UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061693 |
|---|---|
| Receipt number | R000070592 |
| Scientific Title | LOW-PRESSURE VERSUS HIGH-PRESSURE HYDRODISTENTION IN INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME (IC/BPS): A RANDOMISED CONTROLLED TRIAL |
| Date of disclosure of the study information | 2026/05/26 |
| Last modified on | 2026/05/26 14:40:29 |
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Basic information
Public title
LOW-PRESSURE VERSUS HIGH-PRESSURE HYDRODISTENTION IN INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME (IC/BPS): A RANDOMISED CONTROLLED TRIAL
Acronym
LOW-PRESSURE VERSUS HIGH-PRESSURE HYDRODISTENTION IN INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME (IC/BPS): A RANDOMISED CONTROLLED TRIAL
Scientific Title
LOW-PRESSURE VERSUS HIGH-PRESSURE HYDRODISTENTION IN INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME (IC/BPS): A RANDOMISED CONTROLLED TRIAL
Scientific Title:Acronym
LOW-PRESSURE VERSUS HIGH-PRESSURE HYDRODISTENTION IN INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME (IC/BPS): A RANDOMISED CONTROLLED TRIAL
Region
| Asia(except Japan) |
Condition
Condition
NTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME (IC/BPS)
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the optimal hydrodistention technique for IC/BPS patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. To assess and report the effect of hydrodistention in both groups over a period of 4 weeks
Key secondary outcomes
1. To compare the symptom improvement among the patients undergoing high pressure vs low-pressure hydrodistention at 2 and 4 weeks
2. To compare the adverse events between the two groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention arm- Group A- Cystoscopy and bladder filling with saline reservoir at a height of 30cm and distention for 3 minutes
Interventions/Control_2
Control arm- Group B- Cystoscopy and bladder filling with saline reservoir at a height of 80cm and distention for 5 minutes
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with IC/BPS and undergoing cystoscopy and hydrodistention as a therapeutic modality
2. Age more than 18 years
Key exclusion criteria
1. Age <18 years
2. Patients not willing to participate in the study
3. Patients who have cystoscopic findings that are suggestive of an alternate diagnosis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Vibhu |
| Middle name | |
| Last name | Jain |
Organization
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, INDIA
Division name
DEPARTMENT OF UROLOGY
Zip code
160012
Address
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, SECTOR 12, CHANDIGARH, INDIA
TEL
91-7888498913
jainvibhu26@gmail.com
Public contact
Name of contact person
| 1st name | Vibhu |
| Middle name | |
| Last name | Jain |
Organization
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, INDIA
Division name
DEPARTMENT OF UROLOGY
Zip code
160012
Address
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, SECTOR 12, CHANDIGARH, INDIA
TEL
91-7888498913
Homepage URL
jainvibhu26@gmail.com
Sponsor or person
Institute
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, INDIA
Institute
Department
Personal name
Funding Source
Organization
No funding was obtained for this study
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
INSTITUTIONAL ETHICS COMMITTEE, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, INDIA
Address
INSTITUTIONAL ETHICS COMMITTEE, ROOM NO. 6006, 6th FLOOR, PGIMER, CHANDIGARH, INDIA
Tel
911722755266
iecintpgi@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070592
