Stress Urinary Incontinence Stress Urinary Incontinence
Conditions
Interventions
All patients who meet the inclusion/exclusion criteria in both the device run
in and outcomes group will undergo surgical intervention with TVTO-PA.
Sponsors
Johnson & Johnson
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects with demonstrable SUI diagnosed by CST, suitable for surgical repair. 2. Age >
Exclusion criteria
Exclusion criteria: 1. Previous surgical treatment for SUI. 2. Requirement for any concurrent gynecological procedures. 3. Associated pelvic organ prolapse (either symptomatic and/or leading edge >0cm) 4. Exhibits a clinical history of predominantly OAB symptoms. 5. Current anti-cholinergic use. 6. Experimental drug or experimental medical device within 3 months prior to the planned procedure. 7. Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared. 8. Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery. 9. History of pelvic radiation. 10. Systemic disease known to affect bladder or bowel function (e.g. Parkinson*s disease, multiple sclerosis, spina bifida, spinal cord injury or trauma). 11. Nursing, pregnant or intends future pregnancy. 12. In the investigator*s opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the objective cure of urinary incontinence at 12 months after surgery. Objective Success will be defined as: * A negative SCST without surgical re-intervention for SUI Patients who are considered to fail based on the above criteria will be asked to approximate the date of recurrent symptoms in order that a Kaplan-Meier survival curve of time to failure is developed. Surgical re-intervention will include surgical repair of SUI, which will include placement of a further mid-urtheral sling and / or administration of bulking agents. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective Success defined by: * A response of "Very much better" or "Much better" in PGI-I at 12 months Symptom Change defined as: * Change from baseline in incontinence-specific symptoms assessed by UDI-6 at 12 months * Change from baseline in incontinence-specific quality of life assessed by IIQ-7 at 12 months * Change from baseline in ICIQ- SF at 12 months | — |
Countries
Netherlands
Outcome results
None listed