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.

Asan Medical Center

Status: Terminated

Conditions: Interstitial Cystitis

Treatments: Drug: Hyaluronic acid/chondroitin sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT01813565

20130135

Details and patient eligibility

About

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.

Full description

This is a randomized, parallel, 6 month period study.

Enrollment: 15 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

15 participants in 2 patient groups

Additional instillation of hyaluronic acid/chondroitin sulfate

Experimental group

Description:

Transurethral resection of bladder ulcer + instillation of hyaluronic acid/chondroitin sulfate

Treatment:

Drug: Hyaluronic acid/chondroitin sulfate

Transurethral resection of bladder ulcer

Active Comparator group

Description:

Transurethral resection of bladder ulcer

Treatment:

Drug: Hyaluronic acid/chondroitin sulfate