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Mentor inflatable penile prosthesis: clinical experience in 52 patients.

The Mentor inflatable penile prosthesis is manufactured from Bioflex polyurethane, a material which is less elastic and more durable than silicone. Use of this new biocompatible polymer eliminates cylinder aneurysms and wear-induced cylinder leaks. The new prosthesis also incorporates a snap-on connector system designed to eliminate connector leaks and decrease operative time. The Mentor prosthesis has been implanted in 52 patients with organic impotence. The patients have been followed up for 2 to 16 months (average 8.3), the follow-up exceeding 1 year in 15 patients. A satisfactory cosmetic and functional result was achieved in 51 cases. Infection necessitated removal of the prosthesis in one patient. There were no pump, reservoir or tubing failures. After early connector failures there were no connector failures in the subsequent 48 patients. Additional complications included an incisional hernia and a cylinder failure which resulted from a manufacturing defect. There were no failures attributable to wear or material fatigue. The inherent reliability of this new prosthesis and the excellent functional and cosmetic results it produces justify its use in any patient who is a candidate for a penile prosthesis.

Adult↗

[Penile prosthesis for the treatment of erectile dysfunction].

The erectile dysfunction is a pathology that, with different degrees of intensity, affects nearly the 20% of the spanish adult men. The treatment is usually performed in stages, reserving the penile prosthesis for when other previous treatments have failed. The aim of this work is to evaluate, according to the state of present knowledge, the effectiveness and security of the penile prosthesis for the treatment of the erectile dysfunction. With this purpose 52 articles were selected, observing a 5 years prosthesis survival of 78-91% and a 3-8% of surgical complications. Mechanical failures and infection percentages were smaller in the semi-rigid prosthesis that in the inflatable ones, with high levels of postoperative satisfaction in patients as well as in their couples, even greater than in other treatments available at the present time. The penile prosthesis implantation must be reserved for the organic erectile dysfunction when previous treatments have failed, evaluating the risk-benefit relation and informing the patient of the results that are hoped to be obtained and of the possible complications that can arise. In view of the great concern of our society with the erectile function and the availability of effective drugs, an increase in the demand of penile prosthesis implantation is predictable in those patients highly motivated, but refractory to the less invasive treatments.

Erectile Dysfunction↗

[Treatment with sildenafil of cold glands syndrome after inflatable penile prosthesis].

OBJECTIVE: To evaluate the effect of sildenafil on the response of glans penis during sexual intercourse in patients with penile prosthesis who show cold glans syndrome symptoms. MATERIAL AND METHODS: Fourteen patients who had undergone three-piece inflatable penile prosthesis implantation were evaluated. In spite of the normal functioning of the device all of them complained of a degree of dissatisfaction during SI due to a lack of engorgement in the glans penis. The patients were advised to have a dose of 100 mg VO sildenafil about 45 minutes before activating the PP and starting SI. All of them followed this scheme at least three times. They ticked questions 7, 8, 13 and 14 of the International Index of Erectile Function (IIEF) questionnaire with/without having had sildenafil. RESULTS: Twelve out of thirteen patients (85.7%) indicated a more pleasant SI on sildenafil. It was related to an increase in penile glans engorgement and sensitivity. The scores obtained in the IIEF questions showed a significant increase on taking sildenafil. The partners also talked of a more comfortable SI that they related to a less painful penetration. Sildenafil-related morbidity was not found. CONCLUSIONS: Sildenafil could be used to improve functional results of the penile prosthesis in those patients with CGS and seems to increase satisfaction during SI.

Body Temperature↗

Quantifying risk of penile prosthesis infection with elevated glycosylated hemoglobin.

PURPOSE: Elevation of glycosylated hemoglobin above levels of 11.5 mg.% has been considered a contraindication to penile prosthesis implantation in diabetic patients. We determine the predictive value of glycosylated hemoglobin A1C in penile prosthesis infections in diabetic and nondiabetic patients to confirm or deny this prevalent opinion. MATERIALS AND METHODS: We conducted a 2-year prospective study of 389 patients, including 114 diabetics, who underwent 3-piece penile prosthesis implantation. All patients had similar preoperative preparation without regard to diabetic status, control or glycosylated hemoglobin A1C level. Risk of infection was statistically analyzed for diabetics versus nondiabetics, glycosylated hemoglobin A1C values above and below 11.5 mg.%, insulin dependent versus oral medication diabetics, and fasting blood sugars above and below 180 mg.%. RESULTS: Prosthesis infections developed in 10 diabetics (8.7%) and 11 nondiabetics (4.0%). No increased infection rate was observed in diabetics with high fasting sugars or diabetics on insulin. There was no statistically significant increased infection risk with increased levels of glycosylated hemoglobin A1C among all patients or among only the diabetics. In fact, there was no meaningful difference in the median or mean level of glycosylated hemoglobin A1C in the infected and noninfected patients regardless of diabetes. CONCLUSIONS: Use of glycosylated hemoglobin A1C values to identify and exclude surgical candidates with increased risk of infections is not proved by this study. Elevation of fasting sugar or insulin dependence also does not increase risk of infection in diabetics undergoing prosthesis implantation.

Diabetes Complications↗

Quality of life following simultaneous placement of penile prosthesis with radical prostatectomy.

PURPOSE: The present study examined erectile functioning, frequency of sexual contact, psychological functioning, partner/marital satisfaction and overall quality of life (QOL) after immediate sexual rehabilitation for prostate cancer via simultaneous placement of a penile prosthesis at radical retropubic prostatectomy (RP). MATERIALS AND METHODS: Questionnaire packets were sent to and received from 51 men who had undergone simultaneous implantation of a penile prosthesis at the time of RP (PP+) and from a comparison group of 47 men who undergone RP alone (PP-) matched by age and year of surgery. Questionnaires included the Erectile Dysfunction Inventory of Treatment Satisfaction, the Depression Anxiety Stress Scales, the Dyadic Adjustment Scale and a prostate specific European Organization for the Research and Treatment of Cancer (EORTC) QOL questionnaire. Further comparisons were performed for a PP- subgroup consisting of 15 patients who had undergone nerve sparing RP. RESULTS: Higher Erectile Dysfunction Inventory of Treatment Satisfaction, EORTC Sexual Functioning, EORTC Total scores and more frequent sexual contact were reported by the PP+ group compared with the PP- group. The PP+ group also had better outcomes that approached but did not reach statistical significance compared with the nerve sparing subgroup with regard to Depression Anxiety Stress Scales and EORTC Emotional Functioning scores. CONCLUSIONS: Men who chose simultaneous placement of a penile prosthesis with RP reported greater overall QOL, erectile function and more frequent sexual contact than a comparison group of men who underwent RP alone. Placement of penile prosthesis at the time of RP may be a desirable option for men with prostate cancer in whom a nerve sparing procedure may not be ideal. These results underscore the importance of sexual function for men undergoing prostate cancer treatment.

Aged↗

The penile prosthesis: a review.

This paper reviews the literature concerning the penile prosthesis. Included are discussions of the historical development of the penile prosthesis, characteristics of patients treated with prosthetic implantation, assessment techniques utilized in patient selection, and the relative outcome and complication rates for the two major types of prostheses. Recommendations regarding future research and practice are presented throughout.

Erectile Dysfunction↗

Inguinal hernia as a rare cause of penile prosthesis malfunction . A report of two cases.

Penile prosthesis malfunction is associated with mechanical failure as well as with infection requiring removal of the prosthesis. We report on the 2 first cases in the literature of inflatable penile prostheses in the presence of inguinal hernia. We advocate early hernia repair in patients with inflatable penile prostheses to avoid malfunction related to hernia.

Adult↗

Prospective evaluation of neomycin serum concentrations after direct corpora cavernosa irrigation during penile prosthesis placement.

OBJECTIVES: To determine if toxic serum levels of neomycin are generated after direct corpora cavernosa irrigation during penile prosthesis placement. METHODS: We have used an infection prophylaxis technique that involves directly irrigating the corpora cavernosa tissue (through the corporotomy) with 0.5% neomycin solution. Serum neomycin concentrations were measured at 1 hour and 4 hours after irrigation in 13 patients undergoing penile prosthesis placement. A subset of patients who had preimplant and postimplant serum creatinine concentrations was evaluated for changes in renal function. RESULTS: The mean 1-hour postirrigation serum neomycin level was 1.2 micrograms/mL and the mean 4-hour postirrigation level was 1.2 micrograms/mL. These serum neomycin concentrations are lower than those thought to be necessary to produce nephrotoxicity or ototoxicity. Renal function was not significantly affected by the neomycin irrigation. CONCLUSIONS: Although aminoglycosides are ototoxic and neomycin has the highest nephrotoxic potential of the aminoglycosides, we conclude that direct irrigation of the corpora cavernosa with 0.5% neomycin solution does not produce significant systemic exposure to result in nephrotoxicity or ototoxicity. One-time prophylactic neomycin irrigation remains an effective, safe, and economic adjunct to penile prosthesis placement.

Creatinine↗

Bladder herniation through suprapubic incision for penile prosthesis.

To our knowledge, we present the first case of bladder herniation after insertion of an inflatable penile prosthesis. A 65-year-old man presented with a suprapubic bulge. He had his third inflatable penile prosthesis placed 1 year earlier. He had no voiding complaints but requested surgical intervention because the hernia was cosmetically undesirable. After the hernia sac was opened the majority of the bladder was found within it. The defect was repaired with Gore-Tex mesh and the reservoir replaced. One must consider bladder involvement in ventral hernias after penile prosthesis insertion, and a preoperative cystogram might assist in identifying hernia contents.

Aged↗

Penile gangrene: a complication of penile prosthesis.

A case of superficial gangrene of penis after insertion of a malleable penile prosthesis is presented. In all 4 cases previously reported in the literature, the penile prosthesis had to be removed. We managed this patient conservatively without removing the prosthesis. We suggest that in cases of superficial gangrene of penis without infection the prosthesis may not have to be removed.

Anti-Bacterial Agents↗

Development of a penile prosthesis. The Hydroflex.

The development and commercialization of a penile prosthesis is a long and involved process that is influenced by a large number of factors including the patient, surgeon, FDA, commercial viability, and competitive environment. The process is illustrated in this article by historically tracing some of the factors involved in the development of the American Medical Systems self-contained penile prosthesis, the Hydroflex. This device was introduced into unrestricted commercial distribution in May 1985.

Humans↗

The retained penile prosthesis reservoir: a risk.

Complications associated with penile prostheses include malfunction, infection, and patient dissatisfaction. We present a rare complication of a retained abdominal reservoir eroding into the bladder and causing irritative voiding symptoms several years after the removal of the penile components of a three-piece penile prosthesis.

Aged↗

[Penile prosthesis].

In this article the Authors, after describing the history of the penile prosthesis surgery and analyzing the technical progresses made in the last twenty years, offer their personal experience and data from the most recent literature about treatment of erectile dysfunction through the application af penile prosthesis, about the indications for the operation and the choice of the type of prosthesis. They also explain all the possible complications and eventual mechanical failures, which have considerably decreased in the last few years.

Erectile Dysfunction↗

Early experience with the first pre-connected 3-piece inflatable penile prosthesis: the Mentor Alpha-1.

The aim of this clinical investigation was to obtain preliminary treatment outcome data concerning the Mentor Alpha-1, the first 3-piece inflatable penile prosthesis with pre-connected tubing between the pump and the penile cylinders. The study was designed to be the first multi-institutional treatment outcome report for any clinically available penile prosthesis with data analysis to be independent of the participating surgeons. A total of 12 board-certified urologists of mixed surgical training backgrounds and practices implanted the Alpha-1 device in 112 consecutive patients. With a mean of 27 +/- 5 months of followup the surgical complication rate included a 4% mechanical malfunction, 2% infection rate and 9% reoperation rate. Patient experience with the implanted device was computed from information on 96 of the 112 patients who returned a questionnaire. Of the patients 82% stated that the device fulfilled expectations as a treatment for impotence and 83% had improved sexual intercourse by 8 weeks after implantation. Patient satisfaction was computed on a scale of 12 equally weighted interrelated variables. Of the patients 77% recorded 9 or more cumulative satisfaction points. Patient and physician questionnaire data were analyzed for their relation to the cumulative prosthesis satisfaction score. A significant difference in cumulative scores was found for physician reported long-term postoperative problems (mean satisfaction score 8.1 for patients with problems versus 10.2 for patients without problems, p = 0.018). The Alpha-1, with its feature of pre-connected tubing, is a reliable 3-piece inflatable penile prosthesis associated with a high level of patient satisfaction.

Data Collection↗

Experience with the Ultrex and Ultrex Plus inflatable penile prosthesis: new implantation techniques and surgical outcome.

The Ultrex and Ultrex Plus penile prosthesis incorporate sequential design modifications that afford important functional advantages that reduce the potential for mechanical failure. This retrospective study reviews our experience with these models emphasizing innovations in surgical technique and postoperative results. Implantation of Ultrex (31%) and Ultrex Plus (69%) penile prosthesis was performed in 90 impotent men with organic erectile dysfunction following comprehensive multi-disciplinary evaluation. During a follow-up interval of 7-50 months, postoperative outcome was assessed. Of this group, 10% underwent simultaneous explant of another malfunctioning inflatable device or conversion from a semi-rigid prosthesis due to patient preference. Of the remainder, 20% selected implant surgery as their primary therapy while 73% were initially treated with various nonsurgical options prior to implantation. In all patients we employed a single peno-scrotal incision and applied the concept of controlled radial dilatation of all compartments. In our last 32 consecutive patients including eight with previous radical pelvic surgery, we utilized the preperitoneal distention balloon (PDB) facilitating safe and non-traumatic creation of the prevesical space for reservoir insertion. Post operative complications occurred in 8% of patients including pump infection and corporal deformity requiring reimplantation with AMS 700 CX cylinders, or self-contained unitarian prosthesis as a salvage procedure. Satisfactory, functional and anatomic outcome was reported in 95% of patients. Interim advances incorporated into the Ultrex and Ultrex Plus prosthesis have markedly reduced mechanical failure during our follow-up interval of up to 50 months. Importantly, controlled, non-traumatic radial dilatation of the prevesical space by the PDB may encourage broader use of the multicomponent inflatable models, particularly in a setting of pelvic fibrosis due to previous pelvic surgery or radiation.

Adult↗

An unusual complication of penile prosthesis following urethroplasty.

We report a case of an adult who had undergone transpubic urethroplasty for a 5-cm long posterior urethral stricture. A malleable penile prosthesis (AMS 600R) was implanted 19 months later for the trauma-related impotence. The patient was discovered to develop a complete obliteration of the urethra after removal of infected penile prosthesis 18 months later. Perineal urethroplasty cured his restricture. Suggestions are made to prevent urethral restricture if penile prosthesis is required after urethroplasty.

Device Removal↗

Patient satisfaction with Mentor inflatable penile prosthesis.

Patient satisfaction with the Mentor inflatable penile prosthesis was assessed by sending a thirty-six-item questionnaire to 251 patients who had undergone implantation of the device by the senior author (D.C.M.). A total of 152 (61%) of the patients responded. Recovery time, satisfaction, reasons for dissatisfaction, perceptions of erection quality, and psychosexual parameters were evaluated. Eight-eight percent of the patients were engaging in regular sexual activity. Depending on the definition of satisfaction, 81-89 percent of the respondents reported that they were satisfied with the prosthesis. Sixty-eight percent of the survey group were satisfied with the length, width, and firmness of their prosthetic-induced erection. The majority of patients reported improvement in psychosexual functioning after implantation. Reasons for dissatisfaction included inadequate penile length, insufficient firmness, and difficulty with inflation and deflation of the penile cylinders.

Adult↗

OmniPhase penile prosthesis: delayed bilateral central cable breakage.

The OmniPhase* penile prosthesis is a new mechanically activated penile implant. The prosthesis can be alternatively flaccid and rigid depending on the tension of a supporting central cable. We report a case of delayed bilateral central cable breakage with subsequent loss of penile rigidity.

Humans↗