Clinical trial NCT01963988: Comparison of the Efficacy Between Transurethral Coagulation and Transurethral Resection of Ulcer in Bladder Pain Syndrome Patients
Official title: Pilot Study for Comparison of the Efficacy Between Transurethral Coagulation and Transurethral Resection of Ulcer in Bladder Pain Syndrome Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Pain Syndrome
Keywords: Bladder Pain Syndrome
Transurethral Resection of Ulcer
Transurethral Coagulation of Ulcer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be enrolled diagnosed with bladder pain syndrome by ESSIC proposal.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence-free survival between TUC and TUR
timeFrame: Until 12 months after the last subject be enrolled
Secondary outcomes:
measure: The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment
timeFrame: 1,3,6,9 and 12 months
measure: The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)
timeFrame: 1,3,6,9 and 12months.
measure: The change of Global Response Assessment(GRA) score
timeFrame: 1,3,6,9 and 12 months
measure: The change of EQ-5D (EuroQOL five dimensions) Health Questionnaire score
timeFrame: 1,3,6,9 and 12months
measure: The change of Patient Global Assessment(PGA)
timeFrame: 12months
measure: The change of Brief Pain Inventory-short form(BPI-sf) score
timeFrame: 9 and 12months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: