AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence

J

Jewish General Hospital

Status

Unknown

Conditions

Stress Urinary Incontinence

Treatments

Procedure: ARGUS Sling procedure
Procedure: AdVance® sling procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT01866085
12-013

Details and patient eligibility

About

The study is designed to assess efficacy and subject satisfaction of two sling devices: Advance and Argus, in male patients with stress urinary incontinence after prostatectomy.

Enrollment

128 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The subject is male
  • The subject is at least 18 years of age
  • The subject has an estimated life expectancy of more than 5 years
  • The subject has confirmed stress urinary incontinence (SUI) through medical history, urodynamics, and/or physical exam for at least 6 months
  • The subject has intrinsic sphincter deficiency due to one of the following:

post-TURP, simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date

  • Positive Cough Stress Test (CST):
  • Positive 24-hours Pad Test (PT):

A positive PT is confirmed with leakage of >8.O g/24h and < 400 g

  • The subject has completed urodynamics, uroflow, post-void residual, and cystoscopy as per the protocol within 6 months prior to implant
  • The subject is able and willing to complete all follow-up visits and procedures indicated in this protocol
  • 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 commit-tee of the respective site

Exclusion criteria

  • Subjects who meet any of the following criteria are excluded from entry into the study
  • 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
  • The subject has an active urogenital infection or active skin infection in region of surgery
  • The subject has serious bleeding disorders
  • The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, CVA, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
  • The subject had a previous implant to treat stress urinary incontinence
  • The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months
  • The subject is likely to undergo radiation therapy within the next 6 months
  • The subject has active urethral or bladder neck stricture disease, requiring continued treatment
  • The subject has urge predominant incontinence
  • The subject has an atonic bladder or a postvoid residual (PVR) ≥150mL
  • The subject has a condition or disorder likely to require future transurethral procedure
  • The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsors'approval
  • Subjects who in the opinion of the investigator are unable and/or unlikely to to comprehend the nature, scope and possible consequences of the study and to follow the study procedures and instructions and complete all study related measurements.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

128 participants in 2 patient groups

AdVance
Active Comparator group
Description:
sling procedure
Treatment:
Procedure: AdVance® sling procedure
ARGUS
Active Comparator group
Description:
sling procedure
Treatment:
Procedure: ARGUS Sling procedure

Trial contacts and locations

1

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Central trial contact

Jacques Corcos, MD; Oleg Loutochin

Data sourced from clinicaltrials.gov

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