Acupuncture for neurogenic bladder urinary retention after spinal cord injury: a clinical plan for a randomized trial

doi:10.21203/rs.3.pex-2474/v1

Method Article

Acupuncture for neurogenic bladder urinary retention after spinal cord injury: a clinical plan for a randomized trial

https://doi.org/10.21203/rs.3.pex-2474/v1

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Background: Neurogenic bladder urinary retention is one of the most common complications of spinal cord injury, severely affecting patient satisfaction and quality of life. The clinical treatment of urinary retention is generally targeted therapy with intermittent voiding using a urinary catheter combined with the etiology, but the overall treatment effect is not ideal. Men with prostatic hyperplasia also need medication or surgery to reduce bladder outlet obstruction, with cystostomy, suprapubic catheterization, or urethral diversion as a last resort. Acupuncture is accepted by patients because of its simplicity, safety, and effectiveness, and clinical studies have shown that acupuncture can reduce urinary retention and improve patients' quality of life. This study aims to provide scientific basis for the treatment of neurogenic bladder dysfunction after spinal cord injury by acupuncture Ciliao（BL32）、Sanyinjiao（SP6）、Pangguangshu（BL28）and Zhonglvshu（BL29）.

Objective: This paper aims to explore the effectiveness of acupuncture in treating neurogenic bladder dysfunction after spinal cord injury, and to provide more high-quality empirical evidence for the clinical application of acupuncture in treating neurogenic bladder dysfunction after spinal cord injury.

Methods: The study design was a single-blind, multicenter, randomized controlled trial. A total of 136 patients aged 18~70 years old with neurogenic bladderurourinary retention after spinal cord injury were randomly divided into two groups: the experimental group (N=68) adopted the treatment plan based on acupuncture of the Ciliao（BL32）,Sanyinjiao（SP6）,Pangguangshu（BL28）and Zhonglvshu（BL29）,and the control group (N=68) used intermittent urination, manipulative assisted urination and arranged drinking water plan according to the guidelines for urinary management and clinical rehabilitation of patients with spinal cord injury. The trial cycle for both regimens was two weeks, five times a week. The trial results were divided into primary and secondary outcomes. The primary outcome was differences in urinary symptoms before and after treatment, as reported by participants in voiding records or self-report questionnaires, which included mean urine output per 24 hours, number of participants with urinary retention, and number of participants requiring catheterization. Secondary outcomes mainly included the following: (1) changes in urodynamic testing before and after treatment, such as residual urine volume after voiding, maximum bladder capacity and maximum urine flow velocity; (2) changes in quality of life questionnaires before and after treatment; (3) the efficacy rate of treatment; (4) Changes in clinical evaluation before and after treatment.

Discussion: The results of this experiment are helpful to provide scientific clinical evidence for the clinical efficacy and feasibility of acupuncture in the treatment of neurogenic bladder urinary retention after spinal cord injury.

Test registration: Chinese Clinical Trial Registry, ChiCTR2100051049. Registered on 20 October 2023, https://www.chictr.org.cn/bin/project/edit?pid=209451

In China, acupuncture, moxibustion, ear acupuncture and acupoint patches are widely used in the treatment of urinary retention after spinal cord injury, and in recent years, many studies have proved that the use of acupuncture to treat urinary retention can achieve good clinical results，but different schools and theories of acupuncture have their own rhetoric, the purpose of this study is to provide a clinical basis for the treatment of urinary retention after spinal cord injury and to explore the clinical efficacy of acupuncture in improving urinary retention in patients with spinal cord injury.

using millineedle, twisting the needle inward and downward

(1) Zhonglvshu（BL29）

It belongs to the foot solar bladder meridian. Located 1.5 inches from the median sacral crest (under the spinous process of the third sacral vertebra), it has the gluteus maximus muscle and is deep at the beginning of the sacral tubercle ligament. When the branches of the arterial and veins under the gluteus, there is a gluteal cutaneous nerve.

Operation method: routine disinfection, using 0.35 mm×75 mm millineedle, twisting the needle inward and downward, needle puncture about 60~70 mm, through the gluteus maximus and piriformis muscle through the ischial foramen, the needle sinks tightly, can continue to needle, subject to the spread of needle sensation to the perineum and lower abdomen, leave the needle for 20 min. Five times a week for two weeks.

(2) Ciliao（BL32）

One of the commonly used acupoints of the foot solar bladder meridian, located between the posterior superior iliac spine and the posterior median line, the beginning of the gluteus maximus, the lateral sacral arterial arterial and posterior venous ramus, suitable for the second posterior sacral foramen. It has a posterior branch of the second sacral nerve.

Operation method: 0.35 mm×75 mm millineedle was selected, and the twisting and turning method was inserted to make up for the laxative method, and the straight puncture was about 65 mm, twisted once in 10 min, and the needle was left for 20 min. Five times a week for two weeks.

(3) Sanyinjiao（SP6）, Pangguangshu（BL28）

Sanyinjiao（SP6） belongs to the foot taiyin and spleen meridian. It is the meeting of foot taiyin, yin and less yin. On the inside of the calf, 3 inches above the tip of the medial malleolus of the foot, behind the medial edge of the tibia. It has a cutaneous nerve on the medial calf and a tibial nerve at the back of the deep back; And there are great saphenous veins, posterior tibial arterial and venous.

Pangguangshu（BL28） belongs to the foot solar bladder meridian. In the sacrum, 1.5 inches next to the median sacral crest, the second posterior sacral foramen is flat, and there is a posterior arterial and venous ramus on the lateral side of the sacrum. The posterior branches of the first and second sacral nerves are distributed.

Operation method: 0.3mm×40 mm milli needle is selected, and the flat supplement and laxative method is directly pierced for about 25~30 mm, and the needle is performed until there is a local feeling of soreness to get gas, and leave the needle for 20 min. Five times a week for two weeks.

Recruitment for participants began on January 1, 2024 and is expected to close on January 1, 2025, and the recruitment program will end early subject to sufficient eligible volunteers enrolling.

[1] LI J, LUO W, XIAO C, et al. Recent advances in endogenous neural stem/progenitor cell manipulation for spinal cord injury repair [J]. Theranostics, 2023, 13(12): 3966-87.

[2] NING G-Z, WU Q, LI Y-L, et al. Epidemiology of traumatic spinal cord injury in Asia: a systematic review [J]. J Spinal Cord Med, 2012, 35(4): 229-39.

[3] WANG H, ZHOU W-X, HUANG J-F, et al. Endocrine Therapy for the Functional Recovery of Spinal Cord Injury [J]. Front Neurosci, 2020, 14(590570.

[4] DAVID B T, STEWARD O. Deficits in bladder function following spinal cord injury vary depending on the level of the injury [J]. Exp Neurol, 2010, 226(1): 128-35.

[5] DE GROAT W C, YOSHIMURA N. Plasticity in reflex pathways to the lower urinary tract following spinal cord injury [J]. Exp Neurol, 2012, 235(1): 123-32.

[6] WANG J, ZHAI Y, WU J, et al. Acupuncture for Chronic Urinary Retention due to Spinal Cord Injury: A Systematic Review [J]. Evid Based Complement Alternat Med, 2016, 2016(9245186.

[7] HE K, LI X, QIU B, et al. Comparative Efficacy of Acupuncture-Related Techniques for Urinary Retention After a Spinal Cord Injury: A Bayesian Network Meta-Analysis [J]. Front Neurol, 2021, 12(723424.

[8] SAINT S, MEDDINGS J A, CALFEE D, et al. Catheter-associated urinary tract infection and the Medicare rule changes [J]. Ann Intern Med, 2009, 150(12): 877-84.

[9] BARKEN K B, VAABENGAARD R. A scoping review on the impact of hydrophilic versus non-hydrophilic intermittent catheters on UTI, QoL, satisfaction, preference, and other outcomes in neurogenic and non-neurogenic patients suffering from urinary retention [J]. BMC Urol, 2022, 22(1): 153.

[10] SPINU A, ONOSE G, DAIA C, et al. Intermittent catheterization in the management of post spinal cord injury (SCI) neurogenic bladder using new hydrophilic, with lubrication in close circuit devices--our own preliminary results [J]. J Med Life, 2012, 5(1): 21-8.

[11] ZHU P-Y, XU J, JIANG B, et al. [GAO Wei-bin's clinical experience in treatment of neurogenic bladder with acupuncture] [J]. Zhongguo Zhen Jiu, 2023, 43(2): 197-202.

[12] MA K, XU H, ZHANG J, et al. Insulin-like growth factor-1 enhances neuroprotective effects of neural stem cell exosomes after spinal cord injury via an miR-219a-2-3p/YY1 mechanism [J]. Aging (Albany NY), 2019, 11(24): 12278-94.

[13] ZHAO H, LI D, LI Y, et al. Efficacy and safety of acupuncture for hypertension: An overview of systematic reviews [J]. Complement Ther Clin Pract, 2019, 34(185-94.

[14] OLIA M, JAFARIAN A, MOHSENI M. Efficacy of Low-Frequency Electroacupuncture on Urinary Retention After Spinal Anesthesia [J]. J Perianesth Nurs, 2023, 38(5): 745-7.

[15] CAO D, YANG Q, QI F, et al. Acupuncture improves the residual urine volume of bladder of middle age patients with urinary retention post-stroke: A protocol for systematic review and meta analysis [J]. Medicine (Baltimore), 2022, 101(47): e31697.

[16] LIU H-R, GU W-Y, PAN L-J-X, et al. [Clinical observation on Tongdu Tiaoqi acupuncture combined with warming acupuncture for postoperative urinary retention] [J]. Zhongguo Zhen Jiu, 2022, 42(1): 41-4.

[17] YANG Y, XIANG R, LIU Y, et al. [Clinical study on post-stroke urinary retention treated with acupuncture at the twelve jing-well points and bladder function training] [J]. Zhongguo Zhen Jiu, 2017, 37(10): 1041-4.

[18] RUPP R, BIERING-SøRENSEN F, BURNS S P, et al. International Standards for Neurological Classification of Spinal Cord Injury: Revised 2019 [J]. Top Spinal Cord Inj Rehabil, 2021, 27(2):

[19] GUORUI L. The Standards for the Efficacy of Diagnosis of Traditional Chinese Medicine Diseases were issued [J]. Market Regulation and Quality Technology Research, 1995, 02): 5.

[20] XIAOPING C. Surgery [M]. Nine ed. Beijing: The peoples medical publishing house, 2018.

[21] SUTTON G, SHAH S, HILL V. Clean intermittent self-catheterisation for quadriplegic patients--a five year follow-up [J]. Paraplegia, 1991, 29(8): 542-9.

[22] JINGMEI J. Medical Statistics [M]. Science Press ed., 2022.

[23] WENZHI C, LING M, XIUYUN L. Practice Guidelines for Neurogenic Bladder Care (2017 Edition) [M]. Journal of Nursing Science, 2017.

[24] LIMIN L, JUAN W, YANHE J, et al. Guidelines for urinary management and clinical rehabilitation in patients with spinal cord injury [M]. Chinese Journal of Rehabilitation Theory and Practice, 2013.

[25] STEIN R, BOGAERT G, DOGAN H S, et al. EAU/ESPU guidelines on the management of neurogenic bladder in children and adolescent part I diagnostics and conservative treatment [J]. Neurourol Urodyn, 2020, 39(1): 45-57.

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Acupuncture for neurogenic bladder urinary retention after spinal cord injury: a clinical plan for a randomized trial

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