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.

Interstitial Cystitis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01813565
• Other study ID #: 20130135
• Status: Terminated
• Phase: N/A
• Start date: March 20, 2013
• Est. completion date: December 1, 2016

Study information

• Verified date: July 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Drug:
• Hyaluronic acid/chondroitin sulfate
Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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