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

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ClinicalTrials.gov Identifier: NCT01895153
Recruitment Status : Unknown
Verified January 2014 by KYU-SUNG LEE, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : July 10, 2013
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in patients with bladder pain syndrome.

Condition or disease Phase
Bladder Pain Syndrome Pentosan Polysulfate Hydrodistension Phase 4

Study Design

Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy in Patients With Bladder Pain Syndrome
Study Start Date : April 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
pentosan polysulfate cohort
pentosan polysulfate monotherapy
hydrodistension(HD) cohort
hydrodistension(HD) monotherapy
combination cohort
combination therapy of pentosan polysulfate and hydrodistension.


Outcome Measures

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

Secondary Outcome Measures :
  1. 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 . ]
  2. 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 . ]
  3. The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) [ Time Frame: 1,2,4 and 6months after each treatment . ]
  4. The change of Global Response Assessment(GRA) score [ Time Frame: 1,2,4 and 6months after each treatment . ]
  5. The change of EQ-5D Health Questionnaire score [ Time Frame: 1,2,4 and 6months after each treatment . ]
  6. The change of Brief Pain Inventory-short form(BPI-sf) score [ Time Frame: 1 and 6months after each treatment. ]
  7. The estimation of safty and Complications for each treatment [ Time Frame: 1,2,4 and 6months after each treatment . ]

Eligibility Criteria

Information from the National Library of Medicine

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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.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895153


Contacts
Contact: Kyu-Sung Lee, M.D., Ph.D. 82-2-3410-3554 keleedr@skku.edu
Contact: Hyun Wook You, M.D. 82-2-3410-1268 khdoct29@gmail.com

Locations
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    ksleedr@skku.edu   
Contact: Hyun Wook You, MD.    80-2-3410-1268    khdoct29@gmail.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kyu-Sung Lee, MD,Ph.D Samsung Medical Center
More Information

Responsible Party: KYU-SUNG LEE, professor,MD,PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01895153     History of Changes
Other Study ID Numbers: 2012-03-029
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: January 2014

Keywords provided by KYU-SUNG LEE, Samsung Medical Center:
bladder pain syndrome
pentosan polysulfate
hydrodistension

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Cystitis, Interstitial
Disease
Pathologic Processes
Mental Disorders
Cystitis
Urinary Bladder Diseases
Urologic Diseases
Pentosan Sulfuric Polyester
Anticoagulants