Tokyo, May 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061693) titled 'LOW-PRESSURE VERSUS HIGH-PRESSURE HYDRODISTENTION IN INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME (IC/BPS): A RANDOMISED CONTROLLED TRIAL' on May 26.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Dose comparison
Primary Sponsor:
Institute - POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, INDIA
Condition:
Condition - NTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME (IC/BPS)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the optimal hydrodistention technique for IC/BPS patients
Basic objectives2 - Efficacy
Intervention:
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
Eligibility:
Age-lower limit - 18
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 Size - 30
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070592
Disclaimer: Curated by HT Syndication.
