To Investigate the Clinical Effect of Acupuncturing Ba Liao for Neurogenic Bladder Under the Guidance of UltrasoundNCT05447247
Clinical Study on Treatment of Neurogenic Bladder by Electroacupuncture on Ba Liao Point Under Ultrasound Guidance
A study testing Acupuncturing Ba Liao point under ultrasound guidance in people with To Investigate the Clinical Effect of Acupuncturing Ba Liao for Neurogenic Bladder Under the Guidance of Ultrasound, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
To explore acupuncture under the premise of real-time, dynamic and accurate positioning of Ba liao point with ultrasound, observe the clinical efficacy of treating neurogenic bladder, clarify the essence of acupoints, and provide a new method for the standardization of acupuncture and moxibustion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- To Investigate the Clinical Effect of Acupuncturing Ba Liao for Neurogenic Bladder Under the Guidance of Ultrasound
- What is being tested?
- Acupuncturing Ba Liao point under ultrasound guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The diagnosis of neurogenic bladder conforms to the main points;
- Symptoms and signs: patients with lower urinary tract dysfunction such as frequency of urination, urgency of urination, inadequacy of urine or retention of urine, urinary incontinence; Physical examination showed paresthesia in perineum and saddle area.
- Auxiliary examination; Routine urine examination, B - ultrasonography of urinary system and urodynamic examination.
- Indwelling catheter has been removed;
- Conscious and able to accurately express symptoms and signs;
- Patients who inform patients and their families of the research situation in detail and obtain their consent for treatment.
- -
Who cannot join
- Lower urinary tract dysfunction caused by non-nervous system factors such as urethral calculi and organic obstruction;
- patients with serious heart and lung diseases, liver and hematopoietic diseases and mental diseases;
- patients with prostate cancer, urethral stricture, bladder neck fibrosis, interstitial cystitis, glandular cystitis and other diseases;
- patients implanted with urethral stents or sacral nerve electrodes;
- pregnant and lactation women;
- Fear of acupuncture, needle-sickness and blood sickness. -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250001
Yang Zhang, Doctor, +86-18560083582
About this study
To explore acupuncture under the premise of real-time, dynamic and accurate positioning of Ba liao point with ultrasound, observe the clinical efficacy of treating neurogenic bladder, clarify the essence of acupoints, and provide a new method for the standardization of acupuncture and moxibustion.
- Being tested
- Acupuncturing Ba Liao point under ultrasound guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncturing Ba Liao point under ultrasound guidanceOther
Acupuncturing Ba Liao point under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Acupuncturing Ba Liao point under ultrasound guidance | Experimental | Not described Receives: Other: Acupuncturing Ba Liao point under ultrasound guidance |
| Conventional acupuncture | Experimental | Not described Receives: Other: Acupuncturing Ba Liao point under ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urodynamic study
Residual urine volume, maximum urine flow rate, average urine flow rate, urination time, urine flow time and urine flow rate were assessed
Measured: Once every two weeks:Before treatment, two weeks after treatment, four weeks after treatment
Neurogenic bladder symptom score
Patients were evaluated for neurogenic bladder symptoms
Measured: Once every two weeks:Before treatment, two weeks after treatment, four weeks after treatment.followed up for 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Jun 2022
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Investigate the Clinical Effect of Acupuncturing Ba Liao for Neurogenic Bladder Under the Guidance of UltrasoundStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447247
- Sponsor's protocol ID
- QiluH-xinshenglianhua
- Status last verified
- May 2023
- First submitted
- 3 Jul 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Treatment of Neurogenic Bladder by Electroacupuncture on Ba Liao Point Under Ultrasound Guidance
- ClinicalTrials.gov ID
- NCT05447247
- Acronym / sponsor ID
- QiluH-xinshenglianhua
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 7 Jul 2022 (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 explore acupuncture under the premise of real-time, dynamic and accurate positioning of Ba liao point with ultrasound, observe the clinical efficacy of treating neurogenic bladder, clarify the essence of acupoints, and provide a new method for the standardization of acupuncture and moxibustion.
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 |
|---|---|---|
| Acupuncturing Ba Liao point under ultrasound guidance | Experimental | Other: Acupuncturing Ba Liao point under ultrasound guidance |
| Conventional acupuncture | Experimental | Other: Acupuncturing Ba Liao point under ultrasound guidance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- The diagnosis of neurogenic bladder conforms to the main points;
- Symptoms and signs: patients with lower urinary tract dysfunction such as frequency of urination, urgency of urination, inadequacy of urine or retention of urine, urinary incontinence; Physical examination showed paresthesia in perineum and saddle area.
- Auxiliary examination; Routine urine examination, B - ultrasonography of urinary system and urodynamic examination.
- Indwelling catheter has been removed;
- Conscious and able to accurately express symptoms and signs;
Key exclusion criteria (6 listed)
- Lower urinary tract dysfunction caused by non-nervous system factors such as urethral calculi and organic obstruction;
- patients with serious heart and lung diseases, liver and hematopoietic diseases and mental diseases;
- patients with prostate cancer, urethral stricture, bladder neck fibrosis, interstitial cystitis, glandular cystitis and other diseases;
- patients implanted with urethral stents or sacral nerve electrodes;
- pregnant and lactation women;
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 |
|---|---|---|
| Acupuncturing Ba Liao point under ultrasound guidanceAcupuncturing Ba Liao point under ultrasound guidance | Other | Acupuncturing Ba Liao point under ultrasound guidance, Conventional acupuncture |
Primary outcome
Urodynamic study
Time frame: Once every two weeks:Before treatment, two weeks after treatment, four weeks after treatment
Residual urine volume, maximum urine flow rate, average urine flow rate, urination time, urine flow time and urine flow rate were assessed
Neurogenic bladder symptom score
Time frame: Once every two weeks:Before treatment, two weeks after treatment, four weeks after treatment.followed up for 3 months after treatment
Patients were evaluated for neurogenic bladder symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncturing Ba Liao point under ultrasound guidance in people with To Investigate the Clinical Effect of Acupuncturing Ba Liao for Neurogenic Bladder Under the Guidance of Ultrasound, run by Qilu Hospital of Shandong University 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yijun Du, Master (+86-18560083602, duyijun.19871006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urodynamic study (time frame: Once every two weeks:Before treatment, two weeks after treatment, four weeks after treatment). The study lists 2 primary outcomes in all. 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 18 Jun 2023.