MDACC Study Summary 2005-0490 (Archived)

Study Summary
No. 2005-0490:.......Prostate......Ouida L. Westney......Urology

Study Summary Title



Study Summary Number:	2005-0490

Study Title:	A Multi-Center Post-Approval Prospective Study Of The AMS Intemesh™ Silicone-Coated Sling With Inhibizone™

Physician

New Patient Referral



Name:	Ouida L. Westney	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Urology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-3250 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Follow-up is at 3, 6, 12, and 24 months.

Treatment Agents:	None	Home Care:	24 hour pad test at baseline and then at 3,6,12 and 24 months.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Generally less than 24 hours


Description/ Intervention:	The goal of this clinical research study is to look at the safety of the InteMesh™ Silicone-Coated Sling with InhibiZone™, (InhibiZone treated InteMesh) and whether it improves urinary continence in participants as seen in a 24-hour pad weight test. Changes in quality of life will also be evaluated in this study.

Study Objectives / Outcomes

The objectives of this study are to:
- record safety through adverse event reporting;
- evaluate improvement in continence as evidenced by a decrease in the amount of urine lost during the 24-hour pad weight test, increase in total score on the Incontinence Quality of Life Questionnaire (I-QOL), change in incontinence severity as measured by the UCLA/RAND and ICIQ questionnaires from baseline to follow-up;
- assess the correlation of subject's incontinence severity measures with the results of the pad weight tests.

Study Status Information



Study Activation / Registration Date:	06/07/2006

IRB Review and Approval Date:	09/07/2005

Study Type:	Other

Recruitment Status:	Terminated

Projected Accrual:	60

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) The subject has agreed to be implanted with the AMS InteMesh Silicone- Coated Sling with InhibiZone.

2) The subject is willing and able to give valid informed consent.

3) The subject's reading level is judged adequate for reading and understanding the informed consent, quality of life questionnaires, and other study materials.

4) The subject is greater than or equal to 21 years of age.

5) The subject has no known sensitivity to rifampin/rifampicin or to minocycline or other tetracyclines.

6) The subject does not have systemic lupus erythematosus.

7) The subject has confirmed urinary incontinence for at least six months.

8) The subject's primary etiology is post-TUR, post-TURP, post-suprapubic prostatectomy, open prostatectomy, or radical prostatectomy done at least 6 months prior to implantation date.

9) Pre-existing urological conditions, other than incontinence, have been treated and are under control.

10) The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.

11) 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 or a post-void residual greater than or equal to 120 ml.

3) The subject has symptomatic bladder neck stricture disease.

4) The subject has current symptomatic urethral strictures.

5) The subject has any condition or disorder likely to require future transurethral instrumentation.

6) The subject self-catheterizes.

7) The subject has Detrusor-External Sphincter Dys synergia.

8) The subject has a current Urinary Tract Infection (UTI) or active skin infection in the region of surgery.

9) The subject was previously treated with pelvic radiation.

10) The subject has previously had a urethral sling, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (other than injectable bulking agents).

11) The subject has bone deformation or other pathological conditions of the bone, such as severe osteoporosis, which would impair secure bone screw fixation.

12) The subject has previous or active osteomyelitis.

13) The subject has a history of connective tissue or autoimmune conditions.

14) The subject has a compromised immune system. The subject has a compromised immune system. If the immunodeficiency is a primary syndrome or secondary to prior or ongoing chemotherapy, the following counts must be normalized prior to treatment - white blood cell counts (4.0 - 11.0 K/microliter), Neutrophil absolute count (1.70 - 7.30), Lymphocyte absolute count (1.00 - 4.80) and absolute CD4 positive cells (205 - 1451).

15) The subject has renal insufficiency and upper urinary tract relative obstruction. The subject has renal insufficiency and upper urinary tract relative obstruction. Any potential subject with a creatinine greater than 1.5 mg/dl must be evaluated with a diuretic renal scan. A t1/2 of greater than 15 minutes after Lasix administration (for either renal unit) on the scan will result in exclusion from the study.

16) The subject has blood coagulation disorders. The subject has blood coagulation disorders. A subject diagnosed with a primary hypercoaguable or hypocoagualbe state will be excluded. Those on blood thinners or antiplatelet agents must terminate these agents at least 10 days prior to surgery. The following parameters must be confirmed to be in the normal range for the institutional laboratory prior to surgery: PT, PTT, platelet count and bleeding time.

Links

Registration Number: Not Applicable Clinical Trial