Electroacupuncture for Patients With Chronic Urinary Retention Secondary to Lower Motor Neuron Lesion (CUR)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Chronic Urinary Retention

Treatments: Other: Sham electroacupuncture; Other: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03662906

2018-102-KY-01

Details and patient eligibility

About

Chronic Urinary Retention (CUR) is defined as a non-painful bladder which remains palpable or percussible after the patient has passed urine by International Continence Society. Postvoid residual urine volume ≥300 mL seems to be widely accepted.

CUR may be caused by a variety of diseases and events including injury of sacral plexus, cauda equina and sacral spinal cord, pelvic floor nerve lesion after pelvic surgery and peripheral neuropathy due to diabetes, etc.. Aforementioned injuries generally affect lower motor neuron causing detrusor underactivity, acontractile detrusor or detrusor areflexia. The prevalence varies by different causes of lower motor neuron lesion. The symptoms of patients are voiding difficulty, bladder distention, bladder without sensation and overflow incontinence.

A multi-center randomized sham-controlled trial will be conducted. The aim of this study is to assess the efficacy and safety of electroacupuncture for urinary function of patients with CUR caused by lower motor neuron lesion.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Have chronic urinary retention caused by lower motor neuron damage.
• Age 18 to 75 years.
• Have chronic urinary retention caused by injury of sacral plexus, cauda equina and sacral spinal cord, pelvic floor nerve lesion after pelvic surgery and peripheral neuropathy due to diabetes.
• Have postvoid residual urine volume 300 mL or more and sensation of bladder.
• Bladder contractile index is more than 100 or more.
• Duration of disease is more than 3 months.
• Intermittent clean catheterization or indwelling catheterization.
• Sign informed consent and participate in the study voluntarily.
• Exclusion Criteria:
• Have urinary retention due to bladder outlet obstruction (bladder neck contracture, urethral stricture, prostate cancer, prostatic hyperplasia, etc.)
• Have urinary system tumors or stones.
• Have detrusor underactivity due to other non-lower motor neurogenic disease.
• Have bowel and urinary disorder due to lesions or injuries of thoracic spinal cord, cervical spinal cord and brain.
• After suprapubic cystostomy.
• Have heart, liver, kidney, mental disorders or coagulation disorders.
• Have been implanted a cardiac pacemaker, sacral nerve stimulation electrode, pudendal nerve stimulation electrode, or bladder stimulation electrode.
• During pregnancy or in lactation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Electroacupuncture

Experimental group

Description:

Bilateral Shenshu (BL23), Ciliao (BL32), Zhongliao (BL33), Huiyang (BL35), and Sanyinjiao (SP6) will be inserted by the needles (0.30 mm in diameter, 75 mm in length or 0.40 mm diameter, 100 mm in length, Hwato Brand, Suzhou Medical Appliance Factory, China).

Treatment:

Other: Electroacupuncture

Sham electroacupuncture

Sham Comparator group

Description:

Sham Bilateral Shenshu (BL23), Ciliao (BL32), Zhongliao (BL33), Huiyang (BL35), and Sanyinjiao (SP6) will be inserted by the needles (0.20 mm in diameter, 25 mm in length, Hwato Brand, Suzhou Medical Appliance Factory, China).

Treatment:

Other: Sham electroacupuncture