MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by American Medical Systems.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
American Medical Systems
Information provided by:
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00541151
First received: October 5, 2007
Last updated: August 26, 2010
Last verified: August 2010
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Purpose
Multi-center, prospective, single arm study. Qualify patients will receive treatment for stress urinary incontinence by implantation of an AMS Sling System. The study is a long-term evaluation of effectiveness and safety associated with AMS sling systems.
| Condition | Intervention | Phase |
|---|---|---|
|
Stress Urinary Incontinence in Women |
Device: MiniArc |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Long-Term Effectiveness Trial for AMS Sling Systems |
Resource links provided by NLM:
Further study details as provided by American Medical Systems:
Primary Outcome Measures:
- Evaluation of long-term effectiveness after implantation of MiniArc sling via qualitative(i.e.UDI-6 and IIQ-7) and quantitative measurement (i.e.pad weight test and cough stress test) in females for treatment of SUI in general post-market use. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluation of procedural variables of the implantation,outcomes,and long-term safety.These outcomes will be measured via questionnaires, procedural data, and report of adverse events. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 188 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Device: MiniArc
sling system
Other Name: MiniArc or single incision sling
This study is a post market study to evaluate variables of the implantation, safety, and outcomes in a representative population (SUI) indicated for AMS sling systems at various time points. The study duration is 2 year with an estimated 200 enrollment. The outcomes of the treatment will be evaluated via pad weight test, cough stress test, QoLs,and other patient administered questionnaires.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Females 18 years or older who have confirmed SUI
Criteria
Inclusion Criteria:
- Females 18 years or older who have confirmed SUI defined as involuntary loss of urine that occurs during physical activity, such as coughing, sneezing, laughing, or exercise.
Exclusion Criteria:
- Unwilling or unable to sign ICF
- Unable to understand the study or has a history of non-compliance with medical devices
- Contradicted for the implantation surgery due to the following: renal sufficiency, urethral diverticulum, fistula, significant prolapse conditions, pregnant, pelvic cancer, compromise immune system,vulvar pain,blood coagulation disorder, and chronic abscesses
- Pelvic prolapse greater than grade 3
- Is, in the investigator's opinion, otherwise unsuitable for the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541151
Locations
| United States, North Carolina | |
| McKay Urology Research | |
| Charlotte, North Carolina, United States, 28207 | |
Sponsors and Collaborators
American Medical Systems
Investigators
| Principal Investigator: | Michael Kennelly, MD | McKay Urology Research |
More Information
No publications provided
| Responsible Party: | Audrey Singh- Clinical Project Lead, American Medical Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT00541151 History of Changes |
| Other Study ID Numbers: | WC0605 |
| Study First Received: | October 5, 2007 |
| Last Updated: | August 26, 2010 |
| Health Authority: | United States: Western Institutional Review Board and Local Institution Review Boards UK: South Glasgow and Clyde Research Ethics Committee Europe: Commissie voor Medische Ethiek Klinisch Onderzoek Canada:VIHA ethics committee |
Keywords provided by American Medical Systems:
|
Stress urinary incontinence in Women |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013