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Electroacupuncture for Patients With Chronic Urinary Retention Secondary to Lower Motor Neuron Lesion (CUR)

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ClinicalTrials.gov Identifier: NCT03662906
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Chronic Urinary Retention Other: Electroacupuncture Other: Sham electroacupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electroacupuncture
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).
Other: Electroacupuncture

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 Comparator: Sham electroacupuncture
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).
Other: Sham electroacupuncture

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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. The proportions of responders of postvoid residual urine (PVR) [ Time Frame: week 6 ]
    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.

  2. The proportions of responders of postvoid residual urine (PVR) [ Time Frame: week 24 ]
    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.

  3. The proportions of responders of postvoid residual urine (PVR) [ Time Frame: week 36 ]
    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.

  4. The satisfactory spontaneous urination responders [ Time Frame: week 12 ]
    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.

  5. The satisfactory spontaneous urination responders [ Time Frame: week 24 ]
    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.

  6. The satisfactory spontaneous urination responders [ Time Frame: week 36 ]
    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.

  7. The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax) [ Time Frame: week 12 ]
  8. The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax) [ Time Frame: week 36 ]
  9. The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax) [ Time Frame: week 12 ]
  10. The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax) [ Time Frame: week 36 ]
  11. 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 ]
  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 12 ]
  13. 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 ]
  14. 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 ]
  15. 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 ]
    VE is calculated as follows: volume voided/ (volume voided +PVR)*100%

  16. 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 ]
    VE is calculated as follows: volume voided/ (volume voided +PVR)*100%

  17. The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen) [ Time Frame: week 12 ]
    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.

  18. The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen) [ Time Frame: week 36 ]
    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.

  19. The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis [ Time Frame: week 12 ]
  20. The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis [ Time Frame: week 24 ]
  21. The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis [ Time Frame: week 36 ]
  22. The change of the urodynamic parameters from baseline [ Time Frame: week 12 ]
    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).

  23. The change of the bladder contractile index (BCI) [ Time Frame: week 12 ]
    BCI = detrusor pressure at maximum flow rate (Qmax) + 5*Qmax.


Other Outcome Measures:
  1. The correlation between expectation assessment and the primary outcome [ Time Frame: Baseline ]
    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.

  2. The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment [ Time Frame: week 12 ]
    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.

  3. The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment [ Time Frame: week 24 ]
    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.

  4. The proportions of participants in each response category of the GRA (Global Response Assessment) in the two groups after treatment [ Time Frame: week 36 ]
    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.

  5. Patient Blinding assessment [ Time Frame: week 12 ]
    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"

  6. Safety assessment [ Time Frame: week 1 to week 36 ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662906


Contacts
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Contact: Yang Wang, PhD 17710327670 migofree@126.com

Locations
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China
Guangan'men Hospital Recruiting
Beijing, China, 100053
Contact: Jing Zhou, Master    8610-010-88002331    251970215@qq.com   
Principal Investigator: Weiming Wang, Ph.D         
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
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Study Chair: Zhishun Liu, PhD Guang An Men Hospital

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Responsible Party: Liu Zhishun, Principal Investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03662906     History of Changes
Other Study ID Numbers: 2018-102-KY-01
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Chronic urinary retention
Electroacupuncture
Urinary function
Randomized controlled trial
Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases