NCT04059133

The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis of the present study is low intensity extracorporeal low energy shock wave therapy (LiESWT) can decrease inflammatory disorders, increase pelvic floor blood supply, enhanced bladder stem cell activation, Using LiESWT can decrease bladder overactivity, eliminate urinary incontinence and improve stress urinary incontinence (SUI) and overactive bladder (OAB) symptoms. Therefore improve quality of life and improve social activity.

Detailed description

Clinical application of low intensity extracorporeal low energy shock wave therapy (LiESWT) (2000 to 3000 impulses in 0.20-0.25 millijoule/mm2 (mJ/mm2)) initiated wound healing, promoted angiogenesis, reduced the level of oxidative stress, induced the releasing of VEGF, stimulated proliferation and differentiation of stem cells, and resulted in the effect of anti-inflammatory and tissue regeneration. Generally, LiESWT was used clinically to improve tissue regeneration at tendon-bone junctions, ischemic cardiovascular disorders, skin wound healing, chronic injuries of soft tissues and erectile dysfunction. LiESWT has also been shown to increase vascular endothelial growth factor (VEGF) expression in ischemic tissues in vivo and to promote angiogenesis and functional recovery in models of chronic myocardial ischemia, myocardial infarction, and peripheral artery disease. Importantly, the advantages of LiESWT include therapies without medication or surgery, outpatient therapies, short treatment sessions, no anesthesia required, and non-invasive therapy. The hypothesis of the present study is LiESWT can decrease inflammatory disorders, increase pelvic floor blood supply, enhanced bladder stem cell activation, Using LiESWT can decrease bladder overactivity, eliminate urinary incontinence and improve stress urinary incontinence (SUI) and overactive bladder (OAB) symptoms. Therefore improve quality of life and improve social activity.

Conditions

• Stress Urinary Incontinence
• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-Sham arm	Sham treatment (shock wave probe w/o energy)
DEVICE	DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT arm	Low intensity extracorporeal low energy shock wave treatment (shock wave probe w/ energy)

Timeline

• Start date: 2018-02-27
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2019-08-16
• Last updated: 2019-08-20

Locations

1 site across 1 country: Taiwan