NCT00541151

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

August 27, 2010

Status Verified

August 1, 2010

Enrollment Period

2.9 years

First QC Date

October 5, 2007

Last Update Submit

August 26, 2010

Conditions

Stress Urinary Incontinence in Women

Keywords

Stress urinary incontinence in Women

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

MiniArcDEVICE

sling system

Also known as: MiniArc or single incision sling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Females 18 years or older who have confirmed SUI

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McKay Urology Research

Charlotte, North Carolina, 28207, United States

Location

Study Officials

  • Michael Kennelly, MD

    McKay Urology Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 10, 2007

Study Start

September 1, 2007

Primary Completion

August 1, 2010

Study Completion

November 1, 2010

Last Updated

August 27, 2010

Record last verified: 2010-08

Locations

US(1)