Bladder Pain SyndromeNCT01963988
Comparison of the Efficacy Between Transurethral Coagulation and Transurethral Resection of Ulcer in Bladder Pain Syndrome Patients
An observational study of Bladder Pain Syndrome, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
On the EAU (European Association of Urology) guidelines, the ulcer type bladder pain syndrome (BPS) should be treated with transurethral resection (TUR) or coagulation (TUC) of ulcer. But, Up to date, there was no study to compare the therapeutic efficacy of TUR with TUC in ulcer type BPS patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Pain Syndrome
- What is being tested?
- Transurethral Coagulation (TUC) and Transurethral Resection(TUR)
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Dec 2017
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled diagnosed with bladder pain syndrome by ESSIC proposal.
Who may be able to join
- Male and female aged 18 yrs or greater
- Patients diagnosed with BPS(Bladder Pain Syndrome)
- Symptom persisted more than 6 months
- Pain VAS ≥4
- O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores > 2.
- Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) >13
- No history of cystoscopy within 2yrs.
Who cannot join
- History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS
- Child-bearing potential, pregnant or nursing women.
- 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
Show all 9Show fewer
- Recurrent urinary tract infection
- History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
- Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for Comparison of the Efficacy Between Transurethral Coagulation and Transurethral Resection of Ulcer in Bladder Pain Syndrome Patients
On the EAU (European Association of Urology) guidelines, the ulcer type bladder pain syndrome (BPS) should be treated with transurethral resection (TUR) or coagulation (TUC) of ulcer.
But, Up to date, there was no study to compare the therapeutic efficacy of TUR with TUC in ulcer type BPS patients.
We assume TUR have a more therapeutic effect than TUC.
- Conditions
- Bladder Pain Syndrome
- Being tested
- Transurethral Coagulation (TUC), Transurethral Resection(TUR)
- Keywords
- Bladder Pain Syndrome, Transurethral Resection of Ulcer, Transurethral Coagulation of Ulcer
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral Coagulation (TUC)Procedure or surgery
Transurethral Resection(TUR)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transurethral Coagulation (TUC) | This cohort patients will be managed with Transurethral Coagulation (TUC) of IC ulcer lesion Receives: Procedure: Transurethral Coagulation (TUC) | |
| Transurethral Resection(TUR) | This cohort patients will be managed with transurethral resection(TUR) of IC ulcer lesion Receives: Procedure: Transurethral Resection(TUR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival between TUC and TUR
Measured: Until 12 months after the last subject be enrolled
Secondary outcomes (6)
The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment
Measured: 1,3,6,9 and 12 months
The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)
Measured: 1,3,6,9 and 12months.
The change of Global Response Assessment(GRA) score
Measured: 1,3,6,9 and 12 months
The change of EQ-5D (EuroQOL five dimensions) Health Questionnaire score
Measured: 1,3,6,9 and 12months
The change of Patient Global Assessment(PGA)
Measured: 12months
The change of Brief Pain Inventory-short form(BPI-sf) score
Measured: 9 and 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startJun 2012
- Primary completionOct 2017
- Study completionDec 2017
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
- 126 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963988
- Sponsor's protocol ID
- 2013-05-127
- Other IDs
- ksleedr
- Status last verified
- Dec 2017
- First submitted
- 15 Jul 2013
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Comparison of the Efficacy Between Transurethral Coagulation and Transurethral Resection of Ulcer in Bladder Pain Syndrome Patients
- ClinicalTrials.gov ID
- NCT01963988
- Acronym / sponsor ID
- 2013-05-127
- Conditions
- Bladder Pain Syndrome
- Keywords
- Bladder Pain Syndrome, Transurethral Resection of Ulcer, Transurethral Coagulation of Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Oct 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.
On the EAU (European Association of Urology) guidelines, the ulcer type bladder pain syndrome (BPS) should be treated with transurethral resection (TUR) or coagulation (TUC) of ulcer.
But, Up to date, there was no study to compare the therapeutic efficacy of TUR with TUC in ulcer type BPS patients.
We assume TUR have a more therapeutic effect than TUC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transurethral Coagulation (TUC) | – | Procedure: Transurethral Coagulation (TUC)This cohort patients will be managed with Transurethral Coagulation (TUC) of IC ulcer lesion |
| Transurethral Resection(TUR) | – | Procedure: Transurethral Resection(TUR)This cohort patients will be managed with transurethral resection(TUR) of IC ulcer lesion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled diagnosed with bladder pain syndrome by ESSIC proposal.
Key inclusion criteria (7 listed)
- Male and female aged 18 yrs or greater
- Patients diagnosed with BPS(Bladder Pain Syndrome)
- Symptom persisted more than 6 months
- Pain VAS ≥4
- O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores > 2.
Key exclusion criteria (9 listed)
- History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS
- Child-bearing potential, pregnant or nursing women.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transurethral Coagulation (TUC) | Procedure or surgery | Transurethral Coagulation (TUC) |
| Transurethral Resection(TUR) | Procedure or surgery | Transurethral Resection(TUR) |
Primary outcome
Recurrence-free survival between TUC and TUR
Time frame: Until 12 months after the last subject be enrolled
6 secondary outcomes
The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment
Time frame: 1,3,6,9 and 12 months
The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)
Time frame: 1,3,6,9 and 12months.
The change of Global Response Assessment(GRA) score
Time frame: 1,3,6,9 and 12 months
The change of EQ-5D (EuroQOL five dimensions) Health Questionnaire score
Time frame: 1,3,6,9 and 12months
The change of Patient Global Assessment(PGA)
Time frame: 12months
The change of Brief Pain Inventory-short form(BPI-sf) score
Time frame: 9 and 12months
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 14 Dec 2017.
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Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
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Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
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Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 7 inclusion and 9 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 14 Dec 2017. 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?
Recurrence-free survival between TUC and TUR (time frame: Until 12 months after the last subject be enrolled). 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 14 Dec 2017.