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

Effects of Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions: a Prospective Cohort Study

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

Study Overview

• Status: Recruiting
• Conditions: Urinary Retention; Lower Motor Neurone Lesion
• Intervention / Treatment: Device: Electroacupuncture of 2 sessions per week; Device: Electroacupuncture of 3 sessions per week; Device: Electroacupuncture of 4 sessions per week

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Zhishun Liu; Phone Number: +861088002331; Email: zhishunjournal@163.com
• Study Contact Backup: Name: Min Yang; Phone Number: +8618810268077; Email: yangmin2019@yeah.net

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
    • Contact: Min Yang; Phone Number: +8618810268077; Email: yangmin2019@yeah.net
    • Contact: Zhishun Liu, PhD; Phone Number: +861088002331; Email: zhishunjournal@163.com

Participation Criteria

Eligibility Criteria

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

• 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.

Description

Inclusion Criteria:

• Diagnosed with urinary retention caused by lower motor neuron lesions (e.g., sacral plexus, cauda equina, or sacral cord lesions).
• 18 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Electroacupuncture of 2 sessions per week	Device: Electroacupuncture of 2 sessions per week; 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 3 sessions per week	Device: Electroacupuncture of 3 sessions per week; 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 4 sessions per week	Device: Electroacupuncture of 4 sessions per week; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The response rate.	Responders are defined as patients whose post void residuals (PVR) reduced by 50% or more from baseline.	Week 12.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The response rate.	Responders are defined as patients whose post void residuals (PVR) reduced by 50% or more from baseline.	Week 4, Week 8 and Week 24.
The change in post void residuals (PVR) from baseline.	PVR is measured by urethral catheter output after patients' spontaneous urination attempts without catheterization or assisted bladder emptying (including increasing abdominal pressure or other auxiliary manual methods). If catheterization is not needed, which is assessed by urologists, PVR will be measured by ultrasound.	Week 4, Week 8,Week 12 and Week 24.
The change in the proportion of patients reporting severe urinating difficulty from baseline.	The patient' s urinating difficulty is classified into four levels: severe, moderate, mild and none.	Week 4, Week 8,Week 12 and Week 24.
The change in the proportion of patients having stool retention from baseline.	Stool retention is diagnosed according to Rome IV criteria.	Week 4, Week 8,Week 12 and Week 24.
The change in the proportion of patients requiring catheterization from baseline.	If satisfactory spontaneous urination is observed,catheterization will not be needed, which is assessed by urologists.	Week 4, Week 8,Week 12 and Week 24.
The proportion of patients reporting much better or moderately better regarding the Patient Global Impression of Improvement (PGI-I).	The PGI-I assessment has scores of 1 to 7 corresponding to much better to much worse, with higher score representing less improvement.	Week 4, Week 8,Week 12 and Week 24.
The proportion of patients having recurrent symptomatic UTI, hydroureter, or hydronephrosis.	Recurrent UTI is confirmed by characteristic clinical signs.Hydronephrosis and hydroureter are assessed by ultrasound.	Week 4, Week 8,Week 12 and Week 24.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: cohort study; electroacupuncture; chronic urinary retention
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Retention
• Other Study ID Numbers: 2023-183-KY-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Deidentified participant data and data dictionary will be available with the publication until six months after publication.

A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal.

Researchers whose proposal has been approved will sign a data access agreement.

• IPD Sharing Time Frame: The data will be available with the publication until six months after publication.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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