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

Samsung Medical Center1 site in 1 country126 target enrollmentJune 2012

ConditionsBladder Pain Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bladder Pain Syndrome
Sponsor: Samsung Medical Center
Enrollment: 126
Locations: 1
Primary Endpoint: Recurrence-free survival between TUC and TUR
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

We assume TUR have a more therapeutic effect than TUC.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

December 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

KYU-SUNG LEE

professor,MD,PhD

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

•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 \>
•Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) \>13
•No history of cystoscopy within 2yrs.

Exclusion Criteria

•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
•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.

Outcomes

Primary Outcomes

Recurrence-free survival between TUC and TUR

Time Frame: Until 12 months after the last subject be enrolled

Secondary Outcomes

The change of Brief Pain Inventory-short form(BPI-sf) score(9 and 12months)
The change of Global Response Assessment(GRA) score(1,3,6,9 and 12 months)
The change of EQ-5D (EuroQOL five dimensions) Health Questionnaire score(1,3,6,9 and 12months)
The change of Patient Global Assessment(PGA)(12months)
The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment(1,3,6,9 and 12 months)
The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)(1,3,6,9 and 12months.)