Urinary RetentionNCT06354244
Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions
An observational study of Urinary Retention and Lower Motor Neurone Lesion, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The aim of this study is to compare the effects of electroacupuncture of different frequency in patients with chronic urinary retention caused by lower motor neuron lesions Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Retention, Lower Motor Neurone Lesion
- What is being tested?
- Electroacupuncture of 2 sessions per week, Electroacupuncture of 3 sessions per week and Electroacupuncture of 4 sessions per week
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2024to Sep 2024
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There are a group of patients with nerve lesions presenting with chronic urinary retention, having to rely on life-long catheterization to empty the bladder. However, complications of catheterization including recurrent urinary tract infection and urethral stricture formation, negatively impact on patients' daily life and bring heavy burden on family and society, together making it a less ideal option.
Who may be able to join
- Diagnosed with urinary retention caused by lower motor neuron lesions (e.g., sacral plexus, cauda equina, or sacral cord lesions).
- 18 years or older.
- Baseline post void residuals (PVR) ≥150 mL.
- The course of urinary retention ≥1 month.
- Having normal bladder sensation.
- Using clean intermittent catheterization (CIC), indwelling catheterization (IC), manual assisted voiding including putting pressure on abdomen, or cystostomy catheterization.
- Signed informed consent and voluntary participation in the study.
Who cannot join
- Having a lower urinary tract obstruction, such as bladder neck contracture, urethral stricture, prostatic hyperplasia, or large urinary stones that can cause obstruction.
- Having any type of malignant tumors not removed.
- Having severe systemic disorders not controlled.
- Having implanted electrodes of cardiac pacemaker, pudendal nerve stimulation, bladder stimulation, or SNM.
- Pregnancy or lactation.
- Eletroacupuncture treatment duration < 2 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing
Zhishun Liu, PhD, +861088002331, zhishunjournal@163.com
Min Yang, +8618810268077, yangmin2019@yeah.net
About this study
Official title: Effects of Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions: a Prospective Cohort Study
The aim of this study is to compare the effects of electroacupuncture of different frequency in patients with chronic urinary retention caused by lower motor neuron lesions
- Conditions
- Urinary Retention, Lower Motor Neurone Lesion
- Being tested
- Electroacupuncture of 2 sessions per week, Electroacupuncture of 3 sessions per week, Electroacupuncture of 4 sessions per week
- Keywords
- electroacupuncture, chronic urinary retention, cohort study
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture of 2 sessions per weekDevice
Acupoints including bilateral BL23, BL32, BL33, BL35 and SP6 are inserted with acupuncture needles(size 0.30 × 40 mm and 0.30 × 75 mm or 0.40 × 100 mm,Hwato Brand). Bilateral BL32 and BL33 are needled to a depth of 70-95 mm with an angle of 60°-75° inward and downward, into the second and third sacral foramen. Bilateral BL35 are needled to a depth of 60-70 mm in a slightly superolateral direction. Bilateral BL23 and SP6 are vertically needled to a depth of 25-30 mm. After deqi is evoked, electric stimulators with a 5Hz continuous wave (5-10 mA intensity) are separately connected to bilateral BL32, BL33,BL35 and SP6. Current intensity is adjusted according to the patients' individual tolerance. During each session, electroacupuncture(EA) is retained for 30 minutes. The patients receive EA 2 sessions per week for 2-24 weeks.EA can be terminated if the patient acquire satisfactory spontaneous urination.
Electroacupuncture of 3 sessions per weekDevice
Acupoints and electroacupuncture (EA) procedures are the same as in the group of EA of 2 sessions per week, but the patients receive EA 3 sessions per week for 2-24 weeks in this group.EA can be terminated if the patient acquire satisfactory spontaneous urination.
Electroacupuncture of 4 sessions per weekDevice
Acupoints and electroacupuncture (EA) procedures are the same as in the group of EA of 2 sessions per week, but the patients receive EA 4 sessions per week for 2-24 weeks in this group.EA can be terminated if the patient acquire satisfactory spontaneous urination.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture of 2 sessions per week | Not described Receives: Device: Electroacupuncture of 2 sessions per week | |
| Electroacupuncture of 3 sessions per week | Not described Receives: Device: Electroacupuncture of 3 sessions per week | |
| Electroacupuncture of 4 sessions per week | Not described Receives: Device: Electroacupuncture of 4 sessions per week |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate.
Responders are defined as patients whose post void residuals (PVR) reduced by 50% or more from baseline.
Measured: Week 12.
Secondary outcomes (7)
The response rate.
Responders are defined as patients whose post void residuals (PVR) reduced by 50% or more from baseline.
Measured: Week 4, Week 8 and Week 24.
The change in post void residuals (PVR) from baseline.
PVR is measured by urethral catheter output after patients' spontaneous urination attempts without catheterization or assisted bladder emptying (including increasing abdominal pressure or other auxiliary manual methods). If catheterization is not needed, which is assessed by urologists, PVR will be measured by ultrasound.
Measured: Week 4, Week 8,Week 12 and Week 24.
The change in the proportion of patients reporting severe urinating difficulty from baseline.
The patient' s urinating difficulty is classified into four levels: severe, moderate, mild and none.
Measured: Week 4, Week 8,Week 12 and Week 24.
The change in the proportion of patients having stool retention from baseline.
Stool retention is diagnosed according to Rome IV criteria.
Measured: Week 4, Week 8,Week 12 and Week 24.
The change in the proportion of patients requiring catheterization from baseline.
If satisfactory spontaneous urination is observed,catheterization will not be needed, which is assessed by urologists.
Measured: Week 4, Week 8,Week 12 and Week 24.
The proportion of patients reporting much better or moderately better regarding the Patient Global Impression of Improvement (PGI-I).
The PGI-I assessment has scores of 1 to 7 corresponding to much better to much worse, with higher score representing less improvement.
Measured: Week 4, Week 8,Week 12 and Week 24.
The proportion of patients having recurrent symptomatic UTI, hydroureter, or hydronephrosis.
Recurrent UTI is confirmed by characteristic clinical signs.Hydronephrosis and hydroureter are assessed by ultrasound.
Measured: Week 4, Week 8,Week 12 and Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start4 Apr 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354244
- Sponsor's protocol ID
- 2023-183-KY-02
- Status last verified
- May 2024
- First submitted
- 3 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data and data dictionary will be available with the publication until six months after publication. A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06354244
- Acronym / sponsor ID
- 2023-183-KY-02
- Conditions
- Urinary Retention, Lower Motor Neurone Lesion
- Keywords
- electroacupuncture, chronic urinary retention, cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 9 Apr 2024 (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.
The aim of this study is to compare the effects of electroacupuncture of different frequency in patients with chronic urinary retention caused by lower motor neuron lesions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture of 2 sessions per week | – | Device: Electroacupuncture of 2 sessions per week |
| Electroacupuncture of 3 sessions per week | – | Device: Electroacupuncture of 3 sessions per week |
| Electroacupuncture of 4 sessions per week | – | Device: Electroacupuncture of 4 sessions per week |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are a group of patients with nerve lesions presenting with chronic urinary retention, having to rely on life-long catheterization to empty the bladder. However, complications of catheterization including recurrent urinary tract infection and urethral stricture formation, negatively impact on patients' daily life and bring heavy burden on family and society, together making it a less ideal option.
Key inclusion criteria (7 listed)
- Diagnosed with urinary retention caused by lower motor neuron lesions (e.g., sacral plexus, cauda equina, or sacral cord lesions).
- 18 years or older.
- Baseline post void residuals (PVR) ≥150 mL.
- The course of urinary retention ≥1 month.
- Having normal bladder sensation.
Key exclusion criteria (6 listed)
- Having a lower urinary tract obstruction, such as bladder neck contracture, urethral stricture, prostatic hyperplasia, or large urinary stones that can cause obstruction.
- Having any type of malignant tumors not removed.
- Having severe systemic disorders not controlled.
- Having implanted electrodes of cardiac pacemaker, pudendal nerve stimulation, bladder stimulation, or SNM.
- Pregnancy or lactation.
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 |
|---|---|---|
| Electroacupuncture of 2 sessions per weekAcupoints including bilateral BL23, BL32, BL33, BL35 and SP6 are inserted with acupuncture needles(size 0.30 × 40 mm and 0.30 × 75 mm or 0.40 × 100 mm,Hwato Brand). Bilateral BL32 and BL33 are needled to a depth of 70-95 mm with an angle of 60°-75° inward and downward, into the second and third sacral foramen. Bilateral BL35 are needled to a depth of 60-70 mm in a slightly superolateral direction. Bilateral BL23 and SP6 are vertically needled to a depth of 25-30 mm. After deqi is evoked, electric stimulators with a 5Hz continuous wave (5-10 mA intensity) are separately connected to bilateral BL32, BL33,BL35 and SP6. Current intensity is adjusted according to the patients' individual tolerance. During each session, electroacupuncture(EA) is retained for 30 minutes. The patients receive EA 2 sessions per week for 2-24 weeks.EA can be terminated if the patient acquire satisfactory spontaneous urination. | Device | Electroacupuncture of 2 sessions per week |
| Electroacupuncture of 3 sessions per weekAcupoints and electroacupuncture (EA) procedures are the same as in the group of EA of 2 sessions per week, but the patients receive EA 3 sessions per week for 2-24 weeks in this group.EA can be terminated if the patient acquire satisfactory spontaneous urination. | Device | Electroacupuncture of 3 sessions per week |
| Electroacupuncture of 4 sessions per weekAcupoints and electroacupuncture (EA) procedures are the same as in the group of EA of 2 sessions per week, but the patients receive EA 4 sessions per week for 2-24 weeks in this group.EA can be terminated if the patient acquire satisfactory spontaneous urination. | Device | Electroacupuncture of 4 sessions per week |
Primary outcome
The response rate.
Time frame: Week 12.
Responders are defined as patients whose post void residuals (PVR) reduced by 50% or more from baseline.
7 secondary outcomes
The response rate.
Time frame: Week 4, Week 8 and Week 24.
The change in post void residuals (PVR) from baseline.
Time frame: Week 4, Week 8,Week 12 and Week 24.
The change in the proportion of patients reporting severe urinating difficulty from baseline.
Time frame: Week 4, Week 8,Week 12 and Week 24.
The change in the proportion of patients having stool retention from baseline.
Time frame: Week 4, Week 8,Week 12 and Week 24.
The change in the proportion of patients requiring catheterization from baseline.
Time frame: Week 4, Week 8,Week 12 and Week 24.
The proportion of patients reporting much better or moderately better regarding the Patient Global Impression of Improvement (PGI-I).
Time frame: Week 4, Week 8,Week 12 and Week 24.
The proportion of patients having recurrent symptomatic UTI, hydroureter, or hydronephrosis.
Time frame: Week 4, Week 8,Week 12 and Week 24.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Yes. Deidentified participant data and data dictionary will be available with the publication until six months after publication. A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Retention and Lower Motor Neurone Lesion, 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 7 inclusion and 6 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 14 May 2024. 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. 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 Zhishun Liu (+861088002331, zhishunjournal@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response rate. (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 14 May 2024.