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Search / Trial NCT01895153

Efficacy Study of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy for Bladder Pain Syndrome

Launched by SAMSUNG MEDICAL CENTER · Jul 9, 2013

Trial Information

Current as of June 12, 2025

Completed

Keywords

Bladder Pain Syndrome Pentosan Polysulfate Hydrodistension

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. men and women who were over 18 years old and had symptoms over 6 months.
  • 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:
  • 1. history of hydrodistention,augumentation cystoplasty due to IC/BPS
  • 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.

About Samsung Medical Center

Samsung Medical Center (SMC) is a leading healthcare institution in South Korea, renowned for its commitment to advancing medical research and innovation. As a prominent clinical trial sponsor, SMC integrates cutting-edge technology and expert clinical practices to conduct rigorous studies aimed at improving patient outcomes. The center is dedicated to fostering collaborations with global research entities and adhering to the highest ethical standards, ensuring the integrity and reliability of its clinical trials. With a focus on diverse therapeutic areas, SMC plays a pivotal role in translating scientific discoveries into effective treatments, ultimately enhancing the quality of healthcare worldwide.

Locations

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Kyu-Sung Lee, MD,Ph.D

Principal Investigator

Samsung Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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