Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT00904969
Eligibility Criteria:
Inclusion Criteria:
1. The subject has agreed to be implanted with the AMS Male Transobturator Sling System.
2. The subject is willing and able to give valid informed consent.
3. The subject is \> 40 years of age.
4. The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management.
5. The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.
6. Internal sphincter contractility confirmed by endoscopic view.
7. The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy
8. Pre-existing urological conditions, other than incontinence have been treated and are under control.
9. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
10. The subject is a good surgical candidate.
Exclusion Criteria:
1. The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
2. The subject has an atonic bladder.
3. The subject has a post-void residual \> 75 cc.
4. The subject has detrusor-external sphincter dyssynergia.
5. The subject has a urinary tract infection (UTI).
6. The subject was treated with pelvic radiation within the last 6 months.
7. The subject currently has an inflatable penile prosthesis.
8. The subject self-catheterizes.
9. The subject has symptomatic or unstable bladder neck stricture disease.
10. The subject has a history of urethral strictures that may require repetitive instrumentation.
11. The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents).
12. The subject has a history of connective tissue or autoimmune conditions.
13. The subject has a compromised immune system.
14. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
15. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT00904969
Study Brief:
Protocol Section:
NCT00904969