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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01895153
First received: June 7, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in patients with bladder pain syndrome.


Condition Phase
Bladder Pain Syndrome
Pentosan Polysulfate
Hydrodistension
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 ] [ Designated as safety issue: No ]

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 . ] [ Designated as safety issue: No ]
  • 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 . ] [ Designated as safety issue: No ]
  • The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) [ Time Frame: 1,2,4 and 6months after each treatment . ] [ Designated as safety issue: No ]
  • The change of Global Response Assessment(GRA) score [ Time Frame: 1,2,4 and 6months after each treatment . ] [ Designated as safety issue: No ]
  • The change of EQ-5D Health Questionnaire score [ Time Frame: 1,2,4 and 6months after each treatment . ] [ Designated as safety issue: No ]
  • The change of Brief Pain Inventory-short form(BPI-sf) score [ Time Frame: 1 and 6months after each treatment. ] [ Designated as safety issue: No ]
  • The estimation of safty and Complications for each treatment [ Time Frame: 1,2,4 and 6months after each treatment . ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
pentosan polysulfate cohort
pentosan polysulfate monotherapy
hydrodistension(HD) cohort
hydrodistension(HD) monotherapy
combination cohort
combination therapy of pentosan polysulfate and hydrodistension.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 7, 2013
Last Updated: January 10, 2014
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Somatoform Disorders
Cystitis, Interstitial
Mental Disorders
Cystitis
Urinary Bladder Diseases
Urologic Diseases
Pentosan Sulfuric Polyester
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014