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.

NCT01813565 | Terminated DMC

• 1 other identifier: 20130135
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• Change of pain scores on the Visual Analogue Scale

  Change of pain scores on the Visual Analogue Scale

  1month, 3month, 6month

Secondary Outcomes (8)

• Duration of symptom improvement

  1month, 3month, 6month

• Changes of frequency and urgency on voiding diary

  1month, 3month, 6month

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

  1month, 6month

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

  6month

• Occurrence of adverse event

  6month

Study Arms (2)

Additional instillation of hyaluronic acid/chondroitin sulfate

EXPERIMENTAL

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

Drug: Hyaluronic acid/chondroitin sulfate

Transurethral resection of bladder ulcer

ACTIVE COMPARATOR

Transurethral resection of bladder ulcer

Drug: Hyaluronic acid/chondroitin sulfate

Interventions

Hyaluronic acid/chondroitin sulfate DRUG

Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder

Also known as: Ialuril

Additional instillation of hyaluronic acid/chondroitin sulfate; Transurethral resection of bladder ulcer

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan medical center

Seoul, South Korea

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Hyaluronan Receptors; chondroitin sulfate, sodium hyaluronate drug combination

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Receptors, Lymphocyte Homing; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Chondroitin Sulfate Proteoglycans; Proteoglycans; Polysaccharides; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Immunologic; Receptors, Cell Surface; Antigens, Surface; Antigens; Biological Factors

Study Officials

• Myung -Soo Choo, profesor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 19, 2013
• Study Start: March 20, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)