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

NCT01963988 | Completed

• 2 other identifiers: 2013-05-127ksleedr
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Pain Syndrome

Keywords

Bladder Pain Syndrome; Transurethral Resection of Ulcer; Transurethral Coagulation of Ulcer

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival between TUC and TUR

  Until 12 months after the last subject be enrolled

Secondary Outcomes (6)

• 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

Study Arms (2)

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)

Interventions

Transurethral Coagulation (TUC) PROCEDURE

Transurethral Coagulation (TUC)

Transurethral Resection(TUR) PROCEDURE

Transurethral Resection(TUR)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be enrolled diagnosed with bladder pain syndrome by ESSIC proposal.

You may qualify if:

• Male and female aged 18 yrs or greater
• Patients diagnosed with BPS(Bladder Pain Syndrome)
• Symptom persisted more than 6 months
• Pain VAS ≥4
• O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores \> 2.
• Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) \>13
• No history of cystoscopy within 2yrs.

You may not qualify if:

• History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS
• Child-bearing potential, pregnant or nursing women.
• Mean voided volume lesser than 40ml or over than 400ml.
• Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
• Urinary tract infection during run-in periods.
• Genitourinary tuberculosis or bladder,urethral and prostate cancer
• Recurrent urinary tract infection
• History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
• Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor,MD,PhD

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: October 17, 2013
• Study Start: June 1, 2012
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 14, 2017

Record last verified: 2017-12

Locations

KR (1)