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.

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis
• Intervention / Treatment: Drug: Hyaluronic Acid and Chondroitin Sulfate

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center, Sungkyunkwan University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)	Every 3 months for 2 years
Score of Global Response Assessment (GRA)	Every 3 months for 2 years
Patient Global Assessment	at the end of the treatment(2 years)
Occurrence of adverse event	Every 3 months for 2 years

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 25, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 2017-08-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No