Hypothesis / aims of study
Currently, more than 40 different types of synthetic mid-urethral slings are used worldwide for the surgical treatment of stress urinary incontinence (SUI). However, there is a steadily growing body of evidence concerning mesh-related complications associated with the use of polypropylene slings.
The aim of this study is to improve the surgical outcomes of female stress urinary incontinence by using a hybrid allogeneic–synthetic suburethral sling, with the specific goal of preventing implant-associated complications.
Study design, materials and methods
This prospective study included 103 women with SUI who presented to the Clinic of Bashkir State Medical University. Patients were randomized into two groups: Group 1 (n = 51) received a combined sling consisting of a polypropylene mesh with a central allograft; Group 2 (n = 52) underwent a conventional polypropylene transobturator tape (TOT). Preoperatively and postoperatively, patients were assessed using the ICIQ‑SF, OAB‑q, and PISQ‑12 questionnaires to evaluate sexual function. In addition, comprehensive urodynamic testing was performed before surgery and at 1 month postoperatively, and pelvic MRI was obtained at 3, 6, and 12 months.
Interpretation of results
There was a statistically significant reduction in ICIQ‑SF scores from baseline to postoperative assessment (p < 0.001).
A significant intergroup difference was observed in the rate of achieving high OAB‑q total scores (≥8), indicating de novo overactive bladder (OAB). In Group I, one patient (2.0%) had a score >8, compared with seven patients (14%) in Group II (p < 0.05). These findings correlated with objective urodynamic results obtained at 1 month postoperatively in both groups. Statistical analysis demonstrated a significant difference (p < 0.03) in the proportion of patients with normal urodynamic parameters: 86% in Group II vs. 98% in Group I.
Of the total cohort, 78 patients were sexually active: 38 (74.5%) in the allogeneic‑synthetic sling group and 40 (77%) in the control group (p > 0.05). Assessment of sexual function using the PISQ‑12 questionnaire at baseline and at 6 months postoperatively showed improvement in both groups. In the combined sling group, there was a trend toward more pronounced improvement, with nine patients (17.5%) achieving high scores (>35) compared with five patients (10%) in the control group. Pelvic MRI revealed no pathological changes, excessive fibrosis, or implant displacement in Group II.