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

NCT03662906 | Unknown DMC

• 1 other identifier: 2018-102-KY-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The proportions of responders of postvoid residual urine (PVR)

  The responder is defined as a participant with a decline of 50% or more from baseline in the PVR volume after spontaneous urination. The PVR volume is the average value of 2 times of the same measurement method with the interval of 6 hours to 3 days.

  week 12

Secondary Outcomes (23)

• The proportions of responders of postvoid residual urine (PVR)

  week 6

• The proportions of responders of postvoid residual urine (PVR)

  week 24

• The proportions of responders of postvoid residual urine (PVR)

  week 36

• The satisfactory spontaneous urination responders

  week 12

• The satisfactory spontaneous urination responders

  week 24

Other Outcomes (6)

• The correlation between expectation assessment and the primary outcome

  Baseline

• The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment

  week 12

• The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment

  week 24

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

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).

Other: Electroacupuncture

Sham electroacupuncture

SHAM COMPARATOR

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).

Other: Sham electroacupuncture

Interventions

Electroacupuncture 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.

Electroacupuncture

Sham electroacupuncture 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.

Sham electroacupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Guangan'men Hospital

Beijing, 100053, China

RECRUITING

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Zhishun Liu, PhD

  Guang An Men Hospital

  STUDY CHAIR

Central Study Contacts

Yang Wang, PhD

CONTACT

17710327670; migofree@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: October 9, 2018
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

CN (1)