Evidence map›Paper›PMID 39833952›Full record

Trial reportEuropean journal of medical research2025

Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder.

Zhipeng Zhang, Mengzhu Liu, Yangyun Wang, Peng Wu, Yiping Zhu, Bangmin Han, Zhihui Xu, Xudong Li, Chaoliang Shi, Jing Zhang and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of medical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04999657 (A Prospective, Multi-center, Randomized Controlled, Double-blind, Superiority Clinical Trial Evaluating the Safety and Efficacy of a Non-invasive Low-frequency Tibial Nerve Stimulator for the Treatment of Overactive Bladder), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04999657 nacompletednot on this map

A Prospective, Multi-center, Randomized Controlled, Double-blind, Superiority Clinical Trial Evaluating the Safety and Efficacy of a Non-invasive Low-frequency Tibial Nerve Stimulator for the Treatment of Overactive Bladder

TypeinterventionalSponsorMedtecx Co Ltd.Ran2021 to 2022Enrolled109ConditionsOveractive BladderArmsNon-invasive low-frequency tibial nerve stimulator (TNS-01)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Zhipeng Zhang *Department of Urology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, NO.1 DaHua Road, Dong Dan, Beijing, 100730, China.
Mengzhu Liu *Department of Urology, West China Hospital, Sichuan University, No.37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, China.
Yangyun Wang *Department of Urology, Shanghai Fifth People's Hospital Affiliated to Fudan University, No.128 Ruili Road, Minhang District, Shanghai, China.
Peng WuDepartment of Urology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue North, Guangzhou, 510515, Guangdong, China.
Yiping ZhuDepartment of Urology, Shanghai General Hospital, No. 85/86, Wujin Road, Hongkou District, Shanghai, China.
Bangmin HanDepartment of Urology, Shanghai General Hospital, No. 85/86, Wujin Road, Hongkou District, Shanghai, China.
Zhihui XuDepartment of Urology, Zhejiang Provincial People's Hospital, No.158 Shangtang Road, Xiacheng District, Hangzhou, Zhejiang, China.
Xudong LiDepartment of Urology, The First Affiliated Hospital of Xi'an Jiao Tong University, 227 Yanta West Road, Yanta District, Xi'an, Shaanxi, China.
Chaoliang ShiDepartment of Urology, Shanghai Fifth People's Hospital Affiliated to Fudan University, No.128 Ruili Road, Minhang District, Shanghai, China.
Jing ZhangDepartment of Medical Affairs, Floor 4/5, Building 12, No.789 Puxing Road, Minhang District, MedTecXShanghai, China.
Deyi LuoDepartment of Urology, West China Hospital, Sichuan University, No.37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, China. luodeyi@scu.edu.cn.
Guowei ShiDepartment of Urology, Shanghai Fifth People's Hospital Affiliated to Fudan University, No.128 Ruili Road, Minhang District, Shanghai, China. dr.sgw@189.cn.
Yaoguang ZhangDepartment of Urology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, NO.1 DaHua Road, Dong Dan, Beijing, 100730, China. zhang003887@sina.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the efficacy and safety of a non-invasive low-frequency tibial nerve stimulator (TNS-01) vs sham control in relieving the symptoms of overactive bladder (OAB) patients. PATIENTS: Participants who were diagnosed with primary OAB or exhibited at least one OAB symptom. All participants underwent three 30-min intervention sessions weekly.

methodsThe subjects were 1:1randomized (block randomization with a block size of 4) to either active treatment (TNS-01 group) or sham treatment (sham group). Based on the randomization, the subject will be given either an active or sham device system (systems will only differ in the Instructions for Use and electrode size/shape). During the 12-week study period, all participants underwent three 30-min intervention sessions weekly. The primary endpoint was the change in Overactive Bladder Symptom Score (OABSS) at week 12 from the baseline.

resultsOf the 109 recruited OAB patients. In the TNS-01 group, the OABSS change from baseline at week 12 was significantly higher than that in the sham group (2.83 ± 2.53 vs 1.62 ± 2.59, p = 0.02). The absolute and percent changes of average UUI episodes per day from baseline at week 8 in the TNS-01 group were significantly lower from those in the sham group (0.11 ± 1.33 vs 0.68 ± 2.14, p = 0.01; - 27.82% ± 167.33% vs 87.18% ± 25.20%, p = 0.04). One treatment-related adverse event (hematuria) was reported by one patient (1.8%) in the sham group.

conclusionsThe TNS-01 device is effective and safe in relieving OAB symptoms after 12 weeks of stimulation. TRIAL REGISTRATION NUMBER: NCT04999657.

Indexed as

Electric Stimulation TherapyTibial NerveTranscutaneous Electric Nerve StimulationUrinary Bladder, OveractiveAdultAgedFemaleHumansMaleMiddle AgedTreatment OutcomeEfficacyNon-invasive low-frequency tibial nerve stimulatorOveractive bladderRandomized clinical trialSafety

Identifiers

PMID39833952
PMCPMC11748249

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.