Clinical trial NCT03463499: 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
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Cystitis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment
timeFrame: Every 3 months for 2 years
Secondary outcomes:
measure: changes in mean number of daytime frequency episodes
timeFrame: Every 3 months for 2 years
measure: changes in mean number of nocturia episodes
timeFrame: Every 3 months for 2 years
measure: changes in mean number of urgency episodes
timeFrame: Every 3 months for 2 years
measure: Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
timeFrame: Every 3 months for 2 years
measure: Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
timeFrame: Every 3 months for 2 years
measure: Score of Global Response Assessment (GRA)
timeFrame: Every 3 months for 2 years
measure: Patient Global Assessment
timeFrame: at the end of the treatment(2 years)
measure: Occurrence of adverse event
timeFrame: Every 3 months for 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
References: