Extracoporeal Shock Wave Therapy (ESWT) for the Treatment of Detrusor Underactivity/ Underactive … (NCT04161183) | Clinical Trial Compass
CompletedNot Applicable
Extracoporeal Shock Wave Therapy (ESWT) for the Treatment of Detrusor Underactivity/ Underactive Bladder (DU/UAB)
Taiwan11 participantsStarted 2019-10-15
Plain-language summary
To evaluate the efficacy and safety of ESWT for the treatment of patients with DU/UAB
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
. Adult male or female, at least 20 years of age.
. History of UAB (defined as bothersome chronic incomplete bladder emptying) for at least 3 months documented in the medical record with recurring UAB symptoms.
. No UAB symptom relief (unresponsiveness) with previous used medications and/or other treatments.
. Voiding difficulty (complains of difficulty emptying the bladder).
. UAB consistent with diabetes, MS, Parkinson's disease, or aging idiopathic.
. Post void residual ≥ 100 mL.
. Bladder capacity \> 200 mL and \< 800 mL.
. Pressure flow Urodynamic testing demonstrating impaired detrusor contractility or areflexia without evidence of BOO, with maximum detrusor pressure Pdet at Qmax (Pdet@Qmax) of \< 20 cmH2O and Maximum flow rate (Qmax) \< 15 mL/sec for female, and BCI \< 100 and BOOI \< 40 for male.
Exclusion criteria
. Female patients who is pregnant, lactating, plans to become pregnant, or with child-bearing potential without contraception.
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
Net changes of the mean post void residual (PVR) volume (mL) from baseline to 1 month after the last treatment day
. Simultaneously participating in another investigational drug or device study or use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment
. Has been treated with an investigational device, drug, or procedure for UAB within the last 3 months.
. History of cancer in pelvic organs, ureters, or kidneys or any cancer that has undergone treatment within the past 12 months.
. Medical condition or disorder that may limit life expectancy or that may cause protocol deviations (e.g. unable to perform self-evaluations/accurately report medical history, and/or urinary symptoms).
. History of spinal cord injury affecting urinary function.
. Patients with uncontrolled acute urinary tract infection. An active urinary tract infection as evidenced by positive urine culture at the time of baseline assessment. If a UTI is confirmed in the baseline sample (e.g., positive urine culture containing \> 100,000 cfu/mL in midstream urine), the run-in period should be stopped. After successful treatment of the UTI, the patient can be rescreened and if eligible enroll in the study. If the patient has asymptomatic bacteriuria (i.e., a positive urine culture without clinical signs and symptoms of a UTI), the patient should not be excluded.
. Currently taking medication(s) that may affect urination, including prescription drugs (i.e. anticholinergics, tricyclic antidepressants, bethanechol), over the counter drugs, dietary and/or herbal supplements, adrenergic antagonists. Alpha adrenergic blockers are allowed to use in a stable condition (longer than 1 month and keeping use during the study period).