Efficacy and Safety of Incontinence Device URINO in women with Stress Urinary Incontinence : Prospective, Multi-center, Single-arm, Pre-and-Post intervention, Confirmative Trial

Not Applicable

Completed

• Conditions: Diseases of the genitourinary system

• Registration Number: KCT0008369
• Lead Sponsor: Rim Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-01-26
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

1) Women between the ages of 30 and 80
2) Subjects with symptoms of stress urinary incontinence for more than 3 months at the time of screening
3) Subjects with more than 1g in 20-minute pad test with more than 250 ml on ultrasonic examination for bladder residual measurement without URINO
4) Those who understand this clinical trial and voluntarily sign the consent form

Exclusion Criteria

1) A person with a genitourinary disease, such as urinary tract infection or vaginitis, that has occurred within the last 6 months that has been maintained until the time of screening or is likely to recur
2) Those who have undergone procedures or surgeries for the treatment of urinary incontinence
3) A person who has undergone a procedure or surgery on the genitals and/or nearby organs in contact with this clinical trial medical device within the last 6 months (birth, etc.)
4) Those who with non-healing scars, allergies, and/or musculoskeletal diseases at the site of contact with this clinical trial medical device at the time of screening
5) Those who with severe pelvic organ prolapse of Grade 3 or higher
6) Among women who are pregnant or not menopausal at the time of screening, those who did not agree to comply with the contraceptive regimen suggested in this clinical trial during the clinical trial period
7) Those who with urge urinary incontinence
8) Those who have participated in other clinical trials within 30 days prior to screening or are expected to participate during this clinical trial
9) A person who is unable to fully participate in the consent process due to limited autonomy or a vulnerable environment
10) Under the judgment of the clinician, the elderly and those who are considered to have difficulty in using and testing the product
11) Other investigators judged to be inappropriate to participate in this clinical trial

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage (%) of subjects whose 20-minute pad test result at 1 week compared to baseline was reduced by more than 50%

Secondary Outcome Measures

Name	Time	Method
Satisfaction evaluated by VAS (points); irritation points evaluated on the 5-likert scale;duration of use(patient diary)