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

Recruiting

• Conditions: Urinary Retention; Lower Motor Neurone Lesion
• Interventions: Device: Electroacupuncture of 2 sessions per week; Device: Electroacupuncture of 3 sessions per week; Device: Electroacupuncture of 4 sessions per week

• Registration Number: NCT06354244
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-03
• Study Start: 2024-04-04
• Study First Posted: 2024-04-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-12
• Last Update Posted: 2024-05-14
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Electroacupuncture of 2 sessions per week	Electroacupuncture of 2 sessions per week	-
Electroacupuncture of 3 sessions per week	Electroacupuncture of 3 sessions per week	-
Electroacupuncture of 4 sessions per week	Electroacupuncture of 4 sessions per week	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The response rate.	Week 4, Week 8 and Week 24.	Responders are defined as patients whose post void residuals (PVR) reduced by 50% or more from baseline.
The change in the proportion of patients reporting severe urinating difficulty from baseline.	Week 4, Week 8,Week 12 and Week 24.	The patient' s urinating difficulty is classified into four levels: severe, moderate, mild and none.
The change in the proportion of patients having stool retention from baseline.	Week 4, Week 8,Week 12 and Week 24.	Stool retention is diagnosed according to Rome IV criteria.
The change in the proportion of patients requiring catheterization from baseline.	Week 4, Week 8,Week 12 and Week 24.	If satisfactory spontaneous urination is observed,catheterization will not be needed, which is assessed by urologists.
The proportion of patients reporting much better or moderately better regarding the Patient Global Impression of Improvement (PGI-I).	Week 4, Week 8,Week 12 and Week 24.	The PGI-I assessment has scores of 1 to 7 corresponding to much better to much worse, with higher score representing less improvement.
The change in post void residuals (PVR) from baseline.	Week 4, Week 8,Week 12 and Week 24.	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.
The proportion of patients having recurrent symptomatic UTI, hydroureter, or hydronephrosis.	Week 4, Week 8,Week 12 and Week 24.	Recurrent UTI is confirmed by characteristic clinical signs.Hydronephrosis and hydroureter are assessed by ultrasound.

Trial Locations

Locations (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China