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

Not Applicable

Completed

• Conditions: Interstitial Cystitis
• Interventions: Drug: Hyaluronic Acid and Chondroitin Sulfate

• Registration Number: NCT03463499
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-22
• Study First Submitted: 2018-02-25
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-13
• Primary Completion: 2019-09-30
• Study Completion: 2021-12-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

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Exclusion Criteria

1. History of augmentation cystoplasty or previous transurethral coagulation/resection due to IC/BPS
2. Child-bearing potential, pregnant or nursing women.
3. Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
4. Urinary tract infection during run-in periods.
5. Genitourinary tuberculosis or bladder,urethral and prostate cancer
6. Recurrent urinary tract infection
7. History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
8. Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-
9. Using a indwelling catheter or execution of intermittent self catheterization

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment	Every 3 months for 2 years

Secondary Outcome Measures

Name	Time	Method
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)	Every 3 months for 2 years
Occurrence of adverse event	Every 3 months for 2 years
changes in mean number of urgency episodes	Every 3 months for 2 years
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)	Every 3 months for 2 years
Score of Global Response Assessment (GRA)	Every 3 months for 2 years
changes in mean number of daytime frequency episodes	Every 3 months for 2 years
changes in mean number of nocturia episodes	Every 3 months for 2 years
Patient Global Assessment	at the end of the treatment(2 years)

Trial Locations

Locations (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of