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Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury

Primary Purpose

Neurogenic Bladder

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

electroacupuncture

About this trial

This is an interventional treatment trial for Neurogenic Bladder focused on measuring Electroacupuncture, Neurogenic Bladder, Spinal Cord Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

the Second Affiliated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sanyinjiao group

guanyuan group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Perianal surface electromyography

detrusor overactivity (DO)

detrusor overactivity in milliliter,one of the urodynamic parameters

bladder compliance (BC)

bladder compliance in ml/cmH2O,one of the urodynamic parameters

maximum cystometric capacity (MCC)

maximum cystometric capacity in milliliter,one of the urodynamic parameters

maximum urinary flow rate (Qmax)

maximum urinary flow rate in milliliter/second,one of the urodynamic parameters

maximum detrusor pressure

maximum detrusor pressure at filling stage and voiding stage

Secondary Outcome Measures

Full Information

NCT ID

NCT05262816

First Posted

September 7, 2021

Last Updated

March 1, 2022

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05262816

Brief Title

Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury

Official Title

Urodynamic Analysis of the Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 20, 2021 (Actual)

Primary Completion Date

July 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurogenic Bladder

Keywords

Electroacupuncture, Neurogenic Bladder, Spinal Cord Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sanyinjiao group

Arm Type

Experimental

Arm Description

Arm Title

guanyuan group

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

electroacupuncture

Intervention Description

electroacupuncture at Sanyinjiao (SP6)

Primary Outcome Measure Information:

Title

Perianal surface electromyography

Description

Perianal surface electromyography

Time Frame