Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) (NCT03619486) | Clinical Trial Compass
CompletedNot Applicable
Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Taiwan49 participantsStarted 2018-07-04
Plain-language summary
To investigate the efficacy and safety of LESW on participants with IC/BPS
Who can participate
Age range
20 Years
Sex
ALL
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
. Adults with age of 20 years old or above
. Patients with symptoms of unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six months duration, in the absence of infection or other identifiable causes
. Patients has received cystoscopy and ruled out other bladder lesion
. Free of active urinary tract infection
. Free of bladder outlet obstruction on enrollment
. Free of overt neurogenic bladder dysfunction and limitation of ambulation
. Patient or his/her legally acceptable representative has signed the written informed consent form
Exclusion criteria
. Patients had received intravesical hyaluronic acid treatment in recent 3 months, or intravesical Botox injection in recent 12 months Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
. Patients with bladder outlet obstruction on enrollment
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
Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI)
. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
. Patients have laboratory abnormalities at screening including: alanine aminotransferase (ALT)\> 3 x upper limit of normal range, and aspartate aminotransferase (AST) \> 3 x upper limit of normal range
. Patients have abnormal serum creatinine level \> 2 x upper limit of normal range
. Female patients who is pregnant, lactating, or with child-bearing potential without contraception
. Patients with any other serious disease considered by the investigator not in the condition to enter the trial