Solace European Confirmatory Trial: An Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects with Stress Urinary Incontinence.

Completed

Conditions: 10046590
Stress Urinary incontinence

Registration Number: NL-OMON39390

Lead Sponsor: Solace Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

1. Has the patient signed a written informed consent form?
2. Is the patient a female 18 years of age or older with stress urinary incontinence that has been documented by visual confirmation of the leakage during stress maneuvers?
3. Has the patient experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment (behavior modification, bladder training exercises, pelvic muscle rehabilitation, biofeedback, electrical or drug therapy) while incontinent?
4. Is the patient available for the minimum study duration of 12 months with a maximum duration of 3 years?
5. Is the patient willing to undergo cystoscopic and urodynamic procedures required during the study period?
6. Has the patient been on stable medication for a minimum of 3 months?
7. Is the patient free of uncontrolled psychiatric illness?
8. Is the patient alert, oriented, mentally competent, and capable of determining their need to void by sensing and responding to an urge to void?
9. Is the patient free of local genital skin infection?
10. Did the patient have a Positive 1-hour Pad Weight (in-office provocative) Test of * 5 g?
11. Is the patient free of impassable urethral strictures, trauma or necrosis?
12. Does the patient have a baseline I-QOL score of *80?

Exclusion Criteria

1. Is the patient pregnant or planning to become pregnant during the study period?
2. Does the patient have a life expectancy of < 3 years?
3. Is the patient unwilling to adhere to visit or examination schedules as described in the study protocol?
4. Is the patient non-ambulatory or bedridden or physically unable to complete test exercises?
5. Is there a history of alcoholism or illicit drug abuse within the last year?
6. Is the patient morbidly obese (defined as BMI * 40 kg/m2)?
7. Does the patient have a bladder infection (including bladder inflammation or edema), urethral inflammation, urethral edema, urinary tract infection or asymptomatic bacteriuria observer during study entry and for 3 months prior to study entry?
8. Does the patient have a history of recurrent urinary tract infections (* 2 in the past year)?
9. Does the patient have gross hematuria and/or blood clots in the urine?
10. Does the patient have a history of recent urosepsis (within the previous 30 days)?
11. Has the patient had a prior surgical procedure for incontinence during the past 6 months?
12. Is the patient undergoing or has she undergone biofeedback within three months?
13. Is the patient taking medications for urinary incontinence other than anticholinergics?
14. Is the patient taking other pharmacologic agents that may have a significant effect on bladder function (excluding estrogen and progesterone in menopausal women) and has not been stable on the therapy for at least 3 months or does not intend to continue the medication throughout the trial?
15. Does the patient have urinary incontinence of neurogenic etiology?
16. Does the patient have any neurological disease that could impact bladder function including Parkinson*s disease, multiple sclerosis or post stroke sequelae?
17. Does the patient have a history of interstitial or follicular cystitis?
18. Does the patient have a history of an artificial urinary sphincter?
19. Does the patient have a Cystocele with Stage 3 or higher as scored by the PoP-Q Classification?
20. Is the patient undergoing or anticipating a course of radiation therapy or have severe pelvic fibrosis from previous radiation therapy?
21. Does the patient have a history of kidney stones?
22. Does the patient have uncontrolled diabetes?
23. Does the patient have any active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
24. Does the patient have a prosthetic heart valve or other cardiac condition that puts her at increased risk of subacute bacterial endocarditis?
25. Is the patient unable to tolerate any form of antibiotic?
26. Is the patient taking anticoagulation therapy, other than aspirin?
27. Is the patient immunologically suppressed or immunocompromised?
28. Does the patient have a known allergy to polyurethanes or perfluorocarbons?
29. Does the patient have a Valsalva Leak Point Pressure < 60 cm H20?
30. Does the patient have urinary incontinence due to ISD?
31. Does the patient have post-void residual urine of >100 cc consistently?
32. Does the patient have a urinary flow rate of <5 cc/per second with a minimum voided volume of 150 cc?
33. Does the patient have a bladder capacity of <150 cc or >400 cc?
34. Does the p