Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency

March 2, 2024 updated by: Jing-Dung, SHEN, Taichung Armed Forces General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Other (Non US)
      • Taichung, Other (Non US), Taiwan, 41168
        • Recruiting
        • Taichung Armed Forces General Hospital
        • Contact:
        • Principal Investigator:
          • Jing-dung Shen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group-1
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)
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.
Experimental: Group-2
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)
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.
Active Comparator: Group-3
Oral tamsulosin 0.2mg once daily for 8 weeks.
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.
Other Names:
  • Harnalidge 0.2mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder Voiding Efficiency (BVE)
Time Frame: Baseline, Week 4, Week 8, Week 12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Response Assessment scale
Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.
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.
Maximum uroflow rate
Time Frame: Baseline, Week 4, Week 8, Week 12
The maximum uroflow rate during voiding.
Baseline, Week 4, Week 8, Week 12
Post-Voiding Residual urine amount
Time Frame: Baseline, Week 4, Week 8, Week 12
Post-Voiding Residual urine amount is the residual urine in bladder after voiding.
Baseline, Week 4, Week 8, Week 12
Total score of international prostate symptom score
Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Armed Forces General Hospital

Investigators

  • Principal Investigator: Jing-Dung Shen, MD, Taichung Armed Forces General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 27, 2023

First Submitted That Met QC Criteria

August 27, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 2, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A202205205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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