Clinical trial NCT01813565: 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.
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Interstitial Cystitis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a randomized, parallel, 6 month period study.

Eligibility criteria: Inclusion Criteria:

1. must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
2. Pain VAS ≥4
3. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
4. PUF score ≥ 13
5. cystoscopic record within 2 years
6. Hunner ulcer lesion in cystoscopic finding

Exclusion Criteria:

1. 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
2. Patients who are pregnancy or, childbearing age without no contraception
3. Patients with voided volume \<40 or, \> 400ml
4. Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination
5. Patients with urine culture showing evidence of urinary tract infection 1month prior to the study
6. Accompanied medical problem below

   * Tuberculosis in urinary system
   * Bladder cancer, urethral cancer, prostate cancer
   * Recurrent cystitis
   * anatomical disorder
7. Patients had prior surgery (eq, bladder augmentation, cystectomy
8. Patients with neurologic disorder
9. Patients with indwelling catheter or intermittent self-catheterization
10. Patients with psychologic problem

Primary outcomes:
measure: Change of pain scores on the Visual Analogue Scale
timeFrame: 1month, 3month, 6month
Secondary outcomes:
measure: Duration of symptom improvement
timeFrame: 1month, 3month, 6month
measure: Changes of frequency and urgency on voiding diary
timeFrame: 1month, 3month, 6month
measure: Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
timeFrame: 1month, 6month
measure: Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score
timeFrame: 6month
measure: Occurrence of adverse event
timeFrame: 6month
measure: Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
timeFrame: 1month, 6month
measure: Change score of EQ-5D Health Questionnaire
timeFrame: 1month, 6month
measure: Change score of Brief Pain Inventory-short form (BPI-sf)
timeFrame: 1month, 6month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
affiliation: Asan Medical Center
name: Myung -Soo Choo, profesor
role: PRINCIPAL_INVESTIGATOR
References: