Trial Search Results

Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Coloplast A/S

Stanford Investigator(s):

Intervention(s):

  • Device: Altis Sling
  • Device: Transobturator or Retropubic Sling

Eligibility


Inclusion Criteria:

   - The subject is female and at least 18 years of age.

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

   - The subject has confirmed stress urinary incontinence through cough stress test or
   urodynamics.

   - The subject has failed two non-invasive incontinence therapies (such as Kegal
   exercise, behavior modification, pad use, biofeedback, etc.) for > 6 months.

Exclusion Criteria:

   - The subject has an active urogenital infection or active skin infection in region of
   surgery.

   - The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as
   determined by POP-Q prolapse grading.

   - The subject is having a concomitant pelvic floor procedure.

   - The subject has incontinence due to neurological causes (e.g. multiple sclerosis,
   spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter
   dyssynergia, Parkinsons disease, or similar conditions).

   - The subject had a prior surgical stress urinary incontinence treatment.

   - The subject has undergone radiation or brachy therapy to treat pelvic cancer.

   - The subject has urge predominant incontinence by MESA assessment.

   - The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2
   occasions.

   - The subject is pregnant and/or is planning to get pregnant in the future.

   - The subject has a contraindication to the surgical procedure of the product
   Instructions for use (IFU).

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathryn Batham
650-724-7846
Recruiting