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.

Not Applicable

Terminated

• Conditions: Interstitial Cystitis
• Interventions: Drug: Hyaluronic acid/chondroitin sulfate

• Registration Number: NCT01813565
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-19
• Study Start: 2013-03-20
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Additional instillation of hyaluronic acid/chondroitin sulfate	Hyaluronic acid/chondroitin sulfate	Transurethral resection of bladder ulcer + instillation of hyaluronic acid/chondroitin sulfate
Transurethral resection of bladder ulcer	Hyaluronic acid/chondroitin sulfate	Transurethral resection of bladder ulcer

Primary Outcome Measures

Name	Time	Method
Change of pain scores on the Visual Analogue Scale	1month, 3month, 6month	Change of pain scores on the Visual Analogue Scale

Secondary Outcome Measures

Name	Time	Method
Duration of symptom improvement	1month, 3month, 6month	Duration of symptom improvement
Changes of frequency and urgency on voiding diary	1month, 3month, 6month	Changes of frequency and urgency on voiding diary
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)	1month, 6month	Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score	6month	Score of Global Response Assessment (GRA), Patient Global Assessment
Occurrence of adverse event	6month	Occurrence of adverse event
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)	1month, 6month	Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale
Change score of EQ-5D Health Questionnaire	1month, 6month	Change score of EQ-5D Health Questionnaire
Change score of Brief Pain Inventory-short form (BPI-sf)	1month, 6month	Change score of Brief Pain Inventory-short form (BPI-sf)

Trial Locations

Locations (1)

Asan medical center; 🇰🇷 Seoul, Korea, Republic of