전립선수술후발생한복압성요실금에서인공요도괄약근수술의효과및안전성 Efficacy and Safety of Artificial Urinary Sphincter for Stress Urinary Incontinence after Prostate Surgery Jin Bak Yang, Young-Suk Lee, Deok Hyun Han, Kyu-Sung Lee From the Department of Urology, Sungkyunkwan University School of Medicine, Seoul, Korea Purpose: To evaluate the efficacy and safety of artificial urinary sphincter (AUS) for the treatment of stress urinary incontinence (UI) after prostate surgery. Materials and Methods: We performed a retrospective chart review of 19 patients who underwent AUS implantation from July 2003 to November 2008. Efficacy was evaluated in terms of the postoperative changes in daily pad use, incontinence visual analogue scale (I-VAS), International Continence Society male-short Form questionnaire (ICS-male SF), Incontinence Quality of Life questionnaire (I-QoL), and patients satisfaction postoperatively. No pad use was defined as cure, and use of 1 pad or fewer per day as improvement. Cure and improvement were regarded as success. Complications and durability of the AUS were evaluated. Results: The median age of the patients was 70.0 years (range, 47-76 years). With a median follow-up period of 11.8 months (range, 6.2-48.1 months), the success rate was 68.4% (13/19; cure in 12 and improvement in 1). I-VAS, subscale scores of ICS-male SF (incontinence and QoL), and total and subscale scores of I-QoL (psychosocial impact, social embarrassment, avoidance, and limiting behaviors) were significantly improved. Fifteen (78.9%) patients reported being satisfied. Six (31.5%) patients required revision: volume adjustment for 2, second cuff implantation for 2, pump reposition for 1, and pump reposition, volume adjustment, and second cuff implantation for 1. One of the patients who had a second cuff implantation had the sphincter explanted for infection. Conclusions: Despite the high rate of revision, the satisfaction rate was high and the quality of life was significantly improved after AUS implantation for urinary incontinence after prostate surgery. (Korean J Urol 2009;50:854-858) Key Words: Artificial urinary sphincter, Urinary incontinence Korean Journal of Urology Vol. 50 No. 9: 854-858, September 2009 DOI: 10.4111/kju.2009.50.9.854 성균관대학교의과대학비뇨기과학교실 양진백ㆍ이영숙ㆍ한덕현ㆍ이규성 Received:June 23, 2009 Accepted:August 22, 2009 Correspondence to: Kyu-Sung Lee Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50, lwon-dong, Gangnam-gu, Seoul 135-710, Korea TEL: 02-3410-3554 FAX: 02-3410-3027 E-mail: ksleedr@skku.edu C The Korean Urological Association, 2009 서론고령화시대에접어들면서전립선질환과이에따른수술적치료의증가와함께, 술후합병증의발생도증가하고있다. 특히, 전립선수술후발생하는요실금은술기의발달로발생률이낮아지고는있지만, 환자의삶의질을크게저하시키고사회생활과정신건강에부정적인영향을미친다 [1,2]. 전립선수술후발생하는요실금은주로, 수술시외요도괄약근손상에의한것으로, 이로인한내인성요도괄약근기능부전 (intrinsic sphincter deficiency; ISD) 이주된원인인것으로알려진다. 이러한요실금은전립선비대증수술후약 0.4% [3], 전립선암에대한근치적전립선적출술후에는약 8-20% 에서발생하는것으로보고되고있다 [4-6]. 치료는초기 12개월동안은수분제한, 약물치료, 골반저근강화훈련등적극적인보존치료가필요하다. 그러나이러 854
Jin Bak Yang, et al:artificial Sphincter for Urinary Incontinence after Prostate Surgery 855 한치료이후에도증상이지속되거나불편을느끼는환자들에서는배뇨근의저장기능과수축력, 요도괄약근의기능등을평가하여수술적치료를고려해야한다. 수술적치료에는요도내충전물질주입, 남성슬링그리고인공요도괄약근등이있다. 요도내충전물질주입술의경우, 증상이심하지않은소수의환자에게제한적으로사용할수있는방법으로, 현재까지는남성슬링수술이나인공요도괄약근수술이전립선수술후발생한요실금에서가장효과적인방법이다 [7-9]. 이중인공요도괄약근수술은 1972년에 Scott 등에의해처음으로소개되었으며 [10], 1985년에는현재사용되고있는 narrow-back cuff 기법이소개되었다. 이후, 여러보고에서인공요도괄약근의임상적효용성과안전성이입증되면서현재까지전립선절제술후요실금에대한표준치료로자리매김하고있다 [9,11]. 국내에서는 1986년 Moon 등에의해인공요도괄약근설치술이처음소개된이후 [12], 치료성적및합병증에대한보고는적은실정이다. 본연구에서는전립선수술후발생한남성요실금환자에서인공요도괄약근의치료성적및합병증과, 그로인한재수술등에대해본원에서수술한환자들을대상으로후향적으로분석하였다. 대상및방법 1. 대상 2003년 7월부터 2008년 11월까지, 전립선수술후발생한요실금으로본원에서인공요도괄약근수술을받은환자 19 명을대상으로, 술전병력, 요실금치료력, 인공요도괄약근수술소견, 술후증상변화및만족도와합병증및재수술등에대하여의무기록을후향적으로분석하였다. 환자들은전립선수술전에는요실금이없었던환자들로, 뇌졸중, 척추손상, 파킨슨병등과같은신경계장애는없었다. 이들중 17명은전립선암, 2명은전립선비대증으로수술을받은환자였으며, 17명의전립선암환자중 15명은근치적전립선적출술, 2명은고밀도초음파직접술 (high-intensity focused ultrasound; HIFU) 을받은환자였다. 전립선비대증환자중 1명은경요도전립선절제술 (transurethral resection of the prostate; TURP) 을받았으며다른 1명은경요도레이저전립선기화술 (photoselective laser vaporization prostatectomy; PVP) 를받은환자였다. 인공요도괄약근수술전요실금치료로써 3명은요도내충전물질주입술, 1명은슬링수술을받았다. 인공요도괄약근수술전모든환자에서요역동학검사를시행하였으며, 복압성요누출압 (abdominal leak point pressure) 의중간값은 93 cmh 2O (40-123) 였다. 배뇨근과반사는 6명, 배뇨근저활동은 2명에서관찰되었다. 2. AMS 800 TM (American Medical Systems, Minnetonka, Minn) 수술 모든환자들은미국 Amerincan Medical Systems 사에서제조한인공요도괄약근기구인 AMS 800 TM (American Medical Systems, Minnetonka, Minn) 을이용하여단일술자에의해수술을받았다. 총 19명중음낭접근법으로수술한한명을제외한모든환자에서회음부절개로수술을시행하였다. 인공요도괄약근띠는 19명모두구부요도에위치시켰으며, 4.0 cm에서 8.0 cm 사이의기구중에서수술중외경측정자 (cuff sizer) 를이용하여측정된외경을고려하여적합한크기의기구를선택하였다. 풍선저장기 (balloon reservoir) 에는환자에따라 22-25 cc의생리식염수를주입하였다 (Table 1). 모든환자에서풍선은우측 Retzius space에, 펌프는우측음낭에위치시켰다. 수술을마치기전, 요도내시경을통하여요도의폐쇄와개방이적절한지확인하였다. 수술후요도카테타는유치하지않았으며, 인공괄약근은비활성화상태를유지하였다. 괄약근의활성화는술후 6주에외래내원시술자가직접시행하였으며, 활성화한뒤환자가직접펌프를작동하여자가배뇨가원활히이루어지는것을확인하였다. 3. 분석 수술결과는환자의마지막내원시의무기록을바탕으로, 패드를사용하지않는경우를 완치, 하루한개이하의패드를사용하는경우를 호전 으로정의하였고, 완치와호전을 성공 으로정의하였다. 술전과술후의요실금시각상사척도, International Continence Society male-short Form Table 1. Intraoperative findings (n=19) Variables No. of patients Approach Perineal 18 Scrotal 1 Location of cuff Bulbous urethra 19 Cuff size (cm) 4.0 14 4.5 3 5.0 1 5.5 1 Reservoir volume (cc) 22 2 23 9 24 7 25 1
856 Korean Journal of Urology vol. 50, 854-858, September 2009 (ICS-male SF), Incontinence Quality of Life (I-QoL) 설문의변화를분석하였으며, 술후환자들의만족도를조사하였다. 수술과관련된합병증과재수술에대해서도알아보았다. 술전과술후의변화는 p값이 0.05 미만인경우통계적으로유의한것으로정의하였다. 결과총 19명환자들의연령중간값은 70.0세 (47-76) 였으며, 전립선수술후인공요도괄약근수술까지기간의중간값은 26.8개월 (7.6-172.4), 인공요도괄약근수술후추적기간의중간값은 11.8개월 (6.2-48.1) 이었다. 인공요도괄약근시행후완치는 12명 (63.2%) 이었으며, 호전은 1명 (5.3%) 으로, 술후성공률은 68.4% (13/19) 였다. 술후요실금시각상사 척도는평균 95.5점에서 14.4점으로호전되었다 (p=0.006). ICS male-sf 설문은술전에비해술후요실금 (p=0.003) 과삶의질점수 (p=0.005) 항목이유의하게호전되었으며, 배뇨, 빈뇨, 야간뇨항목에서는유의한차이가없었다 (Fig. 1). I-QoL 설문은술후총점과 psychosocial impact, social embarrassment, avoidance/limiting behavior 항목모두의미있게호전되었다 (Fig. 2). 마지막방문시평가한만족도에대해서는 15명 (78.9%) 이만족한다고대답하였으며, 이중 3명은매우만족한다고답하였다. 불만족으로답한 4명중 1명은인공요도괄약근을제거했던환자였으며, 1명은생리식염수추가주입과이차괄약근띠 (second cuff) 장착후에도지속적인요실금을보인환자였다. 이외 2명의환자들은패드를사용하지는않으나간헐적으로발생하는요실금으로불만족으로답하였다. 술후 6명 (31.5%) 의환자에서재수술을시행하였으며한환자에서는 3회의재수술을시행하였다. 재수술은재발성또는지속적요실금을가진 4명에대해 2명에서생리식염 Fig. 1. Change in International Continence Society male-short form questionnaire between before and after the operation. QoL: quality of life. Fig. 2. Change in Incontinence Quality of Life questionnaire between before and after the operation. Table 2. Summary of cases of revision Patients number Duration from AUS Cause of revision Procedure Result insertion (month) 1 Recurrent incontinence Reservoir volume adjustment 5.8 Continence 2 Persistent incontinence Reservoir volume adjustment 2.1 Continence 3 Recurrent incontinence Second cuff insertion 8.3 Explanation due to infection 4 Persistent incontinence Second cuff insertion 6.2 Continence 5 Scrotal pain Pump repositioning 1.6 Pain relief 6 Scrotal pain Pump repositioning 3.1 Pain relief Persistent incontinence Reservoir volume adjustment 7.2 Persistent incontinence Persistent incontinence Second cuff insertion 8.7 Persistent incontinence AUS: artificial urinary sphincter
Jin Bak Yang, et al:artificial Sphincter for Urinary Incontinence after Prostate Surgery 857 수를추가주입하였으며, 2명에서는이차괄약근띠를장착하였다. 이차괄약근띠를장착한 2명의환자중 1명에서는추가띠장착후약 2개월에감염이발견되어인공괄약근을제거하였다. 이외 1명은고환통증으로펌프위치를변경하였으며, 나머지 1명에서는고환통증과지속적인요실금으로펌프위치변경및생리식염수추가주입술을시행하였으나이후에도지속적인요실금이있어이차괄약근띠를장착하였다 (Table 2). 고찰본연구결과, 전립선수술후발생한요실금에서인공요도괄약근수술은재수술률은높았으나요실금을호전시키는데효과적이었으며환자의만족도가높은것으로나타났다. 문헌들에의하면, 인공요도괄약근설치후요자제율은요자제의정의와방사선치료유무등에따라 59-90% 로다양하게보고하고있다 [13,14]. 본연구에서도성공률로본요자제율은 68.4% 로다른연구들과비슷한결과를보였다. 한편, 인공요도괄약근수술후가장흔한합병증은요도미란과감염으로, 이로인한재수술률은각각 8-45% 와 7-17% 정도인것으로알려진다 [15]. 본연구결과에서는요도미란은발생하지않았으며, 1명의환자에서감염이발견되어인공요도괄약근을제거하였다. 인공요도괄약근수술후감염의발생률은약 2% 내로보고되고있으며 [16,17], 위험인자로는, 수술후요도카테터유치, 재수술횟수, 방사선조사등으로알려진다 [16-18], 감염의주된원인균은 Staphylococcus epidermidis이며, 방광확대술과인공요도괄약근수술을동시에시행한경우에빈도가더증가하는것으로보고되고있다 [17]. 인공요도괄약근수술후재수술빈도는 28% 에서 50% 로, 가장흔한원인은지속적인요실금과감염이다 [19,20]. Kim 등은인공요도괄약근을장착한 124명의환자를대상으로평균 6.8년동안추적관찰한결과, 37% 에서재수술을경험하였으며, 대부분 4년이내재수술을하는것으로보고하였다 [21]. 본연구에서는추적관찰기간동안감염및지속적인요실금으로 6명 (31.5%) 의환자가재수술을받았으며, 이중 1명은인공요도괄약근을제거하였다. 이전연구들에의하면, 지속적이거나재발한요실금에대한재수술후요자제율은 1차시술후의요자제율과유사한것으로보고하고있다 [22]. 본연구에서는 1차수술후재발하거나지속적인요실금에대해재수술을시행한 5명중 3명의환자가요자제를획득하였다. 인공요도괄약근설치후지속적또는재발성요실금에대해서는생리식염수추가주입, 띠의크기또는위치변경 ( 예, proximal cuff, transcorporal cuff, tandem cuff), 이차괄약근띠장착등의방법들이소개되고있다 [23]. 본원에서는인공요도괄약근시술후지속적인요실금이발생한 3명의환자에서이차괄약근띠를장착하였으며, 감염으로제거술을받은 1인을제외한 2명중 1명에서만성공적인결과를보였다. 인공요도괄약근수술후환자들의 75-90% 가수술에만족하는것으로알려진다 [9,11]. 본연구에서는, 19명중 15명 (78.9%) 의환자가인공요도괄약근수술에만족하였으며, 불만족원인은재수술후에도지속적인요실금을경험하거나감염으로인해인공요도괄약근을제거한경우였다. 본연구에서수술방법은한명에서음낭절개법을시행하였으며나머지환자에서는회음부절개로수술을시행하였다. 2003년 Wilson 등이소개한음낭절개법은전통적인회음부절개법이복부와희음부두곳에절개를가하는반면, 단일절개를통해인공괄약근의띠, 풍선저장기, 펌프를모두삽입할수있고경우에따라서는음경보형물도동시에삽입할수있는장점이있다 [24]. 음낭절개법의수술성적은초기에는회음부절개법과유사한것으로보고되었지만, 94명의환자를대상으로후향적으로비교분석한연구에의하면, 수술의용이성을제외한요자제의측면에서볼때회음부절개방식이음낭절개방식에비해좋은성적을보이는것으로보고하였다 [25]. 그러한이유로는, 음낭절개방식은띠를근위부구부요도에위치시키기어려워보다얇은원위부요도에띠를위치시킴으로써띠가적절한압력을요도에전달하지못하는것을들수있다. 결과적으로요자제획득률이회음부접근법에비해떨어지고, 요도미란의위험이증가하여이로인한재수술이증가할수있을것이다. 또한재수술시회음부절개법은각각의관을분리하기쉽고, 띠와저장기를각기떨어진절개창을통해개별적으로수술할수있는장점이있다. 본연구에포함된대부분의환자에서괄약근띠의크기는최소크기인 4 cm를사용하였다. 그러나, 이중초기두환자에서는요도의지름이 4 cm의괄약근띠보다작아수술을마치기전시행한요도내시경에서완전한요도의폐색을관찰할수없었다. 이후술자는구부해면체근을박리하지않고측면에서요도에접근한후요도의둘레를측량한후구부해면체근을띠안에포함할지를결정하였다. 즉, 요도의굵기가충분한경우에는구부해면체근을박리하여괄약근띠밖에위치하게하였다. 이러한방법으로수술을시행한이후에는 4 cm 지름의띠가요도지름에비해커서띠의압력이요도로충분히전달이되지않는경우는없었다. 결론적으로인공괄약근은환자의만족도와삶의질을높일수있고, 우려할만한합병증이발생하지않는것으로
858 Korean Journal of Urology vol. 50, 854-858, September 2009 보아효과적이고안전한치료방법이라고생각한다. 향후지속적인추적관찰을통해인공요도괄약근의장기효과및합병증, 기구지속률등에대해조사할예정이다. 결 전립선수술후발생한복압성요실금의치료로서인공요도괄약근수술은높은만족도와삶의질의유의한향상을보였다. 추후인공요도괄약근의장기효과를향상시키고합병증을예방할수있는방법에대한추가적인연구가필요할것으로생각한다. 론 REFERENCES 1. Gaker DL, Gaker LB, Stewart JF, Gillenwater JY. Radical prostatectomy with preservation of urinary continence. J Urol 1996;156:445-9. 2. Arai Y, Okudo K, Aoki Y, Maekawa S, Okada T, Maeda H, et al. Patient-reported quality of life after radical prostatectomy for prostate cancer. Int J Urol 1999;6:78-86. 3. Gundian JC, Barrett DM, Parulkar BG. Mayo Clinic experience with the AS800 artificial urinary sphincter for urinary incontinence after transurethral resection of prostate or open prostatectomy. Urology 1993;41:318-21. 4. Penson DF, McLerran D, Feng Z, Li L, Albertsen PC, Gilliland FD, et al. 5-year urinary and sexual outcomes after radical prostatectomy: results from the prostate cancer outcomes study. J Urol 2005;173:1701-5. 5.Begg CB, Riedel ER, Bach PB, Kattan MW, Schrag D, Warren JL, et al. Variations in morbidity after radical prostatectomy. N Engl J Med 2002;346:1138-44. 6. Steineck G, Helgesen F, Adolfsson J, Dickman PW, Johansson JE, Norlen BJ, et al. Quality of life after radical prostatectomy or watchful waiting. N Engl J Med 2002;347:790-6. 7. Cespedes RD, Leng WW, McGuire EJ. Collagen injection therapy for postprostatectomy incontinence. J Urol 1999;54: 597-602. 8. Castle EP, Andrews PE, Itano N, Novicki DE, Swanson SK, Ferrigni RG. The male sling for post-prostatectomy incontinence: mean followup of 18 months. J Urol 2005;173: 1657-60. 9. Litwiller SE, Kim KB, Fone PD, White RW, Stone AR. Post-prostatectomy incontinence and the artificial urinary sphincter: a long-term study of patient satisfaction and criteria for success. J Urol 1996;156:1975-80. 10.Scott FB, Bradley WE, Timm GW. Treatment of urinary incontinence by implantable prosthetic sphincter. Urology 1973;1:252-9. 11. Montague DK, Angermeier KW, Paolone DR. Long-term continence and patient satisfaction after artificial sphincter implantation for urinary incontinence after prostatectomy. J Urol 2001;166:547-9. 12. Moon YT, Lee KB, Moon WC, Soh BU, Kim SC. A case of urinary incontinence treatment using AMS 800-artificial sphincter. Korean J Urol 1986;27:337-44. 13. Perez LM, Webster GD. Successful outcome of artificial urinary sphincters in men with post-prostatectomy urinary incontinence despite adverse implantation features. J Urol 1992;148:1166-70. 14. Gomha MA, Boone TB. Artificial urinary sphincter for post-prostatectomy incontinence in men who had prior radiotherapy: a risk and outcome analysis. J Urol 2002;167:591-6. 15. Gousse AE, Madjar S, Lambert MM, Fishman IJ. Artificial urinary sphincter for post-radical prostatectomy urinary incontinence: long-term subjective results. J Urol 2001;166:1755-8. 16. Martins FE, Boyd SD. Post-operative risk factors associated with artificial urinary sphincter infection-erosion. Br J Urol 1995;75:354-8. 17. Light MR, Montague DK, Angermeier KW, Lakin MM. Cultures from genitourinary prostheses at reoperation: questioning the role of Staphylococcus epidermidis in periprosthetic infection. J Urol 1995;154:387-90. 18. Martins FE, Boyd SD. Artificial urinary sphincter in patients following major pelvic surgery and/or radiotherapy: Are they less favorable candidates? J Urol 1995;153:1188-93. 19. Elliott DS, Barrett DM. Mayo Clinic long-term analysis of the functional durability of the AMS 800 artificial urinary sphincter: a review of 323 cases. J Urol 1998;159:1206-8. 20. Clemens JQ, Schuster TG, Konnak JW, McGuire EJ, Faerber GJ. Revision rate after artificial urinary sphincter implantation for incontinence after radical prostatectomy: actuarial analysis. J Urol 2001;166:1372-5. 21. Kim SP, Sarmast Z, Daignault S, Faerber GJ, McGuire EJ, Latini JM. Long-term durability and functional outcomes among patients with artificial urinary sphincters: a 10-year retrospective review from the University of Michigan. J Urol 2008;179:1912-6. 22.Raj GV, Peterson AC, Toh KL, Webster GD. Outcomes following revisions and secondary implantation of the artificial urinary sphincter. J Urol 2005;173:1242-5. 23. Webster GD, Sherman ND. Management of male incontinence following artificial urinary sphincter failure. Curr Opin Urol 2005;15:386-90. 24. Wilson SK, Delk JR 2nd, Henry GD, Siegel AL. New surgical technique for sphincter urinary control system using upper transverse scrotal incision. J Urol 2003;169:261-4. 25. Henry GD, Graham SM, Cleves MA, Simmons CJ, Flynn B. Perineal approach for artificial urinary sphincter implantation appears to control male stress incontinence better than the transscrotal approach. J Urol 2008;179:1475-9.