Viewing Study NCT04059133


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Study NCT ID: NCT04059133
Status: UNKNOWN
Last Update Posted: 2019-08-20
First Post: 2019-08-14
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:

Study Overview

Official Title: The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder
Status: UNKNOWN
Status Verified Date: 2019-08
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: