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

Primary Purpose

Detrusor Underactivity

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Low Intensity Shockwave Therapy (LiSWT)
Tamsulosin
Sponsored by
Taichung Armed Forces General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Detrusor Underactivity focused on measuring detrusor underactivity, acupoint, voiding dysfunction, bladder voiding efficiency, low-intensity extracorporeal shockwave therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient who aged over 20 years old and who's bladder voiding efficiency is less than 70%. Exclusion Criteria: 1. Active pelvic malignancy without treatment. 2. Acute urinary tract infection. 3. Pregnancy 4. Active infection on treatment site. 5. Open wound on treatment site.

Sites / Locations

  • Taichung Armed Forces General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group-1

Group-2

Group-3

Arm Description

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

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

Oral tamsulosin 0.2mg once daily for 8 weeks.

Outcomes

Primary Outcome Measures

Bladder Voiding Efficiency (BVE)
Bladder Voiding Efficiency (BVE) is the ratio of the voiding volume of urine over total bladder urine volume

Secondary Outcome Measures

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
Maximum uroflow rate
The maximum uroflow rate during voiding.
Post-Voiding Residual urine amount
Post-Voiding Residual urine amount is the residual urine in bladder after voiding.
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.

Full Information

First Posted
August 27, 2023
Last Updated
August 27, 2023
Sponsor
Taichung Armed Forces General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06020963
Brief Title
Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency: A Pilot Study.
Official Title
Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency: A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Armed Forces General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 we combine the LiESWT and acupuncture to treat the patients with underactive bladder. We 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%, we 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Detrusor Underactivity
Keywords
detrusor underactivity, acupoint, voiding dysfunction, bladder voiding efficiency, low-intensity extracorporeal shockwave therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group-1
Arm Type
Experimental
Arm Description
Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral ST-28) once a week for 8 weeks.
Arm Title
Group-2
Arm Type
Experimental
Arm Description
Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral SP-6) once a week for 8 weeks.
Arm Title
Group-3
Arm Type
Active Comparator
Arm Description
Oral tamsulosin 0.2mg once daily for 8 weeks.
Intervention Type
Procedure
Intervention Name(s)
Low Intensity Shockwave Therapy (LiSWT)
Intervention Description
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
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Harnalidge 0.2mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bladder Voiding Efficiency (BVE)
Description
Bladder Voiding Efficiency (BVE) is the ratio of the voiding volume of urine over total bladder urine volume
Time Frame
Baseline, Week 4, Week 8, Week 12
Secondary Outcome Measure Information:
Title
Global Response Assessment scale
Description
GRA is a scale for subjective evaluation of treatment effects by patients, ranging from the worst -3 points to the best 3 points
Time Frame
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.
Title
Maximum uroflow rate
Description
The maximum uroflow rate during voiding.
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Post-Voiding Residual urine amount
Description
Post-Voiding Residual urine amount is the residual urine in bladder after voiding.
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Total score of international prostate symptom score
Description
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.
Time Frame
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient who aged over 20 years old and who's bladder voiding efficiency is less than 70%. Exclusion Criteria: 1. Active pelvic malignancy without treatment. 2. Acute urinary tract infection. 3. Pregnancy 4. Active infection on treatment site. 5. Open wound on treatment site.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing-Dung Shen, MD
Phone
+886958878129
Email
jdwhydo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-Dung Shen, MD
Organizational Affiliation
Taichung Armed Forces General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Armed Forces General Hospital
City
Taichung
State/Province
Other (Non US)
ZIP/Postal Code
41168
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-dung Shen, MD
Phone
+886958878129
Email
jdwhydo@gmail.com
First Name & Middle Initial & Last Name & Degree
Jing-dung Shen, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32523286
Citation
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Results Reference
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PubMed Identifier
33628099
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.
Results Reference
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PubMed Identifier
29603534
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.
Results Reference
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PubMed Identifier
33676379
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.
Results Reference
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PubMed Identifier
30796726
Citation
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.
Results Reference
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PubMed Identifier
28767169
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.
Results Reference
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PubMed Identifier
33029933
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.
Results Reference
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PubMed Identifier
34502202
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.
Results Reference
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Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency: A Pilot Study.

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