels. and screening, penile arterial Doppler examinations were performed on all patients. Additional studies, such as nocturnal penile tumescence monitoring, repeat hormonal analinjection of papaverine, ysis, intracorporeal
3 patients 0 - 1 elements Organic
3 patients 2 - 4 elements
(7)
5 - 6 elements
1 patient
I 4 elements broken
(1)
Psychogenic
6 elements broken
Invalid NPT 2O ApneaFIGURE
2.
Sleep laboratory
evaluations
,14
19
ELEMENTS
t BROKEN
FIGURE 1. Relationship ken elements and organic
IN TWO NIGHTS
between number of broor psychologic disease. 22
and pudendal and bulbocavernosus electromyography were performed as indicated. Each patient also underwent a two-night evaluation wearing the Snap-Gauge band at home. Patients were instructed on placement of the device at the initial office visit and given a selfaddressed stamped envelope in which to return them. Following this evaluation a roundtable discussion was held on each patient and a working diagnosis as to the etiology of the erectile dysfunction was made. These diagnoses could be updated as additional testing was completed and those results became available. The SnapGauge results were not available to the group in arriving at a diagnosis. Results Of the 105 patients studied, three failed to return the bands, one experienced a mechanical failure with one device, and one failed to complete his one-day initial evaluation. Results are therefore based on 100 patients. An overall incidence of organic etiology was diagnosed in 52 percent of patients. This corresponds with the relative percentage of organic and psychogenic disease reported elsewhere.4 The relationship between the number of broken elements and organic or psychologic disease is presented in Figure 1. Thirty-seven patients broke no elements in two nights, and 32 patients were diagnosed with an organic cause for their erectile dysfunction. Therefore, the failure to break any bands on two consecutive
198
non-rigid
/ erections
1
(n = 9).
pts
O-l
element
broken
pts
2-4
elements
broker
\ 0 pts
5-6
elements
broken
2
pts
O-l
element
1
Pt
2-4
elements
broken
0
pts
5-6
elements
broken
5
Injections C
/
\ \
3 rigid erections
t
\ FIGURE 3.
Evaluation
broken
of papaverine
injections
(n
= 22).
nights was 86 percent accurate in diagnosing organic erectile failure. If those patients who break one band are included, 37 of 47 (79%) were found to be organic causes. If those patients who broke 4 or less bands are examined, then 48 of 83 (57 %) were organic causes. Thus, as increasing numbers of elements are broken, the overall incidence of 52 percent organic causes is approached. The predictive value of other higher numbers of broken bands is less valuable. The percentage of psychogenic to organic etiology varied little whether 2 or 6 bands were broken. In each instance, a psychogenic etiology was more likely, but occurred in approximately 70 percent of patients. Nine patients also had formal nocturnal penile tumescence monitoring in a sleep laboratory. The results of these studies are compared with the Snap-Gauge findings (Fig. 2). In 22 patients erectile function was evaluated by the intracorporeal injection of 30 mg of papaverine. Only 3 of these patients achieved rigid erections: The results of the Snap-Gauge study are compared for the two groups in Figure 3.
UROLOGY
L
/ OCTOBER
1989
Comment Recent advances in the diagnosis and treatment of erectile dysfunction have expanded interest in this field.” An aging society, increasingly effective medical therapy, and improved surgical prosthetics have been responsible for more patients than ever presenting for evaluation of complaints of erectile failure. The burden of accurate diagnosis weighs heavily on the urologist. Impotence is a disease not well suited for definition by objective parameters, and this makes diagnosis most challenging. Urologists therefore are continually seeking methods to better assess the problem objectively. The traditional approach to evaluation recluires a multidisciplinary examination of the patient. This process inspects each of the systems required to achieve an erection to detect any pathology therein. A primary goal has been to differentiate those with organic disease from those tvith psychogenic etiology.” The present results indicate the value of the Snap-Gauge as a screening device. If no elements wrere broken in our two-night study, correlation with organic disease was high. If one or more elements were broken, there was a higher incidence of psychogenic disease, regardless of the number of elements broken. From our study approximately one third of patients with an organic etiolo&T will break a variable number of elements. Therefore, one must rely more heavily on standard evaluations to distinguish etiologies in those who do break some elements. Among the 22 patients studied by intracorporeal injection of papaverine, 19 did not achieve sllfficientl!, rigid erections while three rigid erections were produced (Fig. 3). The 3 patients who did respond fully were diabetics in whom impotence was associated with neuropathic disease. Of these 22 patients with arterial or neurogenie etiologies, 14 (64 % ) broke no bands on two nights of tssting. This correlates well with the sensitivity of the Snap-Gauge observed in our study as a whole (32 of 52 [61.5 % ] patients with an organic etiology broke no elements). In the small group of patients who under\\rent formal three-night nocturnal penile tumescence monitoring in the sleep laboratory, no patient who failed to break any elements achieved sufficiently rigid nocturnal erections by NPT (Fig. 1). Patients with organic sleep laboratory results, however, do at times break variable numbers of elements. The 1 patient who did have adequate tumescence on NPT did break multiple elements on his two-night Snap-
Gauge test. Previous studies in our laboratory7 and other centers8 have noted a high but not perfect correlation between re:sults with the Snap-Gauge and formal NPT monitoring which has many advantages including evaluation of the quality and duration of erection and monitoring of the patient’s sleep pattern. There are several potential sources of error in the diagnostic use of the Snap-Gauge band to evaluate erectile failure. The most obvious is that the study is done by the patient at home and is therefore subject to manipulation, Accidental breakage of the bands ma\- also occur. The potential for tumescence without adequate axial rigidity but sufficient radial force to break the bands must also be considered as an unlikel) source of error. As this study demonstrates, the accuracy of the Snap-Gauge test is greatest when no bands are broken, thus suggesting the errors which can occur wit-h accidental breakage. It is considerably less accurate when any bands are broken. Our results confirm the near11 equal number of impotent men with psychogenic and organic causes in this referred population. The SnapGauge when used in this study context appears to be cost-effective and has a high patient compliance for use and return (97 % ) . The most useful information developed when no elements were broken; this was 86 percent specific for organic disease. If one or more elements were broken, approximately 70 percent \vere diagnosed as psychogenic. The Snap-Gauge. when used as a screening device, can aid in the process of diagnosing the cause of erectile ~d>~~flmctiim. Philadelphia.
Penryl~~ania 19107 rDR. HAGLEY)
1. Jacobs 1.4. cat (11: .4 nlrlltidisciplinar\ approach tion and managrment of male sexual dy\fllnvtloll.
to the w alua-
I I’rol 129:3.5
,1983). 2. Shrom SH, ct ul: Clinical profile ot rxperitvrcr x\ith 130 cow wcutive cases of impotent men, Urolo&~ 13: J I 1 (I X9). .3. Ek A. Bradley WE, and Kranr RI.: Snap-( :auge baud: neu concept in measuring penile rigidity, L’rology 21: 63 (1983). 4. Collins WE, c,t al: Multidisciplinary survq of twctil(~ impstcnce. Can Med ASOC J 128: 1395 (19X3). Ti. Montague DK: Impotence: 1950- IWI. tditcuial. J Ural 131: 526 (19X-1). 6. Van Arsdalen K. ct al: Erectilc Ph!xiol(qq; D>sfunctton and Evaluation. Part II: Etiology and Evaluation of Errctile Dysfunction, Stame! T (Ed): Monographs 111I’rolop?, \ol 3. no 5, Sept, Ott, 19x3. 7. Ellis DJ, Doghramji K, Bagley DH: Snap-Gauge hand versus penile rigidity in impotence asswment, J Ural 140: 61 (1988). 8. Condra M, rf ~1: Screening assessment #IFpenile tumesccncc and rigidity: clinical test of Snap-Caugc, Urologv 29: 254 (1987).