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PubMed2003

Serial assessment of efficacy and satisfaction profiles following penile prosthesis surgery.

PURPOSE: Penile implants are associated with a high level of patient satisfaction. Studies to date have failed to use instruments that accurately record patient satisfaction data. We used 2 validated instruments to assess the chronology of efficacy and satisfaction profiles in men undergoing penile prosthetic surgery. MATERIALS AND METHODS: Men who elected penile implant surgery were administered the International Index of Erectile Function (IIEF) questionnaire preoperatively, and 3, 6 and 12 months postoperatively as well as the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire 3, 6 and 12 months postoperatively. Comparison was done of preoperative and postoperative values for the overall IIEF, IIEF erectile function domain, IIEF satisfaction domain and EDITS. All surgeries were primary and in all patients an inflatable implant device was placed. RESULTS: A total of 96 men with a mean age of 56 years were enrolled in the study. All 12-month scores were statistically significantly higher than baseline scores. The 12-month values were statistically higher than 6-month values for the IIEF satisfaction domain and for EDITS. CONCLUSIONS: This study indicates that implant surgery causes a dramatic improvement in erectile function. It also indicates that satisfaction increases in year 1 after implant surgery with significant improvements in the second half of year 1. Current efforts are aimed at following this cohort of patients in an even more long-term fashion as well as evaluating partner satisfaction profiles. These findings should permit clinicians to provide penile prosthesis candidates with optimistic and realistic expectations for implant device function and postoperative satisfaction.

Adult↗
PubMed1991

Mechanical complications associated with mentor inflatable penile prosthesis.

The Mentor inflatable penile prosthesis was developed in an attempt to decrease the mechanical failure rate of the various prostheses' components. We herein report on the reliability of the device in 46 men implanted with the Mentor device from December 1982 to June 1987. Prior to manufacturer device modification in 1985, mechanical failure mainly attributable to input tubing cracks occurred in 10 of 30 implantations. Since device improvement in April 1985, the mechanical failure rate has decreased to 4 percent. The Mentor inflatable penile prosthesis has been a mechanically reliable device since design improvement in 1985.

Adult↗
PubMed2004

The hydrophilic-coated inflatable penile prosthesis: 1-year experience.

INTRODUCTION: Penile prosthesis infections are a devastating complication for both patient and surgeon. Efforts to reduce the risk of infection from these elective procedures are a major focus of research and development by the major prosthesis companies. The Titan inflatable penile prosthesis (Mentor Corporation, Santa Barbara, CA) is coated with polyvinylpyrrolidone (PVP), a hydrophilic substance that reduces bacterial adherence and absorbs and elutes the antibiotics the device is immersed in intraoperatively. The Titan device was introduced to the American market in September 2002. This study reports the 1-year experience in the U.S. with the Titan and compares infection rates with the noncoated Alpha-1 IPP made by Mentor. MATERIALS AND METHODS: Two thousand three hundred and fifty-seven Titan prostheses were implanted in the U.S. from September 2002 to August 2003, compared with the 482 noncoated Alpha-1 IPPs implanted over the same time period. Infection rates were compared, along with bacterial culture data. All data were collected from Mentor's internal database, as generated from the FDA's mandatory reporting of explanted medical devices, and available on the internet. RESULTS: The infection rate for the coated Titan IPP was 1.06% (25/2,357). During the same time period, the infection rate for the Alpha-1 noncoated prosthesis was 2.07% (10/482). Staphylococcus species predominated in both groups (9/25 Titan, 6/10 Alpha-1). CONCLUSIONS: At 1 year of follow-up, the data demonstrate that the hydrophilic coating on the Titan IPP confers a significant advantage in reducing the rate of infection over the noncoated device. Long-term follow-up on this first year database is needed before this innovation is accepted as the standard of care for prosthetic surgery. Nevertheless, the theoretical reduction in bacterial adhesion conferred by the hydrophilic PVP surface and the ability to choose which antibiotic the device is immersed in intraoperatively gives the implanting surgeon distinct advantages with this new product.

Anti-Bacterial Agents↗
PubMed1981

Management of neurogenic impotence with inflatable penile prosthesis.

The inflatable penile prosthesis was used to manage impotence of neurogenic origin secondary to spinal cord injury. The female partners were also interviewed. Analysis of the results indicated that this was an eminently satisfactory method of managing this distressing complication of spinal cord injury. Both men and women indicated satisfaction with the prosthesis. The incidence of complications was the same as in those patients with non-neurogenic impotence. Erosion of the prosthesis due to pressure necrosis of denervated tissue did not occur.

Adult↗
PubMed1984

Long-term followup in patients with an inflatable penile prosthesis.

An inflatable penile prosthesis was implanted in 95 patients between 1977 and 1983. The patients were divided into 3 groups with roughly equal numbers studied during 2-year intervals. Of the prostheses 48 per cent have been revised or removed, or have failed during followup. The complication rate increased with the duration of followup.

Adult↗
PubMed2003

Diagnosis, treatment and prevention of penile prosthesis infection.

The implantation of inflatable penile prostheses for the treatment of erectile dysfunction continues to be widely practiced in the United States and internationally. As third-line therapy for erectile dysfunction, the numbers of implants continue to rise as the population of men treated for erectile dysfunction increases. Complications of penile prosthesis implantation continued to decline as mechanical malfunctions have decreased as a result of re-engineering inflatable penile prostheses. Inflatable penile prostheses from both available vendors continue to be reliable, effective methods for restoring erectile function with high satisfaction rates. The most troublesome complication of these prostheses, however, is not mechanical but rather that of prosthesis infection. Prosthesis infections may result in further surgery, loss of penile tissue, and even the inability to replace penile prosthesis. While standard sterile technique perioperative antibiotics and careful surgical procedures continue to be the cornerstone of penile prosthesis infection avoidance, newer designs of penile prostheses for antibiotic coating have resulted in an improvement in the prevalence and incidents of penile prosthesis infection. For those patients in whom penile prostheses become infected despite adequate prophylaxis, newer techniques of salvage have demonstrated increasing success. Once and still the most dreaded complication of penile prosthesis implantation, prothesis infections can now be avoided by perioperative preparation and antibiotics as well as antibiotic-coated penile prostheses. Treatment of penile prosthesis infections once associated with severe loss of function can often be successful with modern salvage techniques. Implanting urologists must be familiar prophylaxis, avoidance, and treatment of penile prosthesis infections.

Anti-Bacterial Agents↗
PubMed2006

Efficacy and patient satisfaction associated with penile prosthesis revision surgery.

INTRODUCTION: Complications that arise after placement of a penile prosthesis may result in the need for revision surgery. Few contemporary penile prosthesis series have focused solely on describing the efficacy and patient satisfaction associated with penile prosthesis revision surgery. AIM: To determine the overall success of penile prosthesis revision surgery in providing the patient with a functional implant. Device efficacy and patient satisfaction with penile prosthesis revision surgery will be assessed using psychometrically validated instruments. MAIN OUTCOME MEASURES: The erectile function (EF) and satisfaction domains of the International Index of Erectile Function (IIEF) were used to quantify the overall efficacy and patient satisfaction with revision surgery. METHODS: Data were derived from a prospective database of consecutive patients undergoing penile prosthesis revision surgery performed by a single surgeon (B.R.K.). Eleven patients filled out the IIEF prior to surgery and 26 completed it following surgery. RESULTS: Thirty-nine consecutive patients underwent 55 revision procedures related to a prior penile prosthesis. Thirty-four patients (87%) have a functional implant with a median follow-up of 6.5 months (range 1-42 months). Significant improvements in the overall IIEF, EF domain, and satisfaction domain were seen in those patients studied prior to and following revision surgery. The total IIEF, EF domain, and satisfaction domain of the IIEF for the group of 26 responders were 60.7 +/- 19.3, 26.6 +/- 8.7, and 15.7 +/- 5.6, respectively. Patients with fibrotic corporal bodies scored significantly lower on the EF and satisfaction domains than did any other group. CONCLUSIONS: Penile prosthesis revision surgery is highly successful in providing men with a functional implant. The prostheses function well and patients are satisfied with their devices. Further study of those men with corporal fibrosis is warranted in order to determine the factors needed to improve their overall satisfaction with revision surgery.

Adult↗
PubMed1992

The G.F.S. Mark II inflatable penile prosthesis.

The G.F.S. Mark II inflatable penile prosthesis was implanted in 80 men who were followed for up to 27 months. In this study there have been no mechanical problems. Of the patients 6 required repositioning of the reservoir pump and 4 required postoperative addition of fluid to the reservoir pump. This study indicates that the revised connectorless G.F.S. Mark II inflatable penile prosthesis has eliminated the previous problems with connectors and tubings. The G.F.S. Mark II inflatable penile prosthesis reservoir pump provides a means of postoperative fluid adjustment within the system performed as an office procedure.

Adult↗
PubMed1998

Management of impending penile prosthesis erosion with a polytetrafluoroethylene distal wind sock graft.

PURPOSE: Erosion of penile prostheses can be calamitous, often leaving patients unable to accommodate further implants. There is a paucity of literature describing impending erosion of penile prosthesis. We report on 5 patients with impending erosion of a penile prosthesis who underwent polytetrafluoroethylene distal wind sock graft placement. MATERIALS AND METHODS: From 1993 to 1997, 5 patients with a mean age of 49 years and impending penile prosthesis erosion underwent 6 revisions using a polytetrafluoroethylene distal wind sock graft. Two patients underwent simultaneous bilateral grafts while 1 patient underwent separate right and left grafts 3 years apart. Indications for reconstruction included distal migration of the prosthetic cylinders into the glans in 4 patients and impingement of the distal urethra in 2. Of the patients 3 were spinal cord injured, 1 had lumbar radiculopathy and 1 had a history of pelvic irradiation. Inflatable prostheses were implanted in 4 patients, while 1 received a malleable prosthesis. RESULTS: Patients underwent a mean of 1.5 penile prosthetic revisions (0 to 4) before diagnosis of impending erosion. An interval of 8 to 144 months (mean 66) elapsed from the most recent penile prosthesis insertion until distal wind sock graft placement. Mean operative time was 1 hour 51 minutes (1.3 to 2.5 hours). Mean hospital stay was 6.3 days (3 to 12). At a mean followup of 32 months (0.7 to 5.2 years) all patients had satisfactory and functional erections with no pain or evidence of impending erosion or penile prosthesis infection. CONCLUSIONS: Erosion of a penile prosthesis can have disastrous consequences. We describe a safe and effective technique for managing impending penile prosthesis erosion using a polytetrafluoroethylene distal wind sock graft.

Humans↗
PubMed1997

Intermediate term assessment of the reliability, function and patient satisfaction with the AMS700 Ultrex penile prosthesis.

PURPOSE: The AMS700 Ultrex penile prosthesis is an example of the design changes that penile prostheses have undergone to improve mechanical reliability. Few studies have reviewed an overall experience with the AMS700 Ultrex prosthesis. We review patient outcomes, surgical complications, and Ultrex cylinder intermediate term mechanical reliability and function. MATERIALS AND METHODS: Between March 1990 and November 1994, 145 patients 32 to 79 years old (mean age 58) underwent insertion of an AMS700 Ultrex penile prosthesis. At a followup of 6 to 62 months (mean 42) patients were evaluated with a retrospective clinical record review, and patient and partner questionnaires. RESULTS: From the clinical record review of 145 patients our malfunction, reoperation, infection, erosion, major complication and minor complication rates were 8, 13, 2, 3, 13 and 7%, respectively. Patient responses to our questionnaire showed that 85% were satisfied overall, 85% had durable and reliable implant function, 86% had a sustained level of satisfaction with the implant and 83% remained satisfied after a revision for malfunction. Overall, partner satisfaction with the implant was 76%, and 42% reported maintenance of a good or improved nonsexual relationship after prosthesis implantation. CONCLUSIONS: Our data demonstrate the intermediate term mechanical reliability and function of the AMS700 Ultrex penile prosthesis, and high patient and partner satisfaction with this implant.

Adult↗
PubMed1996

[Penile prosthesis. Indications, classification, technic, complications, and safety].

OBJECTIVES: To review the indications of penile prosthesis in the treatment of erectile dysfunction and describe a new classification based on the design and material of the prosthesis. METHODS: Penile prosthesis are classified. The advantages and disadvantages of the different prosthesis types are given. The surgical technique is described, as well as the pre-, intra- and postoperative complications observed in 300 procedures involving penile prosthesis performed over a 10-year period. RESULTS: 6 of the 300 prosthesis required removal (4 of these 6 prosthesis were reimplanted); 17 prosthesis were changed due to implant failure. CONCLUSIONS: Penile prostheses are the best solution currently available for erectile dysfunction not amenable to any other type of treatment and carry minimal complications if the technique is performed correctly.

Humans↗
PubMed1993

Clinical experience with Mentor Alpha I inflatable penile prosthesis. Report on 333 cases.

Penile prostheses are a well-established form of therapy for erectile dysfunction. We report our experience with 333 cases using the Mentor Alpha I inflatable penile prosthesis. With a follow-up period of 15.4 months, there were 25 (7.5%) complications with 15 (4.5%) major complications that required reoperation. We also review the advantages and the procedures for implanting the penile prosthesis on an outpatient basis or a one-day hospital stay.

Adult↗
PubMedDate not supplied

Multi-institutional outcome study on the efficacy of closed-suction drainage of the scrotum in three-piece inflatable penile prosthesis surgery.

Infection is a devastating complication of penile prosthesis surgery that occurs in approximately 2-5% of all primary inflatable penile primary implants in most series. Prevention of hematoma and swelling with closed-suction drains has been shown not to increase infection rate and yield an earlier recovery time. Despite the intuitive advantages of short-term closed-suction drainage in reducing the incidence of postoperative scrotal swelling and associated adverse effects, many urologists are reluctant to drain the scrotum because of a theoretical risk of introducing an infection. In conclusion, this study was undertaken to evaluate the incidence of infection in three-piece penile prosthesis surgery with scrotal closed-suction drainage. A retrospective review of 425 consecutive primary three-piece penile prosthesis implantations was performed at three institutions in New Jersey, Ohio, and Arkansas from 1998 to 2002. Following the prosthesis insertion, 10 French Round Blake (Johnson & Johnson) or, in a few cases, 10 French Jackson Pratt, closed-suction drains were placed in each patient for less than 24 h. All subjects received standard perioperative antibiotic coverage. Average age at implant was 62 y (range 24-92 y). Operative time (incision to skin closure) was less than 60 min in the vast majority of cases. There were a total of 14 (3.3%) infections and three hematomas (0.7%) during an average 18-month follow-up period. In conclusion, this investigation revealed that closed-suction drainage of the scrotum for approximately 12-24 h following three-piece inflatable penile prosthesis surgery does not result in increased infection rate and is associated with a very low incidence of postoperative hematoma formation, swelling, and ecchymosis.

Adult↗
PubMed1998

Use of a prefabricated tunica vaginalis fascia flap to reconstruct the tunica albuginea after recurrent penile prosthesis extrusion.

PURPOSE: Although a penile prosthesis usually perforates into the urethra, it can extrude through the glans or corporeal shaft. Various materials have been used to reconstruct tunica albuginea but no method of repair has been satisfactory in such difficult cases. Repair of the weakened tunica albuginea should ideally be performed with autogenous tissues. Inasmuch as the scarred tissue bed is inadequate to ensure graft survival and no local flaps are available for this purpose, prefabrication of a local flap has been designed. MATERIALS AND METHODS: We present 2 cases in which the distal corpus was reconstructed with a prefabricated tunica vaginalis fascia flap. The first stage involves grafting rectus fascia onto the external tunica vaginalis of the testicle. At the second stage the prefabricated tunica vaginalis fascia flap is transposed to the distal corpus, placing it as a buttress between the cylinder and urethra medially or between the cylinder and thin lateral and distal tunica albuginea. The flap also replaces part of the tunica albuginea. RESULTS: In both patients repair of the tunica albuginea was successful and each has a functioning inflatable penile prosthesis at 2 1/2 1 1/2 years postoperatively, respectively. CONCLUSIONS: Reconstruction of the weak tunica albuginea with a prefabricated tunica vaginalis fascia flap is an excellent procedure in these difficult cases.

Adult↗
PubMed2002

Distal penile prosthesis extrusion: treatment with distal corporoplasty or Gortex windsock reinforcement.

Subcutaneous extrusion of penile prosthesis cylinders beneath the glans penis is an unusual but difficult complication of penile prosthesis. Without surgical repair, extrusion, infection, and corporeal fibrosis may ensue. Twenty-eight patients with distal corporeal extrusion were reviewed to identify the optimum treatment outcome for these penile prosthesis complications. Records of 28 men with subcutaneous distal penile prosthesis cylinder extrusion were reviewed. Mean age was 56.2 y. Etiology of erectile dysfunction was diabetes mellitus in 11, vasculogenic in 10, Peyronie's disease in five, radical pelvic surgery in five. Duration of penile prosthesis was 8-72 months (mean 42.6). No patient had penile prosthesis infection or device exposure through the skin. Distal corporoplasty was treated on 18/28 men using cylinder repositioning and direct tunica albuginea repair. Ten men underwent repair using a Gortex windsock. 8/18 corporoplasty and 6/10 windsock patients required glans fixation for treatment of hypermobile glans following cylinder relocation. In two patients with windsock repair, extrusion recurrence occurred 6 and 18 months following surgery and 1/6 had post operative infection requiring prosthesis removal. Mean surgical time for corporoplasty was 52.8 minutes while windsock reconstruction was 89.6 minutes. Distal subcutaneous penile prosthesis cylinder extrusion produces coital pain and predisposes to cylinder exposure and infection. Early repair with or without additional prosthetic materials will return penile prostheses to a normal functioning state. Distal corporoplasty with cylinder repositioning appears to be a simple, low morbidity solution to this difficult dilemma. Outcomes with distal corporoplasty result in better function, less pain, and fewer recurrences than Gortex windsock repair.

Adult↗
PubMed2006

Risk of infection with an antibiotic coated penile prosthesis at device replacement for mechanical failure.

PURPOSE: The inflatable penile prosthesis is well established as an effective treatment for select patients with organic erectile dysfunction. The risk of prosthetic infection at primary implantation is approximately 2%. However, for revision or replacement procedures the risk of infection has been reported to be as high as 13.3%. To minimize the overall risk of prosthetic infection an antibiotic coated inflatable penile prosthesis (InhibiZone) has been developed. To assess the impact on infection rates we reviewed our experience with the use of this device at prosthesis replacement for mechanical failure. MATERIALS AND METHODS: We retrospectively reviewed the records of all patients undergoing inflatable penile prosthesis replacement for mechanical failure with an antibiotic coated prosthesis between May 2001 and November 2004. Salvage procedures for clinically infected prostheses were excluded from analysis. Chart review was performed with examination of operative notes, all postoperative contacts and microbiological data. RESULTS: A total of 55 patients underwent replacement of an inflatable penile prosthesis for mechanical failure using a device coated with rifampin and minocycline HCL (InhibiZone). In all patients before reimplantation component spaces were irrigated in standard fashion. With a median followup of 32 months (range 12 to 54) postoperative device infection requiring explantation developed in 1 patient (1.8%). Intraoperative cultures from the pump site grew coagulase negative staphylococcus. CONCLUSIONS: Our data suggest that an antibiotic coated inflatable penile prosthesis may lead to decreased infection rates in patients undergoing penile prosthesis replacement for mechanical failure.

Adult↗
PubMed1996

The prosthesis salvage operation: immediate replacement of the infected penile prosthesis.

PURPOSE: We describe our experience with salvage of the infected penile prosthesis at initial presentation in 11 patients. MATERIALS AND METHODS: All patients with prosthesis infection who presented since 1991 were considered for salvage surgery. Contraindications to a salvage operation included necrotic infections, diabetic patients with purulence in the corporeal bodies, rapidly developing infections and erosion of the device cylinders. RESULTS: In 1 patient in this group a salvage attempt was repeated after re-infection, for an overall success rate of 91%. Mean followup for the group was 21 months (range 9 to 42). Staphylococcus epidermidis was the infecting organism in 75% of our patients. CONCLUSIONS: Our experience demonstrates the safety and advantages of the immediate salvage technique.

Adult↗