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 range20 Years

SexALL

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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.
✕. 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).

What they're measuring

Net changes of the mean post void residual (PVR) volume (mL) from baseline to 1 month after the last treatment day

Timeframe: Baseline and 1 month

Trial details

NCT IDNCT04161183

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-01

View on ClinicalTrials.gov More Detrusor, Underactive trials