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

NCT ID: NCT03987594

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2018-10-31

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.

Conditions

Interstitial Cystitis; Bladder Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TUF

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

Group Type: PLACEBO_COMPARATOR

Transurethral fulguration of the Hunner lesion

Intervention Type: 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+HD

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1. cystoscopically proven Hunner lesion, without other demonstrable lower urinary tract diseases
• 2. Adult patient aged more than 19 years
• 3. Duration of IC/BPS symptom of more than 6 months
• 4. VAS pain score more than point 4 (including point 4)
• 5. 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
• 6. The total score of Pelvic pain urgency/frequency patient symptom scale more than point 13

Exclusion Criteria

• 1. Patient with history of bladder hydrodistension or transurethral fulguration within the period of 3 months
• 2. Women patients who are likely to become pregnant
• 3. Patients with average voided volume more than 400ml
• 4. Patients with hematuria suspicious of malignancy
• 5. Patients with microbiologically proven urinary tract infection during the screening period
• 6. 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
• 7. Patients with previous history of genitourinary tuberculosis
• 8. Patients with previous history of genitourinary malignancy
• 9. Patients with previous history of bladder augmentation
• 10. 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.
• 11. Patients with neurological diseases which might affect bladder function
• 12. patients who rely on assisted emptying ; like clean intermittent catheterization or indwelling catheterization
• 13. patients who are planning to rehabilitation treatment affect the bladder function, like intravesical electronic stimulation
• 14. patient with alcohol or drug addiction
• 15. any patient who are not fit for the study based on the investigator's decision

• Minimum Eligible Age: 29 Years
• Maximum Eligible Age: 83 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role: collaborator

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 29777618 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29566264 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30072210 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29315774 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35704106 (View on PubMed)

Other Identifiers

2016-12-007-001

Identifier Type: OTHER

Identifier Source: secondary_id

4-2015-0492

Identifier Type: -

Identifier Source: org_study_id