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Completed

NCT Number: NCT01895153

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

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

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Key information

Conditions

Bladder Pain Syndrome Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hydrodistension Male Urogenital Diseases Pentosan Polysulfate Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. the change of IC-Q symptom index(ICSI)score from baseline to 6 months after each treatment

    Time frame: 6months

Secondary outcomes

  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 .

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

The Efficacy of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy in Patients With Bladder Pain Syndrome

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2013
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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