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

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):210-5.). 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.

Prospective international multicenter pectopexy trial: Interim results and findings post surgery.

The technique of laparoscopic pectopexy was published in 2010. A subsequent randomized trial focused on pectopexy versus sacropexy revealed no new risks for patients and significant advantages in terms of operating time and de novo defecation disorders compared to sacrocolpopexy. The present international multicenter trial was performed to evaluate the applicability of the technique in clinical routine. MATERIAL AND METHOD: Eleven clinics and 13 surgeons in four European counties participated in the trial. To ensure a standardized approach and obtain comparable data, all surgeons followed the same rules in placing the apical tape, no further mesh was used. Data were collected for 14 months on a secured server; 501 surgeries were documented and evaluated. RESULTS: Patients treated at the leading center (2 surgeons) contributed 44 % of the patient population. We made a distinction between high-volume (48-135 surgeries annually) (n = 4), intermediate-volume (28-37 surgeries annually) (n = 4), and low-volume (7-22 surgeries annually) (n = 5) surgeons. 97.3 % of the patients (n = 501) had delivered children; 5.6 % had had a Caesarian section. 29.7 % of the patients had undergone a hysterectomy. The operating time for pectopexy was less than 60 min in 79 % of cases. The procedures were completed in less than 159 min in 71 % of cases. Severe complications (n = 5) included four cases of organ damage (related to concomitant surgeries or adhesions) and one case of relevant bleeding. De novo incontinence was registered in two cases and voiding dysfunction in three. No intestinal obstruction or defecation disorder was observed. Two complicated infections were noted. Urinary infection occurred in 2 % of patients. CONCLUSION: In clinical routine severe complications occurred in 1 %. The latter were unrelated to pectopexy, but occurred due to concomitant procedures or adhesions. The overall operating time as well as the operating time for pectopexy were similar to those reported in published studies on sacrocolpopexy.