N/A
Completed N=113
The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study
Source: ClinicalTrials.gov NCT01272284 ↗Enrolled (actual)
113
Serious AEs
2.7%
Results posted
Nov 2013
Primary outcomePrimary: Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months — 85.4 percentage of participants — p=<0.0001
Summary
An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months |
85.4 | <0.0001 sig |
| SECONDARY Percentage of Participants With Negative Cough Stress Test at 6 Months |
92.2 | — |
| SECONDARY Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months |
88 | — |
| SECONDARY Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months |
88.6 | — |
| SECONDARY Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months |
93.3 | — |
| SECONDARY Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 6 Months |
87.6 | — |
| SECONDARY Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months |
90.1 | — |
| SECONDARY Percentage of Participants With Negative Cough Stress Test at 12 Months |
90.1 | — |
| SECONDARY Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months |
89.3 | — |
| SECONDARY Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months |
90.3 | — |
| SECONDARY Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 12 Months |
89.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is female at least 18 years of age
- Subject is able and willing to complete all procedures and follow-up visits indicated in this protocol
- Subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics
- The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc) for >6 months
Exclusion Criteria
- Subject has an active urogenital infection or active skin infection in region of surgery
- Subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading
- Subject is having a concomitant pelvic floor procedure
- Subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions)
- Subject had a prior surgical SUI treatment
- Subject has undergone radiation or brachy therapy to treat pelvic cancer
- Subject has urge predominant incontinence
- Subject has an atonic bladder or a post void residual (PVR) consistently about 100cc
- Subject is pregnant and/or is planning to get pregnant in the future
- Subject has a contraindication to the surgical procedure or the Altis Instructions For Use (IFU)
- Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsor's approval
Data sourced from ClinicalTrials.gov (NCT01272284). 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.