Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency

Taichung Armed Forces General Hospital

Status: Enrolling

Conditions: Detrusor Underactivity

Treatments: Procedure: Low Intensity Shockwave Therapy (LiSWT); Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT06020963

A202205205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Group-1

Experimental group

Description:

Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral ST-28) once a week for 8 weeks.

Treatment:

Procedure: Low Intensity Shockwave Therapy (LiSWT)

Group-2

Experimental group

Description:

Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral SP-6) once a week for 8 weeks.

Treatment:

Procedure: Low Intensity Shockwave Therapy (LiSWT)

Group-3

Active Comparator group

Description:

Oral tamsulosin 0.2mg once daily for 8 weeks.

Treatment:

Drug: Tamsulosin