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Procedure

TVT-SECUR as an Office-based Procedure (TVTSOffice Trial)

Dearborn, MI
N/A
Waitlist Available
Led By Salil S Khandwala, MD
Research Sponsored by Michigan Institution of Women's Health PC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

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.

See full description
Eligible Conditions
  • Treatment of Stress Urinary Incontinence
  • Stress Incontinence
  • Urinary Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment Success Based on Patient Report on Validated Questionnaire
Secondary study objectives
Patient Satisfaction

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gynecare TVT-SECUR systemExperimental Treatment1 Intervention
All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gynecare TVT-SECUR system
2008
N/A
~50

Find a Location

Closest Location:Advanced Urogynecology of Michigan PC· Dearborn, MI· 164 miles

Who is running the clinical trial?

Michigan Institution of Women's Health PCLead Sponsor
7 Previous Clinical Trials
341 Total Patients Enrolled
Ethicon, Inc.Industry Sponsor
94 Previous Clinical Trials
62,271 Total Patients Enrolled
Salil S Khandwala, MDPrincipal InvestigatorMichigan Institute of Women's Health PC
~3 spots leftby Mar 2026
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