NCT00223106

Brief Summary

The primary objective of this study is to further evaluate the safety and effectiveness of the use of a sling device in women for stress and mixed urinary incontinence as well as vaginal vault prolapse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
467

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

Enrollment Period

3.5 years

First QC Date

September 12, 2005

Last Update Submit

July 23, 2015

Conditions

Urinary Incontinence, StressMixed IncontinenceVaginal Vault Prolapse

Keywords

urge incontinenceurinary incontinencevault prolapsestess incontinencemixed incontinenceurine leakageenterocelerectocelecystocele

Outcome Measures

Primary Outcomes (1)

  • Safety and efficacy for incontinence and prolapse procedures.

Secondary Outcomes (1)

  • Quality of Life Improvement as determined by Questionnaire.

Interventions

Vaginal SlingDEVICE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be female and \>18 years of age.
  • Subject must have genuine stress or mixed incontinence AND/OR evidence of pelvic organ prolapse.

You may not qualify if:

  • Any subject with clotting defects, bleeding disorders or receiving anticoagulant treatments AND is determined to be at risk for minimally invasive surgery as determined by the investigator
  • Subjects who currently have an untreated urinary tract infection
  • Subject is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent.
  • Subject is pregnant or desires future pregnancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Surgical

Norwalk, Connecticut, 06856, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, StressPelvic Organ ProlapseUrinary Incontinence, UrgeUrinary IncontinenceHerniaRectoceleCystocele

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProlapsePathological Conditions, AnatomicalRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesUrinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Noreen A. Gannon

    Medtronic - MITG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

March 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

July 27, 2015

Record last verified: 2015-07

Locations

US(1)