Efficacy Study of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy for Bladder Pain Syndrome
NCT ID: NCT01895153
Last Updated: 2020-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
91 participants
OBSERVATIONAL
2012-04-30
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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pentosan polysulfate cohort
pentosan polysulfate monotherapy
No interventions assigned to this group
hydrodistension(HD) cohort
hydrodistension(HD) monotherapy
No interventions assigned to this group
combination cohort
combination therapy of pentosan polysulfate and hydrodistension.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. 4 or more with an pain visual analogue score
3. 12 or more O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q) symptom and problem score and with a pain score and nocturia score of 2 or more.
Exclusion Criteria
2. pentosan polysulfate sodium (Elmiron) history over 1 month within 6 months.
3. Women of child-bearing potential who were pregnant or nursing
4. mean voided volume lesser than 40ml or over than 400ml.
5. hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
6. urinary tract infection during run-in periods.
7. genitourinary tuberculosis or bladder,urethral and prostate cancer
8. recurrent urinary tract infection
9. history of hystrectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate opreation or treatment etc within 6months.
10. neurologic disease history of cerebral infaction,multiple sclerosis or parkinsonism etc.
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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KYU-SUNG LEE
professor,MD,PhD
Principal Investigators
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Kyu-Sung Lee, MD,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2012-03-029
Identifier Type: -
Identifier Source: org_study_id