NCT03463499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

February 25, 2018

Last Update Submit

October 26, 2022

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

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

    Every 3 months for 2 years

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

Hyaluronic Acid and Chondroitin Sulfate

EXPERIMENTAL

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

Interventions

Hyaluronic Acid and Chondroitin SulfateDRUG

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

Hyaluronic Acid and Chondroitin Sulfate

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Hyaluronic AcidChondroitin Sulfates

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesChondroitin

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 25, 2018

First Posted

March 13, 2018

Study Start

September 22, 2017

Primary Completion

September 30, 2019

Study Completion

December 31, 2021

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)