Infection Retardant Coatings Impact on Bacterial Presence in Penile Prosthesis Surgery: A Multicenter Study.

OBJECTIVE: To investigate patients for positive culture rates with or without infection retardant coatings (IRC) penile prostheses (PPs) and to examine changes in culture positive isolates found in patients presenting overt clinical infection. METHODS: Cultures were obtained from PPs immediately upon surgical exposure of the pump. 236 patients were broken down into 2 groups, with each further divided into 2 groups. The noninfected group included 208 patients: 133 with uncoated PPs and 75 with IRC implants. The infected group included 28 patients: 16 with uncoated PP and 12 with IRC inflatable penile prostheses (IPP). Additionally, sensitivity to the combination of tetracycline and rifampin were evaluated on all cultures. RESULTS: In the noninfected group, culture positive isolates were found in 85 patients with uncoated PP's and in 32 patients with IRC implants [P value = 0.0003]. Cultures positive for Staphylococcus genus were found in 75 uncoated PP patients, while 20 patients with IRC implants had an isolate of this genus. In the infected group, culture positive isolates were found in 7 patients with uncoated PP and 6 patients with IRC IPPs [P value = 1.000]. Positive cultures for Staphylococcus genus were found in 6 patients with uncoated PP, while 3 patients with IRC IPP had an isolate of this genus. All bacterial isolates were sensitive to the combination of tetracycline and rifampin. CONCLUSION: Positive bacterial cultures have been shown to be present on clinically uninfected IPPs at time of revision surgery. Culture isolates grown from patients with IRC IPPs reveal a nontraditional bacterial profile: fewer cultured isolates of Staphylococcus genus.

A survey of patients with inflatable penile prostheses: assessment of timing and frequency of intercourse and analysis of implant durability.

INTRODUCTION: This study was conducted to determine how long after inflatable penile prosthesis (IPP) surgery patients attempt sexual intercourse and the frequency of subsequent relations. We also examined survival-related factors for the AMS 700 CX, Mentor Alpha 1, and Mentor Alpha Narrow Base. AIMS: The aim was to survey men who received IPPs and collect information about their return to sexual function and frequency of use, and to assess the resilience of their devices. METHODS: Phase I involved retrospective chart review of 1,298 virgin IPP surgeries performed by one surgical team from January 1992 to December 1998. Phase II included 330 subjects selected by stratified, systematic, random sampling from phase I patients. Data were collected by computer-assisted telephone interview, using a 27-question survey. All patients had been instructed to wait 4 weeks before using the implant and were taught how to inflate/deflate their prostheses at the 4-week postsurgical visits. MAIN OUTCOME MEASURES: The survey examines the length of time after surgery for men to resume sexual function. In the same study, information was garnered about mechanical durability of the device. RESULTS: Among phase I subjects, the 5-year survival rate was 83% (N = 1,069) for IPP revision for any reason. Of the 330 phase II subjects, 248 (75%) were successfully contacted; 199 (80%) responded to the full survey and 49 (20%) responded to selected parts of the survey. Sexual intercourse was resumed postoperatively at 1-4 weeks for 41% (78/190), at 5-6 weeks for 31% (59/190), at 7-8 weeks for 16% (30/190), and at >8 weeks for 12% (23/190) of the patients. More than 60% of patients reported using their IPP at least once weekly. CONCLUSION: The three-piece IPP has excellent 5-year survival rates. Most patients return to sexual activity relatively quickly, with high frequency of usage of their prostheses.

Mechanical reliability of AMS 700 CX improved by parylene coating.

INTRODUCTION: Parylene coating was added to the silicone layers of the American Medical Systems (AMS) 700 controlled expansion (CX) penile prosthesis cylinders in January 2001. The coating was placed on non-tissue contacting silicone surfaces to increase lubricity, reduce friction, and silicone wear AIM: We compared mechanical reliability of the original and Parylene-enhanced AMS 700 CX in a large single surgical group series. METHODS: Seven hundred seventy-five consecutive patients receiving the AMS 700CX prosthesis (596 first time [virgin] and 179 revisions) were followed for 3 years. Four hundred fourteen received the non-coated model and 361 received the Parylene-coated device. Revision-free survival was estimated using the Kaplan-Meier product limit method and compared using the log-rank test. MAIN OUTCOME MEASURES: We calculated overall survival from revision for any reason and survival from mechanical problems such as fluid leakage, cylinder, connector or tubing breakage, pump or reservoir defects. RESULTS: For the entire series (virgin + revised) the 3-year revision free survival for any cause improved from 78.6% for non-coated to 87.4% for the Parylene-coated implants. Freedom from mechanical breakage showed similar improvement from 89.2% for the non-coated to 97.5% for enhanced models. CONCLUSIONS: This study documents that short-term mechanical reliability and survival from revision for any cause is significantly increased with Parylene-coated AMS 700CX cylinders compared with the earlier AMS 700CX model with non-coated cylinders.

Tramadol HCL has promise in on-demand use to treat premature ejaculation.

INTRODUCTION: Premature ejaculation (PE) is a worldwide problem without an approved treatment. Selective serotonin reuptake inhibitors (SSRIs) are widely used "off label" as pharmacotherapeutic agents in the treatment of PE. AIM: This study investigates Tramadol efficacy for on-demand treatment of PE. MAIN OUTCOMES MEASURES: Intravaginal ejaculation latency time (IELT) was used as an objective tool to assess the efficacy of the investigated treatments. MATERIALS AND METHODS: Single-blind, placebo-controlled, crossover, stopwatch monitored two-period study was conducted, on 60 patients with lifelong PE. PE was defined as IELT of <2 minutes in 80% of intercourse episodes. A total of 25 mg of Tramadol hydrochloride was given to one group (30) prior to intercourse and placebo was supplied for the other group (30) for 8 weeks. Drugs were taken 1-2 hours before sexual activity and sexual intercourse was required at least once per week. After the initial treatment period, the two groups took the alternate medication for another 2 months. The two 8-week treatment periods were separated by 1 week washout period. IELT was timed by a stopwatch at each intercourse and was reported by patients or partners. RESULTS: The baseline (mean +/- SD) IELT for patients before treatment was 1.17 +/- 0.39 minutes. At the end of the treatment period utilizing the active drug, the mean IELT was increased significantly in patients on Tramadol treatment to 7.37 +/- 2.53 minutes. The same patients on placebo medication had mean IELT of only 2.01 +/- 0.71 minutes. Patients uniformly reported satisfaction with their resulting control over ejaculation. CONCLUSIONS: Tramadol, a drug with a proven safety record as an anti-inflammatory agent, shows promise as a drug for treating rapid ejaculation.

Infection reduction using antibiotic-coated inflatable penile prosthesis.

OBJECTIVES: Inflatable penile prosthesis (IPP) infection remains a devastating surgical complication. American Medical Systems recently introduced an IPP with a coating of minocycline HCL and rifampin (InhibiZone). We report our experience with this coating and compare the rate of infection with our historical rate. METHODS: A total of 467 patients receiving InhibiZone-coated IPPs were followed up for infection. The patients were stratified into four groups: nondiabetic, first-time (virgin) implants; diabetic, virgin implants; revision without washout; and revision with antiseptic solution washout. All patients were observed for longer than 1 year. The infection rates were compared with our published data of noncoated IPPs. RESULTS: No infections developed among the 223 virgin implants in nondiabetic patients. Of the 83 diabetic patients with virgin implants, 1 developed an infection (1%). Of the 39 revision patients without washout, 4 (10%) had infections. When an antiseptic washout was used in patients requiring revision, the infection rate dropped to 3% (4 of 123). Compared with our previous publications of infection rates with noncoated implants, InhibiZone-coated IPPs showed a statistically significant reduction in infection in virgin nondiabetic, virgin diabetic, and revision with washout implants. No reduction in the infection rate occurred among revision patients without washout. CONCLUSIONS: Antibiotic-coated implants become infected less often in virgin, nondiabetic and virgin, diabetic patients than in our historical experience with noncoated implants. However, antibiotic-coated implants used in revision surgery did not reduce the infection rate unless adjunctive antiseptic solution washout was also used.

Long-term survival of inflatable penile prostheses: single surgical group experience with 2,384 first-time implants spanning two decades.

INTRODUCTION: Long-term revision-free survival, greater than 10 years has never been reported for inflatable penile prostheses. We conducted a historical prospective study to estimate 10 and 15 years survival of first time (virgin) implantations in 2,384 patients with four different models. AIM: Evaluation of 10- and 15-year mechanical and overall revision-free survival of inflatable penile prostheses. MAIN OUTCOME MEASURES: Kaplan-Meier product limit method, and comparison using the log rank test, were used to estimate the 10- and 15-year revision-free survival. METHODS: Data were obtained from medical records and patient interviews, entered into a computerized database, and analyzed by a third party. Information included implant type, date, revision history with date, and reason. Fourteen different inflatables were examined. Mentor Alpha 1, Mentor Alpha NB, AMS 700 CX, and AMS 700 Ultrex had usage for an extended period of time. Because of failure times being confounded as a result of prior implants, only virgin implants were examined. RESULTS: For the entire series, estimated 10-year revision-free survival for all reasons was 68.5% and the 15-year revision-free survival was 59.7%. Freedom from mechanical breakage at 10 years was 79.4%; 15 years was 71.2%. Recent mechanically enhanced models did even better. In 1992, Mentor Alpha added pump reinforcement to forestall mechanical breakage. This improved 10-year survival from 65.3% to 88.6% (P = 0.0001). In January 2001, AMS CX added a parylene coating to the cylinders that increased 3-year mechanical survival from 88.4 to 97.9% (P = 0.0002). CONCLUSIONS: This is the first report on long-term reliability of inflatable penile prostheses. We estimated 60% of these virgin implants would survive 15 or more years without revision or extraction. Newer enhanced models are currently available, and our tracking predicts even better long-term survival for these devices.

Upsizing of inflatable penile implant cylinders in patients with corporal fibrosis.

INTRODUCTION: Placement of an inflatable penile prosthesis in a patient with scarred corporal bodies secondary to priapism or removal of a previously infected implant is a formidable surgical challenge; use of downsized implants has improved chances of successful reimplantation. Nevertheless, patients are frequently dissatisfied with the resulting short penises. AIM: This study investigates the use of downsized inflatable penile prosthesis cylinders as tissue expanders in patients with corporal fibrosis. MAIN OUTCOMES MEASURES: Corporal length and width were calibrated before implantation of downsized prostheses and after 1 year of their use as tissue expanders. METHODS: Thirty-seven patients had insertion of Mentor Narrow Base (18), AMS CXM (9), or AMS CXR (10) into scarred corporal bodies. Etiology was previously infected and removed implant (29) or priapism (8). In each of these cases it was not possible to dilate to 12 mm in order to place standard-sized cylinders. Patients were encouraged to inflate their implant for up to 3 hours daily. After several months intracorporal stretching occurred. The patients were reoperated; corporal length and width were recalibrated. RESULTS: Upon reoperation, it was possible to pass dilators of 12 mm width proximally allowing the substitution of standard-sized AMS 700 CX (23), Mentor Alpha 1 (10), or Mentor Titan (2). Additionally, corporal length measurements in the previously infected patients increased an average of 2.2 cm allowing placement of longer cylinders. Although priapism patients did not show this phenomenon of corporal lengthening, the implant space widened enough to permit replacement with standard-size cylinders improving girth, rigidity, and appearance. CONCLUSIONS: Wider and sometimes longer cylinders can be substituted in patients with corporal fibrosis that required implantation with downsized cylinders because of fibrotic corpora. Prolonged inflation over an 8- to 12-month period results in expansion of the cylinder cavity, permitting standard-sized cylinders in all patients.

A survey of patients with inflatable penile prostheses for satisfaction.

PURPOSE: We assessed patient satisfaction with 3 types of penile prostheses, namely the AMS 700 Series(R), Mentor Alpha 1(R) and Mentor Alpha NB(R). MATERIALS AND METHODS: The subjects consisted of 330 patients selected by stratified, systematic random sampling from among 1,298 subjects undergoing virgin 3-piece inflatable penile implant surgeries performed by the same surgical team at 1 hospital between January 1992 and December 1998. Data were collected by computer assisted telephone interviewing with a survey developed by the authors. The survey consisted of 37 questions in 7 sections, including 1 demographic section and 6 patient satisfaction sections. RESULTS: Of the 330 patients selected 248 (75%) could be contacted. Of these, 199 (80%) responded to the full survey and the remaining 49 (20%) agreed to respond only to the question, "How satisfied are you with the prosthesis?" Of the 199 full responders 12 (6%) had AMS implants and 187 (94%) had Mentor implants. Of the 49 single question responders 5 (10%) had AMS implants and 44 (90%) had Mentor implants. Of the 248 patients the overall satisfaction rate was 69%. Although there was no significant difference at the 5% level in patient satisfaction by implant type, responses tended to favor the Alpha IPPs in terms of overall sexual satisfaction (p =0.058), natural feeling of the prosthesis (p =0.061), flaccid appearance of the penis when deflated (p =0.054), and education with demonstration of inflation and deflation (p =0.075). CONCLUSIONS: There was a high degree of overall patient satisfaction across implant types.

Revision washout decreases penile prosthesis infection in revision surgery: a multicenter study.

PURPOSE: Reoperation of penile implants carries a higher risk of infection (7% to 18%). Positive cultures and visible bacterial biofilm have been shown to be present on clinically uninfected inflatable penile prostheses (IPPs) at revision. A salvage irrigation protocol has proved to rescue patients with a clinically infected IPP. During revision surgery for noninfectious reasons we investigated washing out the implant space at revision surgery and using an antibiotic coated replacement prosthesis to determine if it would decrease subsequent infection rates. MATERIALS AND METHODS: At 3 institutions 183 patients with a penile prosthesis underwent revision surgery for noninfectious reasons between June 2001 and October 2003. Of these patients 140 had the entire implant removed and then underwent antiseptic solution lavage of the implant spaces (revision washout), followed by replacement with a 3 piece IPP. This revision washout is a modification of the original Mulcahy salvage procedure. In the remaining 43 patients the implant was removed but they did not undergo antiseptic irrigation before replacement with an antibiotic coated IPP. Patients were followed for 6 to 33 months, while observing for failure. RESULTS: Four of the 140 patients (2.86%) who underwent removal of the entire implant with irrigation of the implant spaces with antiseptic solutions and replacement with an IPP have had infection. In the remaining group 5 of the 43 patients (11.6%) who did not undergo antiseptic irrigation had infection. The difference was statistically significant at the 5% level (Fisher's exact test p = 0.034). CONCLUSIONS: Early results of combining complete implant removal and modified salvage protocol indicate a markedly decreased incidence of infection in patients with a penile prosthesis undergoing revision for noninfectious reasons.

Penile prosthesis cultures during revision surgery: a multicenter study.

PURPOSE: Initial implantation of inflatable penile prosthesis has a 3% risk of infection. Reoperation of penile implants has a higher rate of infection, estimated between 10% and 18%. To explain the higher risk in revision surgery in this prospective study we cultured clinically uninfected prostheses requiring revision. Prosthesis pain was also investigated as a predictor of positive culture. MATERIALS AND METHODS: At 3 institutions cultures were prospectively obtained from 77 clinically uninfected penile prostheses at revision surgery. Immediately upon surgical exposure of the pump cultures were obtained. If a bacterial biofilm was noted on any component it was additionally cultured. All culture isolates positive for a staphylococcus species were tested for sensitivity to rifampin and tetracycline (minocycline). An implant is now available that is coated with these antibiotics. Patient history of chronic prosthesis pain was ascertained. RESULTS: Culture positive bacteria were found in 54 of 77 (70%) patients with clinically uninfected penile prostheses. In some patients more than 1 organism grew and, occasionally, the pump culture was negative but the biofilm was positive. Of 54 patients 49 had positive (90%) culture for staphylococcus genus with 10 different species. All staphylococcal species were sensitive to rifampin and/or tetracycline. We did not find a significant association between prosthesis related pain and culture laboratory results. CONCLUSIONS: The majority of clinically uninfected penile prostheses have organisms growing in the implant spaces at reoperation. Most of these organisms are staphylococcal species that are sensitive to rifampin/minocycline.

New surgical technique for sphincter urinary control system using upper transverse scrotal incision.

PURPOSE: Traditional implantation of the AMS Sphincter 800 Urinary Control System (American Medical Systems, Minnetonka, Minnesota) requires 2 incisions. The cuff is placed via a perineal incision, and the pressure regulating balloon and pump are placed through a separate suprapubic incision. We describe a novel implantation of all the artificial urinary sphincter components using a single upper scrotal incision. The scrotal incision allows excellent access to the proximal bulbar urethra and retropubic and subdartos spaces, and leaves the bulbocavernosus muscle intact. MATERIALS AND METHODS: A total of 37 patients have undergone artificial urinary sphincter implantation using the new operative technique for revisions or reimplantations of a sphincter previously removed for infection/erosion (12) or as an initial procedure (25). In 9 of the 25 patients and 2 of the 12 dual implantation of a 3-piece penile prosthesis through the same incision was performed. RESULTS: All patients are using the devices. Of the patients 66% are completely dry with no pad use and the remainder use 1 pad for accident prevention. Operative time was reduced due to easier exposure of the urethra and a second incision for placement of the pressure regulating balloon was not necessary. Followup at 1 year shows no difference in complication rate with the single incision technique compared to the traditional method. CONCLUSIONS: Artificial urinary sphincter implantation through a single scrotal incision is easier and faster than the traditional 2-incision technique. Success in achieving continence is similar to traditional methods. Long-term followup is necessary to ensure that complications remain low.

The mentor Alpha 1 penile prosthesis with reservoir lock-out valve: effective prevention of auto-inflation with improved capability for ectopic reservoir placement.

PURPOSE: Auto-inflation is a common and annoying complication of 3-piece penile prostheses. In the published literature the rate is approximately 11% with a 2% operative revision rate. We report the results of a review of 160 Alpha 1 and NB implants (Mentor Corp., Santa Barbara, California) with the new lock-out valve located on the reservoir to treat impotence. We compared it with 339 Alpha 1 implants with the standard reservoir. We also investigated the lock-out reservoir for ectopic nonretropubic implantation. MATERIALS AND METHODS: We compared 339 Alpha prostheses with the standard reservoir that were implanted between January 1, 1998 through December 31, 1999 and 160 with the new lock-out valve placed since January 2000 with at least 6 months of followup. Implants were further stratified as first time (virgin) or revision-replacement of a previous implant. In 8 patients with a scarred or obliterated retroperitoneal space the lock-out reservoir was placed superior to the transversalis fascia and beneath the abdominal musculature. RESULTS: Kaplan-Meier estimated 1-year survival was not significantly different in terms of mechanical failure (p = 0.57 and 0.85) revision for any cause (p = 0.92 and 0.92), patient dissatisfaction (p = 0.35 and 0.11) or infection (p = 0.64 and 0.94) for all implants and virgin implants only, respectively. Only 2 patients (1.3%) with a lock-out valve complained of auto-inflation initially and the problem resolved in each after instruction on how to operate the device. Of the patients in the earlier series 11% complained of auto-inflation and 2% required operative correction. None of the 8 patients with an ectopic reservoir location complained of auto-inflation. CONCLUSIONS: Our results indicate that the lock-out valve prevents early auto-inflation. Addition of the lock-out valve does not impact the revision rate compared with the same implant with a standard reservoir. In patients with a scarred retropubic space the lock-out valve offers the penile implant surgeon a decreased probability of auto-inflation with ectopic reservoir placement.