MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems

• Conditions: Stress Urinary Incontinence in Women

• Registration Number: NCT00541151
• Lead Sponsor: American Medical Systems

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-10
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Last Update Submitted: 2010-08-26
• Last Update Posted: 2010-08-27
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 188

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	2 years

Secondary Outcome Measures

Name	Time	Method
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.	2 years

Trial Locations

Locations (1)

McKay Urology Research; 🇺🇸 Charlotte, North Carolina, United States