Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LiESWT arm | Experimental |
|
|
| Sham arm | Sham Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-Sham arm | Device | Sham treatment (shock wave probe w/o energy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pad Weight Difference | The pad test quantifies in grams urinary loss through the absorbent weighing as a measure of stress urinary incontinence. | 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. | 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. | 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. | 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. | Data will be analyzed at study completion at approximately 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| maximum flow rate(Qmax=cc/s) | The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility. | Data will be analyzed at study completion at approximately 3 years. |
| Uroflow |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Recruiting | Kaohsiung City | 807 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32242035 | Derived | Long CY, Lin KL, Lee YC, Chuang SM, Lu JH, Wu BN, Chueh KS, Ker CR, Shen MC, Juan YS. Therapeutic effects of Low intensity extracorporeal low energy shock wave therapy (LiESWT) on stress urinary incontinence. Sci Rep. 2020 Apr 2;10(1):5818. doi: 10.1038/s41598-020-62471-4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT arm | Device | Low intensity extracorporeal low energy shock wave treatment (shock wave probe w/ energy) |
|
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.
| 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). | 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. | Data will be analyzed at study completion at approximately 3 years. |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
Not provided
Not provided