Overview

This trial is active, not recruiting.

Condition stress urinary incontinence in women
Treatment miniarc
Phase phase 4
Sponsor American Medical Systems
Start date September 2007
End date August 2010
Trial size 188 participants
Trial identifier NCT00541151, WC0605

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Long-Term Effectiveness Trial for AMS Sling Systems
Principal investigator Michael Kennelly, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by American Medical Systems.