Removal of UroLume endoprosthesis: experience of the North American Study Group for detrusor-sphincter dyssynergia application.

PURPOSE: We present the experience of the North American UroLume Multicenter Study Group with removal of the UroLume endoprosthesis. MATERIALS AND METHODS: A total of 160 neurologically impaired patients were enrolled in the North American UroLume Multicenter Study Group for detrusor external sphincter dyssynergia application. Analysis was performed in 2 groups of patients in which the device was removed during insertion and after implantation, respectively. RESULTS: Device retrieval was required during insertion in 21 patients (13%) mainly due to misplacement or migration in 17. Extraction was done with minimal complications and in all but 2 cases subsequent UroLume implantation was successful. Of 158 men with the device in place 31 (19.6%) required removal. In 34 procedures 44 devices were removed, mainly due to migration. Time from implantation to removal ranged from 4 days to 66 months (mean 22 months). The UroLume was removed en bloc in 20 cases and in parts or wire by wire in 19. The majority of patients had no or minimal complications after extraction. Only 2 patients had serious temporary complications, including bleeding and urethral injury, with no lasting consequences. No malignancy developed as a result of UroLume insertion. CONCLUSIONS: While there is a potential for urethral injury and bleeding, UroLume endoprosthesis removal is largely a simple procedure with minimal complications and consequences.

Long-term followup of the North American multicenter UroLume trial for the treatment of external detrusor-sphincter dyssynergia.

PURPOSE: We determine the long-term efficacy and safety of the UroLume stent as minimally invasive treatment for external detrusor-sphincter dyssynergia in spinal cord injured men. MATERIALS AND METHODS: A total of 160 spinal cord injured men with a mean age plus or minus standard deviation of 36.3 +/- 12.1 years (range 16 to 74) were prospectively treated with an endoprosthesis at 15 centers as part of the North American UroLume trial for external detrusor-sphincter dyssynergia. Urodynamic parameters, including voiding pressure, residual urine volume and bladder capacity, were compared before treatment and at 1, 2, 3, 4 and 5 years after treatment. RESULTS: Mean voiding pressure was 75.1 +/- 28.2 cm. water before treatment in the 160 patients, and 37.4 +/- 23.9 at year 1 in 97, 39.5 +/- 22.2 at year 2 in 84, 42.6 +/- 27.3 at year 3 in 61, 46.3 +/- 33.2 at year 4 in 57 and 44.2 +/- 28.9 cm. at year 5 in 41 after stent insertion (p <0.001). Residual urine volume decreased after stent placement and was maintained throughout the 5-year followup (p <0.001). Mean cystometric capacity remained constant from 269 +/- 155 before insertion to 337 +/- 182 ml. 5 years later (p = 0.17). Hydronephrosis and autonomic dysreflexia improved or stabilized in most patients with functioning stents. Stent explant was necessary in 24 patients (15%), of whom 4 (16.7%) had another stent implanted. CONCLUSIONS: The UroLume stent demonstrates long-term safety and efficacy for the treatment of external detrusor-sphincter dyssynergia. The outcome was similar in men with and without previous sphincterotomy.

Traumatic posterior urethral injury and early realignment using magnetic urethral catheters.

PURPOSE: We determined the success of early urethral realignment using magnetic urethral catheters. MATERIALS AND METHODS: We retrospectively reviewed the records of 13 patients with complete urethral disruption treated with endourological realignment 0 to 11 days after injury using coaxial magnetic urethral catheters. RESULTS: Urethral realignment was established in 11 of the 13 patients (85%) using magnetic urethral catheters. Of the 10 patients for whom followup was available urethral strictures developed in 5 (50%) a mean of 6.1 months after realignment, necessitating a mean of 1.4 corrective procedures per patient. Impotence was noted in 1 of 7 patients (14%) and no urinary incontinence developed after realignment. CONCLUSIONS: Urethral realignment within 2 weeks of injury using magnetic urethral catheters is a safe and simple technique with minimal morbidity. The stricture formation, impotence and incontinence rates of this technique are comparable to those reported for delayed urethroplasty. We advocate early realignment using magnetic urethral sounds as an alternative treatment for traumatic urethral disruption.

Internal fixation in pelvic fractures and primary repairs of associated genitourinary disruptions: a team approach.

Associated urological and orthopedic injuries of the pelvic ring are complex with numerous potential complications. These patients are treated optimally using a team approach. The combined expertise is not only helpful initially when managing these difficult patients, but also later as problems develop. This study describes a treatment protocol and reports the early results of 23 patients with unstable pelvic fractures and associated bladder or urethral disruptions, or both, treated surgically with open reduction and internal fixation of the anterior pelvic ring injuries at the same anesthetic and using the same surgical exposure as the urethral realignments or bladder repairs or both. Early complications occurred in four patients (17%): one patient sustained a fifth lumbar nerve injury caused by the pelvic reduction procedure, and three patients had anterior pelvic internal fixation failures. Late complications occurred in eight patients (35%). There was one deep wound infection (4.3%) that presented 6 weeks after injury. Late urological complications occurred in seven patients (30%). Four of the nine male patients with urethral disruptions had urethral stricture after their primary urethral realignments (44%). Three of the 18 male patients admitted to impotence (16.7%). One of the three had a residual thoracic paraplegia caused by a burst fracture. One of the five female patients had urinary incontinence and required a bladder suspension operation to restore normal function (20%). A low infection rate can be expected despite the use of internal fixation. Early urethral "indirect" realignments avoid more difficult delayed open repairs; however, late urological complication rates are still high. Early "direct" bladder repairs are easily performed at the time of anterior pelvic open reduction and internal fixation. Suprapubic tubes are not necessary to adequately divert the urine when large diameter urethral catheters are used in these patients.

Urolume endourethral prosthesis for the treatment of urethral stricture disease: long-term results of the North American Multicenter UroLume Trial.

OBJECTIVES: To evaluate the long-term results of the UroLume endourethral prosthesis for the treatment of recurrent bulbar urethral strictures. METHODS: In a multicenter, prospective study 175 patients with recurrent bulbar urethral strictures were enrolled in a Food and Drug Administration (FDA) trial of the UroLume endourethral prosthesis. One hundred thirty-nine patients were available for follow-up at 1 year, and 81 patients were available for follow-up at 2 years. RESULTS: Clinically and statistically significant results were seen at 1 year and sustained at 2 years. Re-treatment rate was down from 75.2% preinsertion to 14.3% 1 year postinsertion of the prosthesis. Explantation was required in only 3% of patients. CONCLUSIONS: Based on these and European data, the UroLume endourethral prosthesis offers a significant advantage over the currently available treatments for recurrent bulbar urethral strictures.

The North American experience with the UroLume endoprosthesis as a treatment for benign prostatic hyperplasia: long-term results. The North American UroLume Study Group.

OBJECTIVES: To determine the efficacy and safety of the UroLume endoprosthesis as a treatment for obstructive benign prostatic hyperplasia in healthy men. METHODS: One hundred twenty-six men were enrolled prospectively in a multicenter North American Clinical Trial. Ninety-five men (mean age 68 +/- 7 years) had moderate or severe prostatism, whereas 31 participants (mean age 76 +/- 8 years) were in urinary retention. Voiding function for all patients was assessed prior to stent placement and in follow-up at 1, 3, 6, 12, and 24 months with the Madsen-Iversen symptom questionnaire, peak urinary flow rate, postvoid residual urine volume, and cystoscopic examination. RESULTS: For the nonretention cohort at 24-month follow-up, the results were as follows: (1) total symptom score decreased from 14.3 +/- 0.5 preinsertion to 5.4 +/- 0.5 (p < 0.001); (2) peak urinary flow rate increased from 9.1 +/- 0.5 mL/s preinsertion to 13.1 +/- 0.7 mL/s (p < 0.001); and (3) postvoid residual urine volume decreased from 85 +/- 9 mL to 47 +/- 8 mL (p = 0.02). For the retention group, the total symptom score, peak urinary flow rate, and postvoid residual urine volume at 24 months were 4.1 +/- 0.5, 11.4 +/- 1.0 mL/s and 46 +/- 7 mL, respectively. By 12-month follow-up, most endoprostheses were completely covered with urothelium. Although significant long-term complications were minimal, 17 endoprostheses have been explanted for an overall removal rate of 13%. All devices were removed transurethrally without subsequent sequelae to the external urinary sphincter or urethra. CONCLUSIONS: The long-term results from this North American Clinical Trial suggest that the UroLume endoprosthesis can be an effective and safe treatment for properly selected healthy men with obstructive benign prostatic hyperplasia. Randomized clinical trials comparing this minimally invasive procedure with transurethral resection of the prostate are now underway to document further its efficacy and safety.

New technique for repair of rectal injury.

Injury to the rectum is a potentially serious complication of pelvic surgery. The management of rectal injury is controversial. We present a technique of using flaps of endopelvic fascia to reinforce the repair and isolate the injury site. We have utilized this approach in 4 men undergoing retropubic prostatectomy without complications.

New endourologic technique for catheter placement after TURP, prostatectomy, and difficult urethroscopy.

Inserting a Foley catheter into a traumatized urethra with false channels or a post-transurethral resection of prostate (TURP) undermined bladder neck can be very difficult if not impossible at times. Likewise, replacing a Foley catheter that has fallen out in the early postoperative period after a radical prostatectomy can be difficult and can cause significant injury to the fresh anastomosis. We describe a technique using a Peel-Away sheath that fits over a cystoscope or a resectoscope, and facilitates accurate insertion of a Foley catheter without trauma to the urethra.

The influence of hepatic cirrhosis on the pharmacokinetics of benazepril hydrochloride.

The influence of hepatic disease on the pharmacokinetics of the new ACE inhibitor, benazepril hydrochloride, was evaluated in 12 male patients suffering from liver cirrhosis. The patients received a single oral 20 mg dose. The plasma concentrations and urinary excretion of unchanged benazepril and its active metabolite benazeprilat were determined. Compared with a historical control group of healthy volunteers treated with the same benazepril. HC1 dose, the plasma concentrations of benazepril were doubled in the cirrhotic patients. However, the time to reach maximum concentration (0.5 h) was not affected. The plasma kinetics and the urinary excretion of the metabolite benazeprilat were not significantly altered: Area under the curve and maximum concentration as well as time to maximum concentration (1.5 h) were comparable with those in the healthy subjects. There was also no significant difference between the two populations for the total urinary excretion and the renal clearance of benazeprilat. Both benazepril and benazeprilat were highly bound to serum proteins (96 and 94 per cent, respectively). In conclusion, the rate and the amount of bioactivation of the inactive prodrug benazepril to the active benazeprilat were virtually unaffected by hepatic cirrhosis. Thus, there seems to be no need for dosage adjustment of benazepril hydrochloride in patients suffering from cirrhosis of the liver.

Hemorrhagic shock. Influence of hyperbaric oxygen on metabolic parameters.

Oxygen therapy at atmospheric and increased pressure was used in the treatment of experimental hemorrhagic shock. Arterial gases, pH, lactate and pyruvate were determined and compared. Survival was carefully followed and complete pathological evaluation was carried out. The results showed no difference between control animals and those in the hyperbaric oxygen therapy group. It was concluded that hyperbaric oxygen therapy post facto did not influence the metabolic or survival data in this experiment.