Status:
COMPLETED
Efficacy Study of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy for Bladder Pain Syndrome
Lead Sponsor:
Samsung Medical Center
Conditions:
Bladder Pain Syndrome
Pentosan Polysulfate
Eligibility:
All Genders
Brief Summary
The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in patients with bladder pain syndrome.
Eligibility Criteria
Inclusion
- men and women who were over 18 years old and had symptoms over 6 months.
- 4 or more with an pain visual analogue score
- 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
- history of hydrodistention,augumentation cystoplasty due to IC/BPS
- pentosan polysulfate sodium (Elmiron) history over 1 month within 6 months.
- Women of child-bearing potential who were pregnant or nursing
- mean voided volume lesser than 40ml or over than 400ml.
- hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
- urinary tract infection during run-in periods.
- genitourinary tuberculosis or bladder,urethral and prostate cancer
- recurrent urinary tract infection
- history of hystrectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate opreation or treatment etc within 6months.
- neurologic disease history of cerebral infaction,multiple sclerosis or parkinsonism etc.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01895153
Start Date
April 1 2012
End Date
May 1 2020
Last Update
December 10 2020
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710