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

Interstitial Cystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463499
• Other study ID #: 2017-08-106
• Status: Completed
• Phase: N/A
• Start date: September 22, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment		Every 3 months for 2 years
Secondary	changes in mean number of daytime frequency episodes		Every 3 months for 2 years
Secondary	changes in mean number of nocturia episodes		Every 3 months for 2 years
Secondary	changes in mean number of urgency episodes		Every 3 months for 2 years
Secondary	Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)		Every 3 months for 2 years
Secondary	Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)		Every 3 months for 2 years
Secondary	Score of Global Response Assessment (GRA)		Every 3 months for 2 years
Secondary	Patient Global Assessment		at the end of the treatment(2 years)
Secondary	Occurrence of adverse event		Every 3 months for 2 years