Patient Satisfaction After Dual Implantation of Inflatable Penile and Artificial Urinary Sphincter Prostheses

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Patient Satisfaction After Dual Implantation of Inflatable Penile and Artificial Urinary Sphincter Prostheses
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  Reconstructive Urology Patient Satisfaction After Dual Implantationof Inflatable Penile and Artificial UrinarySphincter Prostheses John G. Mancini, William S. Kizer, LeRoy A. Jones, Rafael V. Mora, and Allen F. Morey OBJECTIVES Since description of the transverse scrotal approach for artificial urinary sphincter (AUS)placement, simultaneous implantation of an inflatable penile prosthesis (IPP) and AUS througha single incision has been shown to constitute safe, efficient, and cost-effective treatment for menplagued by both erectile dysfunction and urinary incontinence. We present patient satisfactionoutcomes after simultaneous dual implantation (DI) of an IPP and AUS. METHODS We compared outcomes of postprostatectomy patients who underwent DI to those receiving IPPor AUS alone from 2001 to 2006. Telephone interviews using a standard questionnaire wereconducted to evaluate prosthetic functionality, ease of use, and patient satisfaction. RESULTS A total of 95 men were evaluated (31 for IPP alone, 31 for AUS alone, and 33 for DI). Daily padusage decreased from 4.6 to 0.8 pads per day with AUS alone and 6.1 to 1.3 pads per day withDI. Patients were similarly satisfied with IPP rigidity during inflation and flaccidity duringinactivation in both IPP and DI groups (4.1 to 4.4 for rigidity and 3.9 for flaccidity [1  “unhappy” and 5   “happy”]). Ease of scrotal pump operation was similar in all groups, as wasoverall prosthetic satisfaction. Most patients stated that they would recommend the DI procedureto a friend or relative (87% to 94%) or have the procedure done again (77% to 94%). CONCLUSIONS Dual implantation produces encouraging outcomes in patient satisfaction, ease of use and function-ality that are similar to those found after placement of either IPP or AUS alone. UROLOGY 71:893– 896, 2008. © 2008 Elsevier Inc. W hereas urinary incontinence and erectile dys-function remain challenging problems afterradical prostatectomy, an even greater di-lemma is the management of men suffering from both of these problems. Since Wilson et al. introduced transscro-tal placement of an artificial urinary sphincter (AUS) in2003, 1 dual implantation of an inflatable penile prosthe-sis (IPP) and AUS has been shown to constitute a safeand efficient method to treat both morbidities through asingle incision. Although numerous reports have docu-mented the safety, efficacy and patient satisfaction of theIPP and AUS, individually, 2– 6 there are few data in theliterature reviewing outcomes of dual implantation.Kendirci et al. reported safety and efficacy with dualimplantation (DI) in 22 men at a mean follow-up of 17months comparable to single implantation. 7 Sellers et al. showed DI to achieve a 24.7% reduction in operativetime and cost savings of approximately $7000 comparedwith individual implantation of each device. 8  To date,there have been no reports of patient satisfaction afterdual implantation. We sought to evaluate whether dualimplantation was associated with patient satisfaction lev-els equivalent to those reported by men having single IPPor AUS implants. PATIENTS AND METHODS A total of 119 postprostatectomy patients were identified by acomputerized database search to identify men who had under-gone either transscrotal placement of an AUS, IPP, or synchro-nous transscrotal placement of both (DI) for incontinenceand/or impotence (AMS 800 AUS and AMS 700CX IPP;American Medical Systems, Minnetonka, Minn). Men havingprosthetic devices implanted for other etiologies were excludedfrom this study.All procedures were performed by two staff surgeons ateither Brooke Army Medical Center, Audie Murphy Veter-a n s Administration Hospital or Urology San Antonio from2001 to 2006. All surgeries, except for two DI revisions, wereinitial operations and were performed completely via a singleupper transverse scrotal incision. A detailed description of theprocedure, to include preoperative preparation, patient posi-tioning, surgical technique, and postoperative care has recentlybeen published. 8 L.A. Jones is a paid consultant and study investigator partially funded by AMS. A.F.Morey is a proctor for AMS.From the Urology Service, Brooke Army Medical Center, San Antonio, TexasReprint requests: Allen F. Morey, M.D., Department of Urology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9110. E-mail: allen.morey@utsouthwestern.eduSubmitted: April 21, 2007, accepted (with revisions): October 18, 2007 © 2008 Elsevier Inc. 0090-4295/08/$34.00 893 All Rights Reserved doi:10.1016/j.urology.2007.10.018  Under an institutional review board approved protocol, weattempted to contact all 119 patients by telephone, and inter-views were conducted by a single, uninvolved investigator whoasked the patients to complete a survey from a standardizedquestionnaire that focused on device functionality, ease of use,and overall satisfaction. Those who did complete the surveywere divided into three groups (DI, AUS alone, and IPP alone).Data comparing these three groups were analyzed with theWilcoxon rank sum test, Fisher’s exact test, Chi-square test, andtwo-sample  t -test. RESULTS Of the initial 119 patients, 18 could not be contacted, 5did not wish to be included in the study, and 1 wasdeceased. The 95 men who completed the survey com-prised three groups: DI (n  33), AUS alone (n  31),and IPP alone (n  31). The mean age and postoperativefollow-up time was similar at 67.8, 72.3, and 66.0 yearsand 21.6, 18.9, and 32.0 months, respectively. PenileProsthesisOutcomes We evaluated penile prosthetic function by comparingpatient responses between those treated with DI versusIPP placement alone (Table 1). The ease of IPP opera-tion was identical between groups (4.2 on a 5-pointscale). Both groups were similarly happy with rigidityduring inflation (4.4 for DI and 4.1 for IPP alone) andflaccidity during deactivation (3.9 for each group).In the DI group, 32 patients (97.0%) said that the IPPwas rigid enough for intercourse, compared with 27 pa-tients (87.1%) in the IPP-alone group. Each of the 33patients who underwent DI currently has a functioningprosthesis, although 3 (9.1%) required additional surgeryto revise their devices. In the IPP-alone group, 1 patient(3.3%) had revisional surgery and 1 patient (3.3%) re-quired device removal. Patients in both groups reportedpain associated with their prosthesis to be minimal (1.4and 1.6 on a 5-point scale). The overall satisfactionrating of the IPP for DI patients was 4.2, with 31 (94.0%)saying they would have the surgery performed again andwould recommend the surgery to a friend or relative. Inthe IPP-alone group, overall satisfaction was slightly less(4.0), with 24 (77.4%) saying they would have the sur-gery again and 27 (87.1%) saying they would recommendthe surgery to a friend or relative. ArtificialUrinarySphincterOutcomes We compared patient responses relating to the AUSbetween those treated with DI versus AUS placementalone (Table 2). The device was similarly easy to use in both the DI and AUS-alone groups (4.6 and 4.4, respec-tively). In the DI group, patients used a mean of 6.1 padsper day preoperatively and improved to 1.3 pads per dayafter surgery (76% reduction). With social continencedefined as 0 to 1 pad per day, 4 24 patients (72.7%) in theDI group achieved social continence, whereas 31 patients Table1.  Inflatable penile prosthesis (IPP) functionQuestion and Description DI IPP Alone  P  -ValueMean ease of IPP operation (1  “difficult”, 5  “easy”) 4.2 4.2 0.761Rigid enough for intercourse (n) 97.0% (32) 87.1% (27) 0.190Mean rigidity score (1  “not happy”, 5  “happy”) 4.4 4.1 0.383Mean flaccidity score when deflated (1  “poor”, 5  “excellent”) 3.9 3.9 0.877Patients reporting autoinflation (n) 33.3% (11) 48.4% (15) 0.220Revised (n) 9.1% (3) 3.3% (1) 0.614Removed (n) 0% (0) 3.3% (1) 0.484Mean pain score (1  “no pain”, 5  “severe pain”) 1.4 1.6 0.733Mean overall satisfaction (1  “unhappy”, 5  “happy”) 4.2 4.0 0.456Would recommend to friend or relative (n) 94.0% (31) 87.1% (27) 0.419Would do again (n) 94.0% (31) 77.4% (24) 0.078 DI  dual implantation. Table2.  Artificial urinary sphincter (AUS) functionQuestion and Description DI AUS Alone  P  -ValueMean preoperative pads/day 6.1 4.6 0.052Mean postoperative pads/day 1.3 0.8 0.191Reduction in pads/day 76% 77% 0.921Socially continent (  1 pad/day) 72.7% 87.1% 0.153Improvement in continence 93.9% 93.5% 1.000Mean ease of AUS operation (1  “difficult”, 5  “easy”) 4.6 4.4 0.159Revised (n) 18.2% (6) 12.9% (4) 0.734Removed (n) 3.2% (1) 3.2% (1) 1.000Mean pain score (1  “no pain”, 5  “severe pain”) 1.4 1.3 0.315Mean overall satisfaction (1  “unhappy”, 5  “happy”) 4.4 4.4 0.391Would recommend to friend or relative (n) 94.0% (31) 94.0% (29) 1.000Would do again (n) 94.0% (31) 94.0% (29) 1.000 Abbreviation as in Table 1. 894  UROLOGY 71 (5), 2008  (93.9%) showed overall improvement in continence. Inthe AUS-alone group, patients used a mean of 4.6 padsper day preoperatively and improved to 0.8 pads per daypostoperatively (77% reduction). Social continence wasachieved by 27 patients (87.1%) and 29 patients (93.5%)showed overall improvement in continence.One patient in each group required device removal,whereas 6 (18.2%) in the DI group and 4 (12.9%) in theAUS-alone group required revision surgery. In most re-visional cases, urethral cuff replacement proximally wasperformed owing to recurrent incontinence resultingfrom subcuff atrophy.Pain associated with the AUS was minimal in eachgroup (1.4 and 1.3, respectively). The overall satisfactionrating was 4.4 in both groups, whereas 31 patients(94.0%) in the DI group and 29 patients (94.0%) in theAUS-alone group said that they would have the surgeryperformed again and would recommend it to a friend orrelative. DISCUSSION In the vast majority, dual implantation of an IPP and anAUS effectively relieves both impotence and inconti-nence post–radical prostatectomy. Theoretical concernsof patient confusion and difficulty of use with two scrotalpumping devices do not appear to be substantiated by ourexperience.Previous studies evaluating patients with postprostate-ctomy incontinence after AUS placement via a tradi-tional, two-incision approach have shown total conti-nence rates of 20% to 81% and social continence rates of 61% to 96%. 4,5 Although variability exists in the defini-tion of social continence (some report dryness as 2 padsor fewer per day), the most consistently used definition isless than or equal to 1 pad per day. 4,9 Our social conti-nence rates (72.7% DI; 87.1% AUS alone) after AUSplacement through a single, transscrotal incision com-pares similarly to these results.The difference in our social continence rates betweenthose treated by DI and AUS alone (72.7% versus87.1%) requires additional investigation. Preoperativedaily pad usage was greater in the DI group comparedwith the AUS-alone group (6.1 versus 4.6 pads per day,respectively;  P  0.052). One explanation may relate tothe prostatectomy technique: Those eventually requiringtreatment for both incontinence and impotence (DIgroup) may have had a more significant cancer burden,wider local excision, and/or less nerve and bladder necksparing than those requiring treatment for incontinencealone. Nevertheless, reduction in pad use was nearlyidentical in both groups (76% versus 77%,  P    0.921),thus highlighting the success of the AUS regardless of moderate or severe levels of incontinence.In the largest series of secondary AUS implantations todate, Raj  et al.  identified urethral subcuff atrophy as themost common cause of AUS failures in 66 of 119 pa-tients. 10 Whether AUS placement is done through asingle- or dual-incision approach, we agree that urethralsubcuff atrophy is the most common cause of nonme-chanical AUS failures. This may occur years after cuff placement, and this risk is lessened with proximal bulbarplacement, where a more thick and robust spongiosumalleviates this complication.Early experience by Wilson  et al.  with a transscrotalapproach during salvage cases after perineal AUS place-ment suggests that it is possible to achieve the sameproximal bulbous cuff  placement as done with the srci-nal perineal approach. 1 We noted a learning curve withthis procedure, because most of our failures occurred earlyin our experience when proximal bulbar cuff placementwas not emphasized. We now expend additional effortto place the cuff as proximally as possible, but furtherlong-term outcomes with the transscrotal approach areneeded.Because urinary incontinence and erectile dysfunctionare important quality of life issues, it can be argued thatpatient satisfaction and opinion may be the most impor-tant measures of treatment success. Our patients’ satis-faction results were favorable in all three groups and wereconsistent with the high degree of  patient satisfactionthat has been shown in other reports. 2–6 Patients treatedwith IPP alone reported less overall satisfaction thanAUS alone or DI patients, and were less willing torecommend the surgery to a friend or relative or have theprocedure performed again. A likely explanation is thaturinary continence may be more bothersome than impo-tence for most men, which, when surgically relieved,provides greater satisfaction. CONCLUSIONS Dual prosthetic implantation is appropriate treatment formen bothered by both refractory impotence and urinaryincontinence after prostatectomy. Patients should becarefully questioned preoperatively so that synchronousimplantation may be offered initially when indicated,thus preventing the additional time, pain, cost, and riskof secondary procedures. Acknowledgment.  To Jim Wan for statistical assistance. References 1. Wilson SK, Delk JR II, Henry JR,  et al:  New surgical technique forsphincter urinary control system using upper transverse scrotalincision. J Urol  169:  261–264, 2003.2. Carson CC, Mulcahy JJ, Govier FE,  et al:  Efficacy, safety andpatient satisfaction outcomes of the AMS 700CX Inflatable PenileProsthesis: results of a long-term multicenter study. J Urol  164: 376–380, 2000.3. Govier FE, Gibbons RP, Correa RJ,  et al:  Mechanical reliability,surgical complications, and patient and partner satisfaction of themodern three-piece inflatable penile prosthesis. Urology  52:  282–286, 1998.4. Hussain M, Greenwell TJ, Venn SN,  et al:  The current role of theartificial urinary sphincter in the treatment of urinary inconti-nence. J Urol  174:  418–424, 2005. UROLOGY 71 (5), 2008 895  5. Gousse AE, Madjar S, Lambert M,  et al:  Artificial urinary sphincterfor post-radical prostatectomy urinary incontinence: long-term sub-jective results. J Urol  166:  1755–1758, 2001.6. Montague DK, and Angermeier KW: Postprostatectomy urinaryincontinence: the case for artificial urinary sphincter implantation.Urology  55:  2–4, 2000.7. Kendrirci M, Gupta S, Shaw K,  et al:  Synchronous prostheticimplantation through a transscrotal incision: an outcome analysis. J Urol  175:  2218–2222, 2006.8. Sellers CL, Morey AF, and Jones LA: Cost and time benefits of dualimplantation of inflatable penile and artificial urinary sphincterprosthetics by single incision. Urology  65:  852–853, 2005.9. Gundian JC, Barrett DM, and Parkular BG: Mayo Clinic experiencewith use of the AMS800 artificial urinary sphincter for urinary incon-tinence following radical prostatectomy. J Urol  142:  1459–1461, 1989.10. Raj GV, Peterson AC, Toh KL,  et al:  Outcomes following revisionsand secondary implantation of the artificial urinary sphincter. J Urol  173:  1242–1245, 2005. 896  UROLOGY 71 (5), 2008
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