Autologous regenerative cell therapy for female stress urinary incontinence: a systematic review and meta-analysis of clinical outcomes.

OBJECTIVE

To systematically evaluate the clinical outcomes of autologous regenerative cell therapy for female stress urinary incontinence (SUI).

METHODS

A systematic search was conducted in PubMed, Web of Science, EMBASE, Cochrane Library, and CINAHL databases. Data analysis was performed using RevMan and Stata. The primary outcomes were cure and improvement rate. Secondary outcomes included pad test, leakage frequency, questionnaire scores, quality of life, urodynamic parameters, loss to follow-up rate, and adverse events. Subgroup analyses and sensitivity analyses were conducted based on heterogeneity. Publication bias was assessed using funnel plots, begg test, and egger test.

RESULTS

A total of 19 studies encompassing 591 patients were included. The meta-analysis showed that regenerative cell therapy was associated with a pooled cure rate of 41% and a pooled improvement rate of 55% (17 studies). Regenerative cell therapy significantly reduced pad test, decreased leakage frequency, and improved incontinence-specific questionnaires and quality of life. In terms of urodynamic parameters, post-void residual volume was significantly improved, while no significant improvements were observed in maximum urethral closure pressure or maximum flow rate. The loss to follow-up rate and adverse events were no more than 8%. Significant heterogeneity was observed across all outcome measures. Subgroup analysis showed no significant differences and sensitivity analyses confirmed the robustness of the results. Funnel plots suggested potential publication bias, but begg test and egger test were not statistically significant.

CONCLUSION

Autologous regenerative cell therapy for female SUI achieved a 41% cure rate and 55% improvement rate, improved symptoms and quality of life, and demonstrated favorable short-term safety. However, these findings should be interpreted with caution due to short follow-up, lack of magnetic resonance imaging evidence for regeneration, significant heterogeneity, and low-to-moderate study quality. Future large-sample randomized controlled trials with standardized study protocols are needed to further validate these findings.

SYSTEMATIC REVIEW REGISTRATION: The registration URL is as follows: https://www.crd.york.ac.uk/PROSPERO, PROSPERO (CRD420261345945).