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

Stress Urinary Incontinence in Women Clinical Trial

— MiniArc  

Official title:

Long-Term Effectiveness Trial for AMS Sling Systems

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00541151
• Other study ID #: WC0605
• Status: Unknown status
• Phase: Phase 4
• First received: October 5, 2007
• Last updated: August 26, 2010
• Start date: September 2007
• Est. completion date: November 2010

Study information

• Verified date: August 2010
• Source: American Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 188
• Est. completion date: November 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence in Women
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• MiniArc
sling system

Locations

Country	Name	City	State
United States	McKay Urology Research	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
American Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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