Overactive BladderNCT04999657
Evaluation of the The Neuromodulation System for the Treatment of Overactive Bladder Symptoms
A study testing Non-invasive low-frequency tibial nerve stimulator (TNS-01) in people with Overactive Bladder, run by Medtecx Co Ltd. at 7 sites in China.
Trial summary
To evaluate the efficacy and safety of non-invasive tibial nerve stimulator for the treatment of overactive bladder under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. The primary safety endpoint will be device-related adverse events. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Non-invasive low-frequency tibial nerve stimulator (TNS-01)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 7 sitesChina
- Study dates
- 26 Aug 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men aged between 18 and 80 years old (including 18 and 80 years old)；
- Individual with primary OAB, or with OAB symptoms, satisfies one of the following conditions:
- ① Urinary urgency: sudden and strong desire to urinate, and it is difficult to be subjectively suppressed and delayed urination ;
- ② Urge urinary incontinence: accompanied with urinary urgency or immediately after urinary urgency ;
- ③ Urination frequency: adults urination frequency ≥8 times during the daytime，≥2 times at night, and each urine volume <200 ml .
- Individual meets the diagnostic criteria of OAB: According to the OABSS questionnaire, urgency score ≥2 points, total score ≥3 points, and symptoms duration ≥3 months;
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- Individual newly diagnosed with OAB have not been medicated, or is able to stop taking OAB-related drugs (M receptor block, β3 receptor agonists) for at least 2 weeks prior to enrollment;
- The subject has autonomy and can go to the toilet independently;
- Individual is ambulatory and able to use the toilet independently;
- Individual is capable and willing to participate in the study and provide the written informed consent.
Who cannot join
- Woman is pregnant or lactating, or woman of childbearing age who plans to become pregnant during the study period;
- Individual has Stress Urinary Incontinence (SUI);
- Individual has obvious urinary obstruction due to various reasons accompanied by residual urine volume> 100 ml;
- Individual has an implanted pacemaker, embedded cardioverter defibrillator, or other electrical medical devices (including sacral neuromodulation (SNM) devices)
- Individual has uncured urinary system infection;
- Individual has urinary calculus resulting in lower urinary tract symptoms;
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- Individual has congenital urinary tract malformations causing uncured lower urinary tract symptoms;
- Individual has uncured cancers;
- Individual had undergone lower urinary tract surgery within 3 months;
- Individual has neurological diseases or injuries accompanied with uncured lower urinary tract symptoms;
- Individual has skin breakage, malignant tumor or acute purulent inflammation on the surface of the plantar where the electrode pads are to be placed;
- Individual has participated in other drug clinical trials medical dev within 3 months, or participated in other ice clinical trials within 30 days;
- Individual is deemed unsuitable for enrollment in the study by investigator.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Hospital
Beijing, Beijing Municipality
West China Hospital
Chengdu
Nan Fang Hospital
Guangzhou
Zhejiang Provincial People's Hospital
Hangzhou
Shanghai Fifth People's Hospital
Shanghai
Shanghai General Hospital
Shanghai
The First Affiliated Hospital of XI'AN JiaoTong University
Xi'an
About this study
Official title: 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
To evaluate the efficacy and safety of non-invasive tibial nerve stimulator for the treatment of overactive bladder under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be the improvement value of overactive bladder symptom score (OABSS) after 12-week treatment.
- Conditions
- Overactive Bladder
- Being tested
- Non-invasive low-frequency tibial nerve stimulator (TNS-01)
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive low-frequency tibial nerve stimulator (TNS-01)Device
The investigational device is a transcutaneous electrical nerve stimulation (TENS) device that is designed to provide stimulation to the nerves at the site of application via surface electrodes temporarily adhered to the skin.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Device: Non-invasive low-frequency tibial nerve stimulator Receives: Device: Non-invasive low-frequency tibial nerve stimulator (TNS-01) |
| Sham | Sham comparator | Device: Non-invasive low-frequency tibial nerve stimulator (same device operation without real current output) Receives: Device: Non-invasive low-frequency tibial nerve stimulator (TNS-01) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of overactive bladder symptom score (OABSS) after 12-week treatment compared with baseline
OABSS is evaluated via 3-day voiding diary and urinary voiding events of the previous week at week 0, 4, 8 and 12 after treatment. Evaluate OABSS improvement from baseline after 12 weeks of treatment and compared between the Treatment and the Control groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start26 Aug 2021
- Primary completion30 Sep 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtecx Co Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaoguang Zhang, MD, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999657
- Sponsor's protocol ID
- EMK03025P
- Status last verified
- Jan 2023
- First submitted
- 2 Aug 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Z, Liu M, Wang Y, Wu P, Zhu Y, Han B, Xu Z, Li X, Shi C, Zhang J, Luo D, Shi G, Zhang Y. Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder. Eur J Med Res. 2025 Jan 20;30(1):40. doi: 10.1186/s40001-024-02262-z.
PubMed 39833952
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04999657
- Acronym / sponsor ID
- EMK03025P
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Medtecx Co Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of non-invasive tibial nerve stimulator for the treatment of overactive bladder under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be the improvement value of overactive bladder symptom score (OABSS) after 12-week treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Non-invasive low-frequency tibial nerve stimulator (TNS-01)Device: Non-invasive low-frequency tibial nerve stimulator |
| Sham | Sham comparator | Device: Non-invasive low-frequency tibial nerve stimulator (TNS-01)Device: Non-invasive low-frequency tibial nerve stimulator (same device operation without real current output) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women and men aged between 18 and 80 years old (including 18 and 80 years old)；
- Individual with primary OAB, or with OAB symptoms, satisfies one of the following conditions:
- ① Urinary urgency: sudden and strong desire to urinate, and it is difficult to be subjectively suppressed and delayed urination ;
- ② Urge urinary incontinence: accompanied with urinary urgency or immediately after urinary urgency ;
- ③ Urination frequency: adults urination frequency ≥8 times during the daytime，≥2 times at night, and each urine volume <200 ml .
Key exclusion criteria (13 listed)
- Woman is pregnant or lactating, or woman of childbearing age who plans to become pregnant during the study period;
- Individual has Stress Urinary Incontinence (SUI);
- Individual has obvious urinary obstruction due to various reasons accompanied by residual urine volume> 100 ml;
- Individual has an implanted pacemaker, embedded cardioverter defibrillator, or other electrical medical devices (including sacral neuromodulation (SNM) devices)
- Individual has uncured urinary system infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive low-frequency tibial nerve stimulator (TNS-01)The investigational device is a transcutaneous electrical nerve stimulation (TENS) device that is designed to provide stimulation to the nerves at the site of application via surface electrodes temporarily adhered to the skin. | Device | Active, Sham |
Primary outcome
The change of overactive bladder symptom score (OABSS) after 12-week treatment compared with baseline
Time frame: 12 weeks
OABSS is evaluated via 3-day voiding diary and urinary voiding events of the previous week at week 0, 4, 8 and 12 after treatment. Evaluate OABSS improvement from baseline after 12 weeks of treatment and compared between the Treatment and the Control groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 39833952Zhang Z, Liu M, Wang Y, Wu P, Zhu Y, Han B, Xu Z, Li X, Shi C, Zhang J, Luo D, Shi G, Zhang Y. Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder. Eur J Med Res. 2025 Jan 20;30(1):40. doi: 10.1186/s40001-024-02262-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaoguang Zhang, MD principal investigator
Beijing Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive low-frequency tibial nerve stimulator (TNS-01) in people with Overactive Bladder, run by Medtecx Co Ltd. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of overactive bladder symptom score (OABSS) after 12-week treatment compared with baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04999657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.