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

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ClinicalTrials.gov Identifier: NCT01963988
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, 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.


Condition or disease Intervention/treatment
Bladder Pain Syndrome Procedure: Transurethral Coagulation (TUC) Procedure: Transurethral Resection(TUR)

Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study for Comparison of the Efficacy Between Transurethral Coagulation and Transurethral Resection of Ulcer in Bladder Pain Syndrome Patients
Study Start Date : June 2012
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 2017

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)



Primary Outcome Measures :
  1. Recurrence-free survival between TUC and TUR [ Time Frame: Until 12 months after the last subject be enrolled ]

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


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be enrolled diagnosed with bladder pain syndrome by ESSIC proposal.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963988


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: KYU-SUNG LEE, professor,MD,PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01963988     History of Changes
Other Study ID Numbers: 2013-05-127
ksleedr ( Registry Identifier: LKS )
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Keywords provided by KYU-SUNG LEE, Samsung Medical Center:
Bladder Pain Syndrome
Transurethral Resection of Ulcer
Transurethral Coagulation of Ulcer

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Cystitis, Interstitial
Disease
Pathologic Processes
Mental Disorders
Cystitis
Urinary Bladder Diseases
Urologic Diseases