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

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

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

Conditions
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Bladder Pain Syndrome, Pentosan Polysulfate, Hydrodistension

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pentosan polysulfate cohort<br>pentosan polysulfate monotherapy | |
| hydrodistension(HD) cohort<br>hydrodistension(HD) monotherapy | |
| combination cohort<br>combination therapy of pentosan polysulfate and hydrodistension. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of IC-Q symptom index(ICSI)score from baseline to 6 months after each treatment |  | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment. |  | 1,2,4 and 6months after each treatment . | 
| The change of O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q)score after each treatment |  | 1,2,4 and 6months after each treatment . | 
| The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) |  | 1,2,4 and 6months after each treatment . | 
| The change of Global Response Assessment(GRA) score |  | 1,2,4 and 6months after each treatment . | 
| The change of EQ-5D Health Questionnaire score |  | 1,2,4 and 6months after each treatment . | 
| The change of Brief Pain Inventory-short form(BPI-sf) score |  | 1 and 6months after each treatment. | 
| The estimation of safty and Complications for each treatment |  | 1,2,4 and 6months after each treatment . | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder pain syndrome, pentosan polysulfate, hydrodistension