Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT03987594
Status:
COMPLETED
Last Update Posted:
2019-09-03
First Post:
2019-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
Prospective Randomized Controlled Trial Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized controlled trial. Subject population is adult patients with Hunner-type interstitial cystitis. The objective of this study is to compare the therapeutic effect between the two surgical modality; TUF (transurethral fulguration of the Hunner lesion) versus TUF+HD(addition of bladder hydrodistension prior to transurethral fulguration of the Hunner lesion).
Detailed Description:
Subject patients are randomly allocated to 1:1 ratio using Permuted block randomization. For TUF group, only fulguration on the Hunner lesion is performed. For TUF+HD group hydrodistension is performed for 8 minutes at pressure of 80cmH2O, and then fulguration on the Hunner lesion is performed. Therapeutic effect is evaluated using Visual Analogue Scale (VAS) pain score, O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q), Pelvic pain urgency/frequency patient symptom scale (PUF), frequency volume chart parameters, EQ-5D Health Questionnaire, Brief Pain Inventory-short form (BPI-sf), Patient Global Assessment (PGA) at the point of 1, 2, 4 and 6 months after operation. During the observational period, subject patients are not provided with any additional medical, physical or surgical treatment for symptom relief. Subject patient who complains of symptom requiring medical, physical or surgical intervention during the study period, is dropped from the study. Comparison of therapeutic efficacy between the two groups is performed using independent two sample t-test.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-12-007-001 | OTHER | Ewha Womans University Mokdong Hospital | View |