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

Bladder Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963988
• Other study ID #: 2013-05-127
• Secondary ID: ksleedr
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: December 13, 2017
• Start date: June 2012
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis, Interstitial
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• Transurethral Coagulation (TUC)

• Transurethral Resection(TUR)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival between TUC and TUR		Until 12 months after the last subject be enrolled
Secondary	The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment		1,3,6,9 and 12 months
Secondary	The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)		1,3,6,9 and 12months.
Secondary	The change of Global Response Assessment(GRA) score		1,3,6,9 and 12 months
Secondary	The change of EQ-5D (EuroQOL five dimensions) Health Questionnaire score		1,3,6,9 and 12months
Secondary	The change of Patient Global Assessment(PGA)		12months
Secondary	The change of Brief Pain Inventory-short form(BPI-sf) score		9 and 12months