Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions

NCT06354244 | Recruiting DMC

• 1 other identifier: 2023-183-KY-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effects of electroacupuncture of different frequency in patients with chronic urinary retention caused by lower motor neuron lesions

Conditions

Urinary Retention; Lower Motor Neurone Lesion

Keywords

electroacupuncture; chronic urinary retention; cohort study

Outcome Measures

Primary Outcomes (1)

• The response rate.

  Responders are defined as patients whose post void residuals (PVR) reduced by 50% or more from baseline.

  Week 12.

Secondary Outcomes (7)

• The response rate.

  Week 4, Week 8 and Week 24.

• The change in post void residuals (PVR) from baseline.

  Week 4, Week 8,Week 12 and Week 24.

• The change in the proportion of patients reporting severe urinating difficulty from baseline.

  Week 4, Week 8,Week 12 and Week 24.

• The change in the proportion of patients having stool retention from baseline.

  Week 4, Week 8,Week 12 and Week 24.

• The change in the proportion of patients requiring catheterization from baseline.

  Week 4, Week 8,Week 12 and Week 24.

Study Arms (3)

Electroacupuncture of 2 sessions per week

Device: Electroacupuncture of 2 sessions per week

Electroacupuncture of 3 sessions per week

Device: Electroacupuncture of 3 sessions per week

Electroacupuncture of 4 sessions per week

Device: Electroacupuncture of 4 sessions per week

Interventions

Electroacupuncture of 2 sessions per week DEVICE

Acupoints including bilateral BL23, BL32, BL33, BL35 and SP6 are inserted with acupuncture needles(size 0.30 × 40 mm and 0.30 × 75 mm or 0.40 × 100 mm,Hwato Brand). Bilateral BL32 and BL33 are needled to a depth of 70-95 mm with an angle of 60°-75° inward and downward, into the second and third sacral foramen. Bilateral BL35 are needled to a depth of 60-70 mm in a slightly superolateral direction. Bilateral BL23 and SP6 are vertically needled to a depth of 25-30 mm. After deqi is evoked, electric stimulators with a 5Hz continuous wave (5-10 mA intensity) are separately connected to bilateral BL32, BL33,BL35 and SP6. Current intensity is adjusted according to the patients' individual tolerance. During each session, electroacupuncture(EA) is retained for 30 minutes. The patients receive EA 2 sessions per week for 2-24 weeks.EA can be terminated if the patient acquire satisfactory spontaneous urination.

Electroacupuncture of 2 sessions per week

Electroacupuncture of 3 sessions per week DEVICE

Acupoints and electroacupuncture (EA) procedures are the same as in the group of EA of 2 sessions per week, but the patients receive EA 3 sessions per week for 2-24 weeks in this group.EA can be terminated if the patient acquire satisfactory spontaneous urination.

Electroacupuncture of 3 sessions per week

Electroacupuncture of 4 sessions per week DEVICE

Acupoints and electroacupuncture (EA) procedures are the same as in the group of EA of 2 sessions per week, but the patients receive EA 4 sessions per week for 2-24 weeks in this group.EA can be terminated if the patient acquire satisfactory spontaneous urination.

Electroacupuncture of 4 sessions per week

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There are a group of patients with nerve lesions presenting with chronic urinary retention, having to rely on life-long catheterization to empty the bladder. However, complications of catheterization including recurrent urinary tract infection and urethral stricture formation, negatively impact on patients' daily life and bring heavy burden on family and society, together making it a less ideal option.

You may qualify if:

• Diagnosed with urinary retention caused by lower motor neuron lesions (e.g., sacral plexus, cauda equina, or sacral cord lesions).
• years or older.
• Baseline post void residuals (PVR) ≥150 mL.
• The course of urinary retention ≥1 month.
• Having normal bladder sensation.
• Using clean intermittent catheterization (CIC), indwelling catheterization (IC), manual assisted voiding including putting pressure on abdomen, or cystostomy catheterization.
• Signed informed consent and voluntary participation in the study.

You may not qualify if:

• Having a lower urinary tract obstruction, such as bladder neck contracture, urethral stricture, prostatic hyperplasia, or large urinary stones that can cause obstruction.
• Having any type of malignant tumors not removed.
• Having severe systemic disorders not controlled.
• Having implanted electrodes of cardiac pacemaker, pudendal nerve stimulation, bladder stimulation, or SNM.
• Pregnancy or lactation.
• Eletroacupuncture treatment duration \< 2 weeks.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Zhishun Liu

CONTACT

+861088002331; zhishunjournal@163.com

Min Yang

CONTACT

+8618810268077; yangmin2019@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: April 4, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available with the publication until six months after publication.
• Access Criteria: A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved. Researchers whose proposal has been approved will sign a data access agreement.

Locations

CN (1)