Post-Treatment Response and Safety of Stem Cell-Based Urethral Injection Therapy for Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis

Background/Objectives: Cell-based therapies have been proposed as a regenerative treatment for female stress urinary incontinence (SUI), but their efficacy, safety, and optimal delivery characteristics remain uncertain. The aim of this review is to systematically evaluate the post-treatment clinical response and safety of cell-based injection therapies for female SUI and explore factors associated with post-treatment response.

Methods

PubMed, Scopus, and the Cochrane Library were searched from inception to 15 February 2026, and the search was subsequently updated through 25 April 2026 to identify newly published studies. Randomized controlled trials and prospective single-arm studies evaluating urethral injection of cell-based therapies in adult women with SUI were included. Random-effects meta-analysis was used to pool study-defined post-treatment response proportions. Subgroup analyses examined response definition, cell source, urinary incontinence type, ultrasound guidance, injection approach, and post-treatment physiotherapy. Continuous moderators were explored using univariable meta-regression. Placebo-controlled randomized trials reporting a common 12-month response endpoint were additionally pooled using risk ratios (RR).