An interventional study of Extracoporeal shock wave therapy and Placebo in Detrusor, Underactive and Detrusor Underactivity, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-10-05.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
To evaluate the efficacy and safety of ESWT for the treatment of patients with DU/UAB
The prevalence of detrusor underactivity/ underactive bladder (DU/UAB) increased with age, which is 9-28% in young men (\<50 years), and is up to 48% in the elderly men (>70 years) with non-neurogenic lower urinary tract symptoms. In women aged >70 years, the prevalence of DU ranged from 12% to 45%. Currently, there is a lack of effective pharmacological or surgical treatment of DU/UAB. Previously we demonstrated that extracoporeal shock wave therapy (ESWT) was able to mediate a partial recovery in the contractility of cryoinjury induced DU/UAB model in rats. Wang et al. reported the therapeutic effect of ESWT in the streptozotocin induced diabetic underactive bladder rat model with significantly improved voiding function, enhanced detrusor contractility, increased muscle actin expression and muscle proportion of the bladder wall, and recovery of neuronal integrity and innervations. Taken together, these findings suggest that a potential clinical benefit of ESWT treatment for patients with DU/UAB.
A total of 60 patients with DU/UAB will be enrolled to receive ESWT once a week for 6 weeks or placebo treatment. Patients with DU/UAB symptoms with post void residual (PVR) ≥ 100 mL and proven of DU/UAB without bladder outlet obstruction (BOO) by urodynamic study. Patients should not have uncontrolled acute urinary tract infection, and should not have treated with an investigational device, drug, or procedure for UAB within the last 3 months. Retreatment with ESWT at 3 months if patient reports ineffective will be allowed.
Primary end-point is the change of PVR volume (mL) from baseline to 1 month after treatment. Secondary endpoints include daily frequency, nocturia and FBC as record in 3-day voiding diary, Qmax, Pdet@Qmax, voided volume, PVR and global response assessment (GRA). One visit is required at baseline screening (before first treatment), treatment 1 (V1), treatment 2 (V2), treatment 3 (V3), treatment 4 (V4), treatment 5 (V5), treatment 6 (V6) and 1 month post V6 treatment (V7, primary end-point), and 3 months post V6 treatment (V8). Urine samples will be collected at each time-point for NGF and cytokines tests. Cystoscopy bladder biopsy will be performed at baseline and at 3 months post treatment, optional.
31 studies on the registry are indexed under Urinary Bladder, Underactive; 6 are open to participants now.
This study's enrollment of 11 is below the median of 66 across 21 interventional studies indexed under Urinary Bladder, Underactive.
Browse Urinary Bladder, Underactive studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients have laboratory abnormalities at screening including:
> 3 x AST > 3 x upper limit of normal range Serum creatinine level > 2 x upper limit of normal range.
Other single item of Lab examination also can be retested per Investigator's discretion if abnormality. Patient will be rescreened and randomized into the study once confirmed eligible.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo treatment (shock wave probe w/o energy)
Device: Placebo
Extracoporeal shock wave therapy (shock wave probe w/ energy)
Device: Extracoporeal shock wave therapy
Probe be transcutaneous applied to the region of bladder dome, right upper lateral wall, right lower lateral wall, left upper lateral wall, and left lower lateral wall with 2500 shocks, frequency of 4 pulses per second and maximum total energy flow density 0.25 millijoule/mm2 once a week for 6 weeks
Probe be transcutaneous applied to the region of bladder dome, right upper lateral wall, right lower lateral wall, left upper lateral wall, and left lower lateral wall with 2500 shocks, frequency of 4 pulses per second but no energy once a week for 6 weeks
Net changes of the mean post void residual (PVR) volume (mL) from baseline to 1 month after the last treatment day
Net changes of the PVR from baseline to 1 month after the last treatment day (higher PVR volumes represent a worse outcome)
Time frame: Baseline and 1 month
Net changes of the functional bladder capacity (FBC) as assessed by the maximum urine volume (milliliters) as recorded in 3-day voiding diary
Net changes of the functional bladder capacity (FBC) from baseline to 1 month after the last treatment day (higher FBC volumes represent a better outcome)
Time frame: Baseline and 1 month
Net changes of the Global response assessment (GRA)
Global response assessment (GRA) of therapeutic result by the patient (categorized from -3 to +3, indicating markedly worse to markedly improved) at 1 month after the last treatment day
Time frame: Baseline and 1 month
Net changes of the maximum flow rate
Net changes of the maximum flow rate from baseline to 1 month after the last treatment day (higher maximum flow rate represent a better outcome)
Time frame: Baseline and 1 month
Net changes of the voided volume
Net changes of the voided volume from baseline to 1 month after the last treatment day (higher voided volumes represent a better outcome)
Time frame: Baseline and 1 month
Net changes of the Pdet@Qmax
Net changes of the Pdet@Qmax from baseline to 1 month after the last treatment day
Time frame: Baseline and 1 month
Net changes of the postvoid residual volume
Net changes of the postvoid residual volume from baseline to 1 month after the last treatment day (lower postvoid residual volume represent a better outcome)
Time frame: Baseline and 1 month
Changes of the Underactive Bladder Questionnaire (UAB-Q) score
Changes of the UAB-Q score from baseline to 1 month after the last treatment day (lower UAB-Q score represent a better outcome)
Time frame: Baseline and 1 month
Changes of urinary nerve growth factor and cytokines level
Changes of the urinary nerve growth factor and cytokines level from baseline to 1 month after the last treatment day
Time frame: Baseline and 1 month
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2019 to primary completion in Dec 2021, 25 months.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Urinary Bladder, Underactive →
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