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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Wang, PhD | Contact | 17710327670 | migofree@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhishun Liu, PhD | Guang An Men Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangan'men Hospital | Recruiting | Beijing | 100053 | China |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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| Sham electroacupuncture | Other | 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. |
| 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. | 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. | 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. | 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. | week 36 |
| The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax) | week 12 |
| The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax) | week 36 |
| The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax) | week 12 |
| The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax) | 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 | 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 | 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 | 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 | 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% | 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% | 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. | 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. | week 36 |
| The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis | week 12 |
| The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis | week 24 |
| The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis | 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). | week 12 |
| The change of the bladder contractile index (BCI) | BCI = detrusor pressure at maximum flow rate (Qmax) + 5*Qmax. | week 12 |
| 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. | 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. | 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. | 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" | 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. | week 1 to week 36 |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |