Detrusor UnderactivityNCT06020963
Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency
A study testing Low Intensity Shockwave Therapy (LiSWT) and Tamsulosin in people with Detrusor Underactivity, run by Taichung Armed Forces General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Detrusor Underactivity
- What is being tested?
- Low Intensity Shockwave Therapy (LiSWT) and Tamsulosin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Aug 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Bladder voiding efficiency is less than 70%.
Who cannot join
- Patient who has history active pelvic malignancy without treatment.
- Acute urinary tract infection.
- Pregnancy
- Active infective lesion on treatment site.
- Open wound on treatment site.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Armed Forces General Hospital
Taichung, Other (Non US), 41168
Jing-dung Shen, MD, +886958878129, jdwhydo@gmail.com
Jing-dung Shen, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Low Intensity Shockwave Therapy (LiSWT), Tamsulosin
- Keywords
- detrusor underactivity, acupoint, voiding dysfunction, bladder voiding efficiency, low-intensity extracorporeal shockwave therapy
- Medical subject headings
- Urinary Bladder, Underactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Shockwave Therapy (LiSWT)Procedure or surgery
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.
TamsulosinDrug
Also called Harnalidge 0.2mg
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.
| Study group | Role | What they receive |
|---|---|---|
| Group-1 | Experimental | Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral ST-28) once a week for 8 weeks. Receives: Procedure: Low Intensity Shockwave Therapy (LiSWT) |
| Group-2 | Experimental | Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral SP-6) once a week for 8 weeks. Receives: Procedure: Low Intensity Shockwave Therapy (LiSWT) |
| Group-3 | Active comparator | Oral tamsulosin 0.2mg once daily for 8 weeks. Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Voiding Efficiency (BVE)
Bladder Voiding Efficiency (BVE) is the ratio of the voiding volume of urine over total bladder urine volume
Measured: Baseline, Week 4, Week 8, Week 12
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start11 Aug 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Detrusor UnderactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Armed Forces General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jing-Dung, SHEN, Taichung Armed Forces General Hospital
- Investigators
- Jing-Dung Shen, MD, Principal investigator, Taichung Armed Forces General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020963
- Sponsor's protocol ID
- A202205205
- Status last verified
- Mar 2024
- First submitted
- 27 Aug 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simplicio CL, Purita J, Murrell W, Santos GS, Dos Santos RG, Lana JFSD. Extracorporeal shock wave therapy mechanisms in musculoskeletal regenerative medicine. J Clin Orthop Trauma. 2020 May;11(Suppl 3):S309-S318. doi: 10.1016/j.jcot.2020.02.004. Epub 2020 Feb 12.
PubMed 32523286Lee 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.
PubMed 33628099Wang 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.
PubMed 29603534Dimitriadis 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.
PubMed 33676379Chuang 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.
PubMed 30796726Chuang 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.
PubMed 28767169Yoshida 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.
PubMed 33029933Lin 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.
PubMed 34502202
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency: A Pilot Study.
- ClinicalTrials.gov ID
- NCT06020963
- Acronym / sponsor ID
- A202205205
- Conditions
- Detrusor Underactivity
- Keywords
- detrusor underactivity, acupoint, voiding dysfunction, bladder voiding efficiency, low-intensity extracorporeal shockwave therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taichung Armed Forces General HospitalOther government
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group-1 | Experimental | Procedure: Low Intensity Shockwave Therapy (LiSWT)Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral ST-28) once a week for 8 weeks. |
| Group-2 | Experimental | Procedure: Low Intensity Shockwave Therapy (LiSWT)Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral SP-6) once a week for 8 weeks. |
| Group-3 | Active comparator | Drug: TamsulosinOral tamsulosin 0.2mg once daily for 8 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Bladder voiding efficiency is less than 70%.
Key exclusion criteria (5 listed)
- Patient who has history active pelvic malignancy without treatment.
- Acute urinary tract infection.
- Pregnancy
- Active infective lesion on treatment site.
- Open wound on treatment site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group-1, Group-2 |
| TamsulosinAlso: Harnalidge 0.2mgTamsulosin 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. | Drug | Group-3 |
Primary outcome
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
4 secondary outcomes
Global Response Assessment scale
Time frame: 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
Post-Voiding Residual urine amount
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 32523286Simplicio CL, Purita J, Murrell W, Santos GS, Dos Santos RG, Lana JFSD. Extracorporeal shock wave therapy mechanisms in musculoskeletal regenerative medicine. J Clin Orthop Trauma. 2020 May;11(Suppl 3):S309-S318. doi: 10.1016/j.jcot.2020.02.004. Epub 2020 Feb 12.
- Background: PubMed 33628099Lee 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.
- Background: PubMed 29603534Wang 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.
- Background: PubMed 33676379Dimitriadis 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.
- Background: PubMed 30796726Chuang 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.
- Background: PubMed 28767169Chuang 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.
- Background: PubMed 33029933Yoshida 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.
- Background: PubMed 34502202Lin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing-Dung Shen, MD principal investigator
Taichung Armed Forces General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Shockwave Therapy (LiSWT) and Tamsulosin in people with Detrusor Underactivity, run by Taichung Armed Forces General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing-Dung Shen, MD (+886958878129, jdwhydo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Voiding Efficiency (BVE) (time frame: Baseline, Week 4, Week 8, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06020963, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.