Clinical trial NCT06020963: Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency
Official title: Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Detrusor Underactivity
Keywords: detrusor underactivity
acupoint
voiding dysfunction
bladder voiding efficiency
low-intensity extracorporeal shockwave therapy
Lead sponsor: Taichung Armed Forces General Hospital
Sponsor class: OTHER_GOV
First posted: 2023-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bladder Voiding Efficiency (BVE)
timeFrame: Baseline, Week 4, Week 8, Week 12
Secondary outcomes:
measure: Global Response Assessment scale
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.
measure: Maximum uroflow rate
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Post-Voiding Residual urine amount
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Total score of international prostate symptom score
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Armed Forces General Hospital
state: Other (Non US)
Study officials:
affiliation: Taichung Armed Forces General Hospital
name: Jing-Dung Shen, MD
role: PRINCIPAL_INVESTIGATOR
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