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

Completed

• Conditions: Pentosan Polysulfate; Bladder Pain Syndrome; Hydrodistension

• Registration Number: NCT01895153
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-06-07
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-10
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 Global Response Assessment(GRA) score	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 estimation of safty and Complications for each treatment	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 change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)	1,2,4 and 6months after each treatment .

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of