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

NCT ID: NCT03662906

Last Updated: 2021-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-09
• Study Completion Date: 2022-12-31

Brief Summary

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.

Conditions

Chronic Urinary Retention

Keywords

Chronic urinary retention; Electroacupuncture; Urinary function; Randomized controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Electroacupuncture

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).

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: OTHER

Bilateral BL32 and BL 33 will be inserted to a depth of 70-95 mm with an angle of 20-30° inward and downward into the second and third sacral foramen. Bilateral BL35 will be inserted to a depth of 60-70 mm with a slightly superolateral direction using needles (0.30 mm in diameter, 75 mm in length). Bilateral BL23 and SP6 will be inserted vertically to a depth of 25-30 mm using needles (0.30 mm in diameter, 40 mm in length). The electric stimulators (6805-D electroacupuncture apparatus, Guangzhou Jiayu Medical Company, China) will connect the bilateral BL32, BL33, BL35 and SP 6 and a continuous wave of 10 Hz frequency and an intensity of 5-10 mA for BL 32 and BL 33 and an intensity of 1-5 mA for SP 6 will be applied.

The needles will be retained for 60 mins for each treatment session. The participants will be treated three times a week, on alternate days, for 12 successive weeks; 18 sessions for each patient in total.

Sham electroacupuncture

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).

Group Type: SHAM_COMPARATOR

Sham electroacupuncture

Intervention Type: OTHER

Sham BL 23, BL32 and BL33 which are 2 cm lateral to BL23, BL33 and BL35 will be inserted by the needles (0.20 mm in diameter, 25 mm in length) to a depth of 2-3 mm. Sham SP 6 which is at the midpoint between the spleen meridian and the kidney meridian will be inserted by the needles (0.20 mm in diameter, 25 mm in length) to a depth of 2-3 mm. The electric stimulators (SDZ-V electroacupuncture apparatus, Suzhou Medical Appliance Factory, China) will connect bilateral BL32, BL33, BL35 and SP 6 and a continuous wave of 10 Hz frequency and an intensity of 0.1-0.3mA will be applied.

The needles will be retained for 60 mins for each treatment session. The participants will be treated three times a week, on alternate days, for 12 successive weeks; 18 sessions for each patient in total.

Interventions

Electroacupuncture

Bilateral BL32 and BL 33 will be inserted to a depth of 70-95 mm with an angle of 20-30° inward and downward into the second and third sacral foramen. Bilateral BL35 will be inserted to a depth of 60-70 mm with a slightly superolateral direction using needles (0.30 mm in diameter, 75 mm in length). Bilateral BL23 and SP6 will be inserted vertically to a depth of 25-30 mm using needles (0.30 mm in diameter, 40 mm in length). The electric stimulators (6805-D electroacupuncture apparatus, Guangzhou Jiayu Medical Company, China) will connect the bilateral BL32, BL33, BL35 and SP 6 and a continuous wave of 10 Hz frequency and an intensity of 5-10 mA for BL 32 and BL 33 and an intensity of 1-5 mA for SP 6 will be applied.

The needles will be retained for 60 mins for each treatment session. The participants will be treated three times a week, on alternate days, for 12 successive weeks; 18 sessions for each patient in total.

Intervention Type: OTHER

Sham electroacupuncture

Sham BL 23, BL32 and BL33 which are 2 cm lateral to BL23, BL33 and BL35 will be inserted by the needles (0.20 mm in diameter, 25 mm in length) to a depth of 2-3 mm. Sham SP 6 which is at the midpoint between the spleen meridian and the kidney meridian will be inserted by the needles (0.20 mm in diameter, 25 mm in length) to a depth of 2-3 mm. The electric stimulators (SDZ-V electroacupuncture apparatus, Suzhou Medical Appliance Factory, China) will connect bilateral BL32, BL33, BL35 and SP 6 and a continuous wave of 10 Hz frequency and an intensity of 0.1-0.3mA will be applied.

The needles will be retained for 60 mins for each treatment session. The participants will be treated three times a week, on alternate days, for 12 successive weeks; 18 sessions for each patient in total.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Liu Zhishun

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhishun Liu, PhD

Role: STUDY_CHAIR

Guang An Men Hospital

Locations

Guangan'men Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Wang, PhD

Role: CONTACT

Phone: 17710327670

Email: migofree@126.com

Facility Contacts

Jing Zhou, Master

Role: primary

Other Identifiers

2018-102-KY-01

Identifier Type: -

Identifier Source: org_study_id