Hypothesis / aims of study
As life expectancy grows, it is expected that the number of women with pelvic organ prolapse (POP) in the world will increase in the coming decades. POP surgeries using mesh, in countries like Brazil, remains as an option for patients with a high risk of recurrence of prolapse and further studies are needed to define its priority and safety for use in patients with advance prolapse. Objective: to compare the effect and safety of POP treatment at an advanced stage using two hysteropexy techniques.ced stage using two hysteropexy techniques.
Study design, materials and methods
Prospective, randomized, simple blind study comparing two hysteropexy techniques for POP treatment. Adult women, over 45 years old, with advanced pelvic organ prolapse, stage III or IV of POP-Q, anterior and apical (uterus or dome) were selected. Patients with exclusively posterior prolapse were not included. The sample was randomized to treat 86 patients using two different types of commercial mesh (UpHOLD using a CAPIO TM sling suture device x SPLENTIS using a harpoon anchorage fixation) for follow-up up to 12 months. Objective success was defined as a decrease in point C ≤ 1/3 of the total vaginal length, point Ba and Bp ≤ -1, and without reoperation. Subjective success was defined as the absence of POP symptoms (vaginal weight or protrusion) and PGI-I (patient global impression of improvement) alternatives 1 and 2. The patients also responded to the Visual Analogue Scale (VAS) for satisfaction with the treatment and for pain, and ICIQ-VS for vaginal symptoms. The urodynamic study indication was individualized. The concomitant sling was performed when there was a diagnosis of stress or occult urinary incontinence.
Interpretation of results
The overall subjective success rate is 95.3% and so far no difference between groups.