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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.

Primary Purpose

Interstitial Cystitis

Status

Terminated

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Hyaluronic acid/chondroitin sulfate

About this trial

This is an interventional treatment trial for Interstitial Cystitis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
Pain VAS ≥4
O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
PUF score ≥ 13
cystoscopic record within 2 years
Hunner ulcer lesion in cystoscopic finding

Exclusion Criteria:

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
Patients who are pregnancy or, childbearing age without no contraception
Patients with voided volume <40 or, > 400ml
Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination
Patients with urine culture showing evidence of urinary tract infection 1month prior to the study
Accompanied medical problem below
- Tuberculosis in urinary system
- Bladder cancer, urethral cancer, prostate cancer
- Recurrent cystitis
- anatomical disorder
Patients had prior surgery (eq, bladder augmentation, cystectomy
Patients with neurologic disorder
Patients with indwelling catheter or intermittent self-catheterization
Patients with psychologic problem

Sites / Locations

Asan medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Additional instillation of hyaluronic acid/chondroitin sulfate

Transurethral resection of bladder ulcer

Arm Description

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

Transurethral resection of bladder ulcer

Outcomes

Primary Outcome Measures

Change of pain scores on the Visual Analogue Scale

Secondary Outcome Measures

Duration of symptom improvement

Changes of frequency and urgency on voiding diary

Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)

Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score

Score of Global Response Assessment (GRA), Patient Global Assessment

Occurrence of adverse event

Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)

Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale

Change score of EQ-5D Health Questionnaire

Change score of Brief Pain Inventory-short form (BPI-sf)

Full Information

NCT ID

NCT01813565

First Posted

March 11, 2013

Last Updated

July 2, 2019

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01813565

Brief 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.

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Terminated

Why Stopped

No benefit of intravesical instillation of Hyaluronic Acid/Chondroitin Sulfate

Study Start Date

March 20, 2013 (Actual)

Primary Completion Date

December 1, 2016 (Actual)

Study Completion Date

December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Interstitial Cystitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Additional instillation of hyaluronic acid/chondroitin sulfate

Arm Type

Experimental

Arm Description

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

Arm Title

Transurethral resection of bladder ulcer

Arm Type

Active Comparator

Arm Description

Transurethral resection of bladder ulcer

Intervention Type

Drug

Intervention Name(s)

Hyaluronic acid/chondroitin sulfate

Other Intervention Name(s)

Ialuril

Intervention Description

Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder

Primary Outcome Measure Information:

Title

Change of pain scores on the Visual Analogue Scale

Description

Change of pain scores on the Visual Analogue Scale

Time Frame

1month, 3month, 6month

Secondary Outcome Measure Information:

Title

Duration of symptom improvement

Description

Duration of symptom improvement

Time Frame

1month, 3month, 6month

Title

Changes of frequency and urgency on voiding diary

Description

Changes of frequency and urgency on voiding diary

Time Frame

1month, 3month, 6month

Title

Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)

Description

Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)

Time Frame

1month, 6month

Title

Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score

Description

Score of Global Response Assessment (GRA), Patient Global Assessment

Time Frame

6month

Title

Occurrence of adverse event

Description

Occurrence of adverse event

Time Frame

6month

Title

Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)

Description

Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale

Time Frame

1month, 6month

Title

Change score of EQ-5D Health Questionnaire

Description

Change score of EQ-5D Health Questionnaire

Time Frame

1month, 6month

Title

Change score of Brief Pain Inventory-short form (BPI-sf)

Description

Change score of Brief Pain Inventory-short form (BPI-sf)

Time Frame

1month, 6month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study Pain VAS ≥4 O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2) PUF score ≥ 13 cystoscopic record within 2 years Hunner ulcer lesion in cystoscopic finding Exclusion Criteria: 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 Patients who are pregnancy or, childbearing age without no contraception Patients with voided volume <40 or, > 400ml Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination Patients with urine culture showing evidence of urinary tract infection 1month prior to the study Accompanied medical problem below Tuberculosis in urinary system Bladder cancer, urethral cancer, prostate cancer Recurrent cystitis anatomical disorder Patients had prior surgery (eq, bladder augmentation, cystectomy Patients with neurologic disorder Patients with indwelling catheter or intermittent self-catheterization Patients with psychologic problem

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Myung -Soo Choo, profesor

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan medical center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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.

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