Chronic Urinary RetentionCURNCT03662906
Electroacupuncture for Patients With Chronic Urinary Retention Secondary to Lower Motor Neuron Lesion
A study testing Electroacupuncture in people with Chronic Urinary Retention, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Urinary Retention
- What is being tested?
- Electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2018to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangan'men Hospital
Beijing, 100053
Jing Zhou, Master, 8610-010-88002331, 251970215@qq.com
Weiming Wang, Ph.D
About this study
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
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.
- Conditions
- Chronic Urinary Retention
- Being tested
- Electroacupuncture, Sham electroacupuncture
- Keywords
- Chronic urinary retention, Electroacupuncture, Urinary function, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureOther
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 electroacupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Experimental | 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). Receives: Other: Electroacupuncture |
| Sham electroacupuncture | Sham comparator | 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). Receives: Other: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 12
Secondary outcomes (23)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 36
The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax)
Measured: week 12
The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax)
Measured: week 36
The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax)
Measured: week 12
The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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%
Measured: 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%
Measured: 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.
Measured: 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.
Measured: week 36
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
Measured: week 12
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
Measured: week 24
The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis
Measured: 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).
Measured: week 12
The change of the bladder contractile index (BCI)
BCI = detrusor pressure at maximum flow rate (Qmax) + 5*Qmax.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start9 Oct 2018
- Primary completionMay 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, PhD, Study chair, Guang An Men Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662906
- Sponsor's protocol ID
- 2018-102-KY-01
- Acronym
- CUR
- Status last verified
- Nov 2021
- First submitted
- 6 Sep 2018
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03662906
- Acronym / sponsor ID
- CUR / 2018-102-KY-01
- Conditions
- Chronic Urinary Retention
- Keywords
- Chronic urinary retention, Electroacupuncture, Urinary function, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Other: ElectroacupunctureBilateral 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 comparator | Other: Sham electroacupunctureSham 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureBilateral 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. | Other | Electroacupuncture |
| Sham electroacupunctureSham 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. | Other | Sham electroacupuncture |
Primary outcome
The proportions of responders of postvoid residual urine (PVR)
Time frame: 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.
23 secondary outcomes
The proportions of responders of postvoid residual urine (PVR)
Time frame: week 6
The proportions of responders of postvoid residual urine (PVR)
Time frame: week 24
The proportions of responders of postvoid residual urine (PVR)
Time frame: week 36
The satisfactory spontaneous urination responders
Time frame: week 12
The satisfactory spontaneous urination responders
Time frame: week 24
The satisfactory spontaneous urination responders
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
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
Time frame: week 36
The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen)
Time frame: week 12
The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen)
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
Time frame: week 12
The change of the bladder contractile index (BCI)
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhishun Liu, PhD study chair
Guang An Men Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Chronic Urinary Retention, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Wang, PhD (17710327670, migofree@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportions of responders of postvoid residual urine (PVR) (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.