N/A
Completed N=98
Virtue® Male Incontinence Sling Study
Source: ClinicalTrials.gov NCT00856778 ↗Enrolled (actual)
98
Serious AEs
2.0%
Results posted
Apr 2014
Primary outcomePrimary: Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I) — 41.9 % of subjects successful
Summary
This study is a multi-center, global study that will assess the effectiveness and patient satisfaction of the male incontinence sling 12 months after implant as well as the safety profile of the product.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I) |
41.9 | — |
| PRIMARY Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry). |
62.0 | — |
| SECONDARY Assess Change in Subject Satisfaction Through ICIQ |
12.0 | — |
| SECONDARY Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother |
36.5 | — |
| SECONDARY Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function |
37.1 | — |
| SECONDARY Assess Change in Pad Use |
2.4 | — |
| SECONDARY Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward |
4.1; 6.1; 3.1; 24.5; 62.2 | — |
| SECONDARY Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies |
3.1; 13.3; 10.2; 9.2; 64.3 | — |
| SECONDARY Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra |
3.1; 2.0; 3.1; 30.6; 61.2 | — |
Eligibility Criteria
Inclusion Criteria
- Male subject at least 18 yrs old with an estimated life expectancy of more than 5 years
- Confirmed SUI (stress urinary incontinence) through medical history, urodynamics, and/or physical exam
- Subject has completed urodynamics, uroflow, post-void residual and cystoscopy per protocol within 12 months prior to implant
- Subject has intrinsic sphincter deficiency due to one of the following: post-TURP (trans-urethral resection of the prostate), simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date
- Subject is willing to have the Virtue male sling implanted and is able and willing to completed all f/u visits and procedures as indicated in protocol
- Subject agrees to the provisions of the study and has provided written informed consent as approved by the local ethics committee of the respective site
Exclusion Criteria
- Subject is unable or unwilling to sign the Informed Consent Form and/or comply with provisions of the study
- Subject has active urogenital infection or active skin infection in region of surgery
- Subject has serious bleeding disorders
- Subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury,CVA (cerebrovascular accident), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
- Subject has previous implant to treat SUI
- Subject has undergone radiation, cryosurgery, or brachytherapy to treat prostate or other pelvic cancer with 6 months or is likely to undergo radiation therapy within the next 6 months
- Subject has active urethral or bladder neck stricture disease requiring continued treatment
- Subject has urge predominant incontinence
Data sourced from ClinicalTrials.gov (NCT00856778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.