A multicenter study on the perineal versus penoscrotal approach for implantation of an artificial urinary sphincter: cuff size and control of male stress urinary incontinence.

PURPOSE: In a single center retrospective study we previously reported superior dry rates and fewer artificial urinary sphincter revisions when the sphincter cuff was placed via the traditional perineal approach compared with a penoscrotal approach. A multicenter study was performed to compare the approaches further and explain the disparity in outcomes. MATERIALS AND METHODS: We performed a retrospective review of 158 patients who underwent these procedures from April 1987 to October 2007 at 4 centers. RESULTS: During 184 surgeries in 158 patients 201 artificial urinary sphincter cuffs were placed (90 penoscrotal and 111 perineal). Among patients with known followup the completely dry rate for single cuff artificial urinary sphincters was 17 of 62 (27.4%) in the penoscrotal group and 41 of 93 (44.1%) in the perineal group (p = 0.04). Continued incontinence necessitated subsequent tandem cuff in 7 of the 62 (11.3%) penoscrotal cases compared to only 5 of the 93 (5.4%) perineal cases. Cuff size in the penoscrotal group was 5.0 cm in 1 patient (1.1%), 4.5 cm in 11 (12.2%) and 4.0 cm in 78 (86.7%). Cuff size in the perineal group was 5.5 cm in 1 patient (0.9%), 5.0 cm in 8 (7.2%), 4.5 cm in 30 (27.0%) and 4.0 cm in 72 (64.9%). CONCLUSIONS: There appears to be a higher completely dry rate with fewer subsequent tandem cuff additions with the perineal approach compared to the penoscrotal approach. This disparity may be explained by a more proximal artificial urinary sphincter cuff placement in the perineal group as evidenced by a larger cuff size.

Centers of excellence concept and penile prostheses: an outcome analysis.

PURPOSE: Outcome analysis has shown that the center of excellence concept, in which all of a specific type of surgery is done by 1 surgeon rather than by multiple surgeons in a group, provides superior outcomes for total joint replacement, radical cancer and heart valve surgery. We compared penile prosthesis implantation outcomes between the center of excellence and multiple surgeon approaches in a large, single specialty urological surgical practice. MATERIALS AND METHODS: Between February 2001 and August 2004 a total of 57 penile prostheses were implanted by 10 surgeons at a large urology practice (multiple surgeon group). Between July 2004 and April 2005 a total of 57 penile prostheses were placed by a single surgeon (center of excellence group). Chart review of the 2 patient groups was performed. RESULTS: The patient groups showed no statistical differences in age, race, cause of impotence or percent with diabetes. The median cylinder length of prostheses placed by the center of excellence surgeon was 2 cm greater than the length of the cylinders placed by the multiple surgeon team (p <0.0001). Excluding cases requiring additional procedures the median placement time was considerably shorter for the center of excellence surgeon than for the multiple surgeon team (34 vs 94 minutes, p <0.0001). There were 8 iatrogenic failures (infection, erosion and poor positioning) requiring surgical removal in the multiple surgeon group but none in the COE group (p <0.05). Although followup for the multiple surgeon team was longer, Kaplan-Meier revision-free survival curves showed significantly longer survival for the center of excellence group (log rank test p = 0.0283). CONCLUSIONS: The center of excellence concept in penile prosthesis surgery appears to deliver superior surgical outcomes in terms of shorter operative time, longer cylinders and fewer iatrogenic complications.

Perineal approach for artificial urinary sphincter implantation appears to control male stress incontinence better than the transscrotal approach.

PURPOSE: Traditionally cuff placement of an artificial urinary sphincter is done through a perineal approach. A new approach through a penoscrotal incision or transscrotal approach is reportedly more rapid and easier than the traditional incision. These 2 approaches were evaluated to determine which one controlled male stress urinary incontinence better. MATERIALS AND METHODS: We performed a retrospective chart review of 94 patients who underwent artificial urinary sphincter placement procedures from April 1987 to March 2004. RESULTS: A total of 126 artificial urinary sphincter cuffs (120 procedures, including double cuff placement in 6) were placed in 94 patients with 63 placed penoscrotally and 63 placed perineally. Of the double cuff placements 1 was perineal and 5 were transscrotal. In patients with a single initial or revision cuff the self-reported completely dry rate was 28.6% with the penoscrotal approach and 56.5% with the perineal approach (p = 0.01), while for initial cuffs only the dry rate was 28.0% and 56.7% for the penoscrotal and perineal approach, respectively (p = 0.03). Five of 28 patients (17.9%) with initial penoscrotal placement later underwent tandem cuff placement for continued incontinence, whereas only 1 of 32 (3.1%) with initial perineal placement later had a tandem cuff added (p = 0.06). There was no difference in the estimated failure-free survival (failure for any reason) of the device. CONCLUSIONS: When the artificial urinary sphincter cuff is placed through a perineal approach, there appears to be a higher completely dry rate and fewer subsequent tandem cuff additions than when the artificial urinary sphincter cuff is placed through a penoscrotal incision.

Revision washout decreases implant capsule tissue culture positivity: a multicenter study.

PURPOSE: Positive cultures, visible biofilm and confocal micrography confirm bacterial presence on clinically uninfected inflatable penile prostheses at revision surgery. Salvage irrigation has been proved to rescue patients with clinically infected inflatable penile prostheses. Similar washout at revision for noninfectious reasons significantly lowers subsequent infection rates. We investigated a larger series of patients for positive culture rates and evaluated implant capsule tissue culture rates before and after revision washout. MATERIALS AND METHODS: At 4 institutions a total of 148 patients with inflatable penile prostheses underwent revision surgery for noninfectious reasons between June 2001 and September 2005. Swab cultures of the fluid around the pump and visible biofilm were obtained. Also, in 65 patients a wedge of tissue from the capsule that forms around the pump was cultured. After implant removal revision washout of the implant spaces was performed and a second wedge of tissue was cultured. RESULTS: Of the 148 patients 97 (66%) had positive bacterial swab cultures of the fluid around the pump or biofilm. A total of 124 isolates were cultured. Of the 65 implant capsule tissue cultures obtained before washout 28 (43%) were positive for bacteria, while 16 (25%) obtained after revision washout were positive. CONCLUSIONS: Positive cultures and visible bacterial biofilm are present on clinically uninfected inflatable penile prostheses at revision surgery in most patients. Revision washout appears to decrease the bacterial load on implant capsule tissue at revision surgery of inflatable penile prostheses for noninfectious reasons.

Biofilm formation on clinically noninfected penile prostheses.

PURPOSE: Biofilms are matrix enclosed bacterial populations that adhere to each other and/or to surfaces of implanted medical devices. Biofilm formation has consistently been demonstrated in association with infected penile prosthetic material. Clinically noninfected patients undergoing revision for mechanical malfunction have a surprisingly high rate of positive intraoperative cultures. After revision replacement prostheses have a higher rate of postoperative infection than first time implants. We characterized biofilm formation on penile prostheses in clinically noninfected patients undergoing revision surgery. MATERIALS AND METHODS: Ten patients undergoing revision or removal of inflatable penile prosthetic devices due to mechanical malfunction were included. Specimens from the corporeal cylinders, scrotal pump and reservoir were analyzed. Bacterial biofilm coverage was detected and characterized using confocal scanning laser microscopy. RESULTS: Bacterial biofilm formation associated with multiple microorganisms was demonstrated on 8 of 10 prostheses. Biofilms consisted of gram-positive rods, cocci and fungal elements. CONCLUSIONS: The degree of biofilm formation on these prosthetic devices suggests that most patients have bacterial coverage on the implant. Host mechanisms to control infection may lead to a homeostatic balance that enables biofilms to exist on the surface of the prosthesis without generating clinical infection. A critical threshold of biofilm extent may exist beyond which clinical infection may occur. These results justify further evaluation of biofilms and penile prosthesis infections. Furthermore, the findings help to explain why strategies such as mini salvage procedures to eliminate subclinical biofilms may decrease the postoperative infection risk in patients undergoing repair or replacement of penile prostheses.

Birth defects in Arkansas: is folic acid fortification making a difference?

BACKGROUND: Since 1998, fortification of grain products with folic acid has been mandated in the United States, in an effort to reduce the prevalence of neural tube defects (NTDs). Published reports have shown a reduction in the prevalence of spina bifida since fortification was mandated, but no published studies have reported a reduction in birth defects, other than NTDs, that are postulated to be associated with folic acid deficiency. This study was performed to determine if fortification has reduced the prevalence of NTDs and other birth defects in Arkansas. METHODS: Using data from the Arkansas Reproductive Health Monitoring System, prevalences were computed for thirteen specific birth defects with prior evidence supporting a protective effect of folic acid or multivitamins. Prevalences were calculated using data for live births to Arkansas residents for 1993-2000. Exposure to folic acid fortification was classified by birth year as "pre-fortification" (1993-1995), "transition" (1996-1998) or "post-fortification" (1999-2000). Logistic regression analysis was used to compute crude and adjusted prevalence odds ratios comparing the identified time periods. RESULTS: Prevalences decreased between the pre- and post-fortification periods for spina bifida, orofacial clefts, limb reduction defects, omphalocele, and Down syndrome, but only the decrease in spina bifida was statistically significant (prevalence odds ratio 0.56; 95% confidence interval, 0.37, 0.83). CONCLUSION: In Arkansas, the prevalence of spina bifida has decreased since folic acid fortification of foods was implemented. Similar studies by other birth defects surveillance systems are needed to confirm a preventive effect of fortification for malformations other than spina bifida.

Regional bias in birth defect prevalence rates for Arkansas: influence of incomplete ascertainment along surveillance system borders.

BACKGROUND: As part of the continuing evaluation of the Arkansas Reproductive Health Monitoring System (ARHMS), we assessed the effects on birth defect prevalence rates introduced by incomplete case ascertainment along surveillance boundaries. METHODS: Using data from ARHMS and Arkansas Vital Statistics for 1993-1998, we determined birth defect prevalence rates (per 10,000 live births), stratified by race, among three geographic comparison groups of counties. These included: (1) the Northeast Group, near the state border at Memphis, Tennessee; (2) the Central Group, surrounding Little Rock, Arkansas; and (3) the Southwest Group, near Texarkana, Texas. These counties have similar socioeconomic measures and proximity to health care facilities, but are differentiated by limitations imposed by ARHMS' surveillance borders. Maternal age-standardized rates from the control groups were used to impute expected rates, for the Northeast Group and statewide, which were compared with reported rates. RESULTS: We found that there were 620 fewer reported birth defect cases than expected for the Northeast Group. The Northeast Group's prevalence rates were approximately half of the control groups' rates (310.6 vs. 529.8, respectively, for Whites, and 240.8 vs. 550.1, respectively, for African-Americans). Incorporating the missed cases into statewide prevalence calculations could increase prevalence rates from 502.6 to 523.2 for Whites and from 527.4 to 590.7 for African-Americans. CONCLUSIONS: This study identified significant regional differences in reported birth defect rates in Arkansas. Case ascertainment might be incomplete in other surveillance systems lacking the means to share data with neighboring systems. Regional inaccuracy can hinder evaluation of localized birth defect trends or targeted prevention efforts.