Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency

NCT06020963 | Recruiting

• 1 other identifier: A202205205
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Detrusor Underactivity

Keywords

detrusor underactivity; acupoint; voiding dysfunction; bladder voiding efficiency; low-intensity extracorporeal shockwave therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Global Response Assessment scale

  Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.

• Maximum uroflow rate

  Baseline, Week 4, Week 8, Week 12

• Post-Voiding Residual urine amount

  Baseline, Week 4, Week 8, Week 12

• Total score of international prostate symptom score

  Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.

Study Arms (3)

Group-1

EXPERIMENTAL

Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral ST-28) once a week for 8 weeks.

Procedure: Low Intensity Shockwave Therapy (LiSWT)

Group-2

EXPERIMENTAL

Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral SP-6) once a week for 8 weeks.

Procedure: Low Intensity Shockwave Therapy (LiSWT)

Group-3

ACTIVE COMPARATOR

Oral tamsulosin 0.2mg once daily for 8 weeks.

Drug: Tamsulosin

Interventions

Low Intensity Shockwave Therapy (LiSWT) PROCEDURE

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.

Group-1; Group-2

Tamsulosin DRUG

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.

Also known as: Harnalidge 0.2mg

Group-3

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bladder voiding efficiency is less than 70%.

You may not qualify if:

• Patient who has history active pelvic malignancy without treatment.
• Acute urinary tract infection.
• Pregnancy
• Active infective lesion on treatment site.
• Open wound on treatment site.

Sponsors & Collaborators

• Taichung Armed Forces General Hospital: lead

Study Sites (1)

Taichung Armed Forces General Hospital

Taichung, Other (Non US), 41168, Taiwan

RECRUITING

Related Publications (8)

• 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.

  PMID: 32523286 BACKGROUND

• 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.

  PMID: 33628099 BACKGROUND

• 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.

  PMID: 29603534 BACKGROUND

• 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.

  PMID: 33676379 BACKGROUND

• 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.

  PMID: 30796726 BACKGROUND

• 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.

  PMID: 28767169 BACKGROUND

• 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.

  PMID: 33029933 BACKGROUND

• 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.

  PMID: 34502202 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Underactive

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Jing-Dung Shen, MD

  Taichung Armed Forces General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing-Dung Shen, MD

CONTACT

+886958878129; jdwhydo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Urology

Model Details: Evaluate the treatment effect of Low-intensity shockwave therapy on acupoint (CV-4, ST-28, SP-6 once a week for 8 weeks) and the control group is oral tamsulosin 0.2mg daily for 8 weeks.

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: August 11, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)