Bladder Pain SyndromeNCT01895153
Efficacy Study of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy for Bladder Pain Syndrome
An observational study of Bladder Pain Syndrome and Pentosan Polysulfate, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in patients with bladder pain syndrome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Pain Syndrome, Pentosan Polysulfate, Hydrodistension
- How many people
- 91 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Bladder pain syndrome patients have not been treated with hydrodistention.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bladder Pain Syndrome, Pentosan Polysulfate, Hydrodistension
- Keywords
- bladder pain syndrome, pentosan polysulfate, hydrodistension
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pentosan polysulfate cohort | pentosan polysulfate monotherapy | |
| hydrodistension(HD) cohort | hydrodistension(HD) monotherapy | |
| combination cohort | combination therapy of pentosan polysulfate and hydrodistension. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of IC-Q symptom index(ICSI)score from baseline to 6 months after each treatment
Measured: 6months
Secondary outcomes (7)
The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment.
Measured: 1,2,4 and 6months after each treatment .
The change of O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q)score after each treatment
Measured: 1,2,4 and 6months after each treatment .
The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)
Measured: 1,2,4 and 6months after each treatment .
The change of Global Response Assessment(GRA) score
Measured: 1,2,4 and 6months after each treatment .
The change of EQ-5D Health Questionnaire score
Measured: 1,2,4 and 6months after each treatment .
The change of Brief Pain Inventory-short form(BPI-sf) score
Measured: 1 and 6months after each treatment.
The estimation of safty and Complications for each treatment
Measured: 1,2,4 and 6months after each treatment .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startApr 2012
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Kyu-Sung Lee, MD,Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895153
- Sponsor's protocol ID
- 2012-03-029
- Status last verified
- Dec 2020
- First submitted
- 7 Jun 2013
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy in Patients With Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT01895153
- Acronym / sponsor ID
- 2012-03-029
- Conditions
- Bladder Pain Syndrome, Pentosan Polysulfate, Hydrodistension
- Keywords
- bladder pain syndrome, pentosan polysulfate, hydrodistension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in patients with bladder pain syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pentosan polysulfate cohort | – | –pentosan polysulfate monotherapy |
| hydrodistension(HD) cohort | – | –hydrodistension(HD) monotherapy |
| combination cohort | – | –combination therapy of pentosan polysulfate and hydrodistension. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Bladder pain syndrome patients have not been treated with hydrodistention.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the change of IC-Q symptom index(ICSI)score from baseline to 6 months after each treatment
Time frame: 6months
7 secondary outcomes
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 .
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 .
The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)
Time frame: 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 .
The change of EQ-5D Health Questionnaire score
Time frame: 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.
The estimation of safty and Complications for each treatment
Time frame: 1,2,4 and 6months after each treatment .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
Related trials for Bladder Pain Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
RecruitingPhase 2/3
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Painful Bladder Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Sung Lee, MD,Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Pain Syndrome and Pentosan Polysulfate, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of IC-Q symptom index(ICSI)score from baseline to 6 months after each treatment (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.