Objective: To prospectively assess clinical outcomes after pelvic organ prolapse repair with a standardized trocar-guided surgical device using polypropylene mesh.
Methods: This was a prospective multicenter cohort study performed throughout 26 clinics. Evaluation at baseline, 2 months, and 1 year after surgery included prolapse grading using the pelvic organ prolapse quantification system (POP-Q) and symptom assessment using the Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6). For the purpose of this study, postoperative POP-Q stage 0-I was considered anatomic cure.
Results: Two-hundred sixty-one patients were included in the study; 232 (89%) attended the 1-year follow-up. Mean+/-standard deviation age at surgery was 66.3+/-9.4 years. Anatomic cure 1 year after surgery was observed in 96 of 121 women (79%) after anterior repair with mesh (P<.001), and 56 of 68 (82%) after posterior repair with mesh (P<.001). For combined anterior and posterior mesh repair, cure was 51 of 63 (81%) and 54 of 63 (86%) for the anterior and posterior compartment, respectively (P<.001 for both). Bladder and rectal perforations occurred in 9 of 252 patients (3.4%). Vaginal erosions, the majority mild to moderate, occurred in 26 of 232 cases (11%). Surgical intervention due to mesh exposure occurred in seven cases (2.8%). There were significant quality-of-life improvements in all domains of the IIQ-7. Despite significant improvements in UDI-6 scores, symptoms specific for stress urinary incontinence were not ameliorated.
Conclusion: Trocar-guided transvaginal mesh surgery for pelvic organ prolapse is associated with satisfactory objective and subjective outcomes 1 year after surgery.
Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00402844
Level of evidence: II.