A Prospective, Multi-centre Study to Evaluate the Clinical Performance of TVTO-PA as Treatment for Stress Urinary Incontinence

Conditions: Stress Urinary Incontinence

Registration Number: NL-OMON36399

Lead Sponsor: Johnson & Johnson

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

1. Subjects with demonstrable SUI diagnosed by CST, suitable for surgical repair.
2. Age ><=18 years.
3. Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee approved informed consent.
4. Post-void residual volume <100ml as determined prior to the SCST

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be the objective cure of urinary incontinence at 12<br /><br>months after surgery.<br /><br><br /><br>Objective Success will be defined as:<br /><br>* A negative SCST without surgical re-intervention for SUI<br /><br>Patients who are considered to fail based on the above criteria will be asked<br /><br>to approximate the date of recurrent symptoms in order that a Kaplan-Meier<br /><br>survival curve of time to failure is developed. Surgical re-intervention will<br /><br>include surgical repair of SUI, which will include placement of a further<br /><br>mid-urtheral sling and / or administration of bulking agents.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Subjective Success defined by:<br /><br>* A response of Very much better or Much better in PGI-I at 12 months<br /><br><br /><br>Symptom Change defined as:<br /><br>* Change from baseline in incontinence-specific symptoms assessed by UDI-6 at<br /><br>12 months<br /><br>* Change from baseline in incontinence-specific quality of life assessed by<br /><br>IIQ-7 at 12 months<br /><br>* Change from baseline in ICIQ- SF at 12 months</p><br>