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

Completed

• Conditions: Bladder Pain Syndrome
• Interventions: Procedure: Transurethral Coagulation (TUC); Procedure: Transurethral Resection(TUR)

• Registration Number: NCT01963988
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-10-13
• Study First Posted: 2013-10-17
• Primary Completion: 2017-10
• Status Verified: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transurethral Coagulation (TUC)	Transurethral Coagulation (TUC)	This cohort patients will be managed with Transurethral Coagulation (TUC) of IC ulcer lesion
Transurethral Resection(TUR)	Transurethral Resection(TUR)	This cohort patients will be managed with transurethral resection(TUR) of IC ulcer lesion

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival between TUC and TUR	Until 12 months after the last subject be enrolled

Secondary Outcome Measures

Name	Time	Method
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.
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 Brief Pain Inventory-short form(BPI-sf) score	9 and 12months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of