Efficacy of extracorporeal shock wave therapy for female stress urinary incontinence: a systematic review and meta-analysis

Introduction

Stress urinary incontinence (SUI) is a prevalent condition affecting millions of women worldwide, characterised by involuntary urine leakage during physical exertion, sneezing or coughing (1). This condition significantly impacts quality of life, affecting social interactions, physical activities and psychological well-being (2,3). Traditional treatment options range from conservative approaches such as pelvic floor muscle training to surgical interventions (e.g., mid-urethral sling). However, sling procedures carry non-negligible risks of mesh erosion, chronic pain and medico-legal litigation, underscoring the value of developing non-invasive alternatives.

The management of SUI has evolved significantly over recent years, with increasing emphasis on minimally invasive treatment options (4). Among these, extracorporeal shock wave therapy (ESWT) has emerged as a promising intervention, offering potential advantages in terms of being non-invasive, having minimal side effects and requiring no recovery time (5). This form of therapy involves delivering acoustic waves to target tissues, potentially stimulating neovascularisation and tissue regeneration (6).

The mechanism of action of ESWT in treating SUI involves multiple pathways. The mechanical stimulation provided by shock waves may enhance blood flow and promote tissue healing through the release of growth factors and cytokines (7). The mechanical stimulation provided by shock waves augments blood flow and collagen remodelling. These trophic effects precede measurable gains in pelvic floor contractility, offering a biologically plausible link to symptom reduction. Additionally, ESWT has been shown to potentially strengthen pelvic floor muscles and improve urethral sphincter function (8). These physiological changes could contribute to improved continence control and reduced symptoms (9).

Recent clinical studies have reported varying degrees of success with ESWT for SUI treatment (10,11). However, differences in treatment protocols, energy settings and outcome measures have led to inconsistent results across studies (11,12). The optimal parameters for ESWT delivery, including energy flux density, number of pulses and treatment duration, remain topics of ongoing research (12).

Given the increasing adoption of ESWT in clinical practice and the variability in reported outcomes, a comprehensive evaluation of its efficacy is warranted. This systematic review and meta-analysis aims to synthesise current evidence regarding the effectiveness of ESWT in treating SUI, specifically focusing on symptom improvement and quality-of-life outcomes. We present this article in accordance with the PRISMA reporting checklist (available at https://tau.amegroups.com/article/view/10.21037/tau-2025-123/rc).

Methods

Study design and search strategy

A comprehensive literature search was performed across multiple electronic databases, including PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure and Wanfang, from their inception to January 2024. The search strategy employed combinations of relevant terms, including ‘extracorporeal shock wave’, ‘Low Intensity Extracorporeal Shock Wave Therapy’ and ‘stress urinary incontinence’.

Eligibility criteria and study selection

Studies were considered eligible if they were clinical trials or randomised controlled trials (RCTs) investigating the efficacy of ESWT for SUI. The inclusion criteria required studies to report quantitative outcome measures, including the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Quality of Life Questionnaire or other validated assessment tools. Studies were required to have a control group and provide clear documentation of treatment parameters, including energy intensity and treatment duration.

Outcomes

Primary outcomes were changes in ICIQ-SF score and overall treatment efficacy. Efficacy was defined as a ≥50% reduction in 1-h pad-weight test or patient-reported cure/marked improvement. Secondary outcomes included Incontinence Impact Questionnaire-7 (IIQ-7), Overactive Bladder Symptom Score (OABSS) and Urogenital Distress Inventory (UDI) scores, because mixed lower urinary tract symptoms modulate SUI-related quality of life.

Data extraction and quality assessment

Two independent reviewers extracted data from the included studies using a standardised form. The extracted information encompassed study characteristics (author, year, study design), intervention details (shock wave parameters, treatment duration, frequency), participant demographics and outcome measures. Scoring directions for every outcome scale are provided in Table S1.

The methodological quality of included studies was assessed using the Cochrane risk of bias tool. This evaluation covered seven domains: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting and other potential sources of bias. The overall quality of the included studies was determined to be moderate, with some concerns regarding incomplete outcome data in certain studies.

Statistical analysis

The meta-analysis was performed using standardised mean differences (SMDs) with 95% confidence intervals (CIs) for continuous outcomes and risk ratios (RRs) for dichotomous outcomes. Heterogeneity among studies was assessed using the I² statistic and Chi-squared test, with I² values >50% indicating substantial heterogeneity. Random-effects models were employed when significant heterogeneity was present. Subgroup analyses were conducted based on outcome measures, and study weights were calculated to determine the relative contribution of each study to the overall effect size.

Results

Study characteristics

Following the systematic literature search and screening process (Figure 1), four studies (13-16) were included in the final analysis, published between 2020 and 2024 and encompassing a total of 287 participants. The basic characteristics of these studies are summarised in Table 1. Three studies were RCTs (14-16) and one was a clinical trial (13). Treatment protocols varied across studies, with energy intensities ranging from 0.09 to 0.25 mJ/mm² and treatment durations spanning from 3 to 8 weeks.

Figure 1 Flow chart of literature screening.

Primary outcomes

ICIQ-SF scores

Three studies reporting ICIQ-SF scores were included in the meta-analysis (13-15), with a total of 260 participants. As shown in Figure 2, the pooled analysis demonstrated a significant improvement in ICIQ-SF scores, favouring ESWT treatment (SMD =−4.22, 95% CI: −6.71 to −1.73). The pooled SMD (−4.22) equates to approximately 3.8 raw-score points, exceeding the established minimal clinically important difference of 2.5 points and thus representing a clinically meaningful improvement. Substantial heterogeneity was observed among these studies (I²=96.6%, P<0.001). The relative weights of the studies were fairly balanced, with Wang [2024] (13) contributing 33.54%, Lin [2021] (14) contributing 32.28% and Long [2020] (15) contributing 34.18% to the overall effect.

Figure 2 Forest plot of international consultation on ICIQ-SF scores. CI, confidence interval; DL, DerSimonian-Laird; ESWT, extracorporeal shock wave therapy; ICIQ-SF, International Consultation on Incontinence Questionnaire Short Form; SMD, standardised mean difference.

Treatment efficacy

The analysis of treatment efficacy included two studies (13,16) with a combined 127 participants. As illustrated in Figure 3, the meta-analysis revealed a significant advantage for ESWT treatment, with an RR of 0.30 (95% CI: 0.11–0.77). Notably, there was no significant heterogeneity between these studies (I²=0%, P=0.476), suggesting consistency in the observed treatment effect. The studies were weighted at 43.05% for Wang [2024] (13) and 56.95% for Padoa [2024] (16).

Figure 3 Forest plot of treatment non-efficacy rate. CI, confidence interval; ESWT, extracorporeal shock wave therapy; IV, inverse variance.

Secondary outcomes

IIQ-7 scores

Three studies reported IIQ-7 scores (14-16). As shown in Figure 4, the pooled analysis showed a non-significant trend toward improvement (SMD =−1.83, 95% CI: −4.12 to 0.46), with high heterogeneity among studies (I²=96.5%, P<0.001). The studies contributed relatively equally to the analysis, with weights ranging from 32.67% to 34.15%.

Figure 4 Forest plot of incontinence impact IIQ-7 scores. CI, confidence interval; DL, DerSimonian-Laird; ESWT, extracorporeal shock wave therapy; IIQ-7, Incontinence Impact Questionnaire-7; SMD, standardised mean difference.

UDI scores

The analysis of UDI scores included the same three studies (14-16). As Figure 5 shows, there was no significant difference between the treatment and control groups (SMD =0.46, 95% CI: −3.49 to 4.42). Substantial heterogeneity was observed (I²=98.1%, P<0.001), with study weights distributed between 31.73% and 34.43%.

Figure 5 Forest plot of UDI scores. CI, confidence interval; DL, DerSimonian-Laird; ESWT, extracorporeal shock wave therapy; SMD, standardised mean difference; UDI, Urogenital Distress Inventory.

OABSS

Two studies (14,15) reported OABSS. As depicted in Figure 6, the meta-analysis demonstrated a significant improvement in favour of ESWT treatment (SMD =−1.85, 95% CI: −3.31 to −0.39). High heterogeneity was present (I²=91.2%, P<0.001), with Lin [2021] (14) contributing 47.70% and Long [2020] (15) contributing 52.30% to the overall effect.

Figure 6 Forest plot of overactive bladder symptom scores. CI, confidence interval; DL, DerSimonian-Laird; ESWT, extracorporeal shock wave therapy; SMD, standardised mean difference.

Quality assessment

The methodological quality assessment of the included studies is presented in Figures 7,8. The quality was generally moderate to good, with Lin [2021] (14) demonstrating low risk of bias across most domains, and Long [2020] (15) and Wang [2024] (13) showing overall good quality. Padoa [2024] (16) exhibited some concerns regarding incomplete outcome data. The most common limitation across studies was related to incomplete outcome data, whereas other aspects of study design and execution were generally well implemented. The corresponding traffic-light table with individual judgements appears in Table S2.

Figure 7 Risk of bias graph.

Figure 8 Risk of bias summary.

Discussion

This systematic review and meta-analysis provides comprehensive evidence regarding the efficacy of ESWT in treating SUI. The analysis of four high-quality studies (13-16) published between 2020 and 2024 revealed several important findings that have significant implications for clinical practice and future research directions.

The significant improvement in ICIQ-SF scores following ESWT treatment represents a crucial finding of this analysis. The large effect size (SMD =−4.22) demonstrates that ESWT provides substantial clinical benefit in reducing urinary incontinence symptoms, supporting its potential as a primary treatment option (17). The observed high heterogeneity in this analysis, while warranting careful interpretation, may be attributed to variations in treatment protocols and patient characteristics across studies. This variability in study design and implementation actually strengthens the evidence for ESWT’s effectiveness, as positive outcomes were maintained across different treatment parameters and clinical settings (18).

The mechanical stimulation provided by shock waves augments blood flow and collagen remodelling. These trophic effects precede measurable gains in pelvic floor contractility, offering a biologically plausible link to symptom reduction. Recent translational research has further elucidated this mechanism, demonstrating that ESWT stimulates cellular regeneration pathways in the urethral structure, helping restore function through targeted tissue repair (19). The ESWT delivery differed across studies: radial/linear generators were used in three trials, focused waves in one; energy flux density ranged from 0.09 to 0.25 mJ/mm²; and probes were applied either vaginally or perineally. Despite heterogeneity, the benefit was consistent. A 2024 study demonstrated that low-intensity ESWT works via transient potential vanilloid channels in animal models, suggesting a consistent physiological mechanism despite variations in delivery parameters (20).

The analysis of treatment efficacy yielded particularly compelling results, with a favourable RR of 0.30 and notably low heterogeneity between studies. This consistency in therapeutic benefit across different clinical settings strongly supports the reliability of ESWT as a treatment modality (21). The absence of significant heterogeneity in efficacy outcomes, despite variations in treatment protocols, suggests that ESWT’s therapeutic effects are robust across different implementation strategies (22). Furthermore, the non-invasive nature of ESWT compared with traditional surgical interventions positions it as an attractive option for both clinicians and patients, particularly given the favourable safety profile observed across all studies (23).

The impact of ESWT on quality-of-life measures revealed intriguing patterns that merit careful consideration. While improvements in overactive bladder symptoms were significant, the effects on IIQ-7 and UDI scores showed more variable results. This pattern suggests that ESWT’s therapeutic effects may be more pronounced in certain aspects of urinary function than in others (24). The significant improvement in overactive bladder symptoms, in particular, indicates that ESWT’s benefits may extend beyond the primary target of SUI, potentially offering broader therapeutic applications (25).

The methodological assessment of the included studies reveals important insights into the current state of ESWT research in urinary incontinence treatment. While the overall quality of the studies was good, the variations in treatment protocols, outcome measures and follow-up periods highlight the need for more standardised approaches in future research (26). The range of energy intensities used across studies (0.09–0.25 mJ/mm²) provides valuable information on the therapeutic window for ESWT treatment, though questions remain regarding optimal dosing strategies (27).

Only four trials met strict eligibility criteria. While a random-effects model can pool sparse data, future reviews might broaden inclusion to high-quality quasi-experimental studies if RCT output remains limited. A 2024 RCT evaluating shockwave therapy for urological conditions further supports this approach, suggesting that broader inclusion criteria may enhance the understanding of treatment efficacy across different patient populations (28). Heterogeneity underscores the need for adequately powered multicentre RCTs with harmonised protocols and long-term follow-up. A recent narrative review identified patient selection as a significant factor impacting outcomes, noting that cellular regenerative approaches, including shock wave therapy, may be particularly beneficial for specific patient populations based on age, body mass index and baseline symptom severity (29).

A particularly noteworthy aspect of our findings is the consistent positive outcomes across studies using different treatment protocols. This suggests that ESWT may be effective across a range of parameters, offering flexibility in clinical application (30). However, this also raises important questions regarding the potential for protocol optimisation to maximise therapeutic benefits. The variation in treatment durations from 3 to 8 weeks indicates a need for more research to determine the optimal treatment course (31).

The safety profile of ESWT emerged as a significant advantage in our analysis. The absence of serious adverse events across all studies, combined with the non-invasive nature of the treatment, positions ESWT as a particularly attractive option for patients who may be poor candidates for surgical intervention or those who prefer conservative treatment approaches (32). This safety profile, coupled with the observed efficacy, suggests that ESWT could potentially serve as a promising non-invasive option for SUI (33).

The economic implications of ESWT treatment, while not directly assessed in our analysis, warrant consideration in the broader context of urinary incontinence management. The potential for ESWT to reduce the need for more invasive and costly interventions could have significant implications for healthcare resource allocation (34). A 2024 umbrella review evaluating the effectiveness of shock wave therapy across various urological conditions demonstrated consistent improvement in patient outcomes and quality-of-life metrics, suggesting potential cost-effectiveness when compared with conventional surgical approaches, which often require longer recovery periods and carry higher complication risks (35). Future research should address this aspect more directly through formal cost-effectiveness analyses.

Looking ahead, several key areas require further investigation. While our analysis provides strong evidence for ESWT’s short-term efficacy, questions remain regarding the longevity of treatment effects and the potential need for maintenance therapy. Additionally, the identification of patient characteristics that predict better response to ESWT would help optimise patient selection and treatment outcomes. The role of ESWT in combination with other therapeutic modalities, such as pelvic floor exercises or behavioural modifications, also merits exploration.

Conclusions

This systematic review and meta-analysis demonstrates that ESWT is an effective treatment option for female SUI. The analysis of current evidence shows significant improvements in ICIQ-SF scores and overactive bladder symptoms, with a favourable safety profile. While heterogeneity exists in treatment protocols and some outcome measurements, the consistent positive results across studies support ESWT’s clinical utility. The non-invasive nature and minimal side effects of ESWT make it an attractive alternative to traditional treatments. However, future large-scale RCTs with standardised protocols and longer follow-up periods are needed to optimise treatment parameters and evaluate long-term outcomes. The evidence suggests that ESWT represents a promising non-invasive option for SUI, particularly for patients seeking non-invasive alternatives to surgery.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the PRISMA reporting checklist. Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-123/rc

Peer Review File: Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-123/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-2025-123/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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