Hypothesis / aims of study
Pelvic organ prolapse (POP) adversely affects the quality of life in women, and surgical intervention is required for many patients. In recent years, alloplastic mesh has been implanted to stabilize the pelvic floor, significantly improving symptoms. To our knowledge, there is a lack of studies comparing the efficacy and safety of TiLOOP ® Total 4(T4, pfm medical ag, Germany) combined with native tissue apical suspension versus TiLOOP ® Total 6(T6, pfm medical ag, Germany) in POP surgery. This study provides preliminary results.
Study design, materials and methods
This multicentre prospective cohort study enrolled patients with POP who were subjected to either T4 combined with native tissue apical suspension or T6. Baseline characteristics, perioperative outcomes, and follow-up results were collected. To mitigate confounding due to baseline differences between groups, propensity score matching was performed at a 1:3 ratio. Matching variables included age, body mass index (BMI), degree of anterior vaginal wall prolapse, and degree of apical prolapse. Efficacy and safety outcomes were compared between the two groups after matching.
Results
Compared to the T6 group (n=845), the T4 combined with native tissue apical suspension group (n=305) demonstrated a longer operative time (110 vs. 98 min) and higher incidences of acute urinary retention (7.5% vs. 2.1%), postoperative pain (7.9% vs. 2.5%), and thrombosis (4.3% vs. 0.7%) in the perioperative period (all p < 0.001). During long-term follow-up, no statistically significant differences were observed between the T4 combined with native tissue apical suspension group and the T6 group in the rates of pelvic anatomical recurrence or mesh exposure (all p > 0.05). However, recurrence in the apical compartment and posterior compartment occurred later in the T4 combined with native tissue apical suspension group (p = 0.001 and p = 0.032, respectively). The incidence of new-onset or worsening stress urinary incontinence (SUI) was significantly higher in the T4 combined with native tissue apical suspension group than in the T6 group (12% vs. 4.1%, p < 0.001), although the time to new-onset or worsening SUI did not differ significantly between the groups.
Interpretation of results
T4 combined with native tissue apical suspension and T6 were generally comparable in terms of long-term anatomical recurrence and mesh exposure. The T4 combined with native tissue apical suspension procedure provided more durable anatomical support for the apical and posterior compartments, but was associated with a significantly increased risk of new-onset or worsening SUI. The T4 combined with native tissue apical suspension procedure required a longer operative time and had higher incidences of acute urinary retention, postoperative pain, and thrombosis compared to the T6 procedure.
Concluding message
T4 combined with autologous apical surgery and T6 mesh achieve comparable long-term efficacy in pelvic organ prolapse surgery, but they differ in their risk–benefit profiles. T4 combined with autologous apical surgery offers more durable anatomical maintenance of the middle and posterior compartments, yet it is associated with significantly higher perioperative risks (prolonged operative time, acute urinary retention, postoperative pain, and thrombosis) and a greater risk of de novo or worsened stress urinary incontinence compared with the T6 group.