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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Samsung Medical Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center Identifier:
First received: June 7, 2013
Last updated: February 12, 2015
Last verified: January 2014
The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in patients with bladder pain syndrome.

Condition Phase
Bladder Pain Syndrome
Pentosan Polysulfate
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy in Patients With Bladder Pain Syndrome

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • the change of IC-Q symptom index(ICSI)score from baseline to 6 months after each treatment [ Time Frame: 6months ]

Secondary Outcome Measures:
  • The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment. [ Time Frame: 1,2,4 and 6months after each treatment . ]
  • The change of O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q)score after each treatment [ Time Frame: 1,2,4 and 6months after each treatment . ]
  • The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) [ Time Frame: 1,2,4 and 6months after each treatment . ]
  • The change of Global Response Assessment(GRA) score [ Time Frame: 1,2,4 and 6months after each treatment . ]
  • The change of EQ-5D Health Questionnaire score [ Time Frame: 1,2,4 and 6months after each treatment . ]
  • The change of Brief Pain Inventory-short form(BPI-sf) score [ Time Frame: 1 and 6months after each treatment. ]
  • The estimation of safty and Complications for each treatment [ Time Frame: 1,2,4 and 6months after each treatment . ]

Estimated Enrollment: 72
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
pentosan polysulfate cohort
pentosan polysulfate monotherapy
hydrodistension(HD) cohort
hydrodistension(HD) monotherapy
combination cohort
combination therapy of pentosan polysulfate and hydrodistension.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Bladder pain syndrome patients have not been treated with hydrodistention.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01895153

Contact: Kyu-Sung Lee, M.D., Ph.D. 82-2-3410-3554
Contact: Hyun Wook You, M.D. 82-2-3410-1268

Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyu-Sung Lee, M.D., Ph.D.    82-2-3410-3554   
Contact: Hyun Wook You, MD.    80-2-3410-1268   
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Kyu-Sung Lee, MD,Ph.D Samsung Medical Center
  More Information

Responsible Party: KYU-SUNG LEE, professor,MD,PhD, Samsung Medical Center Identifier: NCT01895153     History of Changes
Other Study ID Numbers: 2012-03-029
Study First Received: June 7, 2013
Last Updated: February 12, 2015

Keywords provided by Samsung Medical Center:
bladder pain syndrome
pentosan polysulfate

Additional relevant MeSH terms:
Somatoform Disorders
Cystitis, Interstitial
Pathologic Processes
Mental Disorders
Urinary Bladder Diseases
Urologic Diseases
Pentosan Sulfuric Polyester
Anticoagulants processed this record on May 25, 2017