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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
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 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.
Guangan'men Hospital
Beijing, China
RECRUITINGThe 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.
Time frame: week 12
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.
Time frame: week 6
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.
Time frame: week 24
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.
Time frame: week 36
The satisfactory spontaneous urination responders
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.
Time frame: week 12
The satisfactory spontaneous urination responders
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.
Time frame: week 24
The satisfactory spontaneous urination responders
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.
Time frame: week 36
The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax)
Time frame: week 12
The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax)
Time frame: week 36
The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax)
Time frame: week 12
The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax)
Time frame: 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
Time frame: week 6
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
Time frame: week 12
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
Time frame: week 24
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
Time frame: 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
VE is calculated as follows: volume voided/ (volume voided +PVR)\*100%
Time frame: week 12
The proportion of patients with increase of 50% or more from baseline of the voiding efficiency (VE) measured by the 7-day voiding diaries
VE is calculated as follows: volume voided/ (volume voided +PVR)\*100%
Time frame: week 36
The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen)
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.
Time frame: week 12
The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen)
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.
Time frame: week 36
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
Time frame: week 12
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
Time frame: week 24
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
Time frame: week 36
The change of the urodynamic parameters from baseline
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).
Time frame: week 12
The change of the bladder contractile index (BCI)
BCI = detrusor pressure at maximum flow rate (Qmax) + 5\*Qmax.
Time frame: week 12
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