Overactive Bladder (OAB)NCT06765629
Transcutaneous Tibial Nerve Stimulation Therapy in Children With Overactive Bladder
A study testing Non-invasive Percutaneous Tibial Nerve Stimulation (TTNS) group in people with Overactive Bladder (OAB), run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
Overactive bladder (OAB) is a syndrome characterized by urinary urgency, often accompanied by frequency and nocturia, with or without urge incontinence, without urinary tract infection or other clear pathological changes. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Non-invasive Percutaneous Tibial Nerve Stimulation (TTNS) group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with OAB according to the "Chinese Urology and Male Disease Diagnosis and Treatment Guidelines" 2022 edition;
- Age between 6 and 18 years, gender unrestricted;
- Need to receive and consent to TTNS treatment for medical reasons;
- Urination diary (3 days prior to random enrollment) shows an average of ≥8 urination times per 24 hours;
- The patient or their representative understands the purpose and requirements of this study and signs the informed consent form (if the subject is <8 years old, written consent from the legal guardian is required; if the subject is 8 years old ≤ subject ≤ 18 years old, written informed consent from both the subject and the legal guardian is required); If not co-administering β3 agonists/non-selective β-agonists or anticholinergic drugs during the study period, the medication must be discontinued for at least 7 days before the screening period. If continuing to take β3 agonists/non-selective β-agonists or anticholinergic drugs during the study period, the dosage and method of administration must remain unchanged until the study is completed.
Who cannot join
- Those with an implanted pacemaker or implantable cardioverter-defibrillator;
- Patients with concomitant urinary system diseases: deformities, tumors, obstructions, stones, urinary retention;
- Patients with stress urinary incontinence and other related diseases affecting urine generation and excretion;
- Individuals with cognitive impairment, Parkinson's disease, or complete spinal cord injury;
- Patients with psychiatric disorders who cannot cooperate with medical staff;
- Patients with pelvic organ prolapse at stage III or higher;
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- Patients who do not have sufficient compliance to cooperate with the treatment and are unable to complete the questionnaires and data collection during the treatment period;
- Pregnant women or those planning to become pregnant during the study period;
- Patients who are participating in other clinical studies;
- Other situations deemed unsuitable for inclusion by the researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Urology, Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
Official title: Safety and Efficacy of Transcutaneous Tibial Nerve Stimulation in Children With Overactive Bladder: A Prospective, Multicenter, Single-Arm Study
Overactive bladder (OAB) is a syndrome characterized by urinary urgency, often accompanied by frequency and nocturia, with or without urge incontinence, without urinary tract infection or other clear pathological changes. The prevalence of OAB ranges from 9% to 43% in women and 7% to 27% in men, severely affecting patients' quality of life and mental health. Traditional treatments for OAB include behavioral therapy (bladder retraining, pelvic floor muscle training, etc.) and drug therapy (including anticholinergic, antispasmodic drugs, and tricyclic antidepressants, etc.); for refractory overactive bladder syndrome, surgical interventions include bladder augmentation and urinary diversion, etc. However, due to serious complications, lack of efficacy, or significant trauma, these methods are greatly limited in clinical application.
In recent years, with the continuous development of neuromodulation technology, neurostimulation has gradually been applied in the treatment of lower urinary tract dysfunction. Compared with traditional treatments, it does not have side effects such as dry mouth, constipation, blurred vision, etc., and compared with surgical treatment, it reduces side effects such as bleeding and infection. Among them, Tibial Nerve Stimulation (TNS) has become an optional therapy for OAB treatment due to its non-surgical nature, convenience, low risk, high safety, significant efficacy, and relative cost-effectiveness.
Read more
With the continuous development of technology, and in order to reduce the invasiveness of treatment, improve safety and convenience, Percutaneous Tibial Nerve Stimulation (PTNS) is gradually shifting towards non-invasive Percutaneous Tibial Nerve Stimulation (TTNS). The main difference between the two is that the former uses fine needle electrodes, while the latter mostly uses surface electrodes, which deliver electrical power to the tibial nerve through skin and soft tissue. Studies have shown that TTNS has the same efficacy as drug therapy, is more effective for OAB symptoms than behavioral interventions, and there is no statistically significant difference in efficacy between TTNS and PTNS. It is recommended as an option to improve OAB by the "European Association of Urology Guidelines on Female Non-neurogenic LUTS (2023)" and the "Chinese Guidelines on Diagnosis and Treatment of Urology and Male Diseases (2022)".
However, there is still a lack of large-scale prospective studies on the use of TTNS for OAB in Asian populations, and most existing studies have observation periods of 3 months or less, lacking high-quality research evidence for long-term efficacy. Therefore, a prospective, multicenter, single-arm study is planned to verify the long-term efficacy of percutaneous tibial nerve stimulation in the treatment of OAB in the Chinese population.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- Non-invasive Percutaneous Tibial Nerve Stimulation (TTNS) group
- 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 Percutaneous Tibial Nerve Stimulation (TTNS) groupDevice
After obtaining informed consent from the subjects, the researchers screen the subjects based on the inclusion and exclusion criteria. The wearable non-invasive percutaneous tibial nerve stimulator is placed on the area where the tibial nerve runs at the medial malleolus of the subjects. Once the wearable stimulator is properly fitted, stimulation parameter programming and treatment record management are conducted through the programming software running on the mobile phone.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Percutaneous Tibial Nerve Stimulation (TTNS) group | Experimental | Not described Receives: Device: Non-invasive Percutaneous Tibial Nerve Stimulation (TTNS) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
72-hour Voiding Diary
Measured: A month after treatment；Two months after treatment；Three months after treatment；Half year after treatment；One year after treatment
Secondary outcomes (4)
Overactive bladder syndrome score (OABSS)
The minimum value is 0 and the maximum value is 15. 3≤score≤5: Mild OAB 6≤score≤11: Moderate OAB score≥12: Severe OAB
Measured: A month after treatment；Two months after treatment；Three months after treatment；Half year after treatment；One year after treatment
Patient Perception of Bladder Condition Score (PPBC-S)
The score ranges from 1 to 6, with a higher score indicating a more severe impact of bladder symptoms on quality of life.
Measured: A month after treatment；Two months after treatment；Three months after treatment；Half year after treatment；One year after treatment
American Urological Association-Symptom Index-Quality of life (AUA-SI-QOL)
The score is from 0 to 6, with higher scores indicating worse quality of life.
Measured: A month after treatment；Two months after treatment；Three months after treatment；Half year after treatment；One year after treatment
Self-Rating Anxiety Scale (SAS)
The Anxiety Self-Rating Scale involves subjectively evaluating 20 questions. Each question is rated on a frequency scale from 1 to 4, where:
- point indicates none or very rarely;
- points indicate sometimes;
- points indicate most of the time;
- points indicate almost always or always.
Measured: A month after treatment；Two months after treatment；Three months after treatment；Half year after treatment；One year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start9 Mar 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, Sir Run Run Shaw Hospital, Second Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Principal investigator, Qibo Hu, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765629
- Sponsor's protocol ID
- 2024-IRB-0074-P-01
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Transcutaneous Tibial Nerve Stimulation in Children With Overactive Bladder: A Prospective, Multicenter, Single-Arm Study
- ClinicalTrials.gov ID
- NCT06765629
- Acronym / sponsor ID
- 2024-IRB-0074-P-01
- Conditions
- Overactive Bladder (OAB)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang University, Sir Run Run Shaw Hospital, Second Affiliated Hospital of Wenzhou Medical University
- Study start
- 9 Mar 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 Jan 2025 (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.
Overactive bladder (OAB) is a syndrome characterized by urinary urgency, often accompanied by frequency and nocturia, with or without urge incontinence, without urinary tract infection or other clear pathological changes. The prevalence of OAB ranges from 9% to 43% in women and 7% to 27% in men, severely affecting patients' quality of life and mental health. Traditional treatments for OAB include behavioral therapy (bladder retraining, pelvic floor muscle training, etc.) and drug therapy (including anticholinergic, antispasmodic drugs, and tricyclic antidepressants, etc.); for refractory overactive bladder syndrome, surgical interventions include bladder augmentation and urinary diversion, etc. However, due to serious complications, lack of efficacy, or significant trauma, these methods are greatly limited in clinical application.
In recent years, with the continuous development of neuromodulation technology, neurostimulation has gradually been applied in the treatment of lower urinary tract dysfunction. Compared with traditional treatments, it does not have side effects such as dry mouth, constipation, blurred vision, etc., and compared with surgical treatment, it reduces side effects such as bleeding and infection. Among them, Tibial Nerve Stimulation (TNS) has become an optional therapy for OAB treatment due to its non-surgical nature, convenience, low risk, high safety, significant efficacy, and relative cost-effectiveness.
With the continuous development of technology, and in order to reduce the invasiveness of treatment, improve safety and convenience, Percutaneous Tibial Nerve Stimulation (PTNS) is gradually shifting towards non-invasive Percutaneous Tibial Nerve Stimulation (TTNS). The main difference between the two is that the former uses fine needle electrodes, while the latter mostly uses surface electrodes, which deliver electrical power to the tibial nerve through skin and soft tissue. Studies have shown that TTNS has the same efficacy as drug therapy, is more effective for OAB symptoms than behavioral interventions, and there is no statistically significant difference in efficacy between TTNS and PTNS. It is recommended as an option to improve OAB by the "European Association of Urology Guidelines on Female Non-neurogenic LUTS (2023)" and the "Chinese Guidelines on Diagnosis and Treatment of Urology and Male Diseases (2022)".
However, there is still a lack of large-scale prospective studies on the use of TTNS for OAB in Asian populations, and most existing studies have observation periods of 3 months or less, lacking high-quality research evidence for long-term efficacy. Therefore, a prospective, multicenter, single-arm study is planned to verify the long-term efficacy of percutaneous tibial nerve stimulation in the treatment of OAB in the Chinese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Percutaneous Tibial Nerve Stimulation (TTNS) group | Experimental | Device: Non-invasive Percutaneous Tibial Nerve Stimulation (TTNS) group |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with OAB according to the "Chinese Urology and Male Disease Diagnosis and Treatment Guidelines" 2022 edition;
- Age between 6 and 18 years, gender unrestricted;
- Need to receive and consent to TTNS treatment for medical reasons;
- Urination diary (3 days prior to random enrollment) shows an average of ≥8 urination times per 24 hours;
- The patient or their representative understands the purpose and requirements of this study and signs the informed consent form (if the subject is <8 years old, written consent from the legal guardian is required; if the subject is 8 years old ≤ subject ≤ 18 years old, written informed consent from both the subject and the legal guardian is required); If not co-administering β3 agonists/non-selective β-agonists or anticholinergic drugs during the study period, the medication must be discontinued for at least 7 days before the screening period. If continuing to take β3 agonists/non-selective β-agonists or anticholinergic drugs during the study period, the dosage and method of administration must remain unchanged until the study is completed.
Key exclusion criteria (10 listed)
- Those with an implanted pacemaker or implantable cardioverter-defibrillator;
- Patients with concomitant urinary system diseases: deformities, tumors, obstructions, stones, urinary retention;
- Patients with stress urinary incontinence and other related diseases affecting urine generation and excretion;
- Individuals with cognitive impairment, Parkinson's disease, or complete spinal cord injury;
- Patients with psychiatric disorders who cannot cooperate with medical staff;
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 Percutaneous Tibial Nerve Stimulation (TTNS) groupAfter obtaining informed consent from the subjects, the researchers screen the subjects based on the inclusion and exclusion criteria. The wearable non-invasive percutaneous tibial nerve stimulator is placed on the area where the tibial nerve runs at the medial malleolus of the subjects. Once the wearable stimulator is properly fitted, stimulation parameter programming and treatment record management are conducted through the programming software running on the mobile phone. | Device | Non-invasive Percutaneous Tibial Nerve Stimulation (TTNS) group |
Primary outcome
72-hour Voiding Diary
Time frame: A month after treatment；Two months after treatment；Three months after treatment；Half year after treatment；One year after treatment
4 secondary outcomes
Overactive bladder syndrome score (OABSS)
Time frame: A month after treatment；Two months after treatment；Three months after treatment；Half year after treatment；One year after treatment
Patient Perception of Bladder Condition Score (PPBC-S)
Time frame: A month after treatment；Two months after treatment；Three months after treatment；Half year after treatment；One year after treatment
American Urological Association-Symptom Index-Quality of life (AUA-SI-QOL)
Time frame: A month after treatment；Two months after treatment；Three months after treatment；Half year after treatment；One year after treatment
Self-Rating Anxiety Scale (SAS)
Time frame: A month after treatment；Two months after treatment；Three months after treatment；Half year after treatment；One year after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Percutaneous Tibial Nerve Stimulation (TTNS) group in people with Overactive Bladder (OAB), run by The Children's Hospital of Zhejiang University School of Medicine at 1 site 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 5 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
72-hour Voiding Diary (time frame: A month after treatment；Two months after treatment；Three months after treatment；Half year after treatment；One year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2025.