Back to resultsThe Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder
Primary Purpose
Stress Urinary Incontinence, Overactive Bladder
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-Sham arm
DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT arm
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring low intensity extracorporeal low energy shock wave therapy, stress urinary incontinence, overactive bladder, urine leakage
Eligibility Criteria
Inclusion Criteria:
- Women patients within 20~75 years old;
- OAB symptoms for ≥ 3 months;
- Frequency of micturition ≥ 8 times daytime as well as 2 times nighttime, and ≥ 2 episodes of urgency per week;
- Patients have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported);
- Patients with OAB symptoms including urgency or/and urgency incontinence, urinary frequency and nocturia in the previous 3 months without medical treatments: antimuscarinic or ß3 agonist therapy;
- Patients can understand, obey order and finish the questionnaires;
- Patients would like to sign the informed consent;
- Signature of informed consent form.
Exclusion Criteria:
- Urinary tract infection (UTI) at screening and recurrent UTI defined as ≥ 3 UTIs in the previous 12 months;
- Patients who have other disease: diabetes mellitus, spinal cord injury, stoke history, brain disease and neurogenic disease which can cause OAB;
- Chronic urologic inflammatory condition (Interstitial cystitis, urethral syndrome, painful bladder syndrome);
- Bladder stone;
- History of carcinoma of the urinary tract;
- Lower urinary tract surgery in the last 6 months;
- Patients who have operation, wound or infection around perineum;
- Patients who have catheterization due to poor voiding function of urine;
- Patients who have severe cardiovascular disease;
- Patients who have severe coagulopathy or liver failure or renal failure;
- Patients who have underlying urologic cancer;
- Subjects with gross hematuria;
- Significant bladder outflow obstruction;
- Previous pelvic radiation therapy or previous, current malignant disease of the pelvic organs or having received intravesical injection or electrostimulation in the past 12 months;
- Drug or nondrug treatments of OAB (in the previous 14 days), Concomitant medications that affect detrusor activity;
- Subjects with history of kidneys stones;
- Treatable condition that could cause urinary incontinence or urgency;
- Neurological impairment or psychiatric disorder preventing appropriate understanding of consent and ability to comply with site personnel instructions;
- History of drug or alcohol abuse within the last 12 months;
- Within 1 month before entering the test and receive low-energy in vitro shock wave treatment process using antibiotics or phosphodiesterase inhibitors type 5 (PDE5i);
- There are chronic pelvic pains caused by the merger of other diseases or injuries;
- Urinary incontinence need to install the catheter;
- Severe cardiopulmonary disease or diabetes is obviously poor control;
- Obvious coagulation dysfunction or liver and kidney dysfunction.
Sites / Locations
- Kaohsiung Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
LiESWT arm
Sham arm
Arm Description
For SUI: The LiESWT was applied with 0.25 mJ/mm2 intensity, 3000 pulses of shocks, and frequency of 3 pulses/second, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the left and right labia minora of the genital area, and the applicator was gently placed on the middle, the left side and the right side of the labia with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually. For OAB: The LiESWT was applied with 0.25 mJ/mm2 intensity, 3000 pulses of shocks, and frequency of 3 pulses/second, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the lower abdomen with two fingers apart from the pubic symphysis, tilting to 45°, and the applicator was gently placed on suprapubic skin area over the bladder dome and bilateral bladder walls with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually.
For SUI: The LiESWT was applied with 3000 pulses of shocks, frequency of 3 pulses/second but no energy, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the left and right labia minora of the genital area, and the applicator was gently placed on the middle, the left side and the right side of the labia with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually. For OAB: The LiESWT was applied with 3000 pulses of shocks, frequency of 3 pulses/second but no energy, once weekly for 4-weeks (W4) and 8-weeks (W8). The applicator was gently placed on the suprapubic skin area over the bladder dome (1000 pulses) and bilateral bladder walls (each side 1000 pulses). The probe was placed on the lower abdomen with two fingers apart from the pubic symphysis, tilting to 45°.
Outcomes
Primary Outcome Measures
Pad Weight Difference
The pad test quantifies in grams urinary loss through the absorbent weighing as a measure of stress urinary incontinence.
Overactive bladder symptoms scores (OABSS)
Change in OABSS scores during LiESWT treatment and follow-up period.
International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)
Change in ICIQ-SF scores during LiESWT treatment and follow-up period.
Urogenital distress inventory (UDI-6)
Change in UDI-6 scores during LiESWT treatment and follow-up period.
Incontinence impact questionnaire -7 (IIQ-7)
Change in IIQ-7 scores during LiESWT treatment and follow-up period.
Secondary Outcome Measures
maximum flow rate(Qmax=cc/s)
The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility.
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.
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).
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.
Full Information
NCT ID
NCT04059133
First Posted
August 14, 2019
Last Updated
August 16, 2019
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04059133
Brief Title
The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder
Official Title
The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Overactive Bladder
Keywords
low intensity extracorporeal low energy shock wave therapy, stress urinary incontinence, overactive bladder, urine leakage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LiESWT arm
Arm Type
Experimental
Arm Description
For SUI: The LiESWT was applied with 0.25 mJ/mm2 intensity, 3000 pulses of shocks, and frequency of 3 pulses/second, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the left and right labia minora of the genital area, and the applicator was gently placed on the middle, the left side and the right side of the labia with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually.
For OAB: The LiESWT was applied with 0.25 mJ/mm2 intensity, 3000 pulses of shocks, and frequency of 3 pulses/second, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the lower abdomen with two fingers apart from the pubic symphysis, tilting to 45°, and the applicator was gently placed on suprapubic skin area over the bladder dome and bilateral bladder walls with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually.
Arm Title
Sham arm
Arm Type
Sham Comparator
Arm Description
For SUI: The LiESWT was applied with 3000 pulses of shocks, frequency of 3 pulses/second but no energy, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the left and right labia minora of the genital area, and the applicator was gently placed on the middle, the left side and the right side of the labia with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually.
For OAB: The LiESWT was applied with 3000 pulses of shocks, frequency of 3 pulses/second but no energy, once weekly for 4-weeks (W4) and 8-weeks (W8). The applicator was gently placed on the suprapubic skin area over the bladder dome (1000 pulses) and bilateral bladder walls (each side 1000 pulses). The probe was placed on the lower abdomen with two fingers apart from the pubic symphysis, tilting to 45°.
Intervention Type
Device
Intervention Name(s)
DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-Sham arm
Intervention Description
Sham treatment (shock wave probe w/o energy)
Intervention Type
Device
Intervention Name(s)
DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT arm
Intervention Description
Low intensity extracorporeal low energy shock wave treatment (shock wave probe w/ energy)
Primary Outcome Measure Information:
Title
Pad Weight Difference
Description
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.
Title
Overactive bladder symptoms scores (OABSS)
Description
Change in OABSS scores during LiESWT treatment and follow-up period.
Time Frame
Data will be analyzed at study completion at approximately 3 years.
Title
International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)
Description
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.
Title
Urogenital distress inventory (UDI-6)
Description
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.
Title
Incontinence impact questionnaire -7 (IIQ-7)
Description
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.
Secondary Outcome Measure Information:
Title
maximum flow rate(Qmax=cc/s)
Description
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.
Title
Uroflow
Description
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.
Title
postvoid residual urine volume (PVR)
Description
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.
Title
3-day micturition diary
Description
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women patients within 20~75 years old;
OAB symptoms for ≥ 3 months;
Frequency of micturition ≥ 8 times daytime as well as 2 times nighttime, and ≥ 2 episodes of urgency per week;
Patients have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported);
Patients with OAB symptoms including urgency or/and urgency incontinence, urinary frequency and nocturia in the previous 3 months without medical treatments: antimuscarinic or ß3 agonist therapy;
Patients can understand, obey order and finish the questionnaires;
Patients would like to sign the informed consent;
Signature of informed consent form.
Exclusion Criteria:
Urinary tract infection (UTI) at screening and recurrent UTI defined as ≥ 3 UTIs in the previous 12 months;
Patients who have other disease: diabetes mellitus, spinal cord injury, stoke history, brain disease and neurogenic disease which can cause OAB;
Chronic urologic inflammatory condition (Interstitial cystitis, urethral syndrome, painful bladder syndrome);
Bladder stone;
History of carcinoma of the urinary tract;
Lower urinary tract surgery in the last 6 months;
Patients who have operation, wound or infection around perineum;
Patients who have catheterization due to poor voiding function of urine;
Patients who have severe cardiovascular disease;
Patients who have severe coagulopathy or liver failure or renal failure;
Patients who have underlying urologic cancer;
Subjects with gross hematuria;
Significant bladder outflow obstruction;
Previous pelvic radiation therapy or previous, current malignant disease of the pelvic organs or having received intravesical injection or electrostimulation in the past 12 months;
Drug or nondrug treatments of OAB (in the previous 14 days), Concomitant medications that affect detrusor activity;
Subjects with history of kidneys stones;
Treatable condition that could cause urinary incontinence or urgency;
Neurological impairment or psychiatric disorder preventing appropriate understanding of consent and ability to comply with site personnel instructions;
History of drug or alcohol abuse within the last 12 months;
Within 1 month before entering the test and receive low-energy in vitro shock wave treatment process using antibiotics or phosphodiesterase inhibitors type 5 (PDE5i);
There are chronic pelvic pains caused by the merger of other diseases or injuries;
Urinary incontinence need to install the catheter;
Severe cardiopulmonary disease or diabetes is obviously poor control;
Obvious coagulation dysfunction or liver and kidney dysfunction.
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yung-Shun Juan, MD., PhD
Phone
88673121101
Ext
6361
Email
juanuro@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32242035
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder
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