Botulin-A Toxin Instillations and Overactive Bladder

This is an interventional treatment trial for Overactive Bladder Read More

Inclusion Criteria:

1. Female patient aged 18 years or older
2. Patient with a history of stress urinary incontinence for at least 12 months
3. Patient with Intrinsic Sphincter Deficiency who demonstrate an abdominal leak point pressure of less than 100 cm of water on urodynamic evaluation
4. Patient with urinary incontinence verified by the Provocation test: a mean urinary leakage of 10 g on screening and baseline visits
5. Patient with positive stress test and/or urodynamic stress incontinence
6. Patient who has failed prior non-invasive treatment (e.g. behavior modification, pelvic floor exercises, biofeedback, electrical stimulation and/or drug therapy)
7. Patient with negative Contigen skin test during screening.
8. Patient who is mentally competent with the ability to understand and comply with the requirements of the study
9. Patient who agrees to be available for the follow-up evaluations as required by the protocol
10. Patient who has given signed informed consent

Exclusion Criteria:

1. Patient with Q-tip angle greater than 30 degrees
2. Patient with Functional Bladder capacity <200 ml as recorded in the baseline Bladder Diary
3. Patient with Post-Void Residual Urine (PVRU) greater than 100 ml on repeated measures. (Patient with a single PVRU of >100 ml and followed by two consecutive PVRU measurements of <100 ml may be included in the study)
4. Patient with vesicoureteral reflux, interstitial cystitis, genitourinary fistulae
5. Patient with predominant urge incontinence
6. Patient with detrusor overactivity on filling cystometry
7. Patient with pelvic organ prolapse stage III or IV, i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen (>+1), at straining
8. Patient with urinary incontinence due to neurological disease that is known to affect urinary tract infection
9. Patient with uninvestigated hematuria
10. Patient with genitourinary malignancies
11. Patient on current medication for stress urinary incontinence, such as alpha-adrenergic agonists or duloxetine, within three weeks prior to completing the baseline Bladder Diary (estrogen therapy on a stable dose for at least two months prior to study start is allowed)
12. Patient who has had bulking therapy for stress urinary incontinence
13. Patient with ongoing complications of prior anti-incontinence surgery
14. Patient who is pregnant, lactating, or planning to become pregnant within the study period
15. Patient who has received pelvic radiation
16. Patient with any condition, which could lead to significant postoperative complications, including current infection and uncontrolled diabetes.
17. Patient who is morbidly obese (defined as BMI > 32 Kg/m2)
18. Patient who is bedridden, institutionalized or in such physical condition that she cannot move to the closest bathroom without assistance from another person
19. Patient with current or acute urinary tract infection, including cystitis or urethritis. (Patient with such infections should be treated with antibiotics, with subsequent urinalysis tests confirming the absence of such infection before study inclusion)
20. Patient with any condition that would preclude treatment due to contraindications and/or warnings in the study product's labeling
21. Patient on concomitant medication with anticoagulant properties (e.g., Warfarin, Heparin, Aspirin, Nonsteroidal anti-inflammatory drugs (NSAIDs), except for cox-2 inhibitors) within two weeks prior to treatment
22. Patient on immunomodulatory therapy (suppressive or stimulatory)
23. Patient with a known allergy to bovine collagen
24. Patient with known lidocaine hypersensitivity or hypersensitivity to any anesthetics to be used during the treatment session/surgical procedure
25. Patient with a concurrent use of another study product within two weeks prior to study start, or who concurrently participate in any other clinical study
26. Any disease that in the opinion of the Investigator would make the patient unsuitable for the study
27. Patient with a life expectancy of less than 12 months