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Completed

NCT Number: NCT03463499

The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients

The efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate after transurethral resection of Hunner lesion in interstitial cystitis/bladder pain syndrome patients. To analyze the number and timing of recurrence based on a long-term follow-up.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center, Sungkyunkwan University School of Medicine

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 20 yrs or greater
  • Patients diagnosed with Hunner lesion in IC(interstitial cystitis)/BPS(Bladder Pain Syndrome) and who is scheduled to undergo transurethral resection
  • Symptom persisted more than 6 months
  • Pain VAS ≥4

Exclusion criteria

  • History of augmentation cystoplasty or previous transurethral coagulation/resection due to IC/BPS
  • Child-bearing potential, pregnant or nursing women.
  • 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.-
  • Using a indwelling catheter or execution of intermittent self catheterization

Treatment and study plan

Hyaluronic Acid and Chondroitin Sulfate

Drug

Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients.

Primary outcomes

  1. change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment

    Time frame: Every 3 months for 2 years

Secondary outcomes

  1. changes in mean number of daytime frequency episodes

    Time frame: Every 3 months for 2 years

  2. changes in mean number of nocturia episodes

    Time frame: Every 3 months for 2 years

  3. changes in mean number of urgency episodes

    Time frame: Every 3 months for 2 years

  4. Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)

    Time frame: Every 3 months for 2 years

  5. Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)

    Time frame: Every 3 months for 2 years

  6. Score of Global Response Assessment (GRA)

    Time frame: Every 3 months for 2 years

  7. Patient Global Assessment

    Time frame: at the end of the treatment(2 years)

  8. Occurrence of adverse event

    Time frame: Every 3 months for 2 years

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Mar 13, 2018
Registry last updated
Oct 27, 2022

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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