Objectives. Our first short-term results of transobturator mesh interposition (Perigee System) for the correction of cystoceles are presented. Methods. This is our initial study on 22 women with cystocele > Grade 2 who underwent the Perigee procedure in our Center between January 2006 and March 2007. In 15 cases lateral cystocele defect was ¬diagnosed, whereas other 7 patients had central anterior vaginal wall defect. All patients were assessed by POP-Q staging. Results. The anatomical and functional reconstruction of anterior vaginal wall was achieved in all patients. Preoperatively, mean POP-Q Aa value was +1.1 (± 0.3) and Ba value was + 1.9 (± 1.3) . No major intraoperative or immediate postoperative complications were observed. One and three months postoperatively, mean POP-Q Aa value was – 2.9 (± 0.21) and – 2.82 (± 0.1) respectively and Ba was –2.85 (± 0.4) and – 2.8 (± 0.23) respectively. Patients’ satisfaction and the imposing short-time surgical outcome were achieved in all cases after three months follow-up. Conclusion. We consider Perigee procedure to be highly efficacious, minimally invasive and easy technique for correction of anterior vaginal wall defects.Cilj rada. Prikazati preliminarne rezultate transobturatornog pristupa korekcije cistocela metodom Perigee. Metode. 22 bolesnice s cistocelom drugog stupnja podvrgnute su u našoj ustanovi metodi Perigee u vremenskom razdoblju između sječnja 2006. i ožujka 2007. godine. U 15 bolesnica dijagnosticirano je lateralno paravaginalno oštećenje, dok je u 7 bolesnica verificirano centralno oštećenje prednje vaginale stijenke. Rezultati. Anatomska i funkcionalna korekcija prednje vaginalne stijenke ovom metodom postignuta je kod svih bolesnica. Preoperativno, srednja vrijednost POP-Q Aa točke bila je +1.1 (± 0.3) a Ba točle + 1.9 (± 1.3). Nije bilo intraoperativnih ni perioperativnih komplikacija zahvata. Jedan i tri mjeseca nakon zahvata, srednja vrijednost točke POP-Q Aa bila je – 2.9 (± 0.21) i – 2.82 (± 0.1) dok je srednja vrijednost točke Ba bila –2.85 (± 0.4) i – 2.8 (± 0.23). Zaključak. Smatramo da je Perigee metoda jednostavna, ¬neinvazivna i učinkovita metoda korekcije defekata svih tipova cistokela

Ante Gojević

Držislav Kalafatić

Helena Lovrić

Maja Banović

Slavko Orešković

Tomislav Župić

English

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29STRU^NI ^LANCIPROFESSIONAL PAPERSGynaecol Perinatol 2008;17(1):29–32Department of Obstetrics and Gynecology, School of Medicine, University of Zagreb, CroatiaCYSTOCELE REPAIR BY SYNTHETIC MESHSECURED THROUGH THE OBTURATOR FORAMEN(PERIGEE SYSTEM)KOREKCIJA CISTOKELE SINTETSKOM MRE@ICOMTRANSOBTURATORNIM PRISTUPOM (PERIGEE SISTEM)Slavko Ore{kovi}, Dr`islav Kalafati}, Helena Lovri}, Tomislav @upi},Ante Gojevi}, Maja Banovi}Professional paperKey words: cystocoele, vaginal wall defects, incontinence repair, Perigee procedureSUMMARY. Objectives. Our first short-term results of transobturator mesh interposition (Perigee System) for the correc-tion of cystoceles are presented. Methods. This is our initial study on 22 women with cystocele > Grade 2 who underwentthe Perigee procedure in our Center between January 2006 and March 2007. In 15 cases lateral cystocele defect wasdiagnosed, whereas other 7 patients had central anterior vaginal wall defect. All patients were assessed by POP-Q staging.Results. The anatomical and functional reconstruction of anterior vaginal wall was achieved in all patients. Preopera-tively, mean POP-Q Aa value was +1.1 (± 0.3) and Ba value was + 1.9 (± 1.3) . No major intraoperative or immediatepostoperative complications were observed. One and three months postoperatively, mean POP-Q Aa value was – 2.9(± 0.21) and – 2.82 (± 0.1) respectively and Ba was –2.85 (± 0.4) and – 2.8 (± 0.23) respectively. Patients’ satisfaction andthe imposing short-time surgical outcome were achieved in all cases after three months follow-up. Conclusion. We con-sider Perigee procedure to be highly efficacious, minimally invasive and easy technique for correction of anterior vaginalwall defects.Stru~ni ~lanakKlju~ne rije~i: cistocela, vaginalna stijenka – defekti, inkontinencija urina, Perigee postupakSA@ETAK. Cilj rada. Prikazati preliminarne rezultate transobturatornog pristupa korekcije cistocela metodom Perigee.Metode. 22 bolesnice s cistocelom drugog stupnja podvrgnute su u na{oj ustanovi metodi Perigee u vremenskom raz-doblju izme|u sje~nja 2006. i o`ujka 2007. godine. U 15 bolesnica dijagnosticirano je lateralno paravaginalno o{te}enje,dok je u 7 bolesnica verificirano centralno o{te}enje prednje vaginale stijenke. Rezultati. Anatomska i funkcionalnakorekcija prednje vaginalne stijenke ovom metodom postignuta je kod svih bolesnica. Preoperativno, srednja vrijednostPOP-Q Aa to~ke bila je +1.1 (± 0.3) a Ba to~le + 1.9 (± 1.3). Nije bilo intraoperativnih ni perioperativnih komplikacijazahvata. Jedan i tri mjeseca nakon zahvata, srednja vrijednost to~ke POP-Q Aa bila je – 2.9 (± 0.21) i – 2.82 (± 0.1) dok jesrednja vrijednost to~ke Ba bila –2.85 (± 0.4) i – 2.8 (± 0.23). Zaklju~ak. Smatramo da je Perigee metoda jednostavna,neinvazivna i u~inkovita metoda korekcije defekata svih tipova cistokela.IntroductionGraft augmentation repair of pelvic floor defects hasrecently become exceedingly attractive, since the tradi-tional procedures resulted with failure rate from 40% to60%.1Several innovative approaches using differentgrafts placed vaginally have been confirmed to be effi-cient and safe alternatives for anterior vaginal wall re-pair. The transobturator approach with the principles ofbiosurgery first described by Delorme allowed the de-velopment of innovative simple and minimally invasivemethod for severe and recurrent anterior vaginal wallprolapse.2The Perigee system uses polypropilen meshplaced without tension via strips through the obturatorforamen, and appears to be valuable and time-efficientapproach for all types of anterior vaginal wall defects:central, lateral, proximal and distal. The graft is stronglyattached to four points in the arcus tendineus fasciae pel-vis with intention to reestablish level II support of thevagina. Unlike other vaginal approaches PERIGEE sys-tem ensures finest attachment of apical portion of thegraft near the ischial spine which is crucial for strongvaginal reattachment and endopelvic reconstruction.The obturator route appears to be easy, safe and effec-tual for mesh interposition. According to recent few ini-tial reports the technique itself is accompanied by lowperioperative risks and high satisfactory rate.3–5Thepostoperative complications if occur are minimal andmay be easily manageable. The initial good outcome re-ported in recent analysis is supposed to be permanent.In this preliminary study we report our initial experi-ence, efficacy and operative complications of the PERI-GEE procedure for the cystocele correction. We tried toobtain and describe the optimal route of technique in or-der to reduce the complications reported in previous re-searches and also to prevent recurrent prolapse symp-toms.30Gynaecol Perinatol 2008;17(1):29–32 Ore{kovi} S. et al. Cystocele repair by synthetic mesh secured through the obturator foramen (Perigee system)MethodsThis is the initial descriptive study of the first 22 pa-tients with anterior vaginal wall prolapse grade >2who underwent PERIGEE procedure in our Departmentin the period between January 2006 and March 2007.Mean age of patients was 60,4 (range 50 – 71) and allwere multiparous. 15 women were postmenopausal and10 of them used vaginal estrogen therapy. All patientswere assessed preoperatively by physical examinationand prolapse evaluation by POP-Q staging. Regardingthe urinary and prolapse symptoms 7 women com-plained on straining to void and feel of urinary retentionpreoperatively, and none of them suffered from inconti-nence, frequency and urgency. All patients had sterileurine before the surgery.The procedure was performed under general (13) andspinal (9) anesthesia.We used Perigee system composed of synthetic 5 cm× 10 cm macroporous polypropilen mesh for repairingcentral defects and four self-attached arms for correc-tion of lateral vaginal detachments (Figure 1). Follow-ing a vertical incision from the bladder neck, around 4cm from the apex of vagina the dissection is similar tothat of the anterior colporaphy. Structure of the needleprovides fixation of the mesh at the white line of arcustendineus so there is no need for deep lateral sutures. Af-ter orientation about inferior needle pathway, lateral dis-section toward the white line of the arcus tendineus maybe done. Plication sutures in the midline are placed to re-duce the cystocele but also to prevent the bladder perfo-ration when the inferior needles pass by. Superior bilat-eral incisions are made in the genitofemoral folds at thebase of the adductor longus tendon at the level of clito-ris. The inferior incisions are made 2 cms lateral and 3cms inferior to the superior. Narrow-diameter superiorhelical needles are guided at 45 degrees to patient'smidline and perforate the obturator membrane laterallyto the ischiopubic ramus under the finger guidance toavoid the bladder perforation. The inferior helical nee-dles (Figure 2) are inserted with the handle at 90 degreesand are driven under finger control directly to ischialspines in straightforward direction. After penetrating thelevators they exit along white line at about 1.5–2 cms ofthe spines. It is extremely important to direct the needletips proximally towards spines before rotation through-out the levator muscles. The mesh is subsequently ad-justed to vaginal wall extent in a tension-free mannerand the proximal tail is drown to the lower-most portionof the cystocele. The distal arms are than adjusted withslight tension beneath the bladder neck, to return the an-terior vaginal wall back to its natural anatomical posi-tion (Figure 3). Further step is the fixation of the apicaledge of the graft to the pericervical ring by the sutures inorder to fasten the attachment. The redundant tail of themesh is additionally removed. After rolling over themesh vaginal incision is closed, avoiding the superposi-tion of the mesh and its exposure or infection. The outerplastic sheets are cut at the level of skin incision.After the positioning of the mesh cystoscopy is obli-gate to eliminate the bladder injury and verify potencyof both ureters. The Foley catheter is inserted in thebladder for 24 hours in average. We practice one dayperioperative antibiotic prophylaxis and analgetics if itFigure 1. Four self atached arms and helical needles for mesh introductionSlika 1. ^etiri samostalne ru~ice-igle za uvo|enje mre`iceFigure 2. the inferior helical needle introduction under finger guidanceSlika 2. Uvo|enje donje helikalne igle uz za{titu prstomFigure 3. The mesh position before fixationSlika 3. Postavljena mre`ica prije njena u~vr{}enja31Gynaecol Perinatol 2008;17(1):29–32 Ore{kovi} S. et al. Cystocele repair by synthetic mesh secured through the obturator foramen (Perigee system)is necessary. Patients are recommended to avoid heavylifting, exercise, and sexual activity for at least fourweeks.The incidence of perioperative complications (nerve,vessel, bladder or bowel injury) and postoperative com-plications (erosion, rejection, infection, voiding diffi-culties, retention, urgency, recurrence of prolapse,dyspareunia) were obtained throughout this study. Re-sidual urin was measured by the catheterisation with cuttof point at 50 ml of urine. Also we estimated operatingtime, intraoperative blood loss and hospital stay. All pa-tients were followed-up at the Department 7 days, 1 and3 months postoperatively by urogynecologic inspectionand with regard to postoperative subjective difficultiesand satisfaction.ResultsOut of 22 patients who underwent PERIGEE repair in15 cases lateral cystocele defect was diagnosed, whereasother 7 patients had central anterior vaginal wall defect .Four women had prior hysterectomy and 6 women un-derwent anterior colporaphy previously. None of pa-tients suffered from stress urinary incontinence. Preop-eratively, mean POP-Q Aa value was +1.1 (± 0.3) andBa value was + 1.9 (± 1.3) . The obturator approach wasfeasible in all patients. Mean operating time was 21 min(from 15 to 27 min). No major intraoperative or immedi-ate postoperative complications were experienced. Theanatomical reconstruction of the anterior vaginal wallappeared ideal. No vascular damage or significantbleeding was noticed, and there was no alternations be-tween preoperative and postoperative red blood cellcount. Additionally, no bladder injury was observedduring routine post-op cystoscopy.After removal of Foley catheter all patients could voidvolutionally with no residual urine. One and three monthspostoperatively, mean Aa value was – 2.9 (± 0.21) and– 2.82 (± 0.1) respectively and Ba was –2.85 (± 0.4) and– 2.8 (± 0.23) respectively. Hospitalization interval ran-ged from 1 to 4 days. We observed no rejection or expo-sure of the mesh and subjectively none of patients com-plained on recurrent prolapse symptoms. Mild epithelialerosion was detected in one patient and has been re-solved by reepithelisation after local estrogen therapy.Granulation tissue reaction was not experienced. Norevision has been necessary. There was no incidence ofpost-op stress urinary incontinence or straining to void.In one patient de novo urinary infection developed im-mediately after releasing from the hospital and has beenmanaged promptly by antibiotics. Two patients com-plained on urgency and frequency which dissolvedwithin month after the surgery. Moderate levator painand groin discomfort (5 patients) and dyspareunia (4 pa-tients) were the most prominent postoperative problemsbut have disappeared gradually after analgetic and localestrogen therapy. All remarked postoperative difficul-ties occurred in women who previously underwent vagi-nal operation. At last follow-up visit none of patientscomplained of any recurrent symptom or postoperativedifficulty. Anatomical and functional integrity of thevaginal wall has been accomplished three months post-operatively.All patients were satisfied with postoperative resultsand significantly improved their quality of life. Al-though we keep on with the follow-up after the Perigeeprocedure, we are now able to present maximal short--time success rate and impressively low complicationincidence.DiscussionRather high failure rate of conventional vaginal repairof pelvic organ prolapse triggered the attempts and curi-osity of pelvic surgeons for innovative vaginal ap-proaches and development of new graft augmentationtechniques. Therefore classical mechanical way ofthinking turned out to be almost abandoned changing toa more creative and rational approach to surgery. Onlyrecently has mesh been used transvaginally for correct-ing defects of the endopelvic fascia. First experienceshave been reported by Julian in 1996 who compared an-terior colporaphy with the Marlex graft reinforcementand exceeded 100% objective cure rate at 24 months fol-low up, versus 66% cure rate in conventional repair.6Al-though he observed 25% erosion rate in the mesh groupfurther investigators experienced low complication rateand excellent short-term outcome.7–9A novel vaginalgraft PERIGEE system has been constructed usingtransobturator approach in order to repair all types of an-terior vaginal wall defects (proximal, distal, central andlateral). Bilateral superior and inferior needles allow thesurgeon minimal lateral dissection and therefore reducethe blood loss and other healing abnormalities. The infe-rior helical needles provide the positioning of the proxi-mal part of the mesh adjacent to the ischial spines whichis fundamental route for the reattachment of the vaginalwall to its normal position at the level of the white line.10Consequently, it could be the strongest explanation forhigh success rate and no recurrence of vaginal wall pro-lapse after the PERIGEE procedure reported in recentand in our study.3,11,12The graft is afterwards placed without tension be-neath the bladder as a support of the cystocele instead ofendopelvic fascia and is strongly fixed at four points bythe polypropilen mesh. The advantage of this procedureis that the dissection is simple and there is no need forretropubic or sacrospinous ligament dissection. More-over, the lateral dissection might become redundantwith the surgeon's experience. Since the superior nee-dles pass strictly adjacent to ischiopubic ramus underthe finger guidance toward the level of bladder neck therisks of lower urinary tract, obturator nerve and vesselsinjury should be exceptionally decreased.Concomitant sling methods (SPARC,MONARC)could be performed without disruption of the superiorarms before removing of the plastic sheets. As well the32Gynaecol Perinatol 2008;17(1):29–32 Ore{kovi} S. et al. Cystocele repair by synthetic mesh secured through the obturator foramen (Perigee system)hysterectomy can be carried out simultaneously.10Itseems that strong anchoring of the mesh to the apicalportion of the repair plays a key role in improved out-come and long lasting results of this technique.13Polypropilen mesh carries the advantage over previ-ous synthetic mesh composition with regard to infectionand erosion. In general it has limited foreign body reac-tion, so it is probably the best choice for augmentation.According to some investigators vaginal mesh erosionscontinue to be the serious problems occurring in 2 to 13%.6,7,15,16Usual symptoms include persistent pain andtenderness at the vaginal incision, irritative voiding, re-current urinary tract infections, dyspareunia, vaginalbleeding or persistent SUI. Since this problem com-monly results with recurrent prolapse, in most cases areoperation is required. We observed only one mild ero-sion and no cases of granulations or rejection. Recur-rence of anterior vaginal wall prolapse is well known af-ter the anterior colporaphy and is predisposed by geneticfactor, heavy lifting, smoking and obesity. Recentshort-term pilot studies on Perigee procedure observedno cases of recurrent prolapse symptoms.3,12,13If surgicalfailure and erosions do occur it is expected to happenwithin the first year of surgery, so the assurance and fea-sibility of this procedure might be confirmed in consid-erable time.ConclusionWe consider Perigee procedure to be highly effica-cious, minimally invasive and easy technique for correc-tion of anterior vaginal wall defects. Our experiencesupport initial good impressions of recent publishedstudies, so we intend to evaluate this procedure in a largecomparative well-designed clinical trial for anatomicand functional long term outcome.References1. Weber AM, Walter MD, Diedmonte MR et al. Anteriorcolporaphy: a randomised trial of three surgical techniques.Am JObstet Gynecol 2004;185(6):1300–6.2. Delorme E. Transobturator urethral suspension, mini-in-vasive procedure in the moment of the stress urinary inconti-nence in women. Progress Urol 2001;11:1306–13.3. Palma P, Rane A, Ricceto C et al. Transobturator correc-tion of cystocele. Acta Urol Esp 2005;29:89–92.4. Yan A, Anne M, Karine A et al. Cystocele repair by syn-thetic vaginal mesh secured anteriorly through the obturator fo-ramen. Eur J Obstet Reprod Biol 2004;115:90–4.5. Palma P, Riccetto C, Dambros M et al. New trends in thetransobturator management of cystoceles. BJU Int 2006;97(1):201–10.6. Julian TM. The efficacy of marlex mesh in the repair ofsevere reccurent vaginal prolapse of the anterior mid vaginalwall. Am J Obstet Gynecol 1996;175:1472–5.7. Flood CG, Drutz HP, Waja L. Anterior colporraphy rein-forced with marlex mesh for the treatment of cystoceles. IntUrogynecol J 1998;9:200–4.8. Natale F, Marziali S, Cervigni M. Tension-free cystoce-le repair (TRC): long term follow-up. Proceedings of the 25thAnnual Meeting of the International Urogynecological Associa-tion 2000;120–3.9. Birch C, Fynnes MM. The role of the synthetic and bio-logical protheses in reconstructive pelvic floor surgery. CurrOpin Obstet Gynecol 2002;14:527–35.10. Davila GW. Current concepts in pelvic anatomy and re-constructive surgery. Cleveland Clin J Med, 2005;72:20–7.11. Rane A. A novel transobturator system for the repair ofanterior vaginal wall prolapse: A pilot study. European Associa-tion of the Urology, Annual Meeting 2005:357–9.12. Moore RI, Miklos J. Cystocele repair utilizing anteriorwall mesh graft placed via double trans-obturator approach(Perigee System). International Continence Society, 35th An-nual Meeting, 2005:171–2.13. Gotze W, Melcher J. A new option in the treatment ofpelvic organ prolapse –Perigee (Transobturator anterior prolapserepair system). International Continence Society, 35th AnnualMeetig 2005.14. Karlovsky ME, Kushner L, Baldani GH. Synthetic bio-materials for pelvic floor reconstruction. Current Urol Reports2005;6:376–84.15. Mage P. Interposition of the synthetic mesh by vaginalapproach in the cure of genital prolapse. Gynecol Obstet BiolReprod 1999;28:825.16. de Tayrac R, Gervaise A, Chauveaud A et al. Ten-sion-free polypropilene mesh for vaginal repair of anterior vagi-nal wall prolapse. J Reprod Med 2005;50:75–80.Paper received: 14. 12. 2007.; accepted: 24. 01. 2008. Address for corespondence: Prof. Slavko Ore{kovi}, MD,PhD, Department of Gynecology and Obstetrics, Univ. Med.School, Petrova 13, 10 000 Zagreb, Croatia.

A new option in the treatment of pelvicorganprolapse–Perigee(Transobturatoranteriorprolapse repair system).

A novel transobturator system for the repair of anterior vaginal wall prolapse: A pilot study.

Anterior colporaphy: a randomised trial of three surgical techniques.Am

Anterior colporraphy reinforced with marlex mesh for the treatment of cystoceles.

Chauveaud A et al. Tension-free polypropilene mesh for vaginal repair of anterior vaginal wall prolapse. J Reprod Med 2005;50:75–80. Paper received:

Current concepts in pelvic anatomy and reconstructive surgery.

Cystocele repair utilizing anterior wall mesh graft placed via double trans-obturator approach (Perigee System).

Interposition of the synthetic mesh by vaginal approach in the cure of genital prolapse. Gynecol Obstet Biol Reprod

Karine A et al. Cystocele repair by synthetic vaginal mesh secured anteriorly through the obturator foramen.

New trends in the transobturator management of cystoceles.

Synthetic biomaterials for pelvic floor reconstruction. Current Urol Reports

Tension-free cystocele repair (TRC): long term follow-up.

The efficacy of marlex mesh in the repair of severe reccurent vaginal prolapse of the anterior mid vaginal wall.

The role of the synthetic and biological protheses in reconstructive pelvic floor surgery. Curr Opin Obstet Gynecol

Transobturator correction of cystocele.

Transobturator urethral suspension, mini-invasive procedure in the moment of the stress urinary incontinence in women.

KOREKCIJA CISTOKELE SINTETSKOM MREŽICOM TRANSOBTURATORNIM PRISTUPOM (PERIGEE SISTEM)

KOREKCIJA CISTOKELE SINTETSKOM MREŽICOM TRANSOBTURATORNIM PRISTUPOM (PERIGEE SISTEM)

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