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Clinical Study on Treatment of Neurogenic Bladder by Electroacupuncture on Ba Liao Point Under Ultrasound Guidance

Primary Purpose

To Investigate the Clinical Effect of Acupuncturing Ba Liao for Neurogenic Bladder Under the Guidance of Ultrasound

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncturing Ba Liao point under ultrasound guidance
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for To Investigate the Clinical Effect of Acupuncturing Ba Liao for Neurogenic Bladder Under the Guidance of Ultrasound

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The diagnosis of neurogenic bladder conforms to the main points;
  2. 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.
  3. Auxiliary examination; Routine urine examination, B - ultrasonography of urinary system and urodynamic examination.
  4. Indwelling catheter has been removed;
  5. Conscious and able to accurately express symptoms and signs;

  6. Patients who inform patients and their families of the research situation in detail and obtain their consent for treatment.

    -

Exclusion Criteria:

  1. Lower urinary tract dysfunction caused by non-nervous system factors such as urethral calculi and organic obstruction;
  2. patients with serious heart and lung diseases, liver and hematopoietic diseases and mental diseases;
  3. patients with prostate cancer, urethral stricture, bladder neck fibrosis, interstitial cystitis, glandular cystitis and other diseases;
  4. patients implanted with urethral stents or sacral nerve electrodes;
  5. pregnant and lactation women;
  6. Fear of acupuncture, needle-sickness and blood sickness. -

Sites / Locations

  • Qilu Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acupuncturing Ba Liao point under ultrasound guidance

Conventional acupuncture

Arm Description

Outcomes

Primary Outcome Measures

Urodynamic study
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
Patients were evaluated for neurogenic bladder symptoms

Secondary Outcome Measures

Full Information

First Posted
July 3, 2022
Last Updated
June 14, 2023
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT05447247
Brief Title
Clinical Study on Treatment of Neurogenic Bladder by Electroacupuncture on Ba Liao Point Under Ultrasound Guidance
Official Title
Clinical Study on Treatment of Neurogenic Bladder by Electroacupuncture on Ba Liao Point Under Ultrasound Guidance
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Investigate the Clinical Effect of Acupuncturing Ba Liao for Neurogenic Bladder Under the Guidance of Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncturing Ba Liao point under ultrasound guidance
Arm Type
Experimental
Arm Title
Conventional acupuncture
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Acupuncturing Ba Liao point under ultrasound guidance
Intervention Description
Acupuncturing Ba Liao point under ultrasound guidance
Primary Outcome Measure Information:
Title
Urodynamic study
Description
Residual urine volume, maximum urine flow rate, average urine flow rate, urination time, urine flow time and urine flow rate were assessed
Time Frame
Once every two weeks:Before treatment, two weeks after treatment, four weeks after treatment
Title
Neurogenic bladder symptom score
Description
Patients were evaluated for neurogenic bladder symptoms
Time Frame
Once every two weeks:Before treatment, two weeks after treatment, four weeks after treatment.followed up for 3 months after treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. - Exclusion Criteria: 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yijun Du, Master
Phone
+86-18560083602
Email
duyijun.19871006@163.com
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Zhang, Doctor
Phone
+86-18560083582

12. IPD Sharing Statement

Learn more about this trial

Clinical Study on Treatment of Neurogenic Bladder by Electroacupuncture on Ba Liao Point Under Ultrasound Guidance

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