Clinical trial NCT03662906: Electroacupuncture for Patients With Chronic Urinary Retention Secondary to Lower Motor Neuron Lesion
Official title: The Efficacy and Safety of Electroacupuncture for Urinary Function of Patients With CUR Secondary to Lower Motor Neuron Lesion: A Multi-center Randomized Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Urinary Retention
Keywords: Chronic urinary retention
Electroacupuncture
Urinary function
Randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The proportions of responders of postvoid residual urine (PVR)
timeFrame: week 12
Secondary outcomes:
measure: The proportions of responders of postvoid residual urine (PVR)
timeFrame: week 6
measure: The proportions of responders of postvoid residual urine (PVR)
timeFrame: week 24
measure: The proportions of responders of postvoid residual urine (PVR)
timeFrame: week 36
measure: The satisfactory spontaneous urination responders
timeFrame: week 12
measure: The satisfactory spontaneous urination responders
timeFrame: week 24
measure: The satisfactory spontaneous urination responders
timeFrame: week 36
measure: The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax)
timeFrame: week 12
measure: The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax)
timeFrame: week 36
measure: The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax)
timeFrame: week 12
measure: The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax)
timeFrame: week 36
measure: The change from baseline of the number of catheterizations per day measured by the 7-day voiding diaries for patients with intermittent clean urethral catheterization
timeFrame: week 6
measure: The change from baseline of the number of catheterizations per day measured by the 7-day voiding diaries for patients with intermittent clean urethral catheterization
timeFrame: week 12
measure: The change from baseline of the number of catheterizations per day measured by the 7-day voiding diaries for patients with intermittent clean urethral catheterization
timeFrame: week 24
measure: The change from baseline of the number of catheterizations per day measured by the 7-day voiding diaries for patients with intermittent clean urethral catheterization
timeFrame: week 36
measure: The proportion of patients with increase of 50% or more from baseline of the voiding efficiency (VE) measured by the 7-day voiding diaries
timeFrame: week 12
measure: The proportion of patients with increase of 50% or more from baseline of the voiding efficiency (VE) measured by the 7-day voiding diaries
timeFrame: week 36
measure: The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen)
timeFrame: week 12
measure: The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen)
timeFrame: week 36
measure: The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
timeFrame: week 12
measure: The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
timeFrame: week 24
measure: The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
timeFrame: week 36
measure: The change of the urodynamic parameters from baseline
timeFrame: week 12
measure: The change of the bladder contractile index (BCI)
timeFrame: week 12
Other outcomes:
measure: The correlation between expectation assessment and the primary outcome
timeFrame: Baseline
measure: The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment
timeFrame: week 12
measure: The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment
timeFrame: week 24
measure: The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment
timeFrame: week 36
measure: Patient Blinding assessment
timeFrame: week 12
measure: Safety assessment
timeFrame: week 1 to week 36
Locations:
city: Beijing
country: China
facility: Guangan'men Hospital
Study officials:
affiliation: Guang An Men Hospital
name: Zhishun Liu, PhD
role: STUDY_CHAIR
References: