Robotic Assisted Sacral Colpopexy: A Prospective Study Assessing Outcomes With Learning Curves is an open-label study that is being conducted on a new pelvic floor program for women with pelvic organ prolapse.
A prospective cohort of 100 patients will be recruited and the study will assess surgical time (total and specific essential portions), simulator training, and observed surgeon skills. Secondary endpoints include subjective outcomes for issues of sexual function and incontinence and adverse events such as genitourinary injury, blood loss, wound infection, and mesh erosion.
Kaiser Permanente is the trial sponsor, and patients aged 18-80 years who are undergoing robotic-assisted laparoscopic sacrocolpopexy with or without other procedures for pelvic organ prolapse are being recruited. For more details about the trial, visit https://goo.gl/pWq7qe.
SOURCE: ClinicalTrials.gov: NCT01535833.