An interventional study of Low Intensity Shockwave Therapy (LiSWT) and Tamsulosin in Detrusor Underactivity, sponsored by Taichung Armed Forces General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Taichung Armed Forces General Hospital · Not applicable, Interventional, and Treatment
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.
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.
31 studies on the registry are indexed under Urinary Bladder, Underactive; 6 are open to participants now.
This study's planned enrollment of 100 is above the median of 66 across 21 interventional studies indexed under Urinary Bladder, Underactive.
Browse Urinary Bladder, Underactive studies →Taichung Armed Forces General Hospital is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1.Bladder voiding efficiency is less than 70%.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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)
Oral tamsulosin 0.2mg once daily for 8 weeks.
Drug: Tamsulosin
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.
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.
Also known as: Harnalidge 0.2mg
Bladder Voiding Efficiency (BVE)
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
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.
Plan to share: No
Started Aug 2023 (actual). Primary completion is estimated for Dec 2024, 16 months after the start.
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Urinary Bladder, Underactive →
Taichung Armed Forces General Hospital