Interstitial CystitisNCT03619486
Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
A study testing Low energy shock wave in people with Interstitial Cystitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
To investigate the efficacy and safety of LESW on participants with IC/BPS Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Low energy shock wave
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Jul 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital, Chang Gung University College of Medicine
Kaohsiung City, 833
About this study
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
To investigate the efficacy and safety of LESW on participants with IC/BPS
Read the 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.
- Conditions
- Interstitial Cystitis
- Being tested
- Low energy shock wave, Placebo
- Keywords
- Low Energy Shock Wave (LESW), Extracorporeal Shockwave Therapy, interstitial cystitis/bladder pain syndrome (IC/BPS)
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low energy shock waveDevice
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
PlaceboDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo treatment (shock wave probe w/o energy) Receives: Device: Placebo |
| Low energy shock wave | Experimental | Low energy shock wave treatment (shock wave probe w/ energy) Receives: Device: Low energy shock wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 1 month
Secondary outcomes (9)
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)
Measured: Baseline and 1 month
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)
Measured: Baseline and 1 month
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)
Measured: Baseline and 1 month
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)
Measured: Baseline and 1 month
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
Measured: Baseline and 3 month
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)
Measured: Baseline and 1 month
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)
Measured: Baseline and 1 month
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)
Measured: Baseline and 1 month
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)
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start4 Jul 2018
- Primary completion26 Feb 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsang-Tang Hsieh, MD, Study chair, Institutional Review Board Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619486
- Sponsor's protocol ID
- 201800525A3
- Status last verified
- Jan 2021
- First submitted
- 19 Jul 2018
- Last updated
- 1 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.
PubMed 21497847Hanno PM, Sant GR. Clinical highlights of the National Institute of Diabetes and Digestive and Kidney Diseases/Interstitial Cystitis Association scientific conference on interstitial cystitis. Urology. 2001 Jun;57(6 Suppl 1):2-6. doi: 10.1016/s0090-4295(01)01112-8.
PubMed 11378041Nickel JC, Barkin J, Forrest J, Mosbaugh PG, Hernandez-Graulau J, Kaufman D, Lloyd K, Evans RJ, Parsons CL, Atkinson LE; Elmiron Study Group. Randomized, double-blind, dose-ranging study of pentosan polysulfate sodium for interstitial cystitis. Urology. 2005 Apr;65(4):654-8. doi: 10.1016/j.urology.2004.10.071.
PubMed 15833501Hanno PM, Buehler J, Wein AJ. Use of amitriptyline in the treatment of interstitial cystitis. J Urol. 1989 Apr;141(4):846-8. doi: 10.1016/s0022-5347(17)41029-9.
PubMed 2926877Sairanen J, Forsell T, Ruutu M. Long-term outcome of patients with interstitial cystitis treated with low dose cyclosporine A. J Urol. 2004 Jun;171(6 Pt 1):2138-41. doi: 10.1097/01.ju.0000125139.91203.7a.
PubMed 15126772Hanno PM, Erickson D, Moldwin R, Faraday MM; American Urological Association. Diagnosis and treatment of interstitial cystitis/bladder pain syndrome: AUA guideline amendment. J Urol. 2015 May;193(5):1545-53. doi: 10.1016/j.juro.2015.01.086. Epub 2015 Jan 23.
PubMed 25623737Chancellor MB, Yoshimura N. Treatment of interstitial cystitis. Urology. 2004 Mar;63(3 Suppl 1):85-92. doi: 10.1016/j.urology.2003.10.034.
PubMed 15013658Shie JH, Liu HT, Kuo HC. Increased cell apoptosis of urothelium mediated by inflammation in interstitial cystitis/painful bladder syndrome. Urology. 2012 Feb;79(2):484.e7-13. doi: 10.1016/j.urology.2011.09.049.
PubMed 22310775Lee JD, Lee MH. Increased expression of hypoxia-inducible factor-1alpha and vascular endothelial growth factor associated with glomerulation formation in patients with interstitial cystitis. Urology. 2011 Oct;78(4):971.e11-5. doi: 10.1016/j.urology.2011.05.050. Epub 2011 Aug 2.
PubMed 21813166Chaussy C, Schmiedt E, Jocham D, Brendel W, Forssmann B, Walther V. First clinical experience with extracorporeally induced destruction of kidney stones by shock waves. J Urol. 1982 Mar;127(3):417-20. doi: 10.1016/s0022-5347(17)53841-0.
PubMed 6977650Wang CJ. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J. 2003 Apr;26(4):220-32.
PubMed 12846521Di Meglio F, Nurzynska D, Castaldo C, Miraglia R, Romano V, De Angelis A, Piegari E, Russo S, Montagnani S. Cardiac shock wave therapy: assessment of safety and new insights into mechanisms of tissue regeneration. J Cell Mol Med. 2012 Apr;16(4):936-42. doi: 10.1111/j.1582-4934.2011.01393.x.
PubMed 21790971Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15.
PubMed 22425129Mariotto S, de Prati AC, Cavalieri E, Amelio E, Marlinghaus E, Suzuki H. Extracorporeal shock wave therapy in inflammatory diseases: molecular mechanism that triggers anti-inflammatory action. Curr Med Chem. 2009;16(19):2366-72. doi: 10.2174/092986709788682119.
PubMed 19601786Wang HJ, Lee WC, Tyagi P, Huang CC, Chuang YC. Effects of low energy shock wave therapy on inflammatory moleculars, bladder pain, and bladder function in a rat cystitis model. Neurourol Urodyn. 2017 Aug;36(6):1440-1447. doi: 10.1002/nau.23141. Epub 2016 Dec 30.
PubMed 28035695
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03619486
- Acronym / sponsor ID
- 201800525A3
- Conditions
- Interstitial Cystitis
- Keywords
- Low Energy Shock Wave (LESW), Extracorporeal Shockwave Therapy, interstitial cystitis/bladder pain syndrome (IC/BPS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: PlaceboPlacebo treatment (shock wave probe w/o energy) |
| Low energy shock wave | Experimental | Device: Low energy shock waveLow energy shock wave treatment (shock wave probe w/ energy) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low energy shock waveProbe 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 | Device | Low energy shock wave |
| PlaceboProbe 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 | Device | Placebo |
Primary outcome
Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI)
Time frame: Baseline and 1 month
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).
9 secondary outcomes
Net changes of the Visual Analog Scale (VAS)
Time frame: Baseline and 1 month
Net changes of the functional bladder capacity (FBC) as assessed by the maximum urine volume (milliliters) as recorded in 3-day voiding diary
Time frame: Baseline and 1 month
Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary
Time frame: Baseline and 1 month
Net changes of the voiding frequency at night time as recorded in 3-day voiding diary
Time frame: Baseline and 1 month
Net changes of the Global response assessment (GRA)
Time frame: Baseline and 3 month
Net changes of the maximum flow rate
Time frame: Baseline and 1 month
Net changes of the voided volume
Time frame: Baseline and 1 month
Net changes of the PVR
Time frame: Baseline and 1 month
Net changes of the cytokines level
Time frame: Baseline and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Background: PubMed 21497847Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.
- Background: PubMed 11378041Hanno PM, Sant GR. Clinical highlights of the National Institute of Diabetes and Digestive and Kidney Diseases/Interstitial Cystitis Association scientific conference on interstitial cystitis. Urology. 2001 Jun;57(6 Suppl 1):2-6. doi: 10.1016/s0090-4295(01)01112-8.
- Background: PubMed 15833501Nickel JC, Barkin J, Forrest J, Mosbaugh PG, Hernandez-Graulau J, Kaufman D, Lloyd K, Evans RJ, Parsons CL, Atkinson LE; Elmiron Study Group. Randomized, double-blind, dose-ranging study of pentosan polysulfate sodium for interstitial cystitis. Urology. 2005 Apr;65(4):654-8. doi: 10.1016/j.urology.2004.10.071.
- Background: PubMed 2926877Hanno PM, Buehler J, Wein AJ. Use of amitriptyline in the treatment of interstitial cystitis. J Urol. 1989 Apr;141(4):846-8. doi: 10.1016/s0022-5347(17)41029-9.
- Background: PubMed 15126772Sairanen J, Forsell T, Ruutu M. Long-term outcome of patients with interstitial cystitis treated with low dose cyclosporine A. J Urol. 2004 Jun;171(6 Pt 1):2138-41. doi: 10.1097/01.ju.0000125139.91203.7a.
- Background: PubMed 25623737Hanno PM, Erickson D, Moldwin R, Faraday MM; American Urological Association. Diagnosis and treatment of interstitial cystitis/bladder pain syndrome: AUA guideline amendment. J Urol. 2015 May;193(5):1545-53. doi: 10.1016/j.juro.2015.01.086. Epub 2015 Jan 23.
- Background: PubMed 15013658Chancellor MB, Yoshimura N. Treatment of interstitial cystitis. Urology. 2004 Mar;63(3 Suppl 1):85-92. doi: 10.1016/j.urology.2003.10.034.
- Background: PubMed 22310775Shie JH, Liu HT, Kuo HC. Increased cell apoptosis of urothelium mediated by inflammation in interstitial cystitis/painful bladder syndrome. Urology. 2012 Feb;79(2):484.e7-13. doi: 10.1016/j.urology.2011.09.049.
- Background: PubMed 21813166Lee JD, Lee MH. Increased expression of hypoxia-inducible factor-1alpha and vascular endothelial growth factor associated with glomerulation formation in patients with interstitial cystitis. Urology. 2011 Oct;78(4):971.e11-5. doi: 10.1016/j.urology.2011.05.050. Epub 2011 Aug 2.
- Background: PubMed 6977650Chaussy C, Schmiedt E, Jocham D, Brendel W, Forssmann B, Walther V. First clinical experience with extracorporeally induced destruction of kidney stones by shock waves. J Urol. 1982 Mar;127(3):417-20. doi: 10.1016/s0022-5347(17)53841-0.
- Background: PubMed 12846521Wang CJ. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J. 2003 Apr;26(4):220-32.
- Background: PubMed 21790971Di Meglio F, Nurzynska D, Castaldo C, Miraglia R, Romano V, De Angelis A, Piegari E, Russo S, Montagnani S. Cardiac shock wave therapy: assessment of safety and new insights into mechanisms of tissue regeneration. J Cell Mol Med. 2012 Apr;16(4):936-42. doi: 10.1111/j.1582-4934.2011.01393.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsang-Tang Hsieh, MD study chair
Institutional Review Board Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low energy shock wave in people with Interstitial Cystitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI) (time frame: Baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03619486, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.