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

December 9, 2020 updated by: KYU-SUNG LEE, Samsung Medical Center

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

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

Study Overview

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Bladder pain syndrome patients have not been treated with hydrodistention.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
pentosan polysulfate cohort
pentosan polysulfate monotherapy
hydrodistension(HD) cohort
hydrodistension(HD) monotherapy
combination cohort
combination therapy of pentosan polysulfate and hydrodistension.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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 .
1,2,4 and 6months after each treatment .
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 .
1,2,4 and 6months after each treatment .
The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)
Time Frame: 1,2,4 and 6months after each treatment .
1,2,4 and 6months after each treatment .
The change of Global Response Assessment(GRA) score
Time Frame: 1,2,4 and 6months after each treatment .
1,2,4 and 6months after each treatment .
The change of EQ-5D Health Questionnaire score
Time Frame: 1,2,4 and 6months after each treatment .
1,2,4 and 6months after each treatment .
The change of Brief Pain Inventory-short form(BPI-sf) score
Time Frame: 1 and 6months after each treatment.
1 and 6months after each treatment.
The estimation of safty and Complications for each treatment
Time Frame: 1,2,4 and 6months after each treatment .
1,2,4 and 6months after each treatment .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kyu-Sung Lee, MD,Ph.D, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Actual)

December 10, 2020

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

December 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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