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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture of 2 sessions per week |
| ||
| Electroacupuncture of 3 sessions per week |
| ||
| Electroacupuncture of 4 sessions per week |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture of 2 sessions per week | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The response rate. | Responders are defined as patients whose post void residuals (PVR) reduced by 50% or more from baseline. | Week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| The response rate. | Responders are defined as patients whose post void residuals (PVR) reduced by 50% or more from baseline. | Week 4, Week 8 and Week 24. |
| The change in post void residuals (PVR) from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhishun Liu | Contact | +861088002331 | zhishunjournal@163.com | |
| Min Yang | Contact | +8618810268077 | yangmin2019@yeah.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | China |
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.
The data 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.
Researchers whose proposal has been approved will sign a data access agreement.
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| Electroacupuncture of 3 sessions per week | Device | 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 week | Device | 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. |
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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.
| 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. | 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. | 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. | 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. | 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. | Week 4, Week 8,Week 12 and Week 24. |
| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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