Prospective International Multicenter Pelvic Floor Study: Short-Term Follow-Up and Clinical Findings for Combined Pectopexy and Native Tissue Repair

摘要

Efforts to use traditional native tissue strategies and reduce the use of meshes have been made in several countries. Combining native tissue repair with sufficient mesh applied apical repair might provide a means of effective treatment. The study group did perform and publish a randomized trial focusing on the combination of traditional native tissue repair with pectopexy or sacrocolpopexy and observed no severe or hitherto unknown risks for patients (Noé G.K. J Endourol 2015;29(2):210–215). The short-term follow-up of this international multicenter study carried out now is presented in this article. Material and Methods: Eleven clinics and 13 surgeons in four European counties participated in the trial. In order to ensure a standardized approach and obtain comparable data, all surgeons were obliged to follow a standardized approach for pectopexy, focusing on the area of fixation and the use of a prefabricated mesh (PVDF PRP 3 × 15 Dynamesh). The mesh was solely used for apical repair. All other clinically relevant defects were treated with native tissue repair. Colposuspension or TVT were used for the treatment of incontinence. Data were collected independently for 14 months on a secured server; 501 surgeries were registered and evaluated. Two hundred and sixty-four patients out of 479 (55.1%) returned for the physical examination and interview after 12–18 months. Main Outcome and Results: The mean duration of follow-up was 15 months. The overall success of apical repair was rated positively by 96.9%, and the satisfaction score was rated positively by 95.5%. A positive general recommendation was expressed by 95.1% of patients. Pelvic pressure was reduced in 95.2%, pain in 98.0%, and urgency in 86.0% of patients. No major complications, mesh exposure, or mesh complication occurred during the follow-up period. Conclusion: In clinical routine, pectopexy and concomitant surgery, mainly using native tissue approaches, resulted in high satisfaction rates and favorable clinical findings. The procedure may also be recommended for use by general urogynecological practitioners with experience in laparoscopy.