The aim of this study was to determine the efficacy and operative complications of the suprapubic arc (SPARC) procedure in stress incontinent women with and without previous anti-incontinence surgery. One-hundred and twenty-one patients with stress urinary incontinence (SUI) were treated with SPARC for correction of urethral hypermobility (N = 65) and intrinsic sphincter deficiency (N = 56) between August 2002 and February 2007. The long-term surgical results, operative complications (bladder injury, retropubic hematoma, de novo urgency and urinary infection) and patients' satisfaction were assessed. The overall complication rate was 9.9% (12/121). The perioperative complication rate was 1.7% including 2 urinary bladder injuries. Significant difference in the overall complications rate was detected between women with and without previous surgery (23/45, 51.1% vs. 6/108, 5.5%, chi2 = 49.89, P < 0.001). The overall postoperative complication rate was 8.3% (10/121) including 4 de novo urgencies, 4 urinary infections and 2 retropubic hematomas. There were 3 patients with postoperative urinary retention managed conservatively, without voiding difficulties on control visits. The objective cure rate after the follow-up was 86.8% (105/121). In patients with SUI and without preceding vaginal operations SPARC is a good method with low incidence of perioperative complications, promising long-term results and high patient satisfaction

Babić, Ivan

Gojević, Ante

Gregov, Marija

Kalafatić, Držislav

Lovrić Gršić, Helena

Orešković, Slavko

English

University of Zagreb Medical School Repository

Coll. Antropol. 33 (2009) 1: 201–204Original scientific paperOperative Complications and Resultsof the »Sparc« Procedure for Stress UrinaryIncontinenceSlavko Ore{kovi}1, Dr`islav Kalafati}1, Helena Lovri} Gr{i}1, Ante Gojevi}2,Marija Gregov1 and Ivan Babi}11 Department of Obstetrics and Gynecology, School of Medicine, University of Zagreb, Zagreb, Croatia2 Department of Surgery, School of Medicine, University of Zagreb, Zagreb, CroatiaA B S T R A C TThe aim of this study was to determine the efficacy and operative complications of the suprapubic arc (SPARC) proce-dure in stress incontinent women with and without previous anti-incontinence surgery. One-hundred and twenty-one pa-tients with stress urinary incontinence (SUI) were treated with SPARC for correction of urethral hypermobility (N=65)and intrinsic sphincter deficiency (N=56) between August 2002 and February 2007. The long-term surgical results, oper-ative complications (bladder injury, retropubic hematoma, de novo urgency and urinary infection) and patients’ satisfac-tion were assessed. The overall complication rate was 9.9% (12/121). The perioperative complication rate was 1.7% in-cluding 2 urinary bladder injuries. Significant difference in the overall complications rate was detected between womenwith and without previous surgery (23/45, 51.1% vs. 6/108, 5.5%, c2=49.89, P<0.001). The overall postoperative compli-cation rate was 8.3% (10/121) including 4 de novo urgencies, 4 urinary infections and 2 retropubic hematomas. Therewere 3 patients with postoperative urinary retention managed conservatively, without voiding difficulties on control vis-its. The objective cure rate after the follow-up was 86.8% (105/121). In patients with SUI and without preceding vaginaloperations SPARC is a good method with low incidence of perioperative complications, promising long-term results andhigh patient satisfaction.Key words: stress urinary incontinence, SPARC, complications, efficacyIntroductionThe suprapubic arc (SPARC) polypropylene midure-thral sling is considered as one of the best surgical treat-ment methods for women with stress urinary inconti-nence. The reported success rate of the pubovaginal slingprocedures using various materials fluctuated impres-sively from 80–95%1,2. Until recently, the procedure hasbeen reserved for patients who previously failed othersurgical treatments, but nowadays the indications areextended and the treatment is widely applied in all typesof SUI2. Correction of suburethral support with adequateintrinsic urethral resistance is important in achievingcontinence especially in women with severe intrinsicsphincter deficiency3,4. Since the needle passes at theback surface of the symphysis, the risks for lower urinarytract, bowel and vascular injury are outstandingly de-creased5. In addition, this technique offers the surgeoncontrol of the path of the needle under finger guidanceand the exceptional tensioning design allows reducing orincreasing the tension after sling positioning. Relativelyhigh percentage of early postoperative complications,well documented in the literature, are mostly associatedwith the prior abdominal or vaginal surgery6. On theother hand, certain dissapointing outcome was corre-lated with the surgical technique designed to preventbladder outlet obstruction7,8. Some unsatisfactory surgi-cal results of SPARC might derive from the high gradetype of SUI coupled with pelvic organ prolapse. Long--term outcome and complications of this surgical proce-dure regarding the risk of persistent incontinence orbladder outlet obstruction have not been well deter-mined and explained.The primary objectives of our retrospective cohortstudy were to establish the safety, efficacy and postopera-201Received for publication December 16, 2008tive complications of SPARC in women with previousanti-incontinence surgical treatment and in women whounderwent SPARC-only operation.Patients and MethodsA total of 121 women with SUI received SPARC proce-dure for correction of urethral hypermobility and intrin-sic urethral sphincter deficiency. A retrospective cohortstudy was performed at our institution in the time periodbetween August 2002 and February 2007. All patientswere assessed preoperatively by quality of life questio-nairre, physical examination and urodynamic study. Wo-men were questioned preoperatively with regard to thesymptoms of stress and urge incontinence. Out of 121 pa-tients, 65 women had signs of urethral hypermobility, 56had been diagnosed as intrinsic sphincter deficiency. Alltypes of other vaginal support defects such as cystocoele,rectocoele or uterine prolapse were eliminated from thestudy. If the urgency was the predominant cause of theincontinence participants were ruled out from the study.All patients had sterile urine before the surgery.SurgeryThe SPARC procedure was performed under general(N=87) or spinal anesthesia (N=34). The propylene slingwas positioned under the midurethra into the subcutane-ous tunnel which passes at the posterior wall of thesymphisis through the endopelvic fascia without fixationto the fascia and without tension until the cystoscopy andprovocation test have been completed. After the position-ing of the tape the cystoscopy was done to check for thebladder injury. The optimal tension was achieved by twosteps afterwards when the bladder was full: first the in-strument was placed between the tape and midurethraand then tensioned in order to avoid postoperative reten-tion. Subsequently the continence was attested by deepand intense compression of abdominal wall above thesymphisis. If the drops or slight leakage of urine were ob-tained on the provocation test the tension was clarifiedas ideal, with no risk for postoperative retention. A Foleycatheter was inserted in the bladder for 24 hours in aver-age.Outcome measuresThe incidence of perioperative (bladder injury) andearly and late postoperative complications (retropubichaemoatoma, voiding difficulties, infection, urinary re-tention, de novo urgency), operating time, intraoperativeblood loss and hospitalization period were obtained. Re-tention was defined if the residual urine was more than50 mL after micturition. De novo urgency was identifiedif the frequency, urgency, or urge incontinence developedin patients who lacked urgency before operation and if itpersisted more than 30 days after the procedure. Urinaryinfection was confirmed by the microbiological urineanalysis. All patients were followed-up at our Institution6, 12 and 18 months postoperatively by questionnaireand urogynecologic inspection.QuestionnaireObjective cure rate was determined from the patientssymptoms, physical and urodynamic evaluation at eachpostoperative visit. Satisfaction rate was assessed fromthe straightforward questionnaire regarding the postop-erative condition, improvement and potential postopera-tive difficulties. The objective surgical results were clas-sified as cured: without any lower urinary tract symptom,no incontinence on provocation tests; improved: verymild SUI on provocation test at first postoperative visit,frequency, de novo urgency and strain to void; failed:moderate to severe incontinence.Statistical analysisStatistical analysis was based on Pearson’s chi-squaretest for categorical variables. Probabilities lower than 5%(P<0.05) were considered significant. Statistics was donewith Statistical Package for Social Sciences, version 11(SPSS Inc., Chicago, IL, USA) software.ResultsIn 98 patients SPARC was the first operation, and theremaining 23 had undergone the abdomino-pelvic opera-tion previously (Table 1). There was no significant differ-ence in the mean age, parity duration of symptoms andhormonal state between the SPARC-only operation groupand group with previous surgery. Stress urinary inconti-nence was identified as either urethral hypermobility(N=65) or intrinsic sphincter deficiency (N=56). Themean operating time was 20 ± 8 minutes (range 11–38min). After the pubovaginal sling procedure all patientscould void volitionally with little residual urine (< 50mL) on the first postoperative day after the removal ofthe Foley catheter. The overall complication rate wasS. Ore{kovi} et al.: SPARC and Stress Urinary Incontinence, Coll. Antropol. 33 (2009) 1: 201–204202TABLE 1CHARACTERISTICS OF THE PATIENTS WITH SPARCPatients’ characteristicsNo (%) of patients(N=121)Age (mean ± S.D.) 51 ± 8.2Hormonal age:generative ageperimenopausepostmenopause18 (14.9)59 (48.8)44 (36.3)Parity ± S.D. 2.8 ± 1.4Previous surgery:abdominal hysterectomyvaginal hysterectomy with colporraphycorrection of cystocoelecorrection of urethral insufficiency23 (19.0)12 (9.9)6 (5.0)3 (2.5)2 (1.7)Stress urinary incontinence:urethral hypermobilityintrinsic sphyncter deficiency121 (100)65 (53.7)56 (46.3)SPARC – Suprapubic arc9.9% (12/121) (Table 2). Perioperative complications oc-curred in 2 patients (1.7%) as bladder perforation (N=1)or bladder laceration (N=1) and were both diagnozedduring routine cystoscopy. Lacerations were repaired withsutures and perforations were simply drained until therecovery. Bladder catheterization lasted a mean of 2.7 ±1.9 days. The overall postoperative complication rate was8.3% (10/121). Early postoperative complications wereurinary infection and retropubic hematoma.De novo urinary tract infection occurred in 4 (3.3%)patients and were immediately treated by appropriateantibiotics. Retropubic hematoma occurred in 2 patientsand have been detected on the day after the surgery. In 3patients urinary retention occurred after removal of ca-theter so further 10–14 days of catheterisation was nec-essary. No urinary retention or strain to void occurred onroutine check-up controls. The only late postoperativecomplication, de novo urgency was observed in 4 patients(3.3%). Normal vaginal healing has been noticed in allpatients. None of the patients required releasing of slingtension and none of them had voiding difficulties orstrain to void. Significant difference in the overall com-plications was detected between women with and with-out previous abdominal or vaginal surgery (respectively,9/23, 39.1% vs. 3/98, 3.1%, c2=39.99, P<0.001) (Table 2).Bladder injury (perforation and laceration) occurredin patients who had undergone prior surgery. One ofthem have had prior vaginal hysterectomy and one ante-rior colporraphy with the correction of sphyncter mecha-nism. No bladder injury occured in SPARC-only opera-tion group.De novo urgency and urinary infection appeared morefrequently in patients who underwent SPARC as the sec-ond operation than in women with SPARC-only opera-tion (3/23, 13.0% vs. 1/98, 1.0%; c2=6.86, P<0.005) (Ta-ble 2).Hospitalization interval ranged from 2 to 10 days(mean 3.1 ± 1.4).We achieved the objective cure rate 86,8% (105/121)and improvement was achieved in the remaining 6.7%(8/121). The mean follow-up time was 38 ± 6.4 months.The main postoperative symptom which persisted on thecheck visits was de novo urgency in 4 cases and de novourinary infection in 4 patients. However, patients with denovo urgency had higher satisfactory rate on the furtherfollow-up visits. There was no incident of recurrent SUIand none of the patient failed SPARC procedure. Overallsatisfactory rate was 81.8% (99/121) including patientswith perioperative and postoperative difficulties. Whenthe SPARC was applied to women with pure stress uri-nary incontinence and no preceding operation the objec-tive cure rate was 87.6% (106/121).DiscussionAccording to our results neither persistent urinary re-tention nor severe SUI were detected after operation inour study. Using the tight instrument, which was placedbetween the tape and urethra prior to gradual tensioningof the sling we performed routine cystocscopy by stressprovocation test. Bladder perforation or laceration in ourstudy occurred in women who previously underwent vag-inal hysterectomy and correction of sphyncter mecha-nism. Altered position of pelvic organs, adhesions, andreduction of retropubic space might give explanation ofsuch feeble consequences. No bladder injury occurred inthe patients with SPARC-only operation. Vascular, bowelor nerve injury reported previously, have also not beendetected. No infection, erosions or defective healing ofthe vaginal wall were observed. Two sequels of asymp-tomatic retropubic hematoma occurred in women withhistory of abdominal hysterectomy with spontaneous re-solution occurring two weeks postoperatively. It is valu-able to detect that there were no alterations between thepreoperative and postoperative red blood cells count,even in the patients with hematoma or bladder injury.Even though some authors believe that the large size ofdilating connector attaching the tape to the SPARC nee-dle is responsible for the increased blood loss9, we had nosuch experience. Our most frequent postoperative com-plications were urinary infection and de novo urgency.Previous detrusor instability or chronic inflammation ofthe bladder enhances the possibility of recurrent infec-tion and need of continuous perioperative antibacterialtreatment. Very few cases (3/121) of urinary retention,managed conservatively with no further voiding difficul-ties, usually reported by prior investigations, were ob-served in our study6,10.Quite contradictory results of the SPARC procedureshave been reported by other researchers, mostly regard-ing the cure rate and perioperative complications9–11.High rate of mild to moderate SUI after operation, whichwas associated with too slight tension of the tape and thefear of outlet obstruction, was observed by some in-S. Ore{kovi} et al.: SPARC and Stress Urinary Incontinence, Coll. Antropol. 33 (2009) 1: 201–204?203TABLE 2COMPLICATIONS OF THE SPARC DEPENDING ON HISTORY OF PREVIOUS SURGERYGroup (N)No (%) of patients with complicationoverall12 (9.9)bladder injury2 (1.7)retropubic hematoma2 (1.7)de novo urinaryinfection 4 (3.4)de novo urgency4 (3.4)SPARC only (98) 3 (3.1)* 0 0 1 (1.0)‡ 1 (1.0)‡Previous surgery (23) 9 (39.1)* 2 (8.7) 2 (8.7) 3 (13.0)‡ 3 (13.0)‡SPARC – Suprapubic arc, SUI – Stress urinary incontinence; * P<0.001; ‡ P<0.005vestigators4,8,12. High rate of perioperative complications,particularly the bladder injury, might be somewhat ex-plained by surgeon’s limited experience with the SPARCmethod. Furthermore, current reports respected that therisk of bladder injury was higher if there is a history ofprior anti-incontinence surgery6,13. We have to opposesome previous researches14 and recapitulate that onlyslight vaginal defects that originate from breaking or we-akness of endopelvic fascia could be managed by SPARC,while high grade protrusion of vaginal wall, cystocoellaor other genital descensus accompanied with SUI shouldbe coupled by other surgical techniques rather than com-plementing the SPARC procedure. In addition, duringthe past several years concept has been evolved toward aspectrum of patients having explicitly intrinsic sphincterdeficiency or urethral hypermobility9,15. Uncomplicatedhematomas have been reported by previous multicentertrails and, as in our trial, had reliable final outcome6,13.Urinary infection and de novo urgency have been de-scribed by other previous investigations6,10,16. This com-plex problem has been described in the literature with afrequency of 3 to 24%2. Postoperative detrusor overac-tivity manifested as urgency, frequency and urge inconti-nence, according to previous reports, might result fromsuburethral nervous or myogenic irritation. Other au-thors point out that the bladder instability originates notonly from the age and hormonal status but from thechanges in paraurethral collagen metabolism and sclero-sis induced by polypropylene tape17,18. We consider thatthe etiology of de novo urgency is multifactorial butmainly derives from unrecognized detrusor instabilitybefore the operation rather than from newly developedbladder obstruction.Comparing with the current studies on the SPARC ef-ficiency we achieved promissing objective overall successrate (86.8%). When we respected surgical results of pa-tients with SUI and without preceding abdominal or vag-inal operations objective success rate raised up more(87.6%). Approved by our investigation SPARC has shownup to be available, minimally invasive and rather safemethod for SUI. It especially refers to patients withouthistory of previous surgery and uncured urgency, offer-ing a low incidence of perioperative complications andexceptional objective results with high satisfactory rate.R E F E R E N C E S1. CROSS CA, CESPEDES RD, MCGUIRE EJ. J Urol, 159 (1998)1195. — 2. MORGAN TO JR, WESTNEY OL, MCGUIRE EJ, J Urol, 163(2000) 1845. — 3. DE LANCEY JOL, Am J Obstet Gynecol, 170 (1994)1713. — 4. KLUTKE JJ, KLUTKE CG, BERGMAN J, Urology, 54 (1999)1003. — 5. WANG AC, Acta Obsetet Gynecol Scand, 83 (2004) 293. — 6.DEVAL B, LEVARDON M, SAMAIN E, Europ Urol, 44 (2003) 254. — 7.SWEAT SD, ITANO NB, CLEMENS JQ, J Urol, 168 (2002) 144. — 8.HANN-CHORNG K, Urol Int, 74 (2005) 147. — 9. TSENG LH, WANGAC, Int Urogynecol J, 16 (2005) 230. — 10. KOBASHI KC, GOVIER FE, JUrol, 170 (2003) 1918. — 11. HUDROFF MA, SUTHERLAND SE, KE-SHA JB, Urology, 66 (2005) 760. — 12. FULFORD SC, FLYNNR, BARRIN-GTON J, J Urol, 162 (1999) 135. — 13. BOUBLIL V, CIOFU C, TRAXERO, SEBE P, Curr Opin Obstet Gynecol, 14 (2002) 515. — 14. BARNESNM, DMOCHOWSKI RR, PARK R, Urology, 59 (2002) 856. — 15. RO-DRIGEZ LV, ALMEIDA F, DOREY F, J Urol, 172 (2004) 210. — 16. CLE-MENS JQ, DELANCEY JO, FAERBER GJ, Urology, 56 (2000) 589. — 17.FALCONER C, EKMAN-ORDEBERG G, BLOMGREN B, Acta ObstetGynecol Scand, 77 (1998) 95. — 18. FALCONER C, BLOMGREN B, JO-HANSSON O, Acta Obstet Gynecol Scand, 77 (1998) 87.D. Kalafati}Department of Obstetrics and Gynecology, School of Medicine, University of Zagreb, Petrova 13, 10000 Zagreb, Croatiae-mail: drzislav.kalafatic@zg.t-com.hrOPERATIVNE KOMPLIKACIJE I ISHOD METODE SPARC U LIJE^ENJUSTATI^KE INKONTINENCIJE MOKRA]ES A @ E T A KU radu je prikazana u~inkovitost metode SPARC i usporedba pojave komplikacija u bolesnica koje su prvi putaoperirane SPARCmetodom i bolesnica koje su ve} prethodno imale operacije dna zdjelice. Stotinu dvadeset i jedna `enasa stati~kom inkontinencijom operirana je SPARC metodom zbog hipermobilnosti uretre (n=65) odnosno intrinzi~nogo{te}enja uretralnog sfinktera (n=56) u razdoblju izme|u kolovoza 2002 i velja~e 2007 godine. Prikazan je dugoro~niishod, operativne komplikacije (ozljeda mjehura, retropubi~ni hematom, de novo urgencija, urinarna infekcija) te zado-voljstvo bolesnica. Ukupan udio komplikacija bio je 9,9% (12/121). Perioperativnih komplikacija bilo je 1,7%, {to uklju-~uje 2 ozljede mjehura. Zamije}ena je zna~ajna razlika u broju komplikacija izme|u bolesnica koje su prethodno operi-rane odnosno onih kojima je ovo bila prva korekcija inkontinencije (9/23, 39,1% vs. 3/98, 3,1%, P<0,001). Ukupan brojpostoperativnih komplikacija bio je 8,3% (10/121) uklju~uju}i 4 de novo urgencije, 4 urinarne infekcije i 2 retropubi~nahematoma. Nije bilo slu~ajeva trajne postoperativne urinarne retencije niti ote`anog mokrenja. Ukupna u~inkovitostmetode bila je 86,8% (105/121). U bolesnica s ~istom stati~kom inkontinencijom, a bez prethodne operativne korekcije,SPARC je sigurna metoda, s niskim udjelom komplikacija i zadovoljavaju}im dugoro~nim ishodom.S. Ore{kovi} et al.: SPARC and Stress Urinary Incontinence, Coll. Antropol. 33 (2009) 1: 201–204204

Operative complications and results of the "SPARC" procedure for stress urinary incontinence [Operativne komplikacije i ishod metode SPARC u liječenju statičke inkontinencije mokraće]

Operative complications and results of the "SPARC" procedure for stress urinary incontinence [Operativne komplikacije i ishod metode SPARC u liječenju statičke inkontinencije mokraće]

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