An interventional study of Electroacupuncture and Sham electroacupuncture in Chronic Urinary Retention, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
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.
235 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.
This study's planned enrollment of 200 is above the median of 95 across 185 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 133 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 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
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.
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 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
The correlation between expectation assessment and the primary outcome
Expectation assessment will be assessed at baseline; it includes two brief questions to investigate whether patients are confident that acupuncture treatment will help their chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): "In general, do you believe acupuncture is effective for treating the illness?", "Do you think acupuncture will be helpful to improve your CP/CPPS symptoms?" For each question, participants will choose "Yes", "No", or "unclear" as the answer.
Time frame: Baseline
The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment
GRA consists of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved. We will identify a participant who reports "moderate" or "marked improvement" as a responder.
Time frame: week 12
The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment
GRA consists of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved. We will identify a participant who reports "moderate" or "marked improvement" as a responder.
Time frame: week 24
The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment
GRA consists of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved. We will identify a participant who reports "moderate" or "marked improvement" as a responder.
Time frame: week 36
Patient Blinding assessment
To test the success of blinding, participants will be asked to reply to the following question at the 12th week of treatment (sessions 35 or 36): "Do you think you have received traditional electroacupuncture in the past weeks?" The participants will be able to choose one of the following options as the answer: "Yes", "No"
Time frame: week 12
Safety assessment
Treatment-related adverse events (AEs) include pain, haematoma, localized infection, broken needle, fainting, nausea, headache, dizziness, insomnia, vomiting, or palpitations during or after treatment. In addition, adverse events that are irrelevant to the treatment will be recorded during the study period.
Time frame: week 1 to week 36
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences