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Completed

NCT Number: NCT01137539

TVT-SECUR as an Office-based Procedure

This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires.

This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 3 years.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

21 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Urogynecology of Michigan PC

Dearborn, Michigan, 48124, United States

About this study

The study will include 50 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting from urethral hypermobility with no prior urinary incontinence surgery. Subjects are women who no longer intend to bear children and who do not require any other concomitant surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stress urinary incontinence with hypermobility of the UV junction
  • ASA I or II
  • Age 21-89

Exclusion criteria

  • Prior anti-incontinence surgery
  • Not completed childbearing
  • ASA III or higher
  • Need concomitant surgery
  • Poor compliance for office based approach

Treatment and study plan

Gynecare TVT-SECUR system

Device

All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence

Other names: TVT-S, Mid-urethral sling

Primary outcomes

  1. Treatment Success Based on Patient Report on Validated Questionnaire

    Time frame: 24 months

    Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, "Do you currently experience urine leakage related to physical activity, coughing or sneezing." If a subject answers "No", this is considered success. If a subject answers "Yes", this is considered failure of treatment.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 12 months

    Positive response to a satisfaction question

Sponsors and collaborators

Lead sponsor

Michigan Institution of Women's Health PC

Other

Collaborators

  • Ethicon, Inc.

Registry information

Official study title

TVT-SECUR as an Office-based Procedure - A Pilot Study

Acronym: TVTSOffice

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 4, 2010
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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