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

NCT03987594 | Completed DMC

• 2 other identifiers: 4-2015-04922016-12-007-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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).

Conditions

Interstitial Cystitis; Bladder Pain Syndrome

Keywords

Interstitial Cystitis; Painful Bladder Syndrome; Hydrodistension; Transurethral Fulguration

Outcome Measures

Primary Outcomes (1)

• inter-group difference of VAS pain score at postoperative one month

  Primary end-point is inter-group difference of VAS pain score at postoperative one month. Analysis is performed based on independent two sample t-test. ; About the VAS pain score -'VAS' is abbreviation of 'Visual Analogue Scale'. For evaluation of pain, we use 'Visual Analogue Scale' which has a range from 0 to 10 points. The score increases depending on the severity of the pain symptoms.

  at postoperative one month

Secondary Outcomes (25)

• inter-group differences in drop-out rate at postoperative 6 months

  at postoperative 6 months

• inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires

  at postoperative 1 month

• inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires

  at postoperative 2 months

• inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires

  at postoperative 4 months

• inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires

  at postoperative 6 months

Study Arms (2)

TUF

PLACEBO COMPARATOR

Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion

Procedure: Transurethral fulguration of the Hunner lesion

TUF+HD

EXPERIMENTAL

Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion

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

Interventions

Transurethral fulguration of the Hunner lesion PROCEDURE

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

TUF

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

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.

TUF+HD

Eligibility Criteria

• Age: 29 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. cystoscopically proven Hunner lesion, without other demonstrable lower urinary tract diseases
• \. Adult patient aged more than 19 years
• \. Duration of IC/BPS symptom of more than 6 months
• \. VAS pain score more than point 4 (including point 4)
• \. The total score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem is more than 12 with the score of pain item is more than 2
• \. The total score of Pelvic pain urgency/frequency patient symptom scale more than point 13

You may not qualify if:

• \. Patient with history of bladder hydrodistension or transurethral fulguration within the period of 3 months
• \. Women patients who are likely to become pregnant
• \. Patients with average voided volume more than 400ml
• \. Patients with hematuria suspicious of malignancy
• \. Patients with microbiologically proven urinary tract infection during the screening period
• \. Patients with microbiologically proven recurrent urinary tract infection, more than twice during the last 6 months or more than three times of infection during the last year
• \. Patients with previous history of genitourinary tuberculosis
• \. Patients with previous history of genitourinary malignancy
• \. Patients with previous history of bladder augmentation
• \. Patient with following surgery within recent 6 months at screening; hysterectomy, midureteral or suburethral sling operation, transvaginal operation, pelvic organ prolapse surgery, vaginal delivery, Caesarean section, prostate surgery, and any other treatment that might affect bladder sensation and bladder function.
• \. Patients with neurological diseases which might affect bladder function
• \. patients who rely on assisted emptying ; like clean intermittent catheterization or indwelling catheterization
• \. patients who are planning to rehabilitation treatment affect the bladder function, like intravesical electronic stimulation
• \. patient with alcohol or drug addiction
• \. any patient who are not fit for the study based on the investigator's decision

Sponsors & Collaborators

• Yonsei University: lead
• Ewha Womans University Mokdong Hospital: collaborator

Study Sites (1)

Department of Urology and Urological Science Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

Related Publications (5)

• Malde S, Palmisani S, Al-Kaisy A, Sahai A. Guideline of guidelines: bladder pain syndrome. BJU Int. 2018 Nov;122(5):729-743. doi: 10.1111/bju.14399. Epub 2018 Jun 13.

  PMID: 29777618 BACKGROUND

• Kirk PS, Santiago-Lastra Y, Qin Y, Stoffel JT, Clemens JQ, Cameron AP. The effects of cystoscopy and hydrodistention on symptoms and bladder capacity in interstitial cystitis/bladder pain syndrome. Neurourol Urodyn. 2018 Aug;37(6):2002-2007. doi: 10.1002/nau.23555. Epub 2018 Mar 22.

  PMID: 29566264 BACKGROUND

• Bosch PC. A Randomized, Double-blind, Placebo-controlled Trial of Certolizumab Pegol in Women with Refractory Interstitial Cystitis/Bladder Pain Syndrome. Eur Urol. 2018 Nov;74(5):623-630. doi: 10.1016/j.eururo.2018.07.026. Epub 2018 Jul 30.

  PMID: 30072210 BACKGROUND

• Akiyama Y, Niimi A, Nomiya A, Yamada Y, Nakagawa T, Fujimura T, Fukuhara H, Kume H, Igawa Y, Homma Y. Extent of Hunner lesions: The relationships with symptom severity and clinical parameters in Hunner type interstitial cystitis patients. Neurourol Urodyn. 2018 Apr;37(4):1441-1447. doi: 10.1002/nau.23467. Epub 2018 Jan 9.

  PMID: 29315774 BACKGROUND

• Son HS, Yoon H, Lee HS, Kim JH. Prospective randomized controlled trial comparing fulguration versus fulguration and hydrodistension for Hunner-type interstitial cystitis/bladder pain syndrome. World J Urol. 2022 Aug;40(8):2071-2076. doi: 10.1007/s00345-022-04062-8. Epub 2022 Jun 15.

  PMID: 35704106 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 allocation with Permuted block randomization

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 17, 2019
• Study Start: August 1, 2015
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)