The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incont… (NCT04059133) | Clinical Trial Compass
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The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder
Taiwan180 participantsStarted 2018-02-27
Plain-language 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.
Who can participate
Age range
20 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pad Weight Difference
Timeframe: Data will be analyzed at study completion at approximately 3 years.
2
Overactive bladder symptoms scores (OABSS)
Timeframe: Data will be analyzed at study completion at approximately 3 years.
3
International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)
Timeframe: Data will be analyzed at study completion at approximately 3 years.
4
Urogenital distress inventory (UDI-6)
Timeframe: Data will be analyzed at study completion at approximately 3 years.
5
Incontinence impact questionnaire -7 (IIQ-7)
Timeframe: Data will be analyzed at study completion at approximately 3 years.
Trial details
NCT IDNCT04059133
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital