Interstitial CystitisNCT01813565
The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.
A study testing Hyaluronic acid/chondroitin sulfate in people with Interstitial Cystitis, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy and safety of additional hyaluronic acid/chondroitin sulfate to transurethral resection of bladder ulcer in patient with interstitial cystitis. 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?
- Hyaluronic acid/chondroitin sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Mar 2013to 1 Dec 2016
- 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
- must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
- Pain VAS ≥4
- O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
- PUF score ≥ 13
- cystoscopic record within 2 years
- Hunner ulcer lesion in cystoscopic finding
Who cannot join
- Scheduled for or use of intravesical therapy (eg, bladder distention,transurethral resection of bladder ulcer, instillation) during or within 6months prior to the study and use of pentosan polysulfate sodium within 1 months prior to the study
- Patients who are pregnancy or, childbearing age without no contraception
- Patients with voided volume <40 or, > 400ml
- Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination
- Patients with urine culture showing evidence of urinary tract infection 1month prior to the study
- Accompanied medical problem below
Show all 14Show fewer
- Tuberculosis in urinary system
- Bladder cancer, urethral cancer, prostate cancer
- Recurrent cystitis
- anatomical disorder
- Patients had prior surgery (eq, bladder augmentation, cystectomy
- Patients with neurologic disorder
- Patients with indwelling catheter or intermittent self-catheterization
- Patients with psychologic problem
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate efficacy and safety of additional hyaluronic acid/chondroitin sulfate to transurethral resection of bladder ulcer in patient with interstitial cystitis.
Read the detailed description
This is a randomized, parallel, 6 month period study.
- Conditions
- Interstitial Cystitis
- Being tested
- Hyaluronic acid/chondroitin sulfate
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid/chondroitin sulfateDrug
Also called Ialuril
Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder
| Study group | Role | What they receive |
|---|---|---|
| Additional instillation of hyaluronic acid/chondroitin sulfate | Experimental | Transurethral resection of bladder ulcer + instillation of hyaluronic acid/chondroitin sulfate Receives: Drug: Hyaluronic acid/chondroitin sulfate |
| Transurethral resection of bladder ulcer | Active comparator | Transurethral resection of bladder ulcer Receives: Drug: Hyaluronic acid/chondroitin sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain scores on the Visual Analogue Scale
Change of pain scores on the Visual Analogue Scale
Measured: 1month, 3month, 6month
Secondary outcomes (8)
Duration of symptom improvement
Duration of symptom improvement
Measured: 1month, 3month, 6month
Changes of frequency and urgency on voiding diary
Changes of frequency and urgency on voiding diary
Measured: 1month, 3month, 6month
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Measured: 1month, 6month
Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score
Score of Global Response Assessment (GRA), Patient Global Assessment
Measured: 6month
Occurrence of adverse event
Occurrence of adverse event
Measured: 6month
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale
Measured: 1month, 6month
Change score of EQ-5D Health Questionnaire
Change score of EQ-5D Health Questionnaire
Measured: 1month, 6month
Change score of Brief Pain Inventory-short form (BPI-sf)
Change score of Brief Pain Inventory-short form (BPI-sf)
Measured: 1month, 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study start20 Mar 2013
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Why it stopped: No benefit of intravesical instillation of Hyaluronic Acid/Chondroitin Sulfate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung-Soo Choo, Asan Medical Center
- Investigators
- Myung -Soo Choo, profesor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813565
- Sponsor's protocol ID
- 20130135
- Status last verified
- Jul 2019
- First submitted
- 11 Mar 2013
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.
- ClinicalTrials.gov ID
- NCT01813565
- Acronym / sponsor ID
- 20130135
- Conditions
- Interstitial Cystitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No benefit of intravesical instillation of Hyaluronic Acid/Chondroitin Sulfate
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 20 Mar 2013 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 19 Mar 2013 (estimated)
- 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.
The purpose of this study is to evaluate efficacy and safety of additional hyaluronic acid/chondroitin sulfate to transurethral resection of bladder ulcer in patient with interstitial cystitis.
Detailed description
This is a randomized, parallel, 6 month period study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional instillation of hyaluronic acid/chondroitin sulfate | Experimental | Drug: Hyaluronic acid/chondroitin sulfateTransurethral resection of bladder ulcer + instillation of hyaluronic acid/chondroitin sulfate |
| Transurethral resection of bladder ulcer | Active comparator | Drug: Hyaluronic acid/chondroitin sulfateTransurethral resection of bladder ulcer |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
- Pain VAS ≥4
- O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
- PUF score ≥ 13
- cystoscopic record within 2 years
Key exclusion criteria (14 listed)
- Scheduled for or use of intravesical therapy (eg, bladder distention,transurethral resection of bladder ulcer, instillation) during or within 6months prior to the study and use of pentosan polysulfate sodium within 1 months prior to the study
- Patients who are pregnancy or, childbearing age without no contraception
- Patients with voided volume <40 or, > 400ml
- Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination
- Patients with urine culture showing evidence of urinary tract infection 1month prior to the study
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 |
|---|---|---|
| Hyaluronic acid/chondroitin sulfateAlso: IalurilAdditional Hyaluronic acid/chondroitin sulfate instillation to the bladder | Drug | Additional instillation of hyaluronic acid/chondroitin sulfate, Transurethral resection of bladder ulcer |
Primary outcome
Change of pain scores on the Visual Analogue Scale
Time frame: 1month, 3month, 6month
Change of pain scores on the Visual Analogue Scale
8 secondary outcomes
Duration of symptom improvement
Time frame: 1month, 3month, 6month
Changes of frequency and urgency on voiding diary
Time frame: 1month, 3month, 6month
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Time frame: 1month, 6month
Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score
Time frame: 6month
Occurrence of adverse event
Time frame: 6month
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
Time frame: 1month, 6month
Change score of EQ-5D Health Questionnaire
Time frame: 1month, 6month
Change score of Brief Pain Inventory-short form (BPI-sf)
Time frame: 1month, 6month
Results and safety
The study was stopped early (reason given: No benefit of intravesical instillation of Hyaluronic Acid/Chondroitin Sulfate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Myung -Soo Choo, profesor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid/chondroitin sulfate in people with Interstitial Cystitis, run by Asan Medical Center at 1 site in South Korea.
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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 5 Jul 2019. 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 South Korea. 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. 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 was stopped early (reason given: No benefit of intravesical instillation of Hyaluronic Acid/Chondroitin Sulfate). Results are not available in the source record.
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 pain scores on the Visual Analogue Scale (time frame: 1month, 3month, 6month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2019.