Stress urinary incontinence (SUI) is a prevalent and debilitating condition with limited treatment options. Stem cell therapy, particularly using autologous adipose-derived mesenchymal stem cells (MSCs), has emerged as a promising regenerative approach. This pilot study investigates the safety and preliminary efficacy of non-cultured stromal vascular fraction (SVF) in patients with SUI.

Female patients with SUI were enrolled in this study.Participants were eligible if they met the following criteria:
•	Female patients aged >30 years.
•	Confirmed eligibility for stem cell therapy by a plastic surgeon.
•	Sphincter deficiency confirmed by urodynamic studies and a positive cough test, with prior medical therapies being unsatisfactory.
•	Willingness to provide informed consent.
 Adipose tissue was harvested via needle aspiration, and the SVF was isolated using enzymatic digestion. A standardized dose of 1 × 10⁶ cells per square centimeter was injected into the external urethral sphincter under ultrasound guidance. Patients were followed for six months, with outcomes assessed using the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), ultrasound, and electromyography (EMG).

The study included five female patients diagnosed with stress urinary incontinence (SUI). The mean age of participants was 61.2 ± 6.9 years, ranging from 51 to 67 years. The mean height was 156.2 ± 4.6 cm, while the mean weight was 82.2 ± 13.8 kg. The duration of SUI symptoms varied among participants, with a mean duration of 4.6 ± 2.5 years (range: 1–7 years).

No serious adverse events were reported, confirming the safety of the procedure. The mean baseline scores for the Frequency (F), Incontinency (I), and Voiding Impact (V) subscales were 6.6 ± 1.5, 8.4 ± 1.7, and 1.6 ± 0.5, respectively. At six months, the scores were 6.6 ± 1.3, 8.0 ± 2.0, and 1.4 ± 0.5, indicating no significant improvement in symptom severity or quality of life (p > 0.05).Individual patient variability was observed, with some patients showing modest improvements in urinary frequency.

While no statistically significant improvements in SUI symptoms were observed, the study provides valuable insights into the potential of MSC-based therapies and underscores the need for further optimization.
The use of non-cultured SVF represents a significant advancement in the field of regenerative medicine for SUI. Unlike traditional approaches that rely on cultured MSCs, our method eliminates the need for prolonged cell expansion in vitro, reducing the risk of contamination and genetic instability. This approach also shortens the time from tissue harvesting to cell transplantation, making it more feasible for clinical applications. To our knowledge, this is the first study to evaluate the therapeutic potential of non-cultured SVF in patients with SUI, offering a novel and minimally invasive alternative to existing treatments.

This pilot study demonstrates the safety and feasibility of autologous adipose-derived MSC therapy for SUI. While no significant symptomatic improvement was observed, the absence of adverse events supports further investigation. Larger randomized controlled trials with extended follow-up are needed to evaluate the efficacy and long-term safety of this regenerative approach.