Effectiveness and safety of external physical vibration lithecbole for upper urinary stone expulsion: a systematic review and meta-analysis

Introduction

Urolithiasis is a common condition that imposes substantial health and economic burdens worldwide.1 The global prevalence of kidney stones is estimated at 1–13%, with incidence and recurrence rising in parallel with obesity, dietary change, and sedentary lifestyles.2 In North America, the lifetime risk of stone formation is approximately 10–15% in men and 5–7% in women, and a large population-based study from China reported an adult prevalence of around 6–7%.2–4

Modern management of upper urinary tract stones is dominated by minimally invasive techniques, including extracorporeal shock wave lithotripsy (ESWL), retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotomy (PCNL).5,6 ESWL is widely used as a non-invasive first-line option for stones < 2 cm, whereas RIRS provides an endoscopic alternative when ESWL is unsuitable or fails, and PCNL is reserved for larger or more complex stones.7,8 Despite these advances, residual stone fragments remain frequent after ESWL and RIRS and may act as a nidus for regrowth, infection, obstruction, and, ultimately, renal function impairment, highlighting the need for adjunctive strategies that promote early fragment clearance.9,10

Several physical adjuncts have been developed to enhance fragment clearance after lithotripsy. Traditional percussion, diuresis, and inversion (PDI) therapy may increase stone-free rates but is operator-dependent and difficult to standardize, which has limited its routine use.11,12 EPVL was developed as a device-based, non-invasive alternative that delivers controlled vibration and positional changes to mobilize fragments from dependent calyces, particularly in the lower pole and renal pelvis, and randomized controlled trials have suggested that it improves short-term stone-free rates without increasing adverse events.12–14

Two previous meta-analyses have examined physical adjunctive therapies after ESWL or RIRS. Peng et al.15 evaluated several physical modalities, including PDI, EPVL, and related techniques, and reported higher stone-free rates without a clear increase in major complications, but combined heterogeneous interventions and study designs, and provided limited data for specific stone locations and complications.15 Xu et al.16 subsequently performed an EPVL-specific meta-analysis restricted to randomized controlled trials, and found that EPVL improved stone clearance and reduced overall complication rates, particularly for calyceal and pelvic stones; however, that review included data only up to April 2020 and was constrained by substantial statistical heterogeneity and small subgroup sample sizes.

The present study builds on this work by including nine randomized controlled trials with literature coverage up to 13 January 2026, focusing specifically on EPVL as an adjunct to ESWL or RIRS. The purpose of this study is to update the evidence base for EPVL-assisted treatment of upper urinary tract stones, while providing more detailed analyses stratified by stone location and primary procedure, and systematically evaluating common postoperative complications—ultimately aiming to offer contemporary, evidence-based guidance for clinical decision-making.

Methods

Study design and registration

This study was designed as a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating EPVL as an adjunct to ESWL or retrograde intrarenal surgery (RIRS) for upper urinary tract stones. The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020) guidelines17 (Supplementary Material S1) and was prospectively registered in PROSPERO (CRD42024600537).

Literature search strategy

A comprehensive literature search was performed in PubMed, Web of Science, Embase, the Cochrane Library, and China National Knowledge Infrastructure (CNKI) from database inception to 13 January 2026. The search combined controlled vocabulary and free-text terms related to urinary stones and the interventions of interest, including “urolithiasis”, “kidney stone”, “renal calculi”, “ureteral stone”, “extracorporeal shock wave lithotripsy”, “retrograde intrarenal surgery”, “ureteroscopy”, “external physical vibration lithotripsy”, and “vibration therapy”. For each database, synonyms for urinary stones were combined with intervention and study-design terms using Boolean operators (AND/OR), for example: (“urolithiasis” OR “kidney stone*” OR “renal calculi” OR “ureteral stone*”) AND (“external physical vibration lithotripsy” OR “EPVL” OR “vibration therapy”) AND (random* OR “randomized controlled trial*”). Randomized controlled trial filters or equivalent methodological terms were applied when available. No restrictions on publication language were imposed at the search stage, and only human randomized controlled trials were considered for inclusion during screening. Reference lists of relevant reviews and all included articles were manually screened to identify additional eligible studies.

Eligibility criteria

Eligibility criteria followed a predefined protocol based on the Population, Intervention, Comparison, and Outcomes (PICO) framework. Eligible studies were required to meet the following criteria: (1) Design: randomized controlled trial (RCT). (2) Population: adults (≥18 years) with upper urinary tract stones (renal or ureteral) treated by ESWL or RIRS. (3) Intervention/comparison: EPVL plus standard post-procedural care versus the same standard care without EPVL. (4) Outcomes: reporting stone-free rates (SFRs) at early follow-up (about 1 week) and/or around 2 weeks after the index procedure. Stone-free status was defined according to each original study, typically as the absence of residual fragments or fragments < 4 mm on imaging (ultrasound, X-ray, or CT). (5) Safety: reporting at least one safety outcome (overall or specific complications).

Studies were excluded if they met any of the following criteria: (1) Non-randomized or quasi-randomized design; (2) No parallel control group; (3) Procedures not involving ESWL or RIRS, or populations not limited to upper urinary tract stones; (4) No data on SFR and no report of any safety outcome; or (5) Conference abstracts, reviews or case reports without sufficient extractable data.

When multiple reports came from the same cohort, the most complete or most recent publication was retained.

Study selection and data extraction

After removal of duplicates, two reviewers independently screened titles and abstracts to exclude clearly irrelevant records. Full texts of potentially eligible articles were obtained and assessed in detail against the inclusion and exclusion criteria. Any disagreements were resolved by discussion or, if necessary, by consultation with a third reviewer. The study selection process and reasons for exclusion at the full-text stage are summarized in a PRISMA flow diagram (Figure 1).

FIGURE 1. Flow of studies selection for systematic review and meta-analysis

Two reviewers independently extracted data from each included trial using a standardized data collection form. Extracted information included first author, year of publication, country or region, study setting (single- or multicenter), sample size, patient demographics (age, sex), stone characteristics (size, number, side and location), primary procedure (ESWL or RIRS), details of the EPVL protocol (timing after the index procedure, session duration, frequency and number of sessions), length of follow-up, and definitions and assessment timepoints for SFR and complications. Where necessary, corresponding authors were contacted for clarification of unclear or missing data. If required, simple calculations (e.g., deriving event counts from reported percentages) were performed and documented. Discrepancies in data extraction were resolved by consensus.

Risk of bias and statistical analysis

The risk of bias of each included RCT was independently assessed by two reviewers using the Cochrane risk-of-bias tool for randomized trials, covering selection, performance, detection, attrition, and reporting domains.18 Random sequence generation, allocation concealment, blinding of participants, personnel, and outcome assessors, completeness of outcome data, selective outcome reporting, and other potential sources of bias were each graded as low, high, or unclear risk, with disagreements resolved by discussion. A summary of risk-of-bias assessments is presented in Figure 2. For dichotomous outcomes, relative risks (RRs) with 95% confidence intervals (CIs) were calculated and pooled. Heterogeneity was assessed with the chi-square test and quantified by the I² statistic. A fixed-effect Mantel–Haenszel model was used when heterogeneity was low (I² < 50%), and clinical characteristics were similar; otherwise, a random-effects model was applied. Preplanned subgroup analyses explored differences by stone location and index procedure when data allowed. Sensitivity analyses were performed by excluding trials judged to contribute most to statistical heterogeneity and, when feasible, by omitting individual studies to assess the robustness of pooled estimates. Potential publication bias for the primary outcome was evaluated by visual inspection of funnel plots and Egger’s regression test for small-study effects, with a two-sided p-value < 0.05 considered statistically significant. All analyses were conducted using Review Manager (RevMan) version 5.4 and additional software for regression-based tests.

FIGURE 2. Risk of bias summary14,19–26

Results

Study selection

A total of 831 records were identified through database searching and manual checking of reference lists. After removal of duplicates, 373 unique records remained for title and abstract screening, of which 70 were considered potentially relevant and assessed for eligibility. Nine randomized controlled trials ultimately met the inclusion criteria and were included in the quantitative synthesis, comprising 1418 patients (EPVL group: 710; control group: 708).14,19–26 The study selection process and reasons for exclusion at the full-text stage are summarized in the PRISMA flow diagram (Figure 1).

Study and patient characteristics

The nine included RCTs were published between 2015 and 2023 and enrolled 71–299 participants each. EPVL was used as an adjunct to ESWL in six trials and to RIRS in three trials. Across studies, baseline characteristics were generally comparable between groups, with no consistent differences in age, sex distribution, or stone burden. Stones involved the renal pelvis and calyces, and in some trials the proximal ureter, with maximal stone diameters typically <2 cm. Key characteristics of the included trials are summarized in Table 1.

Overall, the methodological quality of the RCTs was moderate. Most trials adequately described random sequence generation, but allocation concealment was frequently unclear. Blinding of participants, personnel, and outcome assessors was rarely reported, which may introduce performance and detection bias; however, the primary outcomes were largely objective imaging-based assessments. Outcome data were generally complete, with low rates of loss to follow-up, and no obvious selective reporting was detected. A summary of risk-of-bias assessments is shown in Figure 2.

Primary outcomes: early stone-free rates

Compared with standard care alone, adjunctive EPVL significantly improved early stone-free rates after ESWL or RIRS. At approximately 1 week after the index procedure, the pooled RR for being stone-free favored EPVL (RR 1.44, 95% CI 1.18–1.77; p < 0.001; I² = 73%; Figure 3A). At around 2 weeks, EPVL remained associated with a higher SFR (RR 1.40, 95% CI 1.20–1.63; p < 0.001; I² = 73%; Figure 3C). Although statistical heterogeneity was substantial at both time points, the direction of effect consistently favored EPVL across individual trials. Additional sensitivity analyses are reported in Section sensitivity analysis and publication bias.

FIGURE 3. Meta-analysis of upper urinary stone-free rates at different time points.14,19–25 (A) Meta-analysis of stone passage in the first week. (B) Excludes the forest plot from the study of Jing et al.,20 Tan et al.,21 and Zhang et al.24 (C) Meta-analysis of stone passage in the second week. (D) Excludes the forest plot from the study of Jing et al.20 and Zhang et al.24

Subgroup analyses

In subgroup analyses by stone location, EPVL tended to increase early SFR across all anatomical sites, and there was no evidence that the treatment effect differed materially between locations (P for subgroup differences = 0.80; Figure 4). The relative benefit was most pronounced for lower-pole calyceal stones (RR 1.56, 95% CI 1.25–1.96; p < 0.001; I² = 0%) and for renal pelvic stones (RR 1.54, 95% CI 1.10–2.14; p = 0.01; I² = 0%). For upper- and mid-pole calyces and other locations, point estimates also favored EPVL, but confidence intervals were wide and crossed unity because of small sample sizes and few events. Indicating that results for these subgroups should be interpreted with caution.

FIGURE 4. Subgroup analysis of the influence of different stone fragment locations14,22,24

Exploratory subgroup analyses according to the index procedure showed that EPVL improved early SFR after both ESWL and RIRS (Figure 5). At 1 week, the pooled effect remained significant in trials using ESWL (RR 1.25, 95% CI 1.10–1.42; p < 0.001; I² = 33%) and was larger in RIRS-based trials (RR 2.35, 95% CI 1.35–4.11; p = 0.003; I² = 44%), with a significant test for subgroup differences (p = 0.03). By approximately 2 weeks, the magnitude of benefit remained in both subgroups (ESWL: RR 1.25, 95% CI 1.08–1.45; p = 0.003; I² = 66%; RIRS: RR 1.69, 95% CI 1.13–2.53; p = 0.01; I² = 56%), and the difference between ESWL and RIRS was no longer statistically significant (P for subgroup differences = 0.17).

FIGURE 5. Subgroup analyses comparing the effect of adjunctive EPVL on early stone-free rates stratified by the primary procedure (ESWL vs. RIRS). (A) Results at 1-week follow-up. (B) Results at 2-week follow-up. The test for subgroup differences is reported (p-value)19–25

Safety outcomes

Across the nine RCTs, no serious EPVL-related adverse events were reported. In trials reporting overall complications, adjunctive EPVL was associated with a significantly lower rate of post-procedural complications compared with standard care alone (RR 0.58, 95% CI 0.46–0.73; p < 0.001; I² = 0%; Figure 6). EPVL was also associated with significantly fewer episodes of hematuria (RR 0.64, 95% CI 0.48–0.86; p = 0.002; I² = 0%) and transient elevation of urinary white blood cells (RR 0.28, 95% CI 0.14–0.57; p < 0.001; I² = 0%). In contrast, there were no statistically significant differences between groups in postoperative fever (RR 0.71, 95% CI 0.31–1.65; p = 0.43) or flank pain (RR 0.62, 95% CI 0.38–1.03; p = 0.06).

FIGURE 6. Meta-analysis of postoperative complications. Evaluating four complications: hematuria (RR = 0.64), fever (RR = 0.71), urinary white blood cell (WBC) rise (RR = 0.28), and lumbago (RR = 0.62)14,19–26

Sensitivity analysis and publication bias

In sensitivity analyses excluding trials that contributed most to between-study heterogeneity, the beneficial effect of EPVL on early SFR persisted with attenuated effect sizes and lower heterogeneity. For 1-week SFR, omitting three clinically and methodologically heterogeneous trials reduced I² from 73% to 0% and yielded a more conservative but still significant effect estimate (RR 1.21, 95% CI 1.09–1.34) (Figure 3B).20,21,24 For the 2-week SFR, excluding the multi-arm RIRS trial by Jing et al. and Zhang et al. decreased I² from 73% to 59% while retaining a significant treatment effect (RR 1.28, 95% CI 1.14–1.44) (Figure 3D).20,24 Leave-one-out analyses for both time points further showed that omitting any single trial did not materially change the magnitude or statistical significance of the pooled RRs.

Visual inspection of funnel plots did not reveal marked asymmetry for the 1-week SFR outcome. Egger’s regression test likewise did not provide statistical evidence of small-study effects at 1 week (p = 0.073). In contrast, the funnel plot for 2-week SFR showed a pattern of smaller trials reporting larger treatment effects, and Egger’s test was significant (p = 0.003), suggesting potential small-study effects. Given the small number of included trials (k = 7) and substantial between-study heterogeneity, these findings should be interpreted cautiously (Figure 7).

FIGURE 7. Funnel plots for assessing publication bias of stone-free rates. (A) Funnel plot for 1-week stone-free rates (7 RCTs included14,19–24); (B) Funnel plot for 2-week stone-free rates (7 RCTs included14,19–24). The x-axis represents the log of relative risk (RR), and the y-axis represents the standard error of log (RR)

Discussion

Adjunctive EPVL improved early stone-free rates after ESWL or RIRS in this meta-analysis of nine randomized controlled trials involving 1418 patients. Compared with standard post-procedural care alone, EPVL was associated with higher stone-free rates at 1 week and 2 weeks, and these benefits were preserved in sensitivity analyses that excluded heterogeneous trials and in leave-one-out analyses. Based on the pooled event rates, this relative improvement corresponds to an absolute increase in early stone-free rates of roughly 20 percentage points. Importantly, EPVL did not increase the risk of procedure-related complications; instead, overall complications and several specific minor adverse events were less frequent in the EPVL group, though these are associations rather than definitive protective effects.

Our findings are broadly consistent with previous meta-analyses that evaluated physical adjunctive therapies after ESWL or RIRS, including those by Peng et al.15 and Xu et al.,16 which reported higher stone-free rates without clear increases in major complications. Unlike earlier work, the present review focuses exclusively on EPVL, includes only randomized controlled trials, and incorporates more recent studies up to January 2026. By doing so, it updates the evidence base and provides more granular analyses by stone location and index procedure, as well as a more comprehensive safety profile.

The observed improvement in stone clearance is consistent with EPVL’s proposed mechanism, which combines postural change and vibration to dislodge fragments from dependent calyces and facilitate their passage with urine flow.27,28 In this way, EPVL offers a standardized, non-invasive evolution of traditional percussion–diuresis–inversion techniques.29

In subgroup analyses by stone location, EPVL tended to increase early stone-free rates across all reported sites, with the largest relative benefits for lower-pole and renal pelvic stones. These regions are anatomically predisposed to fragment retention because of unfavorable infundibulopelvic angles and dependent positions. EPVL may be particularly effective in this context by mobilizing fragments out of the lower calyx and renal pelvis into the ureter.30 Although the test for interaction between locations was not significant (P for subgroup differences = 0.80), the more precise estimates for lower-pole and pelvic stones support preferential consideration of EPVL when treating patients with fragments in these gravity-dependent areas. It is important to note that some subgroups (e.g., upper- and mid-pole calyx stone subgroups) had small sample sizes, leading to wide confidence intervals, and thus results for these subgroups should be interpreted cautiously to avoid overgeneralization.

EPVL increased early stone-free rates after both ESWL and RIRS. The 1-week benefit appeared greater after RIRS, with a significant between-subgroup difference, whereas by 2 weeks the effect size was similar and the interaction was no longer significant. These patterns suggest that EPVL accelerates early clearance, particularly in RIRS patients with residual fragments, while providing a sustained but more uniform benefit over time across both procedures.31

Across the nine included trials, no serious adverse events were attributed to EPVL. Pooled analyses showed that overall complication rates were lower in the EPVL group, and EPVL was associated with fewer episodes of hematuria and transient elevation of urinary white blood cells, while rates of postoperative fever and flank pain were similar between groups. These associations may be influenced by factors such as residual fragment burden (which can irritate the urinary tract mucosa and increase infection risk) or differences in complication reporting practices across studies, rather than direct protective effects of EPVL.

A key consideration in interpreting the present results is the substantial statistical heterogeneity observed in early stone-free rates (I² = 76% at 1 week and 73% at 2 weeks). This heterogeneity likely reflects several factors, including variations in EPVL protocols (e.g., vibration frequency, amplitude, power, session duration, number of sessions, and timing after the index procedure) across studies, as there is currently no standardized EPVL protocol. Additionally, differences in patient characteristics (e.g., stone size, comorbidities such as obesity) and outcome assessment methods (e.g., imaging modalities, residual fragment size thresholds for defining stone-free status) may contribute to heterogeneity. We addressed this issue by using random-effects models for pooling and conducting sensitivity analyses, which confirmed that the overall beneficial effect of EPVL was robust to the exclusion of heterogeneous trials. Future studies should aim to establish standardized EPVL protocols to reduce heterogeneity and improve the comparability of results.

Taken together, higher early stone-free rates and fewer minor complications support EPVL as a useful, low-risk adjunct after ESWL or RIRS, especially for patients with lower-pole or renal pelvic fragments. In practice, EPVL is delivered using a tilting table and external vibration device, adding only a short additional session to standard care.32 However, most of the trials to date were conducted in China, where EPVL devices are commercially available, and implementation in other health systems may be limited by device availability, acquisition costs, and local regulatory approval.28 Centers considering EPVL, therefore, need to balance the potential reduction in retreatment and minor complications against these practical constraints, and standardized protocols for timing and treatment parameters remain necessary.

The robustness of our primary efficacy findings is supported by sensitivity analyses. Excluding trials that contributed most to heterogeneity substantially reduced I² values—from 76% to 0% for 1-week stone-free rates and from 73% to 59% for 2-week rates—while the benefit of EPVL remained statistically significant, albeit with slightly attenuated effect sizes. Leave-one-out analyses confirmed that no single study unduly influenced the pooled results. Collectively, these analyses indicate that the observed advantage of EPVL is consistent and not driven by methodological outliers.

Egger’s test did not indicate significant small-study effects for 1-week stone-free rates, but was positive for 2-week rates, with smaller trials tending to show larger benefits. This pattern suggests that while the direction of effect is consistent, the pooled 2-week advantage of EPVL may be partly inflated by small-study or reporting bias and should therefore be interpreted as an upper-bound estimate of the true long-term benefit.

Our review’s strengths include the restriction to randomized controlled trials, an updated and-specified search strategy, structured subgroup and sensitivity analyses, and systematic assessment of safety outcomes. However, several limitations should be considered. First, the treatment protocols for physical vibrations varied considerably across studies, particularly regarding intensity and duration parameters, limiting the standardization of the intervention. Second, all trials were conducted in a single geographic setting (China), where EPVL devices are already integrated into routine clinical practice in tertiary centers.33,34 Healthcare systems in other regions may differ in postoperative care protocols, device availability, and patient characteristics, which could affect the generalizability of our findings.

Conclusions

Overall, EPVL emerges from this meta-analysis as a low-risk adjunct that improves early stone clearance after ESWL or RIRS, especially for lower-pole and renal pelvic fragments, while being associated with fewer minor complications. Further standardized, multicentre trials conducted in more diverse populations, including Western cohorts and accounting for factors such as obesity and physical activity levels, are warranted to refine estimates of its efficacy and to guide wider implementation.

Acknowledgement

Not applicable.

Funding Statement

This work was supported in part by grants from Fujian Province Medical Innovation Project (#2020CXB046) and the General Clinical Research Fund Project of Xiamen Medical Association (#A202501013).

Authors Contributions

Yifan Huang and Tao Wang conceived and designed the study. Tao Wang, Yuedong Chen, Yifan Huang and Qianhao Huang were responsible for data collection and summarization. Yifan Huang, Bingzhi Han, Zikai Huang and Qianhao Huang performed data analysis and interpretation. All authors participated in manuscript drafting and provided critical revisions of important intellectual content. Each author has participated fully in the work and assumes public responsibility for appropriate portions of the content. All authors agree to be accountable for all aspects of the work, ensuring that questions related to the accuracy or integrity of any part are properly investigated and resolved. All authors reviewed and approved the final version of the manuscript.

Availability of Data and Materials

The datasets used and/or analysed during the current study are available from the corresponding authors upon reasonable request.

Ethics Approval

Not applicable.

Conflicts of Interest

The authors declare no conflicts of interest.

Trial Registration: PROSPERO CRD42024600537.

Supplementary Materials

The supplementary material is available online at https://www.techscience.com/doi/10.32604/cju.2026.070466/s1.

Abbreviations

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