NCT01657916

Brief Summary

Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

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

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

3.1 years

First QC Date

August 2, 2012

Last Update Submit

June 8, 2017

Conditions

Stress Urinary Incontinence

Keywords

mid-urethral slingAlign urethral support systemtension free vaginal tapecough stress testpelvic examPFDI-20PFIQSSQUrinary retentionmesh erosionurodynamics

Outcome Measures

Primary Outcomes (1)

  • Cough stress test

    Patient will void and their post-void residual amount of urine will be obtained by a catheter. That same catheter will be left in place and used to fill the bladder with 250ml sterile saline. The patient will then be asked to vigorously cough in the upright sitting and standing positions. A positive "cough test" will be defined as any leakage of urine that is visualized during coughing in the sitting or standing position.

    5 year follow up appt

Secondary Outcomes (4)

  • Pelvic exam

    5 year follow up appt

  • Stress urinary incontinence related symptoms

    5 year follow up appointment

  • Urgency incontinence related symptoms

    5 year follow up appointment

  • Quality of life and self-reported data

    5 year follow up appointment

Study Arms (1)

5 year sling implants

Patients who underwent implant of the Align Urethral Support System between June 2007 and December 2008

Eligibility Criteria

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

women who suffered from stress urinary incontinence (leakage of urine will laughing/coughing/sneezing/exercising)

You may qualify if:

  • women
  • complaint of stress urinary incontinence
  • underwent Align urethral support system from June 2007-December 2008

You may not qualify if:

  • concommitant procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Retention

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 6, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

June 9, 2017

Record last verified: 2017-06

Locations

US(1)