CompletedNot Applicable

Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Taiwan49 participantsStarted 2018-07-04

Plain-language summary

To investigate the efficacy and safety of LESW on participants with IC/BPS

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adults with age of 20 years old or above
✓. Patients with symptoms of unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six months duration, in the absence of infection or other identifiable causes
✓. Patients has received cystoscopy and ruled out other bladder lesion
✓. Free of active urinary tract infection
✓. Free of bladder outlet obstruction on enrollment
✓. Free of overt neurogenic bladder dysfunction and limitation of ambulation
✓. Patient or his/her legally acceptable representative has signed the written informed consent form

✕. Patients had received intravesical hyaluronic acid treatment in recent 3 months, or intravesical Botox injection in recent 12 months Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
✕. Patients with bladder outlet obstruction on enrollment
✕. Patients with PVR \>100 ml
✕. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
✕. Patients have laboratory abnormalities at screening including: alanine aminotransferase (ALT)\> 3 x upper limit of normal range, and aspartate aminotransferase (AST) \> 3 x upper limit of normal range
✕. Patients have abnormal serum creatinine level \> 2 x upper limit of normal range
✕. Female patients who is pregnant, lactating, or with child-bearing potential without contraception
✕. Patients with any other serious disease considered by the investigator not in the condition to enter the trial

Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI)

Timeframe: Baseline and 1 month

NCT IDNCT03619486

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-26

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adults with age of 20 years old or above
✓. Patients with symptoms of unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six months duration, in the absence of infection or other identifiable causes
✓. Patients has received cystoscopy and ruled out other bladder lesion
✓. Free of active urinary tract infection
✓. Free of bladder outlet obstruction on enrollment
✓. Free of overt neurogenic bladder dysfunction and limitation of ambulation
✓. Patient or his/her legally acceptable representative has signed the written informed consent form

✕. Patients had received intravesical hyaluronic acid treatment in recent 3 months, or intravesical Botox injection in recent 12 months Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
✕. Patients with bladder outlet obstruction on enrollment
✕. Patients with PVR \>100 ml
✕. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
✕. Patients have laboratory abnormalities at screening including: alanine aminotransferase (ALT)\> 3 x upper limit of normal range, and aspartate aminotransferase (AST) \> 3 x upper limit of normal range
✕. Patients have abnormal serum creatinine level \> 2 x upper limit of normal range
✕. Female patients who is pregnant, lactating, or with child-bearing potential without contraception
✕. Patients with any other serious disease considered by the investigator not in the condition to enter the trial