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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05262816
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Wenzhou Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neurogenic Bladder Other: electroacupuncture Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Urodynamic Analysis of the Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury
Actual Study Start Date : August 20, 2021
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: sanyinjiao group
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.
 Other: electroacupuncture
electroacupuncture at Sanyinjiao (SP6)
Active Comparator: guanyuan group
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.
 Other: electroacupuncture
electroacupuncture at Sanyinjiao (SP6)


Outcome Measures
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Primary Outcome Measures :
  1. Perianal surface electromyography [ Time Frame: Procedure (While doing acupuncture ) ]
    Perianal surface electromyography

  2. detrusor overactivity (DO) [ Time Frame: Procedure (While doing acupuncture ) ]
    detrusor overactivity in milliliter,one of the urodynamic parameters

  3. bladder compliance (BC) [ Time Frame: Procedure (While doing acupuncture ) ]
    bladder compliance in ml/cmH2O,one of the urodynamic parameters

  4. maximum cystometric capacity (MCC) [ Time Frame: Procedure (While doing acupuncture ) ]
    maximum cystometric capacity in milliliter,one of the urodynamic parameters

  5. maximum urinary flow rate (Qmax) [ Time Frame: Procedure (While doing acupuncture ) ]
    maximum urinary flow rate in milliliter/second,one of the urodynamic parameters

  6. maximum detrusor pressure [ Time Frame: Procedure (While doing acupuncture ) ]
    maximum detrusor pressure at filling stage and voiding stage


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05262816


Contacts
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Contact: Junyan Lu 13968769904 huars03@163.com

Locations
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China, Zhejiang
the Second Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325027
Contact: Jun-yan Lu       huars03@163.com   
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
More Information
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Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT05262816    
Other Study ID Numbers: SAHoWMU-CR2021-15-103
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital of Wenzhou Medical University:
Electroacupuncture
Neurogenic Bladder
Spinal Cord Injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Urinary Bladder, Neurogenic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
 Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases