NCT06020963

Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Taichung Armed Forces General Hospital · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Detrusor Underactivity

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	Tamsulosin	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.

Timeline

• Start date: 2023-08-11
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-09-01
• Last updated: 2024-03-05

Locations

1 site across 1 country: Taiwan