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

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.

Study Overview

• Status: Recruiting
• Conditions: To Investigate the Clinical Effect of Acupuncturing Ba Liao for Neurogenic Bladder Under the Guidance of Ultrasound
• Intervention / Treatment: Other: Acupuncturing Ba Liao point under ultrasound guidance

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yijun Du, Master; Phone Number: +86-18560083602; Email: duyijun.19871006@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250001
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Yang Zhang, Doctor; Phone Number: +86-18560083582

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncturing Ba Liao point under ultrasound guidance	Other: Acupuncturing Ba Liao point under ultrasound guidance; Acupuncturing Ba Liao point under ultrasound guidance
Experimental: Conventional acupuncture	Other: Acupuncturing Ba Liao point under ultrasound guidance; Acupuncturing Ba Liao point under ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urodynamic study	Residual urine volume, maximum urine flow rate, average urine flow rate, urination time, urine flow time and urine flow rate were assessed	Once every two weeks:Before treatment, two weeks after treatment, four weeks after treatment
Neurogenic bladder symptom score	Patients were evaluated for neurogenic bladder symptoms	Once every two weeks:Before treatment, two weeks after treatment, four weeks after treatment.followed up for 3 months after treatment

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: July 3, 2022
• First Submitted That Met QC Criteria: July 3, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Neurogenic
• Other Study ID Numbers: QiluH-xinshenglianhua

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No