Hypothesis / aims of study
Pelvic floor dysfunctions (PFD), including stress urinary incontinence (SUI) and female sexual dysfunction (FSD), significantly impair quality of life. Low-Intensity Extracorporeal Shockwave Therapy (Li-ESWT) is an emerging non-invasive regenerative intervention. This study aimed to evaluate the clinical efficacy, safety, and time-to-response of Li-ESWT in women presenting with UI and/or FSD over a longitudinal follow-up.
Study design, materials and methods
A longitudinal clinical study was conducted with a cohort of 47 women (mean age 43.5 years). Participants were stratified into three groups based on primary clinical complaints identified through validated screening questionnaires (Quality of Life, urinary symptoms, and sexual function domains): Urinary Incontinence (UI, n=31), Female Sexual Dysfunction (FSD, n=37), and Mixed Symptoms (n=21). Assessments were performed at Baseline (T0), Mid-treatment (after 4 sessions, T1), and Post-treatment (after 8 sessions, T2). Primary outcomes included leakage frequency, interference in daily life (0–4 scale), and subjective improvement in sexual domains (lubrication, arousal, and orgasm). Data were analyzed using longitudinal tracking. IRB approval and informed consent were obtained.
Results
In the UI group, the "Dry Rate" reached 60% at T2, while the remaining 40% reported a significant reduction in leakage frequency. Symptom interference on daily activities decreased by 65.5% (mean score 2.61 at T0 vs. 0.90 at T2; $p < 0.001$). Regarding FSD, 100% of participants reported improvement in at least one sexual domain, with significant gains in lubrication and arousal. A key finding was the rapid therapeutic response: 78.7% of the total cohort reported significant global improvement as early as T1 (mid-treatment). The procedure was well-tolerated, with no serious adverse events. Follow-up data for 1 and 3 months (T3/T4) are currently being finalized (study completion in January 2026) and will be presented.
Interpretation of results
The results suggest that Li-ESWT induces rapid tissue remodeling and functional improvement in the pelvic floor. The high "Dry Rate" and significant reduction in symptom interference indicate that Li-ESWT is a potent tool for SUI. Furthermore, the 100% improvement rate in at least one sexual domain highlights the regenerative impact on vaginal mucosa and vascularization. The early response at T1 (4 sessions) is particularly relevant for patient adherence and clinical planning.