Autologous Transobturator Fascia Lata Sling for Female Stress Urinary Incontinence: A Pilot Feasibility and Safety Study.

OBJECTIVE

To evaluate the preliminary safety, feasibility, and short-term outcomes of the autologous transobturator fascia lata sling for female SUI to our knowledge the first series using fascia lata via a transobturator route, in view of the mesh-related complications of synthetic midurethral slings and the limitations of rectus fascia harvest in women with prior abdominal surgery, central obesity, or scarred fascia.

METHODS

Prospective single-arm pilot feasibility and safety study of 40 women with SUI or stress-predominant mixed urinary incontinence (MUI) who underwent autologous transobturator fascia lata sling at Al-Azhar University Hospitals (June 2023 to May 2025; NCT05646745). Outcomes were assessed at 24 h, 2 weeks, and 3 months using the cough stress test, ICIQ-FLUTS questionnaire, and VAS pain scores.

RESULTS

Mean age was 48.9 ± 7.8 years; BMI 31.4 ± 4.1 kg/m2. At 3 months, the overall success rate (cured + improved) was 87.5%, and the objective cure rate (negative cough stress test) was 72.5%. ICIQ-FLUTS incontinence score decreased from 12.75 ± 3.41 to 3.23 ± 2.91 (p < 0.001, Cohen's d = 2.79); incontinence QOL from 35.88 ± 5.83 to 4.50 ± 7.22 (p < 0.001, d = 5.38). No voiding dysfunction, sling erosion, or major complications occurred. Grade I incontinence achieved 100% success. Thigh and groin pain resolved by 3 months in 92.5% and 100%, respectively.

CONCLUSION

This preliminary exploratory study suggests that autologous transobturator fascia lata sling is a feasible and promising mesh-free technique for female SUI with favorable short-term outcomes at 3 months. These results must be interpreted cautiously given the small sample size, short follow-up, and absence of a control group. Longer follow-up, multicenter validation, and randomized comparative studies are warranted.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT05646745.