Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency

NCT ID: NCT06020963

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-11
• Study Completion Date: 2024-12-31

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.

Detailed 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.

Conditions

Detrusor Underactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group-1

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

Group Type: EXPERIMENTAL

Low Intensity Shockwave Therapy (LiSWT)

Intervention Type: 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-2

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

Group Type: EXPERIMENTAL

Low Intensity Shockwave Therapy (LiSWT)

Intervention Type: 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-3

Oral tamsulosin 0.2mg once daily for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Tamsulosin

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

Harnalidge 0.2mg

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taichung Armed Forces General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jing-Dung, SHEN

Director of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing-Dung Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Taichung Armed Forces General Hospital

Locations

Taichung Armed Forces General Hospital

Taichung, Other (Non US), Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jing-Dung Shen, MD

Role: CONTACT

jdwhydo@gmail.com

+886958878129

Facility Contacts

Jing-dung Shen, MD

Role: primary

jdwhydo@gmail.com

+886958878129

References

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Reference Type: BACKGROUND

PMID: 32523286 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 33628099 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 33676379 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Other Identifiers

A202205205

Identifier Type: -

Identifier Source: org_study_id