Detrusor Underactivity
Conditions
Keywords
detrusor underactivity, acupoint, voiding dysfunction, bladder voiding efficiency, low-intensity extracorporeal shockwave therapy
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 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.
Interventions
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.
DRUGTamsulosin
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.
Sponsors
Taichung Armed Forces General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Contacts
Primary ContactJing-Dung Shen, MD
Outcome results
None listed