Suburethral implantation of autologous regenerative cells for female stress urinary incontinence management: Results of a pilot study.

OBJECTIVES

To assess the feasibility and the safety of treating female stress urinary incontinence (SUI) with suburethral implantation of a mixture of the stromal vascular fraction from adipose tissue and leukocyte-and platelet-rich-fibrin.

METHODS

Patients with SUI were treated with a mixture of stromal vascular fraction and leukocyte-and platelet-rich fibrin. The stromal vascular fraction was obtained from enzymatic digestion of autologous adipose-tissue and added to an leukocyte-and platelet-rich-fibrin membrane. The mixture was transvaginally implanted into the suburethral area. A fraction of the Stromal vascular fraction sample was used for cellular characterization. Patients were followed for 9 months. Every 3 months, the patients were clinically evaluated with a cough- stress test and a validated-questionnaire. An MRI was performed preoperatively and 3 months after the procedure to assess tissue changes.

RESULTS

Ten patients received the surgical procedure. The validated-questionnaire revealed a subjective SUI improvement in nine patients 3 months after the operation and in seven patients 9 months after the operation. Eight, six, and four patients achieved a negative cough-stress test 3, 6 and 9 months post-injection, respectively. Flow cytometric analysis of stromal vascular fraction cell phenotypes revealed predominantly mesenchymal and endothelial cell heterogeneity. In total, we injected 0,18 × 106 to 13,6 × 106 cells. No adverse events were observed peri- or postoperatively.

CONCLUSION

These preliminary results suggest that the suburethral implantation of a combination of SVF and l-PRF is a feasible and safe modality for treating female SUI. However, evidence is lacking and further research are needed to clarify the respective roles of SVF and l-PRF in female SUI treatment.