Extracoporeal Shock Wave Therapy (ESWT) for the Treatment of Detrusor Underactivity/ Underactive Bladder (DU/UAB)

Launched by CHANG GUNG MEMORIAL HOSPITAL · Nov 10, 2019

Keywords

ClinConnect Summary

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 ther...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult male or female, at least 20 years of age.
• • 2. History of UAB (defined as bothersome chronic incomplete bladder emptying) for at least 3 months documented in the medical record with recurring UAB symptoms.
• • 3. No UAB symptom relief (unresponsiveness) with previous used medications and/or other treatments.
• • 4. Voiding difficulty (complains of difficulty emptying the bladder).
• • 5. UAB consistent with diabetes, MS, Parkinson's disease, or aging idiopathic.
• • 6. Post void residual ≥ 100 mL.
• • 7. Bladder capacity \> 200 mL and \< 800 mL.
• • 8. 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.
• • 9. Total UAB Questionnaire Score ≥ 3.
• • 10. Females of child-bearing potential agree to use reliable birth control for the entire study duration.
• • 11. Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the voiding diaries and self-administered questionnaires.
• • 12. Free of active urinary tract infection.
• • 13. Free of bladder outlet obstruction on enrollment.
• • 14. Patient or his/her legally acceptable representative has signed the written informed consent form.
• • 15. Subject on clean intermittent catheterization (CIC) should have been on CIC for at least 1 month and should be able to void spontaneously and not be completely dependent on CIC.
• Exclusion Criteria:
• • 1. Female patients who is pregnant, lactating, plans to become pregnant, or with child-bearing potential without contraception.
• • 2. 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
• • 3. Has been treated with an investigational device, drug, or procedure for UAB within the last 3 months.
• • 4. History of cancer in pelvic organs, ureters, or kidneys or any cancer that has undergone treatment within the past 12 months.
• • 5. 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).
• • 6. History of spinal cord injury affecting urinary function.
• • 7. 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.
• • 8. 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).
• • 9. Pelvic organ prolapses beyond the introitus (e.g., cystocele, rectocele).
• • 10. Prior mesh surgery for stress urinary incontinence or pelvic prolapse.
• • 11. Any other condition which per investigators' judgement, may affect the patient's safety (e.g. significant cardiovascular disease, asthma or other breathing disorders).
• • 12. Patients with bladder outlet obstruction on enrollment.
• • 13. Patients with any contraindication to be urethral catheterization during diagnostic test or treatment or follow-up period.
• 14. Patients have laboratory abnormalities at screening including:
• • ALT \> 3 x upper limit of normal range AST \> 3 x upper limit of normal range Serum creatinine level \> 2 x upper limit of normal range.
• • 15. Patients with any other serious disease considered by the investigator not in the condition to enter the trial.
• • 16. Patients with cortisone treatment 6 week before first LESW therapy.
• • 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.