Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency

Detrusor Underactivity Clinical Trial

Official title:

Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency: A Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06020963
• Other study ID #: A202205205
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Taichung Armed Forces General Hospital
• Contact: Jing-Dung Shen, MD
• Phone: +886958878129
• Email: jdwhydo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With the increasing of the elderly population, patients with urinary dysfunction caused by inefficiency of bladder emptying becomes much often than before. However, the current treatments for this kind of bladder dysfunction are limited and unsatisfactory. Low-intensity extracorporeal shockwave therapy (LiESWT) is a very popular emerging treatment in recent years, and abundant of literatures have confirmed that this treatment is safe and effective in myofascial pain and male erectile dysfunction. Recently, many animal experiments have showed that LiESWT could improve urinary dysfunction caused by bladder dysfunction. Taiwan based studies also reported that LiESWT could improve symptoms of overactive bladder. LiESWT is a non-drug, low-invasive and high-safety treatment, which is very suitable for elderly patients. In this study investigator combine the LiESWT and acupuncture to treat the patients with underactive bladder. Investigator hypothesize that LiESWT could improve bladder voiding efficiency.

Description:

This is a randomized controlled trial, the inclusion criteria are the patients more than 20 years old and bladder voiding efficiency less than 70%, this trial will enroll 60 male and 40 female , total 100 patients. The male will be randomly assigned into three groups(Group-1, Group-2, Group-3) by ratio 1:1:1, and the female will be randomly assigned into two groups (Group-1, Group-2) by ratio 1:1. Group-1: LiESWT on acupoint CV-4, and bilateral ST-28 once a week for 8 weeks, Group-2: LiESWT on acupoint CV-4 and bilateral acupoint SP-6 once a week for 8 weeks, Group-3: Treatment with oral tamsulosin 0.2mg per-day for 8 weeks. The primary outcome is the improvement of bladder voiding efficiency. The secondary outcomes are global response assessment scale, the improvement of maximum uroflow rate, post-voiding residual urine amount, total score of international prostate symptom score.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1.Bladder voiding efficiency is less than 70%.

Exclusion Criteria:

1. Patient who has history active pelvic malignancy without treatment.

2. Acute urinary tract infection.

3. Pregnancy

4. Active infective lesion on treatment site.

5. Open wound on treatment site.

Related Conditions & MeSH terms

• Detrusor Underactivity
• Hypokinesia
• Urinary Bladder, Underactive

Intervention

Procedure:
• Low Intensity Shockwave Therapy (LiSWT)
Low Intensity Shockwave Therapy (LiSWT) has been used for many years. Its mechanism is to use shock wave energy to promote angiogenesis to achieve the functions of tissue repair and cell regeneration.

Drug:
• Tamsulosin
Tamsulosin is a selective alpha-1 blocker, its main function is to relax the smooth muscles of the base of the prostate, urethra, and bladder, and improve lower urinary tract symptoms.

Locations

Country	Name	City	State
Taiwan	Taichung Armed Forces General Hospital	Taichung	Other (Non US)

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Armed Forces General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (8)

Chuang YC, Tyagi P, Luo HL, Lee WC, Wang HJ, Huang CC, Chancellor MB. Long-term functional change of cryoinjury-induced detrusor underactivity and effects of extracorporeal shock wave therapy in a rat model. Int Urol Nephrol. 2019 Apr;51(4):617-626. doi: 10.1007/s11255-019-02095-4. Epub 2019 Feb 22. — View Citation

Chuang YC, Tyagi P, Wang HJ, Huang CC, Lin CC, Chancellor MB. Urodynamic and molecular characteristics of detrusor underactivity in a rat cryoinjury model and effects of low energy shock wave therapy. Neurourol Urodyn. 2018 Feb;37(2):708-715. doi: 10.1002/nau.23381. Epub 2017 Aug 2. — View Citation

Dimitriadis F, Papaioannou M, Sokolakis I, Fragou A, Hatzichristou D, Apostolidis A. The Effect of Low-Intensity Extracorporeal Shockwave Treatment on the Urinary Bladder in an Experimental Diabetic Rat Model. Int Neurourol J. 2021 Mar;25(1):34-41. doi: 10.5213/inj.2040344.172. Epub 2021 Mar 6. — View Citation

Lee YC, Hsieh TJ, Tang FH, Jhan JH, Lin KL, Juan YS, Wang HS, Long CY. Therapeutic effect of Low intensity Extracorporeal Shock Wave Therapy (Li-ESWT) on diabetic bladder dysfunction in a rat model. Int J Med Sci. 2021 Jan 29;18(6):1423-1431. doi: 10.7150/ijms.55274. eCollection 2021. — View Citation

Lin KL, Lu JH, Chueh KS, Juan TJ, Wu BN, Chuang SM, Lee YC, Shen MC, Long CY, Juan YS. Low-Intensity Extracorporeal Shock Wave Therapy Promotes Bladder Regeneration and Improves Overactive Bladder Induced by Ovarian Hormone Deficiency from Rat Animal Model to Human Clinical Trial. Int J Mol Sci. 2021 Aug 27;22(17):9296. doi: 10.3390/ijms22179296. — View Citation

Simplicio CL, Purita J, Murrell W, Santos GS, Dos Santos RG, Lana JFSD. Extracorporeal shock wave therapy mechanisms in musculoskeletal regenerative medicine. J Clin Orthop Trauma. 2020 May;11(Suppl 3):S309-S318. doi: 10.1016/j.jcot.2020.02.004. Epub 2020 Feb 12. — View Citation

Wang HS, Oh BS, Wang B, Ruan Y, Zhou J, Banie L, Lee YC, Tamaddon A, Zhou T, Wang G, Lin G, Lue TF. Low-intensity extracorporeal shockwave therapy ameliorates diabetic underactive bladder in streptozotocin-induced diabetic rats. BJU Int. 2018 Sep;122(3):490-500. doi: 10.1111/bju.14216. Epub 2018 Apr 20. — View Citation

Yoshida M, Sekido N, Matsukawa Y, Yono M, Yamaguchi O. Clinical diagnostic criteria for detrusor underactivity: A report from the Japanese Continence Society working group on underactive bladder. Low Urin Tract Symptoms. 2021 Jan;13(1):13-16. doi: 10.1111/luts.12356. Epub 2020 Oct 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder Voiding Efficiency (BVE)	Bladder Voiding Efficiency (BVE) is the ratio of the voiding volume of urine over total bladder urine volume	Baseline, Week 4, Week 8, Week 12
Secondary	Global Response Assessment scale	GRA is a scale for subjective evaluation of treatment effects by patients, ranging from the worst -3 points to the best 3 points	Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.
Secondary	Maximum uroflow rate	The maximum uroflow rate during voiding.	Baseline, Week 4, Week 8, Week 12
Secondary	Post-Voiding Residual urine amount	Post-Voiding Residual urine amount is the residual urine in bladder after voiding.	Baseline, Week 4, Week 8, Week 12
Secondary	Total score of international prostate symptom score	International prostate symptom score is a questionnaire used to assess the severity of lower urinary tract symptoms, ranging from best 0, to the worst 35.	Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.