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Clinical Evaluation of Ajust™ in Stress Urinary Incontinence

NCT01290796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2017-03-27

Study results available
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Summary

The purpose of this study is to assess the overall effectiveness of the Ajust Adjustable Single-Incision Sling in the surgical treatment of female stress urinary incontinence.

Conditions

  • Female Stress Urinary Incontinence

Interventions

DEVICE

Ajust Adjustable Single-Incision Sling

The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Vincent Lucente, MD · Institute for Female Pelvic Medicine and Reconstructive Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-06-30
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290796 on ClinicalTrials.gov