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The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients

Primary Purpose

Interstitial Cystitis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hyaluronic Acid and Chondroitin Sulfate
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and female aged 20 yrs or greater
  2. Patients diagnosed with Hunner lesion in IC(interstitial cystitis)/BPS(Bladder Pain Syndrome) and who is scheduled to undergo transurethral resection
  3. Symptom persisted more than 6 months
  4. Pain VAS ≥4

Exclusion Criteria:

  1. History of augmentation cystoplasty or previous transurethral coagulation/resection due to IC/BPS
  2. Child-bearing potential, pregnant or nursing women.
  3. Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
  4. Urinary tract infection during run-in periods.
  5. Genitourinary tuberculosis or bladder,urethral and prostate cancer
  6. Recurrent urinary tract infection
  7. History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
  8. Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-
  9. Using a indwelling catheter or execution of intermittent self catheterization

Sites / Locations

  • Samsung Medical Center, Sungkyunkwan University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyaluronic Acid and Chondroitin Sulfate

Arm Description

Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients.

Outcomes

Primary Outcome Measures

change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment

Secondary Outcome Measures

changes in mean number of daytime frequency episodes
changes in mean number of nocturia episodes
changes in mean number of urgency episodes
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
Score of Global Response Assessment (GRA)
Patient Global Assessment
Occurrence of adverse event

Full Information

First Posted
February 25, 2018
Last Updated
October 26, 2022
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03463499
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic Acid and Chondroitin Sulfate
Arm Type
Experimental
Arm Description
Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients.
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid and Chondroitin Sulfate
Intervention Description
Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients.
Primary Outcome Measure Information:
Title
change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment
Time Frame
Every 3 months for 2 years
Secondary Outcome Measure Information:
Title
changes in mean number of daytime frequency episodes
Time Frame
Every 3 months for 2 years
Title
changes in mean number of nocturia episodes
Time Frame
Every 3 months for 2 years
Title
changes in mean number of urgency episodes
Time Frame
Every 3 months for 2 years
Title
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Time Frame
Every 3 months for 2 years
Title
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
Time Frame
Every 3 months for 2 years
Title
Score of Global Response Assessment (GRA)
Time Frame
Every 3 months for 2 years
Title
Patient Global Assessment
Time Frame
at the end of the treatment(2 years)
Title
Occurrence of adverse event
Time Frame
Every 3 months for 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Facility Information:
Facility Name
Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients

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