Artificial urinary sphincter for post-radical prostatectomy urinary incontinence: long-term subjective results.

PURPOSE: Incontinence affects between 3% and 60% of patients after radical prostatectomy. Insertion of an artificial urinary sphincter is a mainstay therapeutic option available to these patients. We assessed patient satisfaction, outcome and complications long after artificial urinary sphincter implantation. MATERIALS AND METHODS: From a data bank of 131 patients who underwent artificial urinary sphincter prosthesis insertion we identified 71 with a mean age of 72 years who had also undergone radical prostatectomy and were available for evaluation. This group included 29 patients (40.8%) who received an earlier version of the AMS-800 (American Medical Systems, Minnetonka, Minnesota) and 42 (59.2%) who received the newer narrow back cuff device. Information on surgical procedures and followup were obtained from a computerized database. Patients were also contacted by an impartial reviewer who administered a standard telephone questionnaire on the degree of continence, complications, other means used to help with urinary continence, proficiency in device operation and satisfaction. RESULTS: At a mean followup of 7.7 years (range 0.5 to 16) 19 patients (27%) used 0, 23 (32%) used 1, 11 (15%) used 1 to 3 and 18 (25%) used more than 3 daily, while 1 used an external catheter. Surgical revision in 21 cases (29%) was required due to mechanical failure in 18 (25%), device erosion in 3 (4%) and infection in 1 (1.4%). The need for revision correlated significantly with the design of the sphincter (p = 0.005). Only 7 of the 42 patients in whom a narrow cuff AMS-800 was implanted needed revision versus 18 of the 23 with a previous design. Mean time to revision was 2.5 years (range 0.5 to 8). The device was removed in 2 cases (2.8%). Of the patients 41 (58%) are very satisfied, 14 (19%) are satisfied and 16 (23%) are unsatisfied with the device. The degree of satisfaction correlated with the number of pads used (p = 0.0005) and sphincter design (0.028) but not with the number of surgical revisions (p = 0.521) or patient age. CONCLUSIONS: The artificial urinary sphincter is a viable treatment option for post-radical prostatectomy incontinence with a high rate of continence and satisfaction for a long period after the procedure. Patients should be informed that complications necessitating device revision and explantation may appear late in followup. A standard definition of treatment success and studies of homogenous groups of patients with an artificial urinary sphincter would enable better understanding and patient education in the future.

Efficacy and safety of transurethral alprostadil in patients with erectile dysfunction following radical prostatectomy.

PURPOSE: A retrospective analysis of the MUSE clinical trial was performed to evaluate the efficacy and safety of transurethral alprostadil in patients with erectile dysfunction after radical prostatectomy. MATERIALS AND METHODS: Patients received doses of transurethral alprostadil in the clinic and those for whom a suitable dose was determined were treated at home with active drug or placebo for 3 months. Patients had undergone radical prostatectomy no less than 3 months before study entry. RESULTS: Of the 384 patients in whom radical prostatectomy was identified as a cause of erectile dysfunction 70.3% had an erection believed sufficient for intercourse in the clinic and 57.1% on active medication had sexual intercourse at least once at home. The product of clinic and home success rates (70.3 x 57.1%) was an overall success rate (the likelihood of active treatment to lead to intercourse at home) of 40.1%. The frequency of most adverse effects of radical prostatectomy was comparable to that of other organic etiologies of erectile dysfunction (1,127 patients). The percentage of patients with hypotension in the clinic was lower after radical prostatectomy compared to other erectile dysfunction etiologies (0.8 versus 4.2%, p < 0.001) but the percentage of patients with urethral pain/burning was higher (18.3 versus 10.4%, p = 0.027). No urinary tract infection, fibrosis or priapism occurred in the post-radical prostatectomy patients. CONCLUSIONS: Transurethral alprostadil is a well tolerated and efficacious method of treating erectile dysfunction after radical prostatectomy, although psychological changes associated with cancer and surgery may limit home response. The severe neurovascular deficit associated with prostatectomy neither limits the efficacy of transurethral alprostadil nor increases the risks.

Evaluation of erectile dysfunction and sleep-related erections.

Significant advances in this past decade have improved our understanding of erectile physiology. A variety of tests are available for diagnosing impotence. SRE testing provides objective physiological information that is useful for indexing erectile capability and formulating a rational treatment plan. As such, SRE testing is a powerful noninvasive tool for assessing dysfunction. Nonetheless, in making a final diagnosis, the skillful clinician relies on more than one assessment parameter and on clinical acumen.

Pregnancy in patients with the artificial urinary sphincter.

Since 1974, 71 female patients between 3 and 25 years old have undergone implantation of the artificial urinary sphincter for treatment of urinary incontinence. Of these women 9 have become pregnant and delivered 11 normal children. In 2 women the artificial urinary sphincter was removed because of erosion before conceiving, while the remaining 7 had a functional artificial urinary sphincter in place at conception, and subsequent pregnancy and delivery. All 11 women had normal pregnancies and, aside from the normally increased frequency of urination and a slight increase in urinary leakage due to elevated pressure on the bladder from the adjacent uterus, the urinary continence was unchanged. Of the women 4 underwent cesarean section at the advice of their obstetricians and the remainder had uneventful vaginal deliveries. During the course of the pregnancies the patients or their obstetricians consulted 1 of us for advice regarding management of the delivery because of the presence of the artificial urinary sphincter. The normalcy of the pregnancies and deliveries led us to conclude that the presence of a functioning artificial urinary sphincter did not increase the risk of complications during pregnancy and childbearing.

Venous leaks: anatomical and physiological observations.

A total of 50 patients with impotence underwent cavernosometry and cavernosography with intracavernous injection of vasoactive drugs. Several hemodynamic parameters were analyzed, including the pressure response curve after injection of vasoactive drugs and infusion of saline, the volume required to achieve erection, venous outflow resistance, erection maintenance infusion rate, rate of pressure decrease after discontinuation of infusion and post-infusion steady state pressure. On the basis of cavernosometric findings, venous leakage was ruled out in 4 patients. In the remaining 46 patients leak sites visualized during cavernosography included superficial dorsal vein in 1 (2.2%), deep dorsal vein in all 46 (100%), cavernous veins in 32 (69.6%), glans in 19 (41.3%) and corpus spongiosum in 14 (30.4%). Aberrant veins were documented in 7 patients (15.2%) communicating with the saphenous vein in 4 (8.9%), scrotal veins in 2 (4.4%) and femoral veins in 1 (2.2%). Eight patients (17.4%) had leakage through the deep dorsal vein as the only venous site, 17 (36.9%) had leakage through 2 venous sites, 14 (30.4%) had leakage through 3 venous sites and 7 (15.2%) had leakage through 4 venous sites. Correlations among hemodynamic and radiographic observations allowed the identification of 4 different types of cavernosometric findings. While type I represented normal penile vascular findings, types III and IV represented venous leakage. Type II could represent no leak, a mild leak or an undetected arterial problem. Accuracy of interpretation of a study may be improved by taking more than 1 parameter into consideration, including erection maintenance infusion rate, intracavernous pressure decrease within the first 5 seconds after discontinuation of infusion and the final steady state intracavernous pressure. The majority of patients have more than 1 leak site (82.6%). The most commonly combined sites of leakage are the deep dorsal and cavernous veins.

Cigarette smoking and other vascular risk factors in vasculogenic impotence.

A total of 132 consecutive patients with erectile impotence underwent extensive evaluation, including vascular evaluation with intracavernous injection of papaverine and penile duplex ultrasonography, to determine the etiology of impotence. Three vascular risk factors, smoking, diabetes mellitus and hypertension, were investigated for their impact on vasculogenic impotence. The patients were divided into four groups: one with no risk factors, one with one vascular risk factor, one with two vascular risk factors, and one with all three risk factors. The results of penile vascular evaluation in these patient groups were compared. The incidence of penile vascular impairment was found to be higher in patients with one vascular risk factor than in those with none. The proportion of abnormal penile vascular findings significantly increased as the number of risk factors increased. These data confirm the important role of vascular risk factors, smoking, diabetes mellitus, and hypertension, in the pathogenesis of organic impotence.

Ultrastructural changes in impotent penile tissue: a comparison of 65 patients.

To determine whether impotence is caused by specific and consistent changes in erectile tissue, we compared the ultrastructure of the corpora cavernosa in 6 controls with that in 59 patients undergoing implantation of a penile prosthesis. The impotent patients were divided into groups based on a medical history of hypertension (10), pelvic surgery (9), alcoholic smokers (8), hypertensive alcoholics (3), hypertensive alcoholic smokers (3), smokers (3), diabetics (8), diabetic smokers (3), Peyronie's disease (3), spinal cord injury (3) and isolated causes (6). Our data demonstrate that different behavioral and/or medical conditions produce similar degenerative tissue responses. There is no single or specific cause of impotence that is manifest by consistent changes in erectile tissue.

Comparison of penile duplex ultrasonography with nocturnal penile tumescence monitoring for the evaluation of erectile impotence.

A total of 50 patients with erectile dysfunction underwent comprehensive evaluation, including vascular evaluation with penile duplex ultrasonography and papaverine injection, as well as nocturnal penile tumescence monitoring. The latter was performed in a sleep laboratory setting in all patients. The results of penile duplex ultrasonography with papaverine injection were classified as 18 patients with normal vascular findings, 22 with arterial insufficiency, 3 with the pelvic steal syndrome and 7 with isolated venous leakage. Of the patients 15 had normal ultrasonographic and nocturnal penile tumescence findings, 29 had abnormal ultrasonographic vascular and nocturnal penile tumescence findings, 3 had abnormal ultrasonographic vascular findings and normal nocturnal penile tumescence (including 1 with the pelvic steal syndrome as evidenced by penile brachial index) and 3 had normal ultrasonographic vascular findings and abnormal nocturnal penile tumescence (including 2 with neurogenic erectile dysfunction). Penile duplex ultrasonography with papaverine injection appears to be a useful objective method to evaluate vasculogenic impotence and to correlate favorably with nocturnal penile tumescence monitoring. It also may have a higher yield than nocturnal penile tumescence monitoring in patients with the pelvic steal syndrome. While nocturnal penile tumescence is impaired in patients with neurogenic impotence, penile duplex ultrasonography with papaverine injection reveals, as expected, normal findings in patients with neurogenic impotence and normal vascular systems.

Correlation of altered penile ultrastructure with clinical arterial evaluation.

We investigated the ultrastructural changes in the penile erectile tissue from 32 consecutive patients who underwent penile prosthesis implantation. Because most of the patients had undergone papaverine injection with or without duplex ultrasonography, we compared these results with the electron microscopic findings. In patients with a good arterial response and full erection after papaverine injection the ultrastructural findings were similar to those reported in normal men. In patients with moderate arterial disease a distinct increase in mitochondria with aggregation and cytoplasmic vacuolization in smooth muscle cells was noted. These findings could be interpreted as an active cellular attempt to respond to the altered environmental and nutritive situation. In patients with severe arterial insufficiency the cellular structure was markedly altered, the number of intracavernous smooth muscle cells was reduced and the density of the connective tissue separating individual cells was increased. These changes in the smooth muscle cells consisted of contour irregularity with fragmentation and loss of the basal lamina. The cytoplasm was largely devoid of contractile elements. The nuclei tended to be pleomorphic with unevenly distributed chromatin. The endothelium was also altered significantly in this group. A careful clinical evaluation of penile arterial function should be performed in all patients undergoing penile arterial or venous corrective surgery. If doubt remains, a penile biopsy may be indicated.

Evaluation of vasculogenic erectile impotence using penile duplex ultrasonography.

A total of 140 patients underwent penile vascular evaluation with intracavernous papaverine injection combined with duplex ultrasonography. Of these patients 8 were potent men who were evaluated for reasons other than erectile failure. These potent men were used as controls to obtain normal values. The remaining 132 patients had erectile impotence of various etiologies. Real-time imaging with high resolution, high frequency probes allowed for visualization of the cavernous arteries along the entire length in addition to accurate measurement of the diameter. Simultaneous selectively focused Doppler ultrasonography was used to measure the blood velocity and other vascular parameters in the cavernous and dorsal arteries. Comparison of measurements before and after papaverine injection allowed for objective interpretation of the injection results. The results were analyzed and compared to other data available on the same patients, such as history and physical examination, nocturnal penile tumescence, penile blood pressures, selective arteriography and dynamic cavernosography. In addition to the 8 potent men, there were 35 patients (27% of the impotent patients) whose vascular findings were normal. A total of 78 patients (59% of the impotent patients) had arterial insufficiency; a subgroup of 13 patients had the pelvic arterial steal syndrome. Dynamic cavernosography confirmed venous leak in all 19 patients (14% of the impotent patients) whose penile duplex ultrasonography suggested the possibility of a venous leak. Ten patients (7%) had prolonged erection after papaverine injection and they were managed without consequences. One patient had a small hematoma that resolved uneventfully. Penile duplex ultrasonography was a helpful and objective method to evaluate vasculogenic impotence.

The role of transrectal ultrasonography in the diagnosis and management of prostatic and seminal vesicle cysts.

Cysts in the region of the prostate and seminal vesicles are interesting because of their differential diagnosis and embryological relevance. We present our experience with 5 cases that include a müllerian duct cyst, diverticulum of the spermatic tract, seminal vesicle cyst and 2 prostatic cysts. Transrectal ultrasonography had a significant role in the diagnostic evaluation of these cysts. Ultrasonographically guided transperineal needle aspiration added significant diagnostic information and might have a therapeutic value. After a review of the literature, we propose an algorithm for the evaluation and management of prostatic and seminal vesicle cysts.

Experience with the artificial urinary sphincter model AS800 in 148 patients.

The latest version of the artificial urinary sphincter, AS800, was used in 148 patients with urinary incontinence of different etiologies. Followup ranged from 3 to 37 months, with an average of 20.8 months. There were 112 (76 per cent) male and 36 (24 per cent) female patients. The cuff was implanted around the bladder neck in 78 patients (53 per cent) and around the bulbar urethra in 70 (47 per cent). Socially acceptable urinary control was achieved in 90 per cent of the 139 patients with active devices in place. It was necessary to remove the sphincter in 11 patients (7.4 per cent). The reasons for removal were infection and erosion in 8 patients (5.4 per cent), infection without erosion in 2 (1.3 per cent), and erosion due to excess pressure and poor tissues in 1 (0.7 per cent). Comparison of success and failure rates associated with incontinence of different etiologies revealed that patients with incontinence after failure of a conventional antistress incontinence operation and those with incontinence after transurethral resection or radical prostactectomy had the highest success rate, and that patients with incontinence secondary to pelvic fracture or exstrophy and epispadias had the highest failure rates. The deactivation feature (the lock) of the new artificial sphincter model was beneficial for primary deactivation, urethral catheterization or cystoscopy, or for elective nocturnal decompression of the bladder neck or urethral tissues.

Corporeal reconstruction procedures for complicated penile implants.

Implantation of a penile prosthesis is now a very much accepted mode of management of organic erectile impotence. In most situations, this operation will involve little or no corporeal reconstruction. However, in the presence of more severe pathologic processes that may lead to corporeal damage, such as infective corporitis secondary to an earlier penile prosthesis or postpriapism fibrosis, and with the increasing public awareness of the availability of therapeutic modalities for impotence, the urologist must be well versed in the diagnostic and surgical techniques of corporeal reconstruction.

Use of the AS800 device in exstrophy and epispadias.

Urinary continence is one of the more difficult goals to achieve in patients with exstrophy or epispadias. The artificial genitourinary sphincter provides an alternative to reconstruction of the bladder neck for management of this problem. Although excellent continence can be obtained with bladder neck reconstruction, results of a second procedure of this type seldom are reported. We used the AS800 device in 16 patients with exstrophy and epispadias, 13 of whom had undergone a prior bladder neck operation. We defined our results as total success and continence success, and have achieved over-all rates of 69 per cent (excludes those awaiting revision) and 90 per cent (those with an active device), respectively. Although the frequency of revision and erosion was significant, the ultimate outcome in this difficult patient group was satisfactory.

Combined transrectal ultrasonography and urodynamics in the evaluation of detrusor-sphincter dyssynergia.

Thirty-one combined transrectal ultrasonographic and urodynamic studies were performed in 24 patients with spinal cord lesions at different levels between C4 and T12. Ultrasonography provided accurate real-time imaging of the bladder neck, prostatic urethra and external sphincter during the bladder filling phase as well as during the voiding phase. Bladder and rectal pressures, sphincter EMG and uroflow were recorded simultaneously. Transrectal ultrasonography contributed significantly to the accuracy of diagnosing detrusor-sphincter dyssynergia. Sphincter contractions were clearly visualised with ultrasonographic video monitoring. This imaging method was especially helpful in sorting out the problems of 3 patients with poor emptying of bladder after endoscopic sphincterotomy. One had a urethral stricture and the other 2 had sphincters that opened adequately but bladders that emptied poorly because of detrusor hypocontractility. Other problems, such as benign prostatic hyperplasia and false passage, were also easily recognised. Transrectal ultrasonography not only provides accurate information but also involves no exposure to radiation and thus precludes the need for costly lead-shielded examination rooms.

Development of fibrotic penile lesions secondary to the intracorporeal injection of vasoactive agents.

Fibrotic penile lesions developed in 4 patients who had undergone intracorporeal injection of vasoactive agents. These lesions persisted for at least 3 months, and in some instances they caused pain and curvature of the penis during erection.

The use of transrectal longitudinal real-time ultrasonography in urodynamics.

A total of 63 combined transrectal ultrasonographic and urodynamic studies was performed to evaluate the voiding dysfunction in 49 spinal cord injury patients and 7 other patients. Ultrasonography provided excellent real-time imaging of the bladder neck, prostatic urethra, prostate and external sphincter, and allowed for accurate diagnosis of detrusor-sphincter dyssynergia, detrusor-bladder neck dyssynergia, prostatic hypertrophy and bladder neck strictures. In addition to offering these capabilities, ultrasonography is less expensive than x-ray and it does not involve exposure of either the patient or examiner to radiation. However, it does not provide a means to detect vesicoureteral reflux.

Use of fresh placental membranes for bladder reconstruction.

Several biodegradable and artificial materials have been used in the urinary tract for partial or total replacement of the bladder. Most of the graft materials have resulted in stone formation, collapse, rejection, or extrusion of the graft without adequate reconstruction of a functional bladder. In this paper, we present our assessment of the use of placental membranes as a feasible, economic, and acceptable organic agent for bladder reconstruction. Eight mongrel dogs were subjected to supratrigonal cystectomy, and then a 10 X 10 centimeter patch of human placental membrane was sutured to the remaining trigone in a watertight fashion. The dogs were sacrificed twelve weeks after surgery. Histologic examinations revealed evidence of regeneration of normal-appearing smooth muscle along the path of a retracting placental patch, and thus of reconstitution of a normal-appearing and functioning bladder. On the basis of this study, we believe that placental membranes, because of their low antigenic properties and easy availability, provide an excellent graft material for the urinary tract. Further studies concerning the application of this graft material in various pathological conditions are now in progress.