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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Detrusor Underactivity

Intervention / Treatment
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* Procedure: Low Intensity Shockwave Therapy (LiSWT)
* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group-1<br>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)<br>* 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.<br>|
| Experimental: Group-2<br>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)<br>* 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.<br>|
| Active Comparator: Group-3<br>Oral tamsulosin 0.2mg once daily for 8 weeks. | Drug: Tamsulosin<br>* 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.<br>* Other names: Harnalidge 0.2mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12. | 
| Maximum uroflow rate | The maximum uroflow rate during voiding. | Baseline, Week 4, Week 8, Week 12 | 
| Post-Voiding Residual urine amount | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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detrusor underactivity, acupoint, voiding dysfunction, bladder voiding efficiency, low-intensity extracorporeal shockwave therapy