Interstitial CystitisNCT03463499
The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients
A study testing Hyaluronic Acid and Chondroitin Sulfate in people with Interstitial Cystitis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate after transurethral resection of Hunner lesion in interstitial cystitis/bladder pain syndrome patients. To analyze the number and timing of recurrence based on a long-term follow-up. 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 and Chondroitin Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Sep 2017to 31 Dec 2021
- 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
- Male and female aged 20 yrs or greater
- Patients diagnosed with Hunner lesion in IC(interstitial cystitis)/BPS(Bladder Pain Syndrome) and who is scheduled to undergo transurethral resection
- Symptom persisted more than 6 months
- Pain VAS ≥4
Who cannot join
- History of augmentation cystoplasty or previous transurethral coagulation/resection due to IC/BPS
- Child-bearing potential, pregnant or nursing women.
- Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
- Urinary tract infection during run-in periods.
- Genitourinary tuberculosis or bladder,urethral and prostate cancer
- Recurrent urinary tract infection
Show all 9Show fewer
- History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
- Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-
- Using a indwelling catheter or execution of intermittent self catheterization
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
About this study
The efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate after transurethral resection of Hunner lesion in interstitial cystitis/bladder pain syndrome patients. To analyze the number and timing of recurrence based on a long-term follow-up.
- Conditions
- Interstitial Cystitis
- Being tested
- Hyaluronic Acid and 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 and Chondroitin SulfateDrug
Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid and Chondroitin Sulfate | Experimental | Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients. Receives: Drug: Hyaluronic Acid and Chondroitin Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment
Measured: Every 3 months for 2 years
Secondary outcomes (8)
changes in mean number of daytime frequency episodes
Measured: Every 3 months for 2 years
changes in mean number of nocturia episodes
Measured: Every 3 months for 2 years
changes in mean number of urgency episodes
Measured: Every 3 months for 2 years
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Measured: Every 3 months for 2 years
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
Measured: Every 3 months for 2 years
Score of Global Response Assessment (GRA)
Measured: Every 3 months for 2 years
Patient Global Assessment
Measured: at the end of the treatment(2 years)
Occurrence of adverse event
Measured: Every 3 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start22 Sep 2017
- Primary completion30 Sep 2019
- Study completion31 Dec 2021
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 Samsung 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463499
- Sponsor's protocol ID
- 2017-08-106
- Status last verified
- Oct 2022
- First submitted
- 25 Feb 2018
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients
- ClinicalTrials.gov ID
- NCT03463499
- Acronym / sponsor ID
- 2017-08-106
- Conditions
- Interstitial Cystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Mar 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.
The efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate after transurethral resection of Hunner lesion in interstitial cystitis/bladder pain syndrome patients. To analyze the number and timing of recurrence based on a long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid and Chondroitin Sulfate | Experimental | Drug: Hyaluronic Acid and Chondroitin SulfateIntravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female aged 20 yrs or greater
- Patients diagnosed with Hunner lesion in IC(interstitial cystitis)/BPS(Bladder Pain Syndrome) and who is scheduled to undergo transurethral resection
- Symptom persisted more than 6 months
- Pain VAS ≥4
Key exclusion criteria (9 listed)
- History of augmentation cystoplasty or previous transurethral coagulation/resection due to IC/BPS
- Child-bearing potential, pregnant or nursing women.
- Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
- Urinary tract infection during run-in periods.
- Genitourinary tuberculosis or bladder,urethral and prostate cancer
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 and Chondroitin SulfateIntravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients. | Drug | Hyaluronic Acid and Chondroitin Sulfate |
Primary outcome
change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment
Time frame: Every 3 months for 2 years
8 secondary outcomes
changes in mean number of daytime frequency episodes
Time frame: Every 3 months for 2 years
changes in mean number of nocturia episodes
Time frame: Every 3 months for 2 years
changes in mean number of urgency episodes
Time frame: Every 3 months for 2 years
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Time frame: Every 3 months for 2 years
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
Time frame: Every 3 months for 2 years
Score of Global Response Assessment (GRA)
Time frame: Every 3 months for 2 years
Patient Global Assessment
Time frame: at the end of the treatment(2 years)
Occurrence of adverse event
Time frame: Every 3 months for 2 years
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 27 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Chondroitin Sulfate in people with Interstitial Cystitis, run by Samsung 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 4 inclusion and 9 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 27 Oct 2022. 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 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 in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment (time frame: Every 3 months for 2 years). 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 27 Oct 2022.