Electroacupuncture for Patients With Chronic Urinary Retention Secondary to Lower Motor Neuron Lesion
- Conditions
- Chronic Urinary Retention
- Interventions
- Other: ElectroacupunctureOther: Sham electroacupuncture
- Registration Number
- NCT03662906
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electroacupuncture 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). Sham electroacupuncture 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).
- Primary Outcome Measures
Name Time Method The proportions of responders of postvoid residual urine (PVR) week 12 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.
- Secondary Outcome Measures
Name Time Method The proportions of responders of postvoid residual urine (PVR) week 36 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.
The satisfactory spontaneous urination responders week 36 The satisfactory spontaneous urination responders were defined as participants with PVR volume 100 mL or less, without hydronephrosis and recurrent symptomatic urinary tract infection. Recurrent symptomatic urinary tract infection is defined as 2 times or more symptomatic urinary tract infection during the treatment and follow-up period.
The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax) week 36 The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax) week 36 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 week 36 The proportion of patients with increase of 50% or more from baseline of the voiding efficiency (VE) measured by the 7-day voiding diaries week 36 VE is calculated as follows: volume voided/ (volume voided +PVR)\*100%
The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen) week 36 SF-Qualiveen is the only questionnaire that addresses the broad range of urinary problems experienced by patients with neurological disorders voiding symptoms. Qualiveen domain scores are calculated as an average of the scores on items in that domain and, thus, the range is 0 to 4 with an overall score representing the mean of the 4 domains, which also ranges from 0 to 4. A higher score indicates the greater the impact on the quality of life of patients.
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis week 36 The change of the urodynamic parameters from baseline week 12 The urodynamic parameters include: bladder capacity (ml), bladder compliance (cmH2O), vesica-open pressure (Pves-open) (cmH2O), maximum flow rate (mL/s), mean flow rate (ml/s), detrusor pressure at maximum flow rate (ml/s), time to maximum flow rate (sec), maximum detrusor pressure (cmH2O), voided volume (ml), residual urine (ml).
The change of the bladder contractile index (BCI) week 12 BCI = detrusor pressure at maximum flow rate (Qmax) + 5\*Qmax.
Trial Locations
- Locations (1)
Guangan'men Hospital
🇨🇳Beijing, China