Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency

Not Applicable

Recruiting

• Conditions: Detrusor Underactivity
• Interventions: Procedure: Low Intensity Shockwave Therapy (LiSWT); Drug: Tamsulosin

• Registration Number: NCT06020963
• Lead Sponsor: Taichung Armed Forces General Hospital

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.

Study Timeline

• Study Start: 2023-08-11
• Study First Submitted: 2023-08-27
• Study First Submitted QC: 2023-08-27
• Study First Posted: 2023-09-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-02
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-1	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	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	Tamsulosin	Oral tamsulosin 0.2mg once daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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.

Trial Locations

Locations (1)

Taichung Armed Forces General Hospital; 🇨🇳 Taichung, Other (Non US), Taiwan