Neurogenic BladderNCT05262816
Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury
A study testing electroacupuncture in people with Neurogenic Bladder, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Neurogenic bladder after spinal cord injury can be divided into detrusor hyperreflexia and detrusor non reflexia. Acupuncture is recognized as a safe and effective treatment. The most commonly used acupoints are Guanyuan, Zhongji and Sanyinjiao. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurogenic Bladder
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2021to 30 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
- patients diagnosed with traumatic suprasacral SCI.
- the period of the spinal shock has passed.
- patients with voiding dysfunction after SCI.
- patients had stable condition, and suitable for treatment.
- agreed to engage in our study and sign the informed consent.
Who cannot join
- Patients with severe primary diseases such as heart, liver, kidney, hematopoietic system, endocrine system and psychosis.
- dysuria caused by non spinal cord injury, such as prostatic hypertrophy, urethral obstruction, operation.
- Patients who have already taken cystostomy and sacral electrode implantation.
- Patients with urinary tract infection.
- Autonomic hyperreflexes were obvious.
- Unable to cooperate with the healer.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Jun-yan Lu, huars03@163.com
About this study
Official title: Urodynamic Analysis of the Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury
Neurogenic bladder after spinal cord injury can be divided into detrusor hyperreflexia and detrusor non reflexia. Acupuncture is recognized as a safe and effective treatment. The most commonly used acupoints are Guanyuan, Zhongji and Sanyinjiao. The purpose of this study is to clarify the therapeutic effects of different acupoints on different types of bladder. Main process: routine urodynamic examination was performed first, and then electroacupuncture was given to Guanyuan, Zhongji and Sanyinjiao points respectively, and urodynamic examination was performed again to observe the effect of Electroacupuncture on urodynamic parameters in real time.
- Conditions
- Neurogenic Bladder
- Being tested
- electroacupuncture
- Keywords
- Electroacupuncture, Neurogenic Bladder, Spinal Cord Injury
- Medical subject headings
- Urinary Bladder, Neurogenic, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
electroacupuncture at Sanyinjiao (SP6)
| Study group | Role | What they receive |
|---|---|---|
| sanyinjiao group | Experimental | Perpendicular insertion about 0.8-1.2cun at bilateral sanyinjiao(SP6) acupoint.Then,bilateral SP6 were connected with Electronic Acupuncture Treatment Instrument (KWD-808-I,Yingdi, China). The frequency of the pulse was 20 Hz with a pulse duration of 200 us.Intensity of stimulus was depending on patient's tolerance. Receives: Other: electroacupuncture |
| guanyuan group | Active comparator | Perpendicular insertion about 0.8-1.2cun at bilateral Guanyuan(CV4), Zhongji (CV3) acupoints.Then,the two acupoints were connected with Electronic Acupuncture Treatment Instrument (KWD-808-I,Yingdi, China). The frequency of the pulse was 20 Hz with a pulse duration of 200 us.Intensity of stimulus was depending on patient's tolerance. Receives: Other: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perianal surface electromyography
Perianal surface electromyography
Measured: Procedure (While doing acupuncture )
detrusor overactivity (DO)
detrusor overactivity in milliliter,one of the urodynamic parameters
Measured: Procedure (While doing acupuncture )
bladder compliance (BC)
bladder compliance in ml/cmH2O,one of the urodynamic parameters
Measured: Procedure (While doing acupuncture )
maximum cystometric capacity (MCC)
maximum cystometric capacity in milliliter,one of the urodynamic parameters
Measured: Procedure (While doing acupuncture )
maximum urinary flow rate (Qmax)
maximum urinary flow rate in milliliter/second,one of the urodynamic parameters
Measured: Procedure (While doing acupuncture )
maximum detrusor pressure
maximum detrusor pressure at filling stage and voiding stage
Measured: Procedure (While doing acupuncture )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start20 Aug 2021
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262816
- Sponsor's protocol ID
- SAHoWMU-CR2021-15-103
- Status last verified
- Feb 2022
- First submitted
- 7 Sep 2021
- Last updated
- 2 Mar 2022
- 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urodynamic Analysis of the Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05262816
- Acronym / sponsor ID
- SAHoWMU-CR2021-15-103
- Conditions
- Neurogenic Bladder
- Keywords
- Electroacupuncture, Neurogenic Bladder, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 2 Mar 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.
Neurogenic bladder after spinal cord injury can be divided into detrusor hyperreflexia and detrusor non reflexia. Acupuncture is recognized as a safe and effective treatment. The most commonly used acupoints are Guanyuan, Zhongji and Sanyinjiao. The purpose of this study is to clarify the therapeutic effects of different acupoints on different types of bladder. Main process: routine urodynamic examination was performed first, and then electroacupuncture was given to Guanyuan, Zhongji and Sanyinjiao points respectively, and urodynamic examination was performed again to observe the effect of Electroacupuncture on urodynamic parameters in real time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sanyinjiao group | Experimental | Other: electroacupuncturePerpendicular insertion about 0.8-1.2cun at bilateral sanyinjiao(SP6) acupoint.Then,bilateral SP6 were connected with Electronic Acupuncture Treatment Instrument (KWD-808-I,Yingdi, China). The frequency of the pulse was 20 Hz with a pulse duration of 200 us.Intensity of stimulus was depending on patient's tolerance. |
| guanyuan group | Active comparator | Other: electroacupuncturePerpendicular insertion about 0.8-1.2cun at bilateral Guanyuan(CV4), Zhongji (CV3) acupoints.Then,the two acupoints were connected with Electronic Acupuncture Treatment Instrument (KWD-808-I,Yingdi, China). The frequency of the pulse was 20 Hz with a pulse duration of 200 us.Intensity of stimulus was depending on patient's tolerance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients diagnosed with traumatic suprasacral SCI.
- the period of the spinal shock has passed.
- patients with voiding dysfunction after SCI.
- patients had stable condition, and suitable for treatment.
- agreed to engage in our study and sign the informed consent.
Key exclusion criteria (6 listed)
- Patients with severe primary diseases such as heart, liver, kidney, hematopoietic system, endocrine system and psychosis.
- dysuria caused by non spinal cord injury, such as prostatic hypertrophy, urethral obstruction, operation.
- Patients who have already taken cystostomy and sacral electrode implantation.
- Patients with urinary tract infection.
- Autonomic hyperreflexes were obvious.
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 |
|---|---|---|
| electroacupunctureelectroacupuncture at Sanyinjiao (SP6) | Other | guanyuan group, sanyinjiao group |
Primary outcome
Perianal surface electromyography
Time frame: Procedure (While doing acupuncture )
Perianal surface electromyography
detrusor overactivity (DO)
Time frame: Procedure (While doing acupuncture )
detrusor overactivity in milliliter,one of the urodynamic parameters
bladder compliance (BC)
Time frame: Procedure (While doing acupuncture )
bladder compliance in ml/cmH2O,one of the urodynamic parameters
maximum cystometric capacity (MCC)
Time frame: Procedure (While doing acupuncture )
maximum cystometric capacity in milliliter,one of the urodynamic parameters
maximum urinary flow rate (Qmax)
Time frame: Procedure (While doing acupuncture )
maximum urinary flow rate in milliliter/second,one of the urodynamic parameters
maximum detrusor pressure
Time frame: Procedure (While doing acupuncture )
maximum detrusor pressure at filling stage and voiding stage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Neurogenic Bladder, run by Second Affiliated Hospital of Wenzhou Medical 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 5 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 2 Mar 2022. 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 Junyan Lu (13968769904, huars03@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perianal surface electromyography (time frame: Procedure (While doing acupuncture )). The study lists 6 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 2 Mar 2022.