From TVM to Prolift (R) (Gynecare): the development of a technique for the treatment of pelvic prolapse by vaginal route using a prosthetic support, based on a multicenter, retrospective study of 794 patients (684 TVM/110 Prolift)

摘要

abstract_textpObjective: To assess the short-term outcomes of the treatment of pelvic prolapse by vaginal route with the Prolift (R) (Gynecare) device, by comparing the outcomes with those of a previous feasibility study of the transvaginal mesh (TVM) technique./ppMaterials and methods: This is a retrospective study assessing the results of the development of a surgical technique, from its design to its final use as a surgical device. From November 2002 to December 2004, 684 patients in seven medical centres underwent TVM surgery during the technique's evaluation phase. Starting with the release of the Prolift device in March 2005, the outcomes of the first 110 patients treated were combined and compared to previously recorded cases. All the patients had at least one manifestation of preoperative, third-degree pelvic prolapse (to the vulva). In the TVM group, 16.7 had undergone previous prolapse surgery, and 24.3 had had a hysterectomy; the average follow-up was 3.6 months (2-18). In the Prolift group, 22 patients (20) had had one or more surgical interventions for prolapse, while 31 (28.1) had undergone a hysterectomy; the follow-up was a minimum of three months. In all cases, the procedure consisted in inserting a knitted, polypropylene, monofilament mesh implant by vaginal route (soft Prolene (R) from Gynecare): the anterior implant has four strap-like extension arms positioned through the transobturator route, while the posterior implant has two extension arms that are attached to the sacrospinatus ligament or positioned using the transgluteal approach. In the TVM group, 15.8 of the patients received an anterior implant alone, 14.8 a posterior implant alone, and 69.4 both anterior and posterior. In the Prolift group, 20 received the anterior implant alone, 26.3 the posterior alone, and 53.6 both./ppResults: The rate of complications was slightly lower in the Prolift group-0.9 peroperative compared to 2.05, and 1.8 postoperative compared to 2.63. At 3 months, the overall rate of erosion also appeared lower; with the final implant device, it dropped from 11.3 to 4.7. Nonetheless, during the evaluation phase, 50.3 of the patients received a hysterectomy at the same time as the prolapse treatment, although conservation of the uterus is currently the choice in 81 of cases. The failure rate, determined by the recurrence of symptomatic and/or third-(to the vulva) or fourth-degree (protrusion) prolapse, was also lower, dropping from 5.3 (36 recurrences) to 4.7 (5 recurrences)./ppConclusion: These preliminary results of using the Prolift technique to treat pelvic prolapse by vaginal route confirm the feasibility and low peroperative and post-operative morbidity immediately following the TVM first described. The use of an adapted device appears to improve the outcome. The rate of exposure of the mesh device is now much lower, less than 5 and similar to that reported after promontofixation. The results regarding pelvic statics are encouraging, demonstrating a less than 5 risk of recurrence. The results must now be assessed over a longer period of time and compared to other techniques, such as promontofixation, through randomized studies./p/abstract_text