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.

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.

Study Overview

• Status: Terminated
• Conditions: Interstitial Cystitis
• Intervention / Treatment: Drug: Hyaluronic acid/chondroitin sulfate

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Additional instillation of hyaluronic acid/chondroitin sulfate; Transurethral resection of bladder ulcer + instillation of hyaluronic acid/chondroitin sulfate	Drug: Hyaluronic acid/chondroitin sulfate; Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder; Other Names: Ialuril
Active Comparator: Transurethral resection of bladder ulcer	Drug: Hyaluronic acid/chondroitin sulfate; Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder; Other Names: Ialuril

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of pain scores on the Visual Analogue Scale	Change of pain scores on the Visual Analogue Scale	1month, 3month, 6month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Myung -Soo Choo, profesor, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (Estimate): March 19, 2013

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 20130135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No