Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059056) titled 'Determining Optimal Conditions for Compression Stockings Used in the Treatment of Nocturia' on Sept. 11.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Dose comparison
Primary Sponsor:
Institute - Chiba Prefectural Sawara Hospital
Condition:
Condition - Nocturia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective is to determine the optimal length and appropriate compression pressure of compression stockings used for treating nocturia.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Wearing compression stockings during the daytime for one month
Interventions/Control_2 - Wearing compression stockings during the daytime for one month under different conditions for Intervention 1
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients with nocturia (two or more night time frequency)
Patients aged 20 years or older at the time of consent acquisition
Patients who did not refuse participation in this study
Key exclusion criteria - Patients with hypersensitivity to the materials in compression stockings
Patients with a history of urinary tract infections (e.g., cystitis), urinary tract stones (e.g., ureteral stones, urethral stones, bladder stones), urethral disorders (e.g., urethral polyps, urethral diverticula), or recurrent urinary tract infections (occurring three or more times within 180 days prior to compression stocking use)
Patients who underwent pelvic organ surgery (e.g., radical hysterectomy, radical rectal cancer resection, extensive pelvic lymph node dissection) within 30 days prior to compression stocking application
Patients who received physical therapy (pelvic floor muscle training, feedback training, biofeedback training, vaginal cones, bladder training, electrical stimulation therapy, magnetic stimulation therapy, etc.) within 30 days prior to wearing compression stockings
Patients with severe arterial circulatory disorders, congestive heart failure, or painful cyanotic varicose veins
Patients with suppurative phlebitis
Other patients deemed unsuitable for this study by the principal investigator or others
Target Size - 40
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2024 Year 10 Month 21 Day
Date of IRB - 2024 Year 10 Month 21 Day
Anticipated trial start date - 2024 Year 10 Month 21 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067549
Disclaimer: Curated by HT Syndication.
