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

NCT ID: NCT01963988

Last Updated: 2017-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Bladder Pain Syndrome

Keywords

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Bladder Pain Syndrome Transurethral Resection of Ulcer Transurethral Coagulation of Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transurethral Coagulation (TUC)

This cohort patients will be managed with Transurethral Coagulation (TUC) of IC ulcer lesion

Transurethral Coagulation (TUC)

Intervention Type PROCEDURE

Transurethral Resection(TUR)

This cohort patients will be managed with transurethral resection(TUR) of IC ulcer lesion

Transurethral Resection(TUR)

Intervention Type PROCEDURE

Interventions

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Transurethral Coagulation (TUC)

Intervention Type PROCEDURE

Transurethral Resection(TUR)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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KYU-SUNG LEE

professor,MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ksleedr

Identifier Type: REGISTRY

Identifier Source: secondary_id

2013-05-127

Identifier Type: -

Identifier Source: org_study_id