Status:
UNKNOWN
Efficacy and Safety of Low Energy Shock Wave Plus BotulinumToxin A in Treating Patients With Interstitial Cystitis
Lead Sponsor:
Buddhist Tzu Chi General Hospital
Collaborating Sponsors:
Ministry of Science and Technology, Taiwan
Hualien Tzu Chi General Hospital
Conditions:
Interstitial Cystitis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
Low energy shock wave (LESW) is known to facilitate tissue regeneration with analgesic and anti-inflammatory effects. LESW treatment has been demonstrated effective in treatment of nonbacterial prosta...
Detailed Description
Interstitial cystitis/ bladder pain syndrome (IC/BPS) is a bladder disorder with unknown etiology and difficult treatment. Novel treatments have been searched to adequately improved symptoms. Low ener...
Eligibility Criteria
Inclusion
- Adults with age of 20 years old or above
- Patients with symptoms of frequency, urgency, and bladder pain at full bladder for more than 6 months.
- Proven to have glomerulations (at least grade 1) by cystoscopic hydrodistention under anesthesia in recent 1 year
- Free of active urinary tract infection
- Free of bladder outlet obstruction on enrolment
- Free of overt neurogenic bladder dysfunction and limitation of ambulation.
- Patient or his/her legally acceptable representative agrees to sign the written informed consent form
Exclusion
- Patient's lower urinary tract symptoms can be effectively treated by conventional therapy
- Patient or his/her legally acceptable representative cannot sign the written informed consent form
- Patient cannot complete the consecutive 3- day voiding diary on the visiting day
- Patient had been treated for overactive bladder by enterocystoplasty
- Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
- Patient has bladder outlet obstruction on enrollment
- Patients has post-void residual \>250ml
- Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
- Patients have laboratory abnormalities at screening including: ALT\> 3 x upper limit of normal range, AST\> 3 x upper limit of normal range; Patients have abnormal serum creatinine level \> 2 x upper limit of normal range
- Patient has coagulation disorder
- 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
- Patient had received intravesical hyaluronic acid insillation treatment for IC within recent 6 months before enrolment
- Patient had received intravesical onabotulinumtoxinA treatment for IC within recent 12 months before enrolment
- Patients participated investigational drug trial within 1 month before entering this study
Key Trial Info
Start Date :
May 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05275647
Start Date
May 18 2021
End Date
September 1 2024
Last Update
March 25 2022
Active Locations (1)
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1
Buddhist Tzu Chi General Hospital
Hualien City, Taiwan, 970