MDACC Study Summary 2008-0775 (Archived)

Study Summary
No. 2008-0775:.......Bladder; Genitourinary; Prostate......Ouida L. Westney......Urology

Study Summary Title



Study Summary Number:	2008-0775

Study Title:	VIRTUE Male Sling Study

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:	Bladder Genitourinary Prostate	Supported By:	Coloplast Corporation

Phase of Study:	N/A	Return Visit:	At 6 weeks, 3 months, 6 months and 12 months post implant

Treatment Agents:	VIRTUE Male Sling	Home Care:	Activity will limited for 4-6 weeks after surgery. Lifting, bike riding, running, walking fast or any other physical activities may cause problems with the sling causing it to not work properly.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	The operation to implant male sling is considered major surgery. The physician may decide to send patient home from the hospital on the same day as the surgery or may keep the patient in the hospital overnight.


Description/ Intervention:	The goal of this clinical research study is to learn if the VIRTUE male sling helps improve urinary control. Researchers also want to learn how difficult the sling is to implant, and the safety of the sling in patients with urinary incontinence.

Study Objectives / Outcomes

The primary objective of this study is to assess efficacy through subject satisfaction of the VIRTUE male sling at one-year post implant.

Secondary objectives will assess efficacy, standardization of surgical protocol, ease of implant, determine a safety profile through reporting of adverse events, and assess subject satisfaction and daily pad use.

This is a post-market study being conducted by Coloplast to assess patient satisfaction and efficacy of the device. This is strictly for the company to evaluate the device with respect to standardized outcome measures and is not being required by any regulatory body.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	04/17/2009

Study Type:	Other

Recruitment Status:	Terminated

Projected Accrual:	120

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 is male

2) The subject is at least 18 years of age

3) The subject has an estimated life expectancy of more than 5 years

4) The subject has confirmed stress urinary incontinence (SUI) through medical history, urodynamics, and/or physical exam for at least 6 months

5) The subject has intrinsic sphincter deficiency due to one of the following: post TURP (Transurethral Resection of the Prostate), simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date

6) The subject is willing to have the VIRTUE male sling implanted

7) The subject is able and willing to complete all follow-up visits and procedures indicated in this protocol

8) The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the local ethics committee of the respective site

Exclusion Criteria:

1) The subject is unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements according to the study protocol

2) The subject has an active urogenital infection or active skin infection in region of surgery

3) The subject has serious bleeding disorders

4) The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, Cardiovascular Accident (CVA), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions

5) The subject had a previous implant to treat stress urinary incontinence

6) The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months. At M.D. Anderson we will not enroll patients who have been previously radiated.

7) The subject is likely to undergo radiation therapy within the next 6 months

8) The subject has active urethral or bladder neck stricture disease, requiring continued treatment

9) The subject has urge predominant incontinence

10) The subject has an atonic bladder or a postvoid residual (PVR) >/=150mL

11) The subject has a condition or disorder likely to require future transurethral procedure

12) The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsors' approval

13) The subject is deemed unfit for male sling implantation or participation in a research protocol as determined by the attending physician

Links

Registration Number: NCT00856778
Study Information on Clinical Trials Registry (clinicaltrials.gov)