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

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Samsung Medical Center

Status

Completed

Conditions

Hydrodistension
Bladder Pain Syndrome
Pentosan Polysulfate

Study type

Observational

Funder types

Other

Identifiers

NCT01895153
2012-03-029

Details and patient eligibility

About

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

Enrollment

91 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

91 participants in 3 patient groups

pentosan polysulfate cohort
Description:
pentosan polysulfate monotherapy
hydrodistension(HD) cohort
Description:
hydrodistension(HD) monotherapy
combination cohort
Description:
combination therapy of pentosan polysulfate and hydrodistension.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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