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NCT01895153 Clinical Trial

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

Bladder Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01895153
Other study ID # 2012-03-029
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2012
Est. completion date May 2020

Study information
Verified date December 2020
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 91
Est. completion date May 2020
Est. primary completion date May 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

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