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Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome

NCT03987594 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2019-09-03

No results posted yet for this study

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).

Conditions

  • Interstitial Cystitis
  • Bladder Pain Syndrome

Interventions

PROCEDURE

Transurethral fulguration of the Hunner lesion

Hunner lesion of the bladder is fulgurated with electronic surgical device under cystoscopic inspection. For the intervention, general or spinal anesthesia is required.

PROCEDURE

Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion

Prior to Hunner lesion fulguration, bladder hydrodistension is performed for 8 minutes at pressure of 80cmH2O. And then transurethral fulguration is performed on the Hunner lesion.

Sponsors & Collaborators

  • Ewha Womans University Mokdong Hospital

    collaborator OTHER

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
29 Years
Max Age
83 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03987594 on ClinicalTrials.gov