Mechanical reliability, surgical complications, and patient and partner satisfaction of the modern three-piece inflatable penile prosthesis.

OBJECTIVES: The modern three-piece inflatable penile prosthesis (IPP) has undergone multiple revisions since its introduction in 1973. We reviewed devices placed since the last major revision by American Medical Systems (AMS) in 1987. METHODS: A retrospective chart review was refined with data from an independent patient and partner survey. RESULTS: Two hundred twelve consecutive penile prosthetic devices placed by a single surgeon over an 8-year period are reviewed. One hundred sixty-nine of the devices were three-piece inflatables with 146 being primary implants. The average device has been in place 36.5 months (range 9 to 102). The infection rate in 146 primary three-piece devices was 2.1%. The infection rate in 46 secondary implants or revisions was 6.5%, excluding seven salvage attempts. Mechanical failure in 122 primary AMS devices placed was 4.1%. Mechanical failure in 24 Mentor devices was 4.2% if one discounts connector failures that were revised in 1990. A surgical complication and revision rate of 1.4% was noted in the 146 primary implants. An independent telephone survey achieved a 57% and 24% response rate in patients and partners with three-piece devices placed. In the group of 86 patients with a primary three-piece device placed and complete follow-up, the probability of having a normally functioning device placed in a single operative procedure was 90.6% at 3 years. On a 1 to 10 scale looking at all primary devices, secondary devices, revisions, and infections, the average and median satisfaction rate was as follows: 8.2, 8.5; 8.4, 9.0; 7.7, 7.75 for the Ultrex patients, CX 700 and Mentor patients, and all partners, respectively. CONCLUSIONS: The modern three-piece IPP is an excellent surgical option offering a very safe, reliable return to sexual activity for our patients.

Extracorporeal shock-wave lithotripsy for bile duct calculi.

BACKGROUND: Bile duct calculi (BDC) can be cleared or treated with modern endoscopic techniques in most patients. However, large stones, bile duct strictures, or unusual anatomy may make endoscopic clearance difficult. The purpose of the present study was to determine the efficacy of extracorporeal shock-wave lithotripsy (ESWL) in treating patients with complicated BDC. METHODS: Between 1989 and January 1995, 16 patients with BDC were treated at our institution with ESWL using a Dornier HM-3 lithotropter. The average age of patients was 62 years (range 32 to 88). Endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy and attempted stone extraction (100%), nasobiliary drainage (83%), and biliary stents (6%) were used prior to ESWL. Eleven patients (61 %) had solitary stones, ranging in diameter from 0.5 to 2.6 cm, whereas 7 patients had multiple stones, ranging in diameter from 0.5 to 5.0 cm. The indications for ESWL were stone impaction (56%), stone size (38%), and bile duct stricture (6%). RESULTS: The 16 patients received 27 ESWL treatments (mean = 2101 shock at 21 kV); with 4 patients (22%) requiring multiple treatments. Stone fragmentation was achieved in 94% of patients. All patients had ERCP performed post-ESWL, and only 2 (13%) patients required immediate operations. At discharge, 94% of patients were stone-free. Minor complications (eg, pain, hematuria) were common. With an average follow-up of 3 years, only 1 patient (6%) has required retreatment for BDC. Hepatic transplantation was required in an additional patient. CONCLUSIONS: In this cohort of patients with both major medical comorbidities and/or technical contraindications to standard methods of endoscopic and surgical clearance of BDC, we found that ESWL facilitated stone clearance in 94% of patients with minimal morbidity and no mortality. In our opinion, ESWL should be used more frequently in the treatment of these complex patients.

Extracorporeal shock wave lithotripsy for obstructing pancreatic duct calculi.

PURPOSE: A review was done to determine the effectiveness of extracorporeal shock wave lithotripsy (ESWL) in the treatment of impacted pancreatic duct calculi. MATERIALS AND METHODS: A total of 19 patients, who were potential candidates for radical pancreatic surgery after unsuccessful endoscopic retrograde cholangiopancreatography, sphincterotomy and attempted stone extraction from the pancreatic ducts, underwent ESWL of the calculi. Followup ranged from 6 months to 6 years. RESULTS: Of the 19 patients 14 avoided a major operation and 6 have remained pain-free for the long term. Two patients died of causes not related to ESWL or endoscopic retrograde cholangiopancreatography. Five patients eventually underwent a Whipple or Puestow procedure for relief of symptoms or persistent obstruction. Complications were minimal. CONCLUSIONS: ESWL is a valuable adjunct in patients with impacted pancreatic duct calculi unretrievable by primary endoscopic retrograde cholangiopancreatography.

Pubovaginal slings using fascia lata for the treatment of intrinsic sphincter deficiency.

PURPOSE: Various materials and techniques have been used to construct a pubovaginal sling. We believe that fascia lata has several advantages and report our experience. MATERIALS AND METHODS: A total of 32 female patients with urodynamically proved intrinsic sphincter deficiency underwent a pubovaginal sling procedure using fascia lata. An unscarred fascial strip 24 to 28 x 2 cm. was attached to itself over a 3 to 4 cm. bridge of abdominal wall fascia. Results were tabulated by chart review and an independent patient survey. RESULTS: Chart review revealed that 28 of 32 patients (87%) required no pads, and 3 improved and 1 did not. An independent patient survey revealed that 70% of patients (21 of 30) required no pads, 20% required 1 to 3 small pads and 10% required more than 3 small pads per day. Of the patients 80% would undergo the procedure again. CONCLUSIONS: Excellent results can be obtained with fascia lata for the treatment of intrinsic sphincter deficiency. A long, wide strip of fascia attached to itself allows for precise tensioning and good urethral closure, and minimizes the risk of obstruction.

Evaluation of adjuvant estramustine phosphate, cyclophosphamide, and observation only for node-positive patients following radical prostatectomy and definitive irradiation. Investigators of the National Prostate Cancer Project.

In 1978 the National Prostate Cancer Project launched two protocols evaluating adjuvant therapy following surgery (Protocol 900) or irradiation (Protocol 1,000) for clinically localized prostate cancer. All patients underwent staging pelvic lymphadenectomy. Following definitive treatment, patients were randomized to either cyclophosphamide 1 gram/m2-IV every 3 weeks for 2 years, estramustine phosphate 600 mg/m2-po daily for up to 2 years, or to observation only. Patient accession closed in 1985 and includes 184 to Protocol 900 (170 evaluable) and 253 to Protocol 1,000 (233 evaluable). Lymph node involvement was identified in 198 patients (49% of total), 29% in Protocol 900, 63% in Protocol 1,000. Median progression-free survival (PFS) for patients with nodal involvement in Protocol 1,000 receiving estramustine phosphate adjuvant was longer (37.3 mo) compared to cyclophosphamide (30.9 mo) and to no treatment (20.9 mo). Median PFS for patients with limited nodal disease in Protocol 1,000 was longer (39.9 mo), regardless of adjuvant, compared to extensive nodal disease (20.7 mo). However for patients with extensive nodal involvement, those receiving adjuvant estramustine phosphate experienced a significantly longer median PFS (32.8 mo) compared to adjuvant cyclophosphamide (22.7 mo) and no adjuvant (12.9 mo). We conclude that adjuvant estramustine phosphate is of benefit in prostate cancer patients with extensive pelvic node involvement receiving irradiation as definitive treatment.

Adjuvant therapy for clinical localized prostate cancer treated with surgery or irradiation.

OBJECTIVE: Because of efficacy demonstrated with chemotherapy in patients with metastatic disease, the National Prostate Cancer Project in 1978 initiated two protocols evaluating adjuvant therapy following surgery (Protocol 900) and irradiation (Protocol 1000) for patients with localized disease at high risk for relapse. METHODS: All patients underwent staging pelvic lymph node dissection. Following definitive treatment, patients were randomized to either cyclophosphamide 1 g/m2 intravenously every 3 weeks for 2 years, estramustine phosphate 600 mg/m2 orally daily for 2 years or to observation only. Accession closed in 1985 and included 184 patients in Protocol 900 (170 evaluable) and 253 in Protocol 1000 (233 evaluable). RESULTS: Nodal involvement was identified in 198 patients (49% of total): 29% in Protocol 900 and 63% in protocol 1000. Median progression-free survival (PFS) and survival have been greater for patients in Protocol 900 regardless of adjuvant, reflecting their lower pathologic stage. Median PFS is significantly greater for patients in Protocol 1000 receiving estramustine (52.2 months) compared to cyclophosphamide (35.0 months). Median PFS for patients with nodal involvement in Protocol 1000 receiving estramustine is increased (43.5 months) compared to no treatment (21.5 months). Patients with limited nodal involvement in Protocol 1000 have a longer median PFS (45.6 months) compared to patients with extensive disease (23.6 months). But in the latter group patients receiving estramustine experienced a significantly longer median PFS (43.5 months) compared to cyclophosphamide (29.1 months) or no adjuvant (13.5 months). Increased PFS with estramustine adjuvant was also noted in stage C patients (only Protocol 900) and in those with high-grade (grade 3) tumors (both protocols). CONCLUSIONS: With now over 10 years mean follow-up for this series of patients, we conclude that adjuvant estramustine is beneficial for prostate cancer patients receiving definitive irradiation. This benefit is particularly noted in those patients with extensive nodal involvement (N+, D-1).

Prostate Cancer Clinical Guidelines Panel Summary report on the management of clinically localized prostate cancer. The American Urological Association.

PURPOSE: The American Urological Association convened the Prostate Cancer Clinical Guidelines Panel to analyze the literature regarding available methods for treating locally confined prostate cancer, and to make practice policy recommendations based on the treatment outcomes data insofar as the data permit. MATERIALS AND METHODS: The panel searched the MEDLINE data base for all articles from 1966 to 1993 on stage T2 (B) prostate cancer and systematically analyzed outcomes data for radical prostatectomy, radiation therapy and surveillance as treatment alternatives. Outcomes considered most important were survival at 5, 10 and 15 years, progression at 5, 10 and 15 years, and treatment complications. RESULTS: The panel found the outcomes data inadequate for valid comparisons of treatments. Differences were too great among treatment series with regard to such significant characteristics as age, tumor grade and pelvic lymph node status. The panel elected to display, in tabular form and graphically, the ranges in outcomes data reported for each treatment alternative. CONCLUSIONS: In making its recommendations, the panel presented treatment alternatives as options, identifying the advantages and disadvantages of each, and recommended as a standard that patients with newly diagnosed, clinically localized prostate cancer should be informed of all commonly accepted treatment options.

Experience with triple-drug therapy in a pharmacological erection program.

A group of 170 impotent men achieved usable erections during a 26-month period with a combination of papaverine, phentolamine and prostaglandin E1 (triple-drug therapy) injected intracorporeally. Of the patients 146 elected to enter a pharmacological erection program using this combination. Patient age ranged from 24 to 85 years and the average duration on the program was 11.2 months. Average injection volume was 0.36 cc per injection (range 0.1 to 1). Among those patients managed by our nurse clinician, only 3 episodes of priapism were encountered (1.7%). Scarring was documented in 7 of 170 patients (4.2%) 1 week to 21 months after starting the injections. Pain was encountered in 6 of 170 patients (3.5%). A superior dose response coupled with a low incidence of priapism, pain and scarring have led us to use triple-drug therapy as our agent of choice in the pharmacological management of erectile dysfunction.

Localized prostate carcinoma. Surgical management.

Total prostatectomy in the properly selected patient will provide disease-free survival rates comparable to the expected survival in similarly aged men for up to 30 years of observation (Figure 4). Patients who undergo total prostatectomy accept a very small risk of long-term permanent complications or mortality, and effective treatment is available for most complications. The morbidity and costs associated with hormone refractory metastatic prostate cancer are significant, with bone pain and anemia from bone marrow invasion, bladder dysfunction (retention, incontinence, and hematuria), urinary tract infection, anorexia, and uremia from obstructed ureters being common sequelae in the months before death. In the properly selected patient, minimal risk is incurred from total prostatectomy, the potential complications are well defined and manageable, and long-term disease-free survival is seen in most patients.

Hyperbaric oxygen therapy for radiation-induced hemorrhagic cystitis.

From May 1988 through May 1991, 14 patients with radiation-induced hemorrhagic cystitis confirmed by cystoscopy and biopsy, who had failed all other attempts at management and who had no evidence of infection or recurrent malignancy, were treated with hyperbaric oxygen therapy. During followup ranging from 10 to 42 months 8 patients (57%) had complete resolution of symptoms and 2 (14%) had marked improvement, for a total of 10 patients (71%) with a positive outcome. Of 4 patients (29%) with a poor outcome 3 had limited improvement and were later diagnosed as having recurrent malignancy that was not present on biopsy before hyperbaric treatment. One patient was withdrawn from hyperbaric treatment due to illness. The average cost per patient was $10,000 to $15,000, comparing favorably to the cost of multiple conservative treatments to control symptoms. Hyperbaric oxygen therapy for radiation-induced hemorrhagic cystitis appears to be an efficacious treatment modality for patients who have failed other forms of management.

Adjuvant therapy for localized prostate cancer.

BACKGROUND: In 1978, the National Prostatic Cancer Project launched two protocols evaluating adjuvant therapy after surgery (Protocol 900) or irradiation (Protocol 1000) for clinically localized prostate cancer. All patients underwent staging pelvic lymphadenectomy. METHODS: After definitive treatment, the patients were randomized either to receive cyclophosphamide 1 g/m2 intravenously every 3 weeks for 2 years or estramustine phosphate 600 mg/m2 orally daily for up to 2 years or to undergo observation only. Patient accession closed in 1985 and includes 184 patients in Protocol 900 (170 evaluable) and 253 in Protocol 1000 (233 evaluable). RESULTS: Lymph node involvement was identified in 198 patients (49% of total), 29% in Protocol 900 and 63% in Protocol 1000. The median progression-free survival (PFS) and survival were greater for patients in Protocol 900 compared with 1000, regardless of the adjuvant therapy. This reflected the greater proportion of patients with lower pathologic stage disease in the surgically treated group. The median PFS was significantly greater for all patients in Protocol 1000 receiving estramustine phosphate adjuvant (48.2 months) compared with patients randomized to receive cyclophosphamide (35.6 months). The median PFS for patients with nodal involvement in Protocol 1000 who received estramustine phosphate adjuvant was prolonged significantly (37.3 months) compared with no treatment (20.9 months). The median PFS for patients with limited nodal disease in Protocol 1000 was longer (39.9 months), regardless of the adjuvant therapy, compared with those with extensive nodal disease (20.7 months). However, in the latter patient group, those receiving adjuvant estramustine phosphate had a significantly longer median PFS (32.8 months) compared with those receiving adjuvant cyclophosphamide (22.7 months) or no adjuvant therapy (12.9 months). CONCLUSION: Adjuvant estramustine phosphate was beneficial in patients with prostate cancer and pelvic node involvement who received irradiation as definitive treatment.

Is deleting the digital rectal examination a good idea?

Many groups have taken the position that the digital rectal examination should be discontinued as part of the annual screening physical examination. We examined the effects of not doing a digital rectal examination on the early diagnosis of prostate cancer. The average time since a previous rectal examination increased as the stage of cancer increased. The digital rectal examination proved to be a relatively insensitive test, with 40% of stage D cancers being detected initially within 12 months of the most recent examination. Nevertheless, an annual digital rectal examination did detect a greater percentage of lower stage (and thus more localized and potentially curable) cancers when repeated within 12 months. When the last rectal examination was more than 24 months previous, cancers detected were more likely to be advanced. Without a digital rectal examination, patients would have their disease detected only by the presence of symptoms. When it was done because of symptoms, 81% of our patients had stage D cancers compared with 32% of stage B and 38% of stage C patients. Without the routine use of this examination, patients with prostate cancer would be more likely to have higher stage and less potentially curable lesions at the time of diagnosis. We conclude that the digital rectal examination remains an important part of routine annual physical examinations.

Pulsed dye laser fragmentation of ureteral calculi: a review of the first 50 cases performed at Virginia Mason Medical Center.

During the preceding 2 1/2 years 50 patients have undergone laser fragmentation of ureteral calculi at our medical center. Of these 50 patients 48 (96%) became free of stones without the need for an open operation: 44 (88%) were managed in 1 setting and 4 required adjunctive extracorporeal shock wave or ultrasonic lithotripsy, or a repeat session with the laser. Two patients (4%) eventually required an open operation: 1 required ureterolithotomy for a large impacted stone overlying the bony pelvis after a ureteroscope could not be advanced to this level and 1 had a good initial result with the laser but a persistent ureteral stricture developed and he required ureteroureterostomy 4 months later. Both open procedures were necessitated by mid ureteral stones, and the ureteral stricture was believed to be related to ureteroscopy and the impacted nature of the stone, rather than any damage by the laser probe.

Prognosis in stage D-1 prostate cancer relative to anatomic sites of nodal metastases. National Prostatic Cancer Treatment Group.

The investigators of the National Prostatic Cancer Treatment Group (NPCTG) have entered 212 patients with surgically confirmed stage D-1 prostate cancer in studies to determine the efficacy of adjuvant therapy after either definitive surgery (Protocol 900) or definitive radiotherapy (Protocol 1000). Follow-up indicates that this group represents 70% of all patients with recurrent disease. Because patients with less than 20% nodal involvement were found to have a statistically significant better progression-free-survival (PFS) than those with greater than 20% nodal involvement, we examined the exact anatomic sites of nodal metastases. The status of obturator, external iliac, internal iliac, and common iliac nodes was compared to PFS and overall survival in 198 patients with D-1 disease in both protocols. Results demonstrate no significant difference in either PFS or overall survival relative to anatomic sites of positive nodes. These data suggest that although minimal pelvic nodal metastasis is consistent with improved PFS, there is no predictable anatomic distribution of disease consonant with that better prognosis.

Total prostatectomy for clinically localized prostatic cancer: long-term results.

The fate of the first 52 patients with clinically localized prostate cancer who underwent total perineal prostatectomy at our clinic and have been followed for a minimum of 15 years is reviewed to evaluate the long-term impact of this operation on the disease. None of these patients received any adjuvant therapy. Nine patients (17 per cent) had recurrence and 5 (10 per cent) died of disease during this interval. The actual observed over-all survival at 15 years was 64 per cent, the actuarial survival was 67 per cent and the cause-specific survival was 90 per cent.