Back to resultsElectroacupuncture for Patients With Chronic Urinary Retention Secondary to Lower Motor Neuron Lesion (CUR)
Primary Purpose
Chronic Urinary Retention
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture
Sham electroacupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Urinary Retention focused on measuring Chronic urinary retention, Electroacupuncture, Urinary function, Randomized controlled trial
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.
Sites / Locations
- Guangan'men HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Electroacupuncture
Sham electroacupuncture
Arm Description
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 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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax)
The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax)
The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax)
The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax)
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
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
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
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
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%
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%
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.
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.
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
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).
The change of the bladder contractile index (BCI)
BCI = detrusor pressure at maximum flow rate (Qmax) + 5*Qmax.
Full Information
NCT ID
NCT03662906
First Posted
September 6, 2018
Last Updated
November 20, 2021
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03662906
Brief Title
Electroacupuncture for Patients With Chronic Urinary Retention Secondary to Lower Motor Neuron Lesion
Acronym
CUR
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Urinary Retention
Keywords
Chronic urinary retention, Electroacupuncture, Urinary function, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroacupuncture
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham electroacupuncture
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Electroacupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportions of responders of postvoid residual urine (PVR)
Description
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
Secondary Outcome Measure Information:
Title
The proportions of responders of postvoid residual urine (PVR)
Description
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
Title
The proportions of responders of postvoid residual urine (PVR)
Description
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
Title
The proportions of responders of postvoid residual urine (PVR)
Description
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
Title
The satisfactory spontaneous urination responders
Description
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
Title
The satisfactory spontaneous urination responders
Description
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
Title
The satisfactory spontaneous urination responders
Description
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
Title
The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax)
Time Frame
week 12
Title
The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax)
Time Frame
week 36
Title
The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax)
Time Frame
week 12
Title
The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax)
Time Frame
week 36
Title
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
Title
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
Title
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
Title
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
Title
The proportion of patients with increase of 50% or more from baseline of the voiding efficiency (VE) measured by the 7-day voiding diaries
Description
VE is calculated as follows: volume voided/ (volume voided +PVR)*100%
Time Frame
week 12
Title
The proportion of patients with increase of 50% or more from baseline of the voiding efficiency (VE) measured by the 7-day voiding diaries
Description
VE is calculated as follows: volume voided/ (volume voided +PVR)*100%
Time Frame
week 36
Title
The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen)
Description
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
Title
The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen)
Description
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
Title
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
Time Frame
week 12
Title
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
Time Frame
week 24
Title
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
Time Frame
week 36
Title
The change of the urodynamic parameters from baseline
Description
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
Title
The change of the bladder contractile index (BCI)
Description
BCI = detrusor pressure at maximum flow rate (Qmax) + 5*Qmax.
Time Frame
week 12
Other Pre-specified Outcome Measures:
Title
The correlation between expectation assessment and the primary outcome
Description
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
Title
The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment
Description
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
Title
The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment
Description
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
Title
The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment
Description
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
Title
Patient Blinding assessment
Description
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
Title
Safety assessment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Wang, PhD
Phone
17710327670
Email
migofree@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu, PhD
Organizational Affiliation
Guang An Men Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Guangan'men Hospital
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Zhou, Master
Phone
8610-010-88002331
Email
251970215@qq.com
First Name & Middle Initial & Last Name & Degree
Weiming Wang, Ph.D
12. IPD Sharing Statement
Learn more about this trial
Electroacupuncture for Patients With Chronic Urinary Retention Secondary to Lower Motor Neuron Lesion
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