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

Sponsor

Taichung Armed Forces General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06020963

Collaborator

(none)

100

Enrollment

Location

Arms

16.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Detrusor Underactivity	Procedure: Low Intensity Shockwave Therapy (LiSWT) Drug: Tamsulosin	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 11, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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)

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

Outcome Measures

Primary Outcome Measures

Bladder Voiding Efficiency (BVE) [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

Secondary Outcome Measures

Global Response Assessment scale [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
Maximum uroflow rate [Baseline, Week 4, Week 8, Week 12]
The maximum uroflow rate during voiding.
Post-Voiding Residual urine amount [Baseline, Week 4, Week 8, Week 12]
Post-Voiding Residual urine amount is the residual urine in bladder after voiding.
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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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.