Capio TM Slim Suture Device x Tissue Anchoring System in treatment of advanced pelvic organ prolapse. Prospective and Randomized study: Partial Results with 12 months follow-up

Moreira de Jesus R1, Richetti R1, Vidotti S1, Hwang S1, Mendonca A1, Machado A1, Morato Toledo L1, Mendonca R1

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 431
On Demand Pelvic Organ Prolapse
Scientific Open Discussion Session 28
On-Demand
Prolapse Symptoms Pelvic Floor Surgery Pelvic Organ Prolapse
1. Vila Nova Cachoeirinha Maternity Hospital
Presenter
R

Raphael Moreira de Jesus

Links

Abstract

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.
Results
Mean follow-up was 12 months. Baseline characteristics were similar between the groups. Mean age was 64 years, body mass index 26.7 and parity of 4.5 children. The overall objective success rate to date is 89.6% considering all compartments. One patient (1.16%) presented extrusion. 20.6% of non-preoperative continent patients developed DENOVO urinary incontinence and 66% required sling surgery during follow-up. The overall subjective success rate is 95.3% and so far no difference between groups.
Interpretation of results
The overall subjective success rate is 95.3% and so far no difference between groups.
Concluding message
The partial results do not show the statistical difference between the groups so far. The overall objective success rates are 89.6% and 95.3% of subjective success in the treatment of patients with advanced pelvic organ prolapse.ctive success in the treatment of patients with advanced pelvic organ prolapse.
Figure 1 POP-Q before and after surgery using Tissue Anchoring System (TAS) vesus Capio Sling Suture Device
Disclosures
Funding None Clinical Trial No Subjects None
26/04/2024 17:57:18