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Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT02348112
Recruitment Status : Recruiting
First Posted : January 28, 2015
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:
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.

Condition or disease Intervention/treatment
Stress Urinary Incontinence Device: Altis Sling Device: Transobturator or Retropubic Sling

Detailed Description:
This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=266) and transobturator and/or retropubic slings (n=133) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress incontinence who are clinically indicated for surgical intervention with a mesh sling.

Study Type : Observational
Estimated Enrollment : 399 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence
Study Start Date : January 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Altis Sling
Subjects will have an Altis sling placed to treat stress urinary incontinence.
Device: Altis Sling
Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.
Other Name: Altis Single Incision Sling System

Transobturator or Retropubic Sling
Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.
Device: Transobturator or Retropubic Sling
Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.




Primary Outcome Measures :
  1. Observed device and/or procedure-related serious adverse events [ Time Frame: 36 months ]
  2. Observed effectiveness, defined as a reduction from baseline in 24-hour pad weight of at least 50% [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Observed rates for the following: organ perforation, bleeding, mesh exposure in the vagina, mesh erosion into the bladder, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary or neuromuscular problems [ Time Frame: 6, 12, 18, 24, and 36 months ]
  2. Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50%. [ Time Frame: 12, 18, 24, and 36 months ]
  3. Quality of Life [ Time Frame: 6, 12, 18, 24, and 36 months ]
    Measured through the following questionnaires: Patient Global Impression of Improvement (PGI-I), Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), Surgical Satisfaction Questionnaire (SSQ-8), Visual Analog Scale for Pain (VAS Pain)

  4. Observed adverse events of the index procedure [ Time Frame: 6, 12, 18, 24, and 36 months ]
  5. Observed revision/re-surgery [ Time Frame: 6, 12, 18, 24, and 36 months ]
  6. Observed effectiveness for subjects considered dry (pad weight less than or equal to 4.0 grams) [ Time Frame: 6, 12, 18, 24, and 36 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be selected from urology or urogynecology specialties.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348112


Contacts
Contact: Kris Veltum 763-248-5744 uskve@coloplast.com

  Show 29 Study Locations
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Ty Erickson, MD Rosemark WomenCare Specialists

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT02348112     History of Changes
Other Study ID Numbers: SU020
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Coloplast A/S:
stress urinary incontinence
Altis 522
urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders