NCT04059133|Unknown
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Sponsor study identifier
interventional
180
1 country
1
Study Start
February 27, 2018
Actual (reported)Primary Completion
July 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 27, 2018
Actual (reported)August 14, 2019
Actual (reported)August 16, 2019
Actual (reported)July 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
maximum flow rate(Qmax=cc/s)
Data will be analyzed at study completion at approximately 3 years.
Uroflow
Data will be analyzed at study completion at approximately 3 years.
postvoid residual urine volume (PVR)
Data will be analyzed at study completion at approximately 3 years.
3-day micturition diary
Data will be analyzed at study completion at approximately 3 years.
1. 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. 2. 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.
1. 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. 2. 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°.
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, 807, Taiwan
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.
First Submitted
August 14, 2019
First Posted
August 16, 2019
Study Start
February 27, 2018
Actual (reported)Primary Completion
July 31, 2020
Estimated (date passed)Stress Incontinence Trial With Elitone Device
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 20, 2019
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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