search
Back to results

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
Sponsored by
Second Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

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
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

First Posted
September 7, 2021
Last Updated
March 1, 2022
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
search

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
No
Studies a U.S. FDA-regulated Device Product
No

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
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.
Arm Title
guanyuan group
Arm Type
Active Comparator
Arm Description
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.
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
Procedure (While doing acupuncture )
Title
detrusor overactivity (DO)
Description
detrusor overactivity in milliliter,one of the urodynamic parameters
Time Frame
Procedure (While doing acupuncture )
Title
bladder compliance (BC)
Description
bladder compliance in ml/cmH2O,one of the urodynamic parameters
Time Frame
Procedure (While doing acupuncture )
Title
maximum cystometric capacity (MCC)
Description
maximum cystometric capacity in milliliter,one of the urodynamic parameters
Time Frame
Procedure (While doing acupuncture )
Title
maximum urinary flow rate (Qmax)
Description
maximum urinary flow rate in milliliter/second,one of the urodynamic parameters
Time Frame
Procedure (While doing acupuncture )
Title
maximum detrusor pressure
Description
maximum detrusor pressure at filling stage and voiding stage
Time Frame
Procedure (While doing acupuncture )

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junyan Lu
Phone
13968769904
Email
huars03@163.com
Facility Information:
Facility Name
the Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-yan Lu
Email
huars03@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs