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.

Ectopic placement of AMS 800 urinary control system pressure-regulating balloon.

OBJECTIVES: The AMS 800 sphincter urinary control system (artificial urinary sphincter) is frequently placed in patients with scarred retroperitoneal spaces. Placement of the pressure-regulating balloon (PRB) requires a second abdominal incision in the traditional perineal surgical technique. In the new transverse scrotal incision method of sphincter placement, the transversalis fascia is pierced to place the PRB in the space of Retzius. We present a novel technique of ectopic PRB placement requiring neither a second incision nor piercing the fascia. TECHNICAL CONSIDERATIONS: Nineteen patients underwent ectopic PRB placement during artificial urinary sphincter placement. Most patients (n = 17) were incontinent after radical prostatectomy, two were incontinent after transurethral resection of the prostate. Cuff placement was through a scrotal (n = 10) or perineal (n = 9) incision. In all patients, the incision was displaced toward either inguinal ring. A finger was passed through the ring forcibly cephalad and a space developed anterior to the transversalis fascia but beneath the abdominal muscles. The PRB was passed into this space. CONCLUSIONS: The results of our study have shown that ectopic placement is easier and quicker. The PRB is usually not palpable. Two PRB hernias into the upper scrotum were noted after vigorous coughing. Two patients developed urethral atrophy under the cuff at 3 and 5.5 years. No erosions, infections, or mechanical failures were noted. Early outcomes with ectopic PRB placement seemed similar to that of traditional locations.

Treating symptoms of female sexual arousal disorder with the Eros-Clitoral Therapy Device.

OBJECTIVE: The aim of this study was to determine the effect of the Eros-Clitoral Therapy Device (Eros-CTD) on the sexual function of women with and without symptoms of female sexual arousal disorder (FSAD). DESIGN: Periodic survey of sexual function in women using the Eros-CTD over a six-week period. SUBJECTS: A total of 19 women participated in the study--10 with symptoms of FSAD and nine without symptoms of FSAD--ranging in age from 28 to 65 years, with a mean age of 45.2 years. METHODS: Ten patients with symptoms of FSAD and 10 without symptoms were instructed in the use of the small, portable vacuum device, Eros-CTD. One woman without symptoms of FSAD withdrew early in the study for personal reasons. The patients were instructed in the correct use of the device and were asked to complete one Female Intervention Efficacy Index (FIEI) each week. The patients also kept diaries of their use of the device, noting the frequency, length, and strength of vacuum. RESULTS: There was a significant improvement in all symptoms of FSAD (P < .05), including increased sensation, improved vaginal lubrication, enhanced ability to orgasm, and greater overall satisfaction. Patients without FSAD also reported similar changes in sensation, lubrication, ability to orgasm, and overall satisfaction. LIMITATIONS: This study was done on a small sample of self-selected patients, was of limited duration, and had no long-term follow-up. All of these factors should be considered in interpreting the data. CONCLUSION: The Eros-CTD was safe and effective in improving symptoms of FSAD in this group of women. Further studies on the efficacy of the Eros-CTD are indicated.

Long-term followup of treatment for Peyronie's disease: modeling the penis over an inflatable penile prosthesis.

PURPOSE: We originally reported inflatable penile implants used to treat impotence in patients with Peyronie's disease in 1993. We now present a historical prospective study of 104 patients in whom the modeling procedure was used to correct Peyronie's curvature after implantation with the Mentor Alpha 1dagger and AMS 700CXdouble dagger penile prostheses. We compared revision-free survival experience of these implants with 905 similar implants in men with nonPeyronie's disease. MATERIALS AND METHODS: The reasons for revision were classified as mechanical failure, patient dissatisfaction, infection and medical causes, including reoperation for straightening. Overall and cause specific revision-free survival in the 2 study cohorts was compared. Maximum followup was more than 12 years and average followup was more than 5. RESULTS: No significant difference in device survival was observed in the 2 study cohorts in 5 years. Similarly each prosthesis provided the same permanent straightening without the need for revision. In Peyronie's disease cases mechanical survival of the Mentor Alpha 1 was superior to that of the AMS 700CX (p = 0.0270). There was no significant difference in mechanical reliability of the devices in nonPeyronie's disease cases. CONCLUSIONS: Implantation and modeling appear to provide permanent straightening without an increase in revisions. In the nonmodeled group there was no significant difference in mechanical reliability of the AMS 700CX or Mentor Alpha 1. In modeled cases the Mentor Alpha 1 appeared less likely to fail mechanically than the AMS 700CX when followed more than 5 years. Based on this single series modeling may predispose the AMS 700CX to earlier mechanical failure.

Reservoir herniation as a complication of three-piece penile prosthesis insertion.

OBJECTIVES: To obtain data concerning the incidence and management of reservoir herniation in inflatable penile prosthesis surgery in a clinical investigation. Reservoir herniation after scrotal placement of inflatable penile prosthesis is an unusual complication, and a review of the published medical reports reveals only anecdotal reports and no definitive articles. METHODS: A multi-item self-addressed questionnaire was mailed to the members of the Society for the Study of Impotence questioning the occurrence of reservoir migration from the prevesical space to the inguinal canal or scrotum. In addition, the database of one of us was reviewed to determine the incidence of reservoir migration in a large series of 1206 three-piece penile prostheses. RESULTS: The response rate was 38%. A minority of respondents (28%) were familiar with the problem. Of those who had experienced this complication, the occurrence was very rare and usually appeared in the immediate postoperative period, often in association with vigorous coughing spells or vomiting. The responders also indicated that imperfect surgical technique might have been implicated in some cases. Management usually consisted of reservoir replacement or repositioning through an inguinal incision with repair of the defect. Alternatively, several surgeons used the existing scrotal incision if the patient presented in the immediate postoperative period. The incidence of reservoir herniation was 0.7%. CONCLUSIONS: Reservoir herniation is a rare complication of inflatable penile prosthesis surgery that occurs almost exclusively in penoscrotally placed prostheses. Familiarity with various approaches to the management of this complication is clinically useful to urologists performing penile prosthesis surgery.

Historical advances in penile prostheses.

In the 25 y since their introduction, semi-rigid and inflatable penile implants have become remarkably dependable mechanical instruments associated with high patient satisfaction. This report attempts to quantify the historical milestones of significance pertaining to these devices. As with any historical 'best of ' list, there will be controversy and omissions. Three broad topics contributing to the advancement of penile prosthetic surgery, devices and techniques are discussed: (1) Prosthetic design changes contributing to freedom from revision: distention controlled cylinders, Bioflex cylinders, connectionless systems and reservoir lockout valves; (2) Instrument innovations to facilitate prosthetic surgery: Scott retractor, Furlow inserter, Brooks dilators, Carrion-Rossello cavernotomes; (3) Clever surgical applications: SST repair, transverse scrotal incision, modeling for Peyronie's disease, salvage for infection and natural tissue repair. International Journal of Impotence Research (2000) 12, Suppl 4, S101-S107.

Implantation of inflatable penile prosthesis in patients with severe corporeal fibrosis: introduction of a new penile cavernotome.

PURPOSE: Implantation of penile prosthetic cylinders into scarred corpora remains a challenge in the field of prosthetic urology. We describe a new penile cavernotome, which allows for easier dilation of fibrotic corpora cavernosa and facilitates inflatable penile prosthesis cylinder insertion. MATERIALS AND METHODS: A set of 5 cavernotomes between 6 and 13 mm. in diameter are used to drill a space in fibrotic corpora with controlled 1 mm. cuts. The cavernotomes are advanced in an oscillating fashion and also allow shaving of severely stenotic areas for easier cavity development. They were used in 16 patients with fibrotic corpora secondary to different etiologies. A high transverse scrotal incision was used in all cases. Of the 16 patients 14 received downsized cylinders. RESULTS: Implantation of both cylinders of an inflatable 3-piece device was successful in all cases. Proximal crural perforation occurred intraoperatively in 5 patients and was corrected by attaching the rear tip extender to the tunica with nonabsorbable suture. Postoperatively, distal tunical perforation of the corpora in 4 patients was repaired with natural tissue. Operative time was reduced compared to our previous experience with implantation in cases of corporeal fibrosis using extensive corporotomies or the Carrion-Rossello cavernotomes. In no case was the procedure terminated for urethral laceration or inadequate dilation for cylinder insertion. No grafting materials were necessary to close the corporotomy. CONCLUSIONS: The new cavernotomes along with the high transverse scrotal incision and downsized prostheses resulted in successful implantation in all of our cases. Dilation of fibrotic corpora was easier and quicker with the new cavernotomes because extensive corporeal resection was not necessary. Complications were acceptable for these difficult cases and prosthesis survival is 100% to date.

Comparison of mechanical reliability of original and enhanced Mentor Alpha I penile prosthesis.

PURPOSE: We report the results of a prospective study of 1,381 Mentor Alpha I penile prostheses implanted to treat impotence, and compare original and enhanced penile prosthesis mechanical reliability. MATERIALS AND METHODS: The study consisted of 410 original models manufactured before November 1992 and 971 enhanced models manufactured since December 1992. Implants were further stratified as first time (virgin) or replacements of a previous implant. Mechanical failure-free survival rates for the original prosthetic and enhanced models were compared. RESULTS: The 5-year survival rate increased from 75.3% for the original to 92.6% for the enhanced model overall (log rank p<0.0001), and from 75.3 to 93.6%, respectively, for the virgin implants only (log rank p<0.0001). The estimated failure rate of approximately 5.6% for the original model was fairly consistent during followup, while the significantly lower failure rate of 1.3% for the enhanced model was not. The failure rate of the enhanced model implants was about 0.8% per year during the first 3.5 years and increased to approximately 3.1% per year thereafter. CONCLUSIONS: Our results strongly support the premise that mechanical reliability is superior with the enhanced compared to the original model.

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.

Long-term results with Hydroflex and Dynaflex penile prostheses: device survival comparison to multicomponent inflatables.

PURPOSE: We compared our experience with self-contained inflatable and multicomponent prostheses during similar intervals. MATERIALS AND METHODS: We followed 295 patients with self-contained prostheses and 1,026 with multicomponent inflatable devices for up to 8 years. Revision rates for mechanical failure, infection or patient dissatisfaction were statistically analyzed. RESULTS: Multicomponent inflatable prostheses were superior with regard to mechanical reliability and patient satisfaction, with no differences in rate of infection. Self-contained prostheses were best replaced with the AMS 700CX device, thus avoiding aneurysm. CONCLUSIONS: Self-contained inflatable prostheses may be of limited value for the treatment of impotence. The AMS 700CX is the device of choice for replacement of explanted self-contained prostheses.

Prevention and treatment of complications of inflatable penile prosthesis surgery: a review article.

Over the last 16 years more than 3,000 procedures involving multi-component inflatable penile prosthesis have been performed. A variety of types of complications have been encountered, including mechanical problems with the prosthesis, intraoperative complications, postoperative complications, problems with infection and patient dissatisfaction. During the course of this experience we have made some observations and developed techniques to minimize and treat the complications seen with both routine and difficult inflatable penile prosthesis implantation surgery.

Ultrex cylinders: problems with uncontrolled lengthening (the S-shaped deformity).

PURPOSE: We investigated whether the AMS Ultrex cylinder, developed to provide cylinder lengthening while controlling girth expansion, acted as a tissue expander and, thus, promoted penile lengthening. MATERIALS AND METHODS: Between December 1990 and January 1992, 59 AMS Ultrex prostheses were implanted. Cylinder length corresponded to intracorporeal measurements. The results of lengthening and occurrence of an S-shaped deformity were statistically analyzed. RESULTS: No penile lengthening occurred. In 19 patients (32%) cylinder replacement was required for the S-shaped deformity. CONCLUSIONS: Ultrex cylinders should be downsized and prolonged inflation should be avoided. They should not be implanted in cases of Peyronie's disease, or to replace malleable or self-contained inflatable implants.

A personal approach to the management of the complications of penile implant surgery.

Over the last 16 years more than 3000 procedures involving multi-component inflatable penile prostheses have been performed. A variety of types of complications have been encountered, including mechanical problems with the prostheses, intraoperative complications, postoperative complications, problems with infection and patient dissatisfaction. During the course of this experience we have made some observations and developed techniques to minimize and treat the complications seen with both routine and difficult inflatable penile prosthesis implantation surgery.

Inflatable penile implant infection: predisposing factors and treatment suggestions.

A retrospective review of 1,337 consecutive inflatable prosthesis implantations was done to detect predisposing factors for infection. Operations were performed by the same team during a 7-year period. Of the procedures 823 were primary implantations, while the remaining 514 were either revisions (mechanical failure, iatrogenic causes or patient dissatisfaction), salvage operations or removals for infection. The etiology of impotence as a predisposition for infection in primary implantations was significant for spinal cord injury (9% of the cases) and steroid use (50%). Diabetes had a statistically insignificant 3% risk of infection, with all other causes having a 1% infection rate. A total of 428 revisions was performed with an overall infection rate of 10%. Rates of infection ranged from 8% in nondiabetics to 18% in diabetics requiring revision. Staphylococcus species were the most commonly cultured organisms. Salvage operations (29 cases) of several types were attempted for infected prostheses. Our results with salvage were poor and we currently routinely remove the entire prosthesis for infection except in cases of urethral erosion of 1 cylinder.

A new treatment for Peyronie's disease: modeling the penis over an inflatable penile prosthesis.

We treated 138 patients with severe Peyronie's disease by insertion of an inflatable penile prosthesis and manual modeling of the erect penis. This novel technique was successful in 118 patients (86%) in achieving a straight, rigid erection. In 11 patients (8%) penile modeling did not result in satisfactory straightening and relaxing plaque incisions were performed. Complications of penile modeling included urethral perforation in 4 patients (3%). Infection of the prosthesis occurred postoperatively in 4 patients (3%). At a mean followup of 32 months (range 9 to 84) 124 patients (90%) were actually using the penile prostheses and none reported penile shortening or impairment of glandular sensation. We suggest that penile modeling over an inflatable penile prosthesis is an important new technique for the patient with severe Peyronie's disease.