Outcomes following anterior pelvic flooor repair using Perigee system

1. 32 nd Annual Meeting of IUGA—Cancun, Mexico June 12-16, 2007 Outcomes following anterior pelvic flooor repair using Perigee system Götze, Wolfgang und Melcher, Jana; Dept. Obst. & Gyn. KH MOL Strausberg, Germany Objectives: To evaluate surgical outcomes and long term results in patients with Perigee-implantation (AMS Co.) for anterior repair. Material and Methods: This is a prospective observational case-study of up to now 195 patients with pelvic organ prolapse (POP grade III) who underwent Perigee implantation between 1.10.2004 and 31.12.2006. All patients were re-examined 8 weeks after the operation and all 106 cases operated on before 31.12.2005 had one year follow up – examination and interview. Assessment was made of anatomical reconstruction results, mesh presentation, shrinkage effects, erosions, the development of reactive entero/ recto-celes, residual urine, cure or persistence of incontinence etc. Patient satisfaction, improvement or worsening of quality of life and side effects such as dyspareunia, dysuria etc. were surveyed during interviews. The study is planned to extend over a period of at least 5 years. Median patient age = 66 years (41 to 89 years). Simultaneous hysterectomy was only performed in 4 cases with level I defect. Indication n Prolapsing cystocele III° ( Desc. vag. ant. III° ) 161 Cystocele II° + SUI or urge 8 Subtotalprolaps of uterus 14 Totalprolaps of uterus 7 Sub/Totalprolaps of vagina after hysterectomy 5 History : previous operation , SUI, RU etc. n Prior Hysterectomia 52 Prior Colporrhaphia 39 Prior Apogee 3 Stress urinary incontinence I-II° 66 Urinary retention 41 Operation and perioperative management: At first we perform a midline vaginal incision - then strictly blunt preparation to the Arcus tendineus and the Spina ischiadica. No vaginal resection or fascial suture. After Implantation of the mesh suburethral meshfixation with paraurethal 2/0 vicryl sutures. In all cases covers the mesh 2/3 of total urethralength. This is different to the recommondation of the AMS- manual. Mesh fixation sutures also at the cervix or the apical vaginal wall for an good streching of the mesh . We give full tension to all anchoring mesh straps for a proper mesh placement. Contingous closure suture for vagina Intraoperative antibiosis with Pipril. Catheter und Betaisodona vaginal tamponage for 24 h. The skin incisions were provided with steristrips. Mean operating time: 30 minutes. Cystoscopy only if the urine is not clear. No immobilisation. No restrictions ( sport, sex, heavy work) 6 weeks after operation. Results: No intra operative adverse effects were observed ( except one bladder lesion caused by blunt dissection in the right Fossa obturatoria- with no direct relation to the perigee implantation system – which led us change intraoperative procedure to a successful classic anterior Colporrhaphia without any late complications.) The intraoperative blood loss was minimal (less than 100 ml). 3 (of 195) postoperative hematomas were observed in the anterior wall zone and treated by revision. 2 (of 195) hematomas in the Fossa obturatoria were treated conservatively and were spontaneously resorbed after 6 weeks. No mesh- infection or abscess was observed. 8 (of 195) asymptomatic mesh-erosions ( exactly = little meshparts in the midline after incomplett primary woundhealing ) were treated successfully. No secondary erosions were observed 49 of 66 patients with case histories of urinary incontinence I-II° were continent and free of complaints after the operation. 3 of the 66 were overcorrected and required treatment (minimal mesh division). 9 of 66 patients with persistent postoperative urinary incontinence became continent following a second intervention with Sparc or Zuidex implants. Urinary problems persisted with 5 patients. 36 of 41 patients with residual urine and disturbances of micturition were postoperatively free of residual urine. No postoperative de novo renal congestion has been observed to date. Reactive Entero/Rectocele was a real problem in 12 (of 195 ) patients –cured by 9 Apogee-implantations and 3 classic posterior colporrhaphia. One hysterectomy and two amputation of cervix uteri were necessary in 3 (of 195) cases with development of Elongatio colli uteri. There were no reports of pain or irritation following removal of the tamponage and the catheter. A few patients described an initial sensation of muscle ache in the inner thigh during the first hours after operation. One Year follow up: Reconstruction results (97 of 106 optimal, 4 of 106 sufficient, 5 of 106 suboptimal – but only one case with an anterior high cystocele-relapse needed re-treatment). Patient satisfaction regarding all complaints (94 of 106 very satisfied or satisfied). Patient satisfaction does not correlate with the anatomical result and is influenced by associated problems, such as persistent urge incontinence or reactive enterocele. No worsening of quality of life was reported by our patients. 104 (of 106) would recommend this operation to others. 2 (of 106) cases of de novo dyspareunie were observed. Main problem was persistence of urge in 6 of 106. Some patient start excessive sport activities ( walking , aerobic ) after implantation of perigee. Up to now we see in such cases no adverse side effects or recurrence of anterior prolaps. Conclusions: The perigee system allowed a safe and effective treatment of pelvic floor defects at all 3 levels and could be the first choice in the future of POP-treatment– if more long term data confirms our results. Our concept of minimal therapy avoids simultaneous hysterectomies, unnecessary vaginal skin excision, opening of the peritoneum, etc. In comparison with other systems, the Perigee implantation instruments offer reduced-trauma and ergonomically favorable tissue penetration. No severe complications were observed. We were able to cure all adverse events, such as mesh erosions, hematomas and reactive hernias. Update: About 50 of 195 patient had recently the 2-year-follow up –examination and interview. There is no change compared to the 1-year-follow-up. Declaration: This study is not supported by the industry. The authors are not employee or consultants of the industry.