Clinical trial NCT03987594: Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
Official title: Prospective Randomized Controlled Trial Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Cystitis
Bladder Pain Syndrome
Keywords: Interstitial Cystitis
Painful Bladder Syndrome
Hydrodistension
Transurethral Fulguration
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Ewha Womans University Mokdong Hospital
First posted: 2019-06-17
Enrollment: 55
Sex: ALL
Minimum age (years): 29
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 allocation with Permuted block randomization
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: inter-group difference of VAS pain score at postoperative one month
timeFrame: at postoperative one month
Secondary outcomes:
measure: inter-group differences in drop-out rate at postoperative 6 months
timeFrame: at postoperative 6 months
measure: inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
timeFrame: at postoperative 1 month
measure: inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
timeFrame: at postoperative 2 months
measure: inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
timeFrame: at postoperative 4 months
measure: inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
timeFrame: at postoperative 6 months
measure: inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
timeFrame: at postoperative 1 month
measure: inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
timeFrame: at postoperative 2 months
measure: inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
timeFrame: at postoperative 4 months
measure: inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
timeFrame: at postoperative 6 months
measure: inter-group differences in EQ-5D Health Questionnaire
timeFrame: at postoperative 1 month
measure: inter-group differences in EQ-5D Health Questionnaire
timeFrame: at postoperative 2 months
measure: inter-group differences in EQ-5D Health Questionnaire
timeFrame: at postoperative 4 months
measure: inter-group differences in EQ-5D Health Questionnaire
timeFrame: at postoperative 6 months
measure: Brief Pain Inventory-short form (BPI-sf)
timeFrame: at postoperative 1 month
measure: Brief Pain Inventory-short form (BPI-sf)
timeFrame: at postoperative 2 months
measure: Brief Pain Inventory-short form (BPI-sf)
timeFrame: at postoperative 4 months
measure: Brief Pain Inventory-short form (BPI-sf)
timeFrame: at postoperative 6 months
measure: Patient Global Assessment (PGA)
timeFrame: at postoperative 1 month
measure: Patient Global Assessment (PGA)
timeFrame: at postoperative 2 months
measure: Patient Global Assessment (PGA)
timeFrame: at postoperative 4 months
measure: Patient Global Assessment (PGA)
timeFrame: at postoperative 6 months
measure: frequency volume chart parameters
timeFrame: at postoperative 1 month
measure: frequency volume chart parameters
timeFrame: at postoperative 2 months
measure: frequency volume chart parameters
timeFrame: at postoperative 4 months
measure: frequency volume chart parameters
timeFrame: at postoperative 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology and Urological Science Institute, Yonsei University College of Medicine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.