Interstitial CystitisNCT03987594

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

A study testing Transurethral fulguration of the Hunner lesion and Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 29 to 83 years
Conditions the study is for: Interstitial Cystitis, Bladder Pain Syndrome
What is being tested?: Transurethral fulguration of the Hunner lesion and Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 1 siteSouth Korea
Study dates: 1 Aug 2015to 31 Oct 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 29 to 83 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

Other trials in South Korea

About this study

Official title: Prospective Randomized Controlled Trial Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome

Read the 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
Being tested: Transurethral fulguration of the Hunner lesion, Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion
Keywords: Interstitial Cystitis, Painful Bladder Syndrome, Hydrodistension, Transurethral Fulguration
Medical subject headings: Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transurethral fulguration of the Hunner lesionProcedure or surgery
Hunner lesion of the bladder is fulgurated with electronic surgical device under cystoscopic inspection. For the intervention, general or spinal anesthesia is required.
Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesionProcedure or surgery
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.

Study groups in NCT03987594
Study group	Role	What they receive
TUF	Placebo comparator	Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion Receives: 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 Receives: Procedure: Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: at postoperative one month

Secondary outcomes (25)

inter-group differences in drop-out rate at postoperative 6 months
Assessment of Drop-out rate is performed at the point of postoperative 6 months (both using the Intention-To-Treat and Per-Protocol analysis)
Measured: at postoperative 6 months
inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index
Measured: at postoperative 1 month
inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index
Measured: at postoperative 2 months
inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index
Measured: at postoperative 4 months
inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index
Measured: at postoperative 6 months
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is questionnaire which evaluates symptoms of pain, urgency, and frequency and how much they bother the patient. PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is composed of two compartment; symptom score (7 items) and bother score (4 items). The symptom scores range from 2~23 points and the symptom scores range from 0~12 points. The higher the score, the worse the symptoms.
Measured: at postoperative 1 month
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is questionnaire which evaluates symptoms of pain, urgency, and frequency and how much they bother the patient. PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is composed of two compartment; symptom score (7 items) and bother score (4 items). The symptom scores range from 2~23 points and the symptom scores range from 0~12 points. The higher the score, the worse the symptoms.
Measured: at postoperative 2 months
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is questionnaire which evaluates symptoms of pain, urgency, and frequency and how much they bother the patient. PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is composed of two compartment; symptom score (7 items) and bother score (4 items). The symptom scores range from 2~23 points and the symptom scores range from 0~12 points. The higher the score, the worse the symptoms.
Measured: at postoperative 4 months
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is questionnaire which evaluates symptoms of pain, urgency, and frequency and how much they bother the patient. PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is composed of two compartment; symptom score (7 items) and bother score (4 items). The symptom scores range from 2~23 points and the symptom scores range from 0~12 points. The higher the score, the worse the symptoms.
Measured: at postoperative 6 months
inter-group differences in EQ-5D Health Questionnaire
The EQ-5D questionnaire is a tool for brief evaluation of subject's health status. The EQ-5D questionnaire has five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number. The 5-digit number is finally converted to a single summary index by a specific formula.
Measured: at postoperative 1 month
inter-group differences in EQ-5D Health Questionnaire
The EQ-5D questionnaire is a tool for brief evaluation of subject's health status. The EQ-5D questionnaire has five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number. The 5-digit number is finally converted to a single summary index by a specific formula.
Measured: at postoperative 2 months
inter-group differences in EQ-5D Health Questionnaire
The EQ-5D questionnaire is a tool for brief evaluation of subject's health status. The EQ-5D questionnaire has five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number. The 5-digit number is finally converted to a single summary index by a specific formula.
Measured: at postoperative 4 months
inter-group differences in EQ-5D Health Questionnaire
The EQ-5D questionnaire is a tool for brief evaluation of subject's health status. The EQ-5D questionnaire has five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number. The 5-digit number is finally converted to a single summary index by a specific formula.
Measured: at postoperative 6 months
Brief Pain Inventory-short form (BPI-sf)
Brief Pain Inventory-short form (BPI-sf) is composed of two domains measured by the "pain severity" and the "pain interference", Pain severity compartment is composed of 4 items, and pain interference compartment is composed of 7 items (of 24-hour recall period). Each item has 0-10 scales. Brief pain severity score is calculated by adding the scores of 4 questions and then dividing by 4. Brief pain interference score is calculated by adding the scores for 7 questions and then dividing by 7.
Measured: at postoperative 1 month
Brief Pain Inventory-short form (BPI-sf)
Brief Pain Inventory-short form (BPI-sf) is composed of two domains measured by the "pain severity" and the "pain interference", Pain severity compartment is composed of 4 items, and pain interference compartment is composed of 7 items (of 24-hour recall period). Each item has 0-10 scales. Brief pain severity score is calculated by adding the scores of 4 questions and then dividing by 4. Brief pain interference score is calculated by adding the scores for 7 questions and then dividing by 7.
Measured: at postoperative 2 months
Brief Pain Inventory-short form (BPI-sf)
Brief Pain Inventory-short form (BPI-sf) is composed of two domains measured by the "pain severity" and the "pain interference", Pain severity compartment is composed of 4 items, and pain interference compartment is composed of 7 items (of 24-hour recall period). Each item has 0-10 scales. Brief pain severity score is calculated by adding the scores of 4 questions and then dividing by 4. Brief pain interference score is calculated by adding the scores for 7 questions and then dividing by 7.
Measured: at postoperative 4 months
Brief Pain Inventory-short form (BPI-sf)
Brief Pain Inventory-short form (BPI-sf) is composed of two domains measured by the "pain severity" and the "pain interference", Pain severity compartment is composed of 4 items, and pain interference compartment is composed of 7 items (of 24-hour recall period). Each item has 0-10 scales. Brief pain severity score is calculated by adding the scores of 4 questions and then dividing by 4. Brief pain interference score is calculated by adding the scores for 7 questions and then dividing by 7.
Measured: at postoperative 6 months
Patient Global Assessment (PGA)
Patient Global Assessment (PGA) is composed of a single questionnaire assessing the subjective patients-reported outcome. The question is "How is your bladder condition today?". The patients choose one of the following five answers; very-good, god, moderate, bad, very bad.
Measured: at postoperative 1 month
Patient Global Assessment (PGA)
Patient Global Assessment (PGA) is composed of a single questionnaire assessing the subjective patients-reported outcome. The question is "How is your bladder condition today?". The patients choose one of the following five answers; very-good, god, moderate, bad, very bad.
Measured: at postoperative 2 months
Patient Global Assessment (PGA)
Patient Global Assessment (PGA) is composed of a single questionnaire assessing the subjective patients-reported outcome. The question is "How is your bladder condition today?". The patients choose one of the following five answers; very-good, god, moderate, bad, very bad.
Measured: at postoperative 4 months
Patient Global Assessment (PGA)
Patient Global Assessment (PGA) is composed of a single questionnaire assessing the subjective patients-reported outcome. The question is "How is your bladder condition today?". The patients choose one of the following five answers; very-good, god, moderate, bad, very bad.
Measured: at postoperative 6 months
frequency volume chart parameters
frequency volume chart is a tool for assessment of micturition time, volume of urination and urgency episode. 24-hr frequency of micturition, maximum voided volume, episode of urgency, and nocturia is evaluated.
Measured: at postoperative 1 month
frequency volume chart parameters
frequency volume chart is a tool for assessment of micturition time, volume of urination and urgency episode. 24-hr frequency of micturition, maximum voided volume, episode of urgency, and nocturia is evaluated.
Measured: at postoperative 2 months
frequency volume chart parameters
frequency volume chart is a tool for assessment of micturition time, volume of urination and urgency episode. 24-hr frequency of micturition, maximum voided volume, episode of urgency, and nocturia is evaluated.
Measured: at postoperative 4 months
frequency volume chart parameters
frequency volume chart is a tool for assessment of micturition time, volume of urination and urgency episode. 24-hr frequency of micturition, maximum voided volume, episode of urgency, and nocturia is evaluated.
Measured: at postoperative 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201531 Oct 2018

First posted17 Jun 2019
Study start1 Aug 2015
Primary completion31 Oct 2018
Study completion31 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Interstitial CystitisStudies of the same condition, open and under way.
More trials run by Yonsei UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 1:1 allocation with Permuted block randomization
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03987594
Sponsor's protocol ID: 4-2015-0492
Other IDs: 2016-12-007-001
Status last verified: Aug 2019
First submitted: 13 Jun 2019
Last updated: 3 Sep 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Currently, we do not plan to share patient data with third parties.

Publications

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.
PubMed 29777618
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.
PubMed 29566264
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.
PubMed 30072210
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.
PubMed 29315774
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.
PubMed 35704106

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Controlled Trial Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
ClinicalTrials.gov ID: NCT03987594
Acronym / sponsor ID: 4-2015-0492
Conditions: Interstitial Cystitis, Bladder Pain Syndrome
Keywords: Interstitial Cystitis, Painful Bladder Syndrome, Hydrodistension, Transurethral Fulguration
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Collaborators: Ewha Womans University Mokdong Hospital
Study start: 1 Aug 2015 (actual)
Primary completion: 31 Oct 2018 (actual)
Study completion: 31 Oct 2018 (actual)
First posted: 17 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 1:1 allocation with Permuted block randomization

Arm	Type	Receives
TUF	Placebo comparator	Procedure: Transurethral fulguration of the Hunner lesionSubjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion
TUF+HD	Experimental	Procedure: Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesionSubjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion

Who may qualify

Ages: 29 to 83 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transurethral fulguration of the Hunner lesionHunner lesion of the bladder is fulgurated with electronic surgical device under cystoscopic inspection. For the intervention, general or spinal anesthesia is required.	Procedure or surgery	TUF
Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesionPrior 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.	Procedure or surgery	TUF+HD

Primary outcome

inter-group difference of VAS pain score at postoperative one month
Time frame: 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.

25 secondary outcomes

inter-group differences in drop-out rate at postoperative 6 months
Time frame: at postoperative 6 months
inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
Time frame: at postoperative 1 month
inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
Time frame: at postoperative 2 months
inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
Time frame: at postoperative 4 months
inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
Time frame: at postoperative 6 months
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
Time frame: at postoperative 1 month
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
Time frame: at postoperative 2 months
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
Time frame: at postoperative 4 months
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
Time frame: at postoperative 6 months
inter-group differences in EQ-5D Health Questionnaire
Time frame: at postoperative 1 month
inter-group differences in EQ-5D Health Questionnaire
Time frame: at postoperative 2 months
inter-group differences in EQ-5D Health Questionnaire
Time frame: at postoperative 4 months
inter-group differences in EQ-5D Health Questionnaire
Time frame: at postoperative 6 months
Brief Pain Inventory-short form (BPI-sf)
Time frame: at postoperative 1 month
Brief Pain Inventory-short form (BPI-sf)
Time frame: at postoperative 2 months
Brief Pain Inventory-short form (BPI-sf)
Time frame: at postoperative 4 months
Brief Pain Inventory-short form (BPI-sf)
Time frame: at postoperative 6 months
Patient Global Assessment (PGA)
Time frame: at postoperative 1 month
Patient Global Assessment (PGA)
Time frame: at postoperative 2 months
Patient Global Assessment (PGA)
Time frame: at postoperative 4 months
Patient Global Assessment (PGA)
Time frame: at postoperative 6 months
frequency volume chart parameters
Time frame: at postoperative 1 month
frequency volume chart parameters
Time frame: at postoperative 2 months
frequency volume chart parameters
Time frame: at postoperative 4 months
frequency volume chart parameters
Time frame: at postoperative 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
Background: PubMed 29777618Malde 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.
Background: PubMed 29566264Kirk 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.
Background: PubMed 30072210Bosch 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.
Background: PubMed 29315774Akiyama 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.
Derived from this study: PubMed 35704106Son 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.
Individual participant dataSharing planned: No. Currently, we do not plan to share patient data with third parties.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

inter-group difference of VAS pain score at postoperative one month (time frame: at postoperative one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03987594, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.