- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01895153
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
Status
Completed
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
-
-
-
Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
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:
- 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.
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-03-029
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.
Clinical Trials on Bladder Pain Syndrome
-
NYU Langone HealthCompletedInterstitial Cystitis Bladder Pain SyndromesUnited States
-
IRCCS Policlinico S. MatteoCompletedInterstitial Cystitis, Bladder Pain Syndrome, Quality of LifeItaly
-
University of Sao Paulo General HospitalGuangzhou Women and Children's Medical Center; Beijing Fangshan District Maternal... and other collaboratorsCompletedInterstitial Cystitis | Painful Bladder Syndrome | Bladder Pain SyndromeBrazil
-
University Hospital Inselspital, BerneCompletedOveractive Bladder | Cystitis, Interstitial | Painful Bladder Syndrome | Chronic Pelvic Pain SyndromeSwitzerland
-
Johns Hopkins UniversityWithdrawnInterstitial Cystitis | Painful Bladder Syndrome | Prostatitis | Chronic Prostatitis | Bladder Pain SyndromeUnited States
-
Shanghai Institute of Acupuncture, Moxibustion...CompletedPainful Bladder SyndromeChina
-
Cantonal Hospital, FrauenfeldCompletedOveractive Bladder | Interstitial Cystitis | Bladder Pain SyndromeSwitzerland
-
Aquinox Pharmaceuticals (Canada) Inc.UnknownInterstitial Cystitis | Painful Bladder Syndrome | Bladder Pain Syndrome | Chronic Interstitial CystitisUnited States, Belgium, Canada, Czechia, Denmark, Hungary, Latvia, Netherlands, Poland, Romania, Spain, United Kingdom
-
University Hospital Inselspital, BerneTerminatedBladder Pain Syndrome | Chronic Pelvic Pain SyndromeSwitzerland
-
AllerganRecruitingInterstitial Cystitis/Bladder Pain Syndrome (IC/BPS)United States, Canada