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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Sham treatment (shock wave probe w/o energy)
Low intensity extracorporeal low energy shock wave treatment (shock wave probe w/ energy)
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
RECRUITINGPad Weight Difference
The pad test quantifies in grams urinary loss through the absorbent weighing as a measure of stress urinary incontinence.
Time frame: Data will be analyzed at study completion at approximately 3 years.
Overactive bladder symptoms scores (OABSS)
Change in OABSS scores during LiESWT treatment and follow-up period.
Time frame: Data will be analyzed at study completion at approximately 3 years.
International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)
Change in ICIQ-SF scores during LiESWT treatment and follow-up period.
Time frame: Data will be analyzed at study completion at approximately 3 years.
Urogenital distress inventory (UDI-6)
Change in UDI-6 scores during LiESWT treatment and follow-up period.
Time frame: Data will be analyzed at study completion at approximately 3 years.
Incontinence impact questionnaire -7 (IIQ-7)
Change in IIQ-7 scores during LiESWT treatment and follow-up period.
Time frame: Data will be analyzed at study completion at approximately 3 years.
maximum flow rate(Qmax=cc/s)
The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility.
Time frame: Data will be analyzed at study completion at approximately 3 years.
Uroflow
Uroflow curve pattern: There are 5 uroflow curve patterns, bell-shaped, tower-shaped, interrupted-shaped, staccato-shaped and plateau shaped by uroflowmetry. The shape is determined by detrusor contractility and influenced by abdominal straining, coordination with the bladder outlet musculature and any distal anatomic obstruction.
Time frame: Data will be analyzed at study completion at approximately 3 years.
postvoid residual urine volume (PVR)
PVR (cc): ultrasonographic bladder scan machines calculates bladder volume. PVR measurements in neurologically intact children are highly variable. PVR must be obtained immediately after voiding(\<5min).
Time frame: Data will be analyzed at study completion at approximately 3 years.
3-day micturition diary
The mean number of Intake (ml), output (ml), average urine volume (ml), functional bladder capacity (ml), urinary frequency (times/24hrs), urgency (times), and nocturia (times) per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Time frame: Data will be analyzed at study completion at approximately 3 years.
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