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Completed

NCT Number: NCT01963988

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

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.

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Key information

Conditions

Bladder Pain Syndrome Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Transurethral Coagulation (TUC)

Procedure

Transurethral Resection(TUR)

Procedure

Primary outcomes

  1. Recurrence-free survival between TUC and TUR

    Time frame: Until 12 months after the last subject be enrolled

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2013
Registry last updated
Dec 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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