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

Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT03662906
Collaborator
(none)
200
1
2
49.7
4

Study Details

Study Description

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
  • Other: Electroacupuncture
  • Other: Sham electroacupuncture
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 9, 2018
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The proportions of responders of postvoid residual urine (PVR) [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) [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) [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) [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 [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 [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 [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) [week 12]

  8. The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax) [week 36]

  9. The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax) [week 12]

  10. The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax) [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 [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 [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 [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 [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 [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 [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) [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) [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 [week 12]

  20. The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis [week 24]

  21. The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis [week 36]

  22. The change of the urodynamic parameters from baseline [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) [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guangan'men Hospital Beijing China 100053

Sponsors and Collaborators

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

  • Study Chair: Zhishun Liu, PhD, Guang An Men Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liu Zhishun, Principal Investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT03662906
Other Study ID Numbers:
  • 2018-102-KY-01
First Posted:
Sep 10, 2018
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Liu Zhishun, Principal Investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2021