Observational Study of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome

NCT02150811 | Completed DMC

• 1 other identifier: 20131119
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to observe change of distribution pattern of Hunner's ulcer in patient with interstitial cystitis/bladder pain syndrome

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• Change of distribution pattern of Hunner's ulcer

  1 month, 6month, 12month

Study Arms (1)

Hunner's ulcer

Eligibility Criteria

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

Study Population

Tertiary care clinic

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, 138-736, South Korea

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

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

Study Officials

• Myung-Soo Choo, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: June 2, 2016
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)