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

Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06354244
• Other study ID #: 2023-183-KY-02
• Status: Recruiting
• Start date: April 4, 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Zhishun Liu
• Phone: +861088002331
• Email: zhishunjournal[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lower Motor Neurone Lesion
• Urinary Retention

Intervention

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
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
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.

Locations

Country	Name	City	State
China	Guang'anmen Hospital, China Academy of Chinese Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The response rate.	Responders are defined as patients whose post void residuals (PVR) reduced by 50% or more from baseline.	Week 12.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.