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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11
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
Chang Gung Memorial Hospital, Chang Gung University College of Medicine
Kaohsiung City, Taiwan
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
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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