NCT01137539

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

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

October 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

June 28, 2017

Completed
Last Updated

June 28, 2017

Status Verified

May 1, 2017

Enrollment Period

4 years

First QC Date

May 24, 2010

Results QC Date

April 12, 2017

Last Update Submit

May 25, 2017

Conditions

Urinary IncontinenceStress Urinary Incontinence

Keywords

urinary incontinencestress urinary incontinencemid-urethral slingsTension-free vaginal tapingTVT

Outcome Measures

Primary Outcomes (1)

  • Treatment Success Based on Patient Report on Validated Questionnaire

    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.

    24 months

Secondary Outcomes (1)

  • Patient Satisfaction

    12 months

Study Arms (1)

Gynecare TVT-SECUR system

EXPERIMENTAL

All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence

Device: Gynecare TVT-SECUR system

Interventions

Gynecare TVT-SECUR systemDEVICE

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

Also known as: TVT-S, Mid-urethral sling
Gynecare TVT-SECUR system

Eligibility Criteria

Age21 Years - 89 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Urogynecology of Michigan PC

Dearborn, Michigan, 48124, United States

Location

MeSH Terms

Conditions

Urinary IncontinenceUrinary Incontinence, Stress

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 Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Results Point of Contact

Title
Salil Khandwala/Medical Director
Organization
Michigan Institute of Women's Health
313-982-0200

Study Officials

  • Salil S Khandwala, MD

    Michigan Institute of Women's Health PC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President, Michigan Institution of Women's Health PC

Study Record Dates

First Submitted

May 24, 2010

First Posted

June 4, 2010

Study Start

October 1, 2008

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

June 28, 2017

Results First Posted

June 28, 2017

Record last verified: 2017-05

Locations

US(1)