Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Primary Purpose
Interstitial Cystitis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Low energy shock wave
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Low Energy Shock Wave (LESW), Extracorporeal Shockwave Therapy, interstitial cystitis/bladder pain syndrome (IC/BPS)
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Patients had received intravesical treatment for IC within recent 1 month
- Patients had participated investigational drug trial within 1 month before entering this study
- Patients with coagulopathy
Sites / Locations
- Chang Gung Memorial Hospital, Chang Gung University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Low energy shock wave
Arm Description
Placebo treatment (shock wave probe w/o energy)
Low energy shock wave treatment (shock wave probe w/ energy)
Outcomes
Primary Outcome Measures
Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI)
Change of the O'Leary-Sant symptom score from baseline to 1 month after the treatment day.
Subscales ICSI and ICPI are graded from 0 to 20 and 0 to 16, respectively. The items are summed to obtain OSS (range from 0 to 36, higher values represent a worse outcome).
Secondary Outcome Measures
Net changes of the Visual Analog Scale (VAS)
Net changes of the Visual Analog Scale from baseline to 1 month after the treatment day (VAS range from 0 to 10, higher values represent a worse outcome)
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 treatment day (higher FBC volumes represent a better outcome)
Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary
Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary from baseline to 1 month after the treatment day (higher voiding frequency at daytime represent a worse outcome)
Net changes of the voiding frequency at night time as recorded in 3-day voiding diary
Net changes of the voiding frequency at night time as recorded in 3-day voiding diary from baseline to 1 month after the treatment day (higher voiding frequency at night time represent a worse outcome)
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 3 months after the last treatment day
Net changes of the maximum flow rate
Net changes of the maximum flow rate from baseline to 1 month after the treatment day (higher maximum flow rate represent a better outcome)
Net changes of the voided volume
Net changes of the voided volume from baseline to 1 month after the treatment day (higher voided volumes represent a better outcome)
Net changes of the PVR
Net changes of the PVR from baseline to 1 month after the treatment day (higher PVR volumes represent a worse outcome)
Net changes of the cytokines level
Net changes of the cytokines level from baseline to 1 month after the treatment day (e.g. NGF and IL-6, higher values represent a worse outcome)
Full Information
NCT ID
NCT03619486
First Posted
July 19, 2018
Last Updated
January 27, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03619486
Brief Title
Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Official Title
Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) - a Randomized, Double-blind, Placebo-controlled, Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 4, 2018 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To investigate the efficacy and safety of LESW on participants with IC/BPS
Detailed Description
Low energy shock wave (LESW) is known to facilitate tissue regeneration with analgesic and anti-inflammatory effects. LESW has been proved to have therapeutic effects in patients with nonbacterial prostatitis and chronic pelvic pain syndrome (CPPS). Investigator's previous study has demonstrated that LESW treatment inhibited nerve growth factor (NGF), interleukin-6 (IL-6), and cyclooxygenase-2 (COX-2) expression, and blocked the bladder pain, inflammation and overactivity in a cyclophosphamide induced cystitis model in rats. These findings suggest that a potential clinical benefit of LESW treatment for patients with interstitial cystitis/bladder pain syndrome (IC/BPS).
A total of 50 participants with IC/BPS will be enrolled to receive LESW (transcutaneous applied to the suprapubic bladder region with 2000 shocks, frequency of 3 pulses per second and maximum total energy flow density 0.25 millijoule/mm2) once a week for 4 weeks or placebo (same condition but with no energy) treatment.
All participants should have IC symptoms for at least 6 months, and have received cystoscopy to rule out other bladder lesion. Participants should not have urinary tract infection (UTI) in recent 3 months, and no urinary tract stone. Participants should not receive intravesical hyaluronic acid treatment in recent 3 months, or intravesical Botox injection in recent 12 months. Retreatment with LESW at 3 months if participants reports ineffective.
Primary end-point is the change of the O'Leary-Sant symptom score (OSS), including Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI) from baseline to 1 month after treatment. Secondary endpoints include Visual Analogue Scale (VAS), daily frequency, nocturia and functional bladder capacity (FBC) as record in 3-day voiding diary, maximum flow rate (Qmax), voided volume, postvoiding residual (PVR) and global response assessment (GRA). Two visits are required at baseline screening (before first treatment), treatment (V1), 1 week (V2), 2 weeks (V3), 3 weeks (V4) and 1 week post V4 treatment (V5), 1 month post V4 treatment (V6, primary end-point), and 3 months post V4 treatment (V7) . Urine samples will be collected at each time-point for NGF and cytokines tests. Bladder biopsy will be performed at baseline and repeat cystoscopy at 3 months post treatment optional.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
Low Energy Shock Wave (LESW), Extracorporeal Shockwave Therapy, interstitial cystitis/bladder pain syndrome (IC/BPS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind, placebo control study. Eligible participants will be assigned a randomization number in sequential order and each of the randomization will determine the allocation of one of the two treatment groups (LESW and Placebo) in 1: 1 ratio as shown below. The LESW and placebo will be controlled by a research assistance who will not evaluate the therapeutic outcome to ensure the double blind method.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo treatment (shock wave probe w/o energy)
Arm Title
Low energy shock wave
Arm Type
Experimental
Arm Description
Low energy shock wave treatment (shock wave probe w/ energy)
Intervention Type
Device
Intervention Name(s)
Low energy shock wave
Intervention Description
Probe be transcutaneous applied to the suprapubic bladder region with 2000 shocks, frequency of 3 pulses per second and maximum total energy flow density 0.25 millijoule/mm2 once a week for 4 weeks
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Probe be transcutaneous applied to the suprapubic bladder region with 2000 shocks, frequency of 3 pulses per second but no energy once a week for 4 weeks
Primary Outcome Measure Information:
Title
Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI)
Description
Change of the O'Leary-Sant symptom score from baseline to 1 month after the treatment day.
Subscales ICSI and ICPI are graded from 0 to 20 and 0 to 16, respectively. The items are summed to obtain OSS (range from 0 to 36, higher values represent a worse outcome).
Time Frame
Baseline and 1 month
Secondary Outcome Measure Information:
Title
Net changes of the Visual Analog Scale (VAS)
Description
Net changes of the Visual Analog Scale from baseline to 1 month after the treatment day (VAS range from 0 to 10, higher values represent a worse outcome)
Time Frame
Baseline and 1 month
Title
Net changes of the functional bladder capacity (FBC) as assessed by the maximum urine volume (milliliters) as recorded in 3-day voiding diary
Description
Net changes of the functional bladder capacity (FBC) from baseline to 1 month after the treatment day (higher FBC volumes represent a better outcome)
Time Frame
Baseline and 1 month
Title
Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary
Description
Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary from baseline to 1 month after the treatment day (higher voiding frequency at daytime represent a worse outcome)
Time Frame
Baseline and 1 month
Title
Net changes of the voiding frequency at night time as recorded in 3-day voiding diary
Description
Net changes of the voiding frequency at night time as recorded in 3-day voiding diary from baseline to 1 month after the treatment day (higher voiding frequency at night time represent a worse outcome)
Time Frame
Baseline and 1 month
Title
Net changes of the Global response assessment (GRA)
Description
Global response assessment (GRA) of therapeutic result by the patient (categorized from -3 to +3, indicating markedly worse to markedly improved) at 3 months after the last treatment day
Time Frame
Baseline and 3 month
Title
Net changes of the maximum flow rate
Description
Net changes of the maximum flow rate from baseline to 1 month after the treatment day (higher maximum flow rate represent a better outcome)
Time Frame
Baseline and 1 month
Title
Net changes of the voided volume
Description
Net changes of the voided volume from baseline to 1 month after the treatment day (higher voided volumes represent a better outcome)
Time Frame
Baseline and 1 month
Title
Net changes of the PVR
Description
Net changes of the PVR from baseline to 1 month after the treatment day (higher PVR volumes represent a worse outcome)
Time Frame
Baseline and 1 month
Title
Net changes of the cytokines level
Description
Net changes of the cytokines level from baseline to 1 month after the treatment day (e.g. NGF and IL-6, higher values represent a worse outcome)
Time Frame
Baseline and 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Patients had received intravesical treatment for IC within recent 1 month
Patients had participated investigational drug trial within 1 month before entering this study
Patients with coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsang-Tang Hsieh, MD
Organizational Affiliation
Institutional Review Board Chang Gung Medical Foundation
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Chang Gung University College of Medicine
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
12. IPD Sharing Statement
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Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
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