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At least 127 records · Page 7Linked to original sources

PubMed1998

Penile prosthesis implantation surgery: a statewide population based analysis of 2354 patients.

AIMS OF THE STUDY: Minimally invasive therapy for erectile dysfunction (ED) has changed the frequency of penile prosthesis surgery. The purpose of this study is to describe the changes in frequency, hospital stay, hospital charges and penile prosthesis type in North Carolina. MATERIALS AND METHODS: The data source was a statewide hospital discharge database which includes data on hospitalized patients for all 151 hospitals in North Carolina. RESULTS: From 1988-1993, 2354 patients underwent implantation of penile prostheses. The total number of penile prostheses implanted has declined over this six year period. Similarly, hospital stay has declined from an average of 4.03-2.96 d with a 46.6% decrease in total hospital days. Despite this change in hospital stay, hospital charges rose significantly from an average of $7252.48 to $12,842.18 driving total charges from $2973,516.80 to $3,826,969.60 (1993) representing a 28.7% increase. CONCLUSIONS: Minimally invasive therapy and changes in reimbursement have had a major impact on the number of patients undergoing penile prosthesis implantation for ED. This downward trend may continue as more treatment options develop from the marked increase in research in this field. However, this may result in an increase of patients seeking treatment overall.

Erectile Dysfunction↗

PubMed2001

Mechanical reliability of the AMS 700CXM inflatable penile prosthesis for the treatment of male erectile dysfunction.

PURPOSE: The AMS 700CXM inflatable penile prosthesis with medium controlled expansion cylinders was introduced in 1990 to provide a device with controlled expansion in girth and fitness for Asian men. We reviewed our experience with the AMS 700CXM prosthesis with particular regard to postoperative complications and reliability. MATERIALS AND METHODS: From January 1991 to April 1999, 273 men with erectile dysfunction underwent primary penile prosthesis implantation with the AMS 700CXM. Functional status of the prosthesis was assessed retrospectively by reviewing the medical records and a telephone interview. RESULTS: Patient age was 24 to 78 years and mean followup was 49 months. Of the 28 complications (10.3%) 8 (3%) were nonmechanical and 20 (7.3%) were mechanical. Nonmechanical complications included infection in 2 cases, erosion in 3, surgical complications in 2 and tube kinking in 1. Mechanical complications involved a cylinder tear in 11 cases (4%), pump failure in 4 (1.5%) and a reservoir tear in 2 (0.7%). Mechanical reliability of the device was 98.2% after 2, 95.7% after 3 and 90.4% after 5 years. CONCLUSIONS: The AMS 700CXM is suitable for Asian men and its mechanical reliability is excellent. However, more device modifications are needed to guarantee good reliability during long-term followup.

Adult↗

PubMed1999

Distal corporoplasty for lateral extrusion of penile prosthesis cylinders.

PURPOSE: Lateral extrusion of a penile prosthesis cylinder is an uncommon but distressing problem. A technique is described to reseat the cylinder in a more medial and secure position under the glans penis by creating a new cavity for the cylinder behind the back wall of the fibrotic sheath containing it. MATERIALS AND METHODS: A total of 14 patients underwent corporoplasty using this technique with followup as long as 2 years. RESULTS: All patients had a satisfactory result with no recurrence of the original problem. CONCLUSION: This method which places the cylinder behind 2 secure layers is straightforward, simple and reliable.

Humans↗

PubMed1996

A randomized prospective comparison of antibiotic tissue levels in the corpora cavernosa of patients undergoing penile prosthesis implantation using gentamicin plus cefazolin versus an oral fluoroquinolone for prophylaxis.

PURPOSE: We performed a prospective randomized trial comparing the efficacy, safety and cost of parenteral antibiotics and oral fluoroquinolones for prophylaxis in penile prosthesis surgery. MATERIALS AND METHODS: We prospectively randomized 20 consecutive patients undergoing penile prosthesis surgery to receive ofloxacin orally or gentamicin and cefazolin parenterally followed by cephradine orally. Intraoperatively corpora cavernosa tissue and simultaneous peripheral serum samples were evaluated for antibiotic levels. Median followup was 16 months (range 8 to 21, mean 15.35). RESULTS: There were no implant losses or reoperations and complications were comparable in the 2 groups. The difference in mean serum-to-tissue ratios of ofloxacin versus the combination of cefazolin and gentamicin was statistically significant (p < 0.03). The minimum inhibitory concentrations of ofloxacin met or exceeded those of the 2 most common offending organisms, Staphylococcus epidermidis and Escherichia coli, in 80% of patients, which was comparable to the results of the parenteral regimen. Cost savings of the medications alone were more than $250,000 in the ofloxacin group. By eliminating a hospital stay of the 25,000 cases of penile prosthesis placement in the United States yearly a total cost savings of more than $36 million would be realized. CONCLUSIONS: When oral ofloxacin is given for prophylaxis in penile implant surgery, the procedure may be performed on an outpatient basis and health care dollars are saved.

Administration, Oral↗

PubMed1988

Implantation of model AMS 700 penile prosthesis: long-term results.

The American Medical Systems inflatable penile prosthesis has undergone periodic design changes to improve device reliability and longevity while maintaining a high degree of patient and partner satisfaction. Previous data reported from this institution did not consider these frequent design changes and the assessment of device reliability incorporated consecutive cases involving several different designs. This study was designed to evaluate followup data on 120 patients who received the model 700 inflatable penile prosthesis, permitting assessment of device reliability of a single design. Two groups were evaluated: a pre-fix group of 57 patients and a post-fix group of 63 patients. Over-all, 11.7 per cent of the total group required revision (21 per cent of the pre-fix and 3.2 per cent of the post-fix groups). Careful life-table analysis of the results with the current model 700 device (post-fix) reveals that this model has a 97 per cent chance of maintaining normal mechanical function for 3 years. Further assessment of these patients in the future will provide additional data on long-term reliability of this design.

Erectile Dysfunction↗

PubMed2000

Current status of penile prosthesis implantation.

Today most men with erectile dysfunction (ED) can be effectively treated with less invasive means than penile prosthesis implantation. Nevertheless, there remain men who do not respond to simple treatments such as systemic medication and who either do not respond to or reject intermediate treatment such as penile injection therapy. For these men, penile prosthesis implantation remains a reasonable option. This review discusses types of penile prostheses, how to choose among prosthesis types, key features of implant techniques, infection management, penile reconstruction related to prosthesis implantation, and patient and partner satisfaction.

Erectile Dysfunction↗

PubMed2005

[Penile prosthesis. Quality outcomes and morbidity].

OBJECTIVES: To study patient satisfaction and complications appeared in a series of patients with erectile dysfunction undergoing implant of penile prosthesis. METHODS: Retrospective study of all patients undergoing surgical treatment for erectile dysfunction by penile prosthesis implant between 1993 and 2003. Collected data included patient age at the time of surgery, previous treatment, and significant medical history. We reviewed the models of prosthesis employed, incisions, and complications appeared. Finally, a questionnaire was elaborated to establish the level of patient satisfaction. RESULTS: 24 prostheses were implanted between 1993 and 2003. Mean patient age was 56.6 +/- 7.56 years (36-63), median 59.5 yr. Penile-scrotal incision was employed in 13 (54.16%) patients, suprapubic incision in 6 (25%) and subcoronal incision in 1 (4.16%). Type of prosthesis: semirrigid AMS 600 9 (37.5%), semirrigid AMS 650 10 (41.66%); the two component hydraulic prosthesis AMS Ambicor was used only in one case. Six (25%) patients presented complications. 16.66% were minor, cavernositis, pain, hematoma or prosthesis extrusion. Prosthesis extraction was necessary in 2 (8.33%) cases. 13 (54.16%) patients responded to the telephone survey 85% of them use their prosthesis. 54% percent refer adequate self-satisfaction and partner satisfaction (well satisfied/much satisfaction). 23% not too bad, and the remainder 23% bad or very bad. CONCLUSIONS: Despite the highest rate of postoperative complications, penile prosthesis is adequately accepted by patients with erectile dysfunction, even malleable models. Patient satisfaction is high, being higher in partners. Most patients would desire to undergo surgery again if they were in the same situation.

Humans↗

PubMed1993

The Hydroflex penile prosthesis: a test case for the introduction of new urological technology.

The AMS Hydroflex* penile prosthesis was introduced for commercial distribution in 1985 but 5 years later this device was no longer available on the United States market. In an attempt to understand why this device, which initially enjoyed substantial popularity, was abruptly withdrawn from the market, patients who underwent implantation at the University of Wisconsin were interviewed and a critical analysis of the Food and Drug Administration approval process of medical devices was performed. An AMS Hydroflex penile prosthesis was implanted in 17 patients (mean age 57.7 years, range 27 to 84 years). The followup period ranged from 37 to 73 months with a mean of 58 months, and 3 patients died within that time. Of the remaining patients 10 (71%) were satisfied with the device in the first months after implantation but only 6 (43%) were satisfied at the time of followup, 9 (64%) were more satisfied with sexual relationships after receiving the prosthesis and 7 (50%) found the prosthesis simple to operate. Mechanical failure was noticed by 11 patients (79%), of whom 5 (45%) underwent further surgery. Classification of medical devices started with the enactment of the Medical Device Amendment to the Federal Food, Drug and Cosmetic Act, May 28, 1976. All medical devices that were in commercial distribution at that time were classified in 3 regulatory control categories depending upon the degree of regulation necessary to assure safety and effectiveness of each device. Before May 28, 1976 no approved application was necessary for marketing medical devices, and the Food and Drug Administration has variable amounts of information about safety and effectiveness of the different devices marketed prior to that date. Since May 1976 approved applications have been mandated for new or significantly changed devices. The specific process by which the Hydroflex prosthesis, as well as other medical devices, is approved is critically reviewed.

Adult↗

PubMed1990

Experience with Duraphase penile prosthesis: its use as replacement device.

The Duraphase Penile Prosthesis is a new, articulating type of semirigid prosthesis which appears to have several advantages over other semirigid penile prostheses. This series describes the experience with this prosthesis in 12 patients and highlights the experience in 4 patients who underwent removal of other types of prostheses due to mechanical or functional problems and replacement with the Duraphase prosthesis. The device has been mechanically reliable during short follow-up, and there has been excellent patient satisfaction.

Aged↗

PubMed1989

[A clinical evaluation of AMS 700 penile prosthesis in the treatment of impotence].

The AMS 700TM & 700 CXTM penile prosthesis was implanted in 34 organic and mixed-type impotent patients between November, 1984 and July, 1988. The patients' ages ranged between 32 and 70, with an average age of 57.2. Twelve weeks after implantation, the prosthesis was evaluated in terms of patient satisfaction with sexual intercourse and postoperative complications. Twenty three patients (67.7%) were highly satisfied, 7 (20.3%) satisfied, 3 (8.8%) dissatisfied and 1 patient worsened (2.9%). Severe complication was found in two cases, both of them being complicated by infection; as a result the prosthesis was removed. Utility of the prosthesis, e.g. effectiveness and safety was; high utility in 26 cases (76.5%), moderate utility in 7 cases (20.6%), and no favorable in one case (2.9%). Thus, overall effectiveness and safety of the AMS 700 penile prosthesis, with its excellent cosmetic appearance upon implantation, were demonstrated by the above findings.

Adult↗

PubMed1993

Osseous fixation of a penile prosthesis after transsexual phalloplasty: a case report.

We report on a patient who had undergone female-to-male transsexual surgery and subsequent phalloplasty by means of a free latissimus dorsi muscle graft with pudendal nerve coaptation elsewhere 10 years ago. The surgical strategy for implantation and osseous fixation of a penile prosthesis is described. We discuss whether the primary implantation of a penile prosthesis during 1-stage surgical phalloplasty is more advantageous in comparison with the currently favored secondary implantation. Phalloplasty should be represented by a 1-stage surgical procedure encompassing the creation of a neourethra, restoration of tactile and possibly erogenous sensibility, and implantation of a penile prosthesis. The result should have aesthetic value and be pleasing to the patient.

Adult↗

PubMed2002

Penile prosthesis: patient teaching and perioperative care.

As more options become available for treating erectile dysfunction (ED), more men are seeking treatment. Despite excellent efficacy of available medical management, a percentage of these patients will be refractory to the less invasive options for treatment, leaving the surgical implantation of a penile prosthesis as their remaining option for definitive treatment of ED. The patient seeking penile prosthesis surgery faces many challenges as he proceeds through the perioperative processes. A thorough understanding of indications, preoperative assessment and teaching, intraoperative procedure, and postoperative care and teaching for the patient receiving a penile prosthesis will enable him to achieve the best possible outcome.

Contraindications↗

PubMed1997

Fifteen years experience of penile prosthesis insertion.

INTRODUCTION AND OBJECTIVES: To review the outcome and patient satisfaction of penile prosthesis insertion over a 15 y period. PATIENTS/MATERIALS AND METHODS: We reviewed the notes of 172 patients who underwent penile prosthesis insertion between January 1980 and May 1995. From the notes information was determined on age of the patient, type of prosthesis, surgical approach and length of stay. Also noted were risk factors for erectile dysfunction and the aetiology. Twenty patients were known to have died or moved away. To assess the impact the operation had on quality of life, 152 questionnaires were sent of which 103 were returned (67%). The questionnaire gained information about sexual activity, before and after the operation and the overall satisfaction of the patient and his partner and whether they felt the operation was a success. RESULTS: Overall 149 patients were known to have had malleable prostheses inserted and 23 had inflatables. The commonest organic groups were vascular disease, diabetes and Peyronies disease. Fifteen patients had two procedures. Four patients required revision of the prosthesis due to erosion, and there was one death due to pulmonary embolism. One hundred and three completed questionnaires have been returned to date the median time since operation was 4 y, the range being six months to 16 y and 78% thought the operation was a success. CONCLUSIONS: The insertion of malleable prostheses is associated with low complication rates, good patient satisfaction and improved quality of life for the couple. Concealment was not a major problem.

Adult↗

PubMed1980

Small-Carrion penile prosthesis for the management of diabetic impotence.

Of 128 patients who had insertion of a Small-Carrion prosthesis, 36 were diabetic. The insertion of a penile prosthesis in diabetic patients proved to be safe, without increased incidence of infection or rejection of the prosthesis, provided diabetes is under good control before operation. Cystoscopy and cystometrogram are necessary to exclude any possible obstruction or decompensation, thus eliminating potential risk of urinary infection or further decompensation by penile prosthesis. An interval of six weeks after insertion of the prosthesis is needed for resuming sexual activity.

Diabetes Complications↗

PubMed2003

Prospective long-term results and quality-of-life assessment after Dura-II penile prosthesis placement.

OBJECTIVES: To evaluate prospectively the long-term device reliability and patient satisfaction after Dura-II malleable penile prosthesis implantation. METHODS: Between 1992 and 1996, 94 patients underwent Dura-II implantation for erectile dysfunction. Patients were prospectively examined and completed standardized questionnaires regarding sexual activity, prosthesis function, intercourse satisfaction, and overall quality of life. An independent statistician analyzed these data. RESULTS: The mean patient age was 63 years, and the mean patient follow-up was 5.7 years. Eighty-five patients were available for long-term evaluation. Fourteen patients died during the follow-up period. One patient was lost to follow-up, and eight prostheses (9%) were explanted; however, no mechanical defects were found in the explanted prostheses. Seventy-six percent and 87% of patients reported satisfactory rigidity and ease of concealing the device, respectively. Seventy-six percent of patients remained sexually active during the evaluation period, and 87% of patients reported that the prosthesis improved their overall quality of life. Eighty-five percent would undergo the implant surgery again, and 88% percent of patients would recommend the Dura-II prosthesis to a friend. CONCLUSIONS: The Dura-II malleable penile prosthesis provides good rigidity, ability to conceal the device, and mechanical reliability, as demonstrated by the results of this long-term study. Most patients stated they would have the prosthesis placed again and would recommend it to a friend.

Adult↗

PubMed1998

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.

Evaluation Studies as Topic↗

PubMed1982

Placement of penile prosthesis during surgery for malignancies.

Insertion of either a semirigid or inflatable penile prosthesis at the completion of surgery for various malignancies was performed. Twelve men had implants and were followed at least one year with excellent results. Careful preoperative sexual counseling with the patient's spouse is recommended and adds immeasureably to the mental well-being of the patient in the postoperative period. Penile prostheses can be placed easily after radical cystectomy, radical prostatectomy (perineal or retropubic), urethrectomy, and bilateral orchiectomy. Penile prosthesis placement may also be recommended for patients with less than adequate erectile function who may be undergoing pelvic lymphadenectomy with 125I implantation for prostatic carcinoma.

Genital Neoplasms, Male↗

PubMed2003

Three-piece inflatable penile prosthesis components (surgical pearls on reservoirs, pumps, and rear-tip extenders).

Erectile dysfunction (ED) is a major quality-of-life disorder that affects greater than 30 million American men each year. Since the introduction of Viagra, more and more men are presenting with ED that is not responding to oral or local therapies. Penile prosthesis implantation is recognized as the most effective, although most invasive, ED therapy with a high satisfaction rate. With an aging population both aware of and requesting therapy for ED, the number of penile prosthesis implantations will remain stable, especially at centers specializing in ED treatment. Therefore, a better understanding of the techniques used for placement of the penile prosthesis is necessary. The following review will discuss the techniques and a few clinical pearls in the placements of inflatable penile prostheses.

Erectile Dysfunction↗