None listed
Conditions
Interventions
Medical Device : Urinary incontinence is a common condition experienced by many women and has a significant impact on quality of life. The conventional Transobturator Tape (TOT) device has been widely
Sponsors
Pusan National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Individuals aged 19 years or older, or those confirmed to have completed skeletal growth 2)Patients who have experienced stress urinary incontinence within the past 12 months 3)Patients diagnosed with stress urinary incontinence based on urodynamic studies performed within the past 12 months 4)Individuals with a post-void residual (PVR) urine volume of 100 mL or less, as measured by bladder ultrasound 5)Individuals willing to use clean intermittent catheterization (CIC) if necessary during the clinical trial period 6)Individuals who understand the informed consent form and voluntarily agree to participate in the clinical trial by signing the consent form, either personally or through a legally authorized representative 7)Individuals who are willing and able to comply with the study visit schedule and other requirements outlined in the clinical trial protocol
Exclusion criteria
Exclusion criteria: 1)Patients with severe cardiovascular, respiratory, or renal diseases 2)Individuals with a history or current diagnosis of neurogenic bladder dysfunction 3)Individuals in whom urgency-predominant urinary incontinence is considered the main cause of incontinence, as determined by the investigator 4)Individuals with pelvic or urological abnormalities that may affect bladder function within 6 months prior to screening, such as interstitial cystitis, bladder stones, previous lower urinary tract surgery, bladder disease, or other conditions affecting bladder function 5)Individuals with significant bladder outlet obstruction 6)Individuals with a history of two or more urinary tract infections (UTIs) within 6 months prior to screening, or with a current UTI at the time of screening 7)Individuals who are currently using or have used clean intermittent catheterization (CIC) or an indwelling catheter within 6 months prior to screening 8)Individuals who have undergone surgical treatment for stress urinary incontinence within 6 months prior to screening or who plan to undergo such treatment during the study period 9)Individuals with bleeding tendencies, those taking anticoagulants other than NOACs (New Oral Anticoagulants), or those who are taking NOACs or antiplatelet agents and are unable to discontinue their use for 3 days prior to the procedure and 24 hours after the procedure 10)Women who are pregnant, breastfeeding, or confirmed to be pregnant through serum or urine pregnancy tests 11)Individuals currently participating in another clinical trial, or who have participated in another clinical trial within 30 days prior to screening 12)Individuals with mental or cognitive impairments that may hinder their understanding of or compliance with the study 13)Individuals who, in the opinion of the investigator, are deemed unsuitable for participation in the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of urinary incontinence recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the incidence of postoperative complications such as infection, bleeding, and pain | — |
Countries
Korea, Republic of
Contacts
Public ContactDonggil Shin
Pusan National University Hospital
Outcome results
None listed