Comparison of the Efficacy Between Transurethral Coagulation and Transurethral Resection of Ulcer in Bladder Pain Syndrome Patients

December 13, 2017 updated by: KYU-SUNG LEE, Samsung Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

126

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

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will be enrolled diagnosed with bladder pain syndrome by ESSIC proposal.

Description

Inclusion Criteria:

  1. Male and female aged 18 yrs or greater
  2. Patients diagnosed with BPS(Bladder Pain Syndrome)
  3. Symptom persisted more than 6 months
  4. Pain VAS ≥4
  5. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores > 2.
  6. Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) >13
  7. No history of cystoscopy within 2yrs.

Exclusion Criteria:

  1. History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS
  2. Child-bearing potential, pregnant or nursing women.
  3. Mean voided volume lesser than 40ml or over than 400ml.
  4. Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
  5. Urinary tract infection during run-in periods.
  6. Genitourinary tuberculosis or bladder,urethral and prostate cancer
  7. Recurrent urinary tract infection
  8. History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
  9. Neurologic disease history of cerebral infarction,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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transurethral Coagulation (TUC)
This cohort patients will be managed with Transurethral Coagulation (TUC) of IC ulcer lesion
Procedure: Transurethral Coagulation (TUC)
Transurethral Resection(TUR)
This cohort patients will be managed with transurethral resection(TUR) of IC ulcer lesion
Procedure: Transurethral Resection(TUR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-free survival between TUC and TUR
Time Frame: Until 12 months after the last subject be enrolled
Until 12 months after the last subject be enrolled

Secondary Outcome Measures

Outcome Measure
Time Frame
The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment
Time Frame: 1,3,6,9 and 12 months
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.
1,3,6,9 and 12months.
The change of Global Response Assessment(GRA) score
Time Frame: 1,3,6,9 and 12 months
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
1,3,6,9 and 12months
The change of Patient Global Assessment(PGA)
Time Frame: 12months
12months
The change of Brief Pain Inventory-short form(BPI-sf) score
Time Frame: 9 and 12months
9 and 12months

Collaborators and Investigators

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

Sponsor

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

June 1, 2012

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

October 13, 2013

First Posted (ESTIMATE)

October 17, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 14, 2017

Last Update Submitted That Met QC Criteria

December 13, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-05-127
  • ksleedr (Other Identifier: Samsung Medical Center)

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

Clinical Trials on Transurethral Coagulation (TUC)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe