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.

NCT ID: NCT01813565

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-20
• Study Completion Date: 2016-12-01

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.

Conditions

Interstitial Cystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Additional instillation of hyaluronic acid/chondroitin sulfate

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

Group Type: EXPERIMENTAL

Hyaluronic acid/chondroitin sulfate

Intervention Type: DRUG

Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder

Transurethral resection of bladder ulcer

Transurethral resection of bladder ulcer

Group Type: ACTIVE_COMPARATOR

Hyaluronic acid/chondroitin sulfate

Intervention Type: DRUG

Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder

Interventions

Hyaluronic acid/chondroitin sulfate

Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder

Intervention Type: DRUG

Other Intervention Names

Ialuril

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Myung-Soo Choo

Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myung -Soo Choo, profesor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan medical center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

20130135

Identifier Type: -

Identifier Source: org_study_id