search
Back to results

Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence (SECURiTy)

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
tension-free vaginal tape
TVT-SECUR device
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, sling procedures, tension-free vaginal tape

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Urinary incontinence symptoms
  • Urodynamic stress incontinence confirmed with multichannel urodynamic testing
  • Age of at least 21 years
  • Desires surgical correction of stress urinary incontinence

Exclusion Criteria:

  • Post-void residual volume >100cc
  • Detrusor overactivity on preoperative multichannel urodynamic testing
  • History of previous synthetic, biologic or fascial sub-urethral sling
  • Desires future childbearing
  • History of bleeding diathesis or current anti-coagulation therapy
  • Current genitourinary fistula or urethral diverticulum
  • Reversible cause of incontinence (i.e. drug effect)
  • Contraindication to surgery

Sites / Locations

  • Washington Hospital Center
  • Greater Baltimore Medical Center
  • Duke University Medical Center
  • Good Samaritan Hospital
  • Cleveland Clinic
  • Main Line Health
  • Women & Infants Hospital of Rhode Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Tension-free vaginal tape procedure (TVT)

TVT-SECUR device

Outcomes

Primary Outcome Measures

Subjective Cure of Urinary Incontinence at 12 Months After Surgery
Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.

Secondary Outcome Measures

Post Operative Complications at 6 Week or Less
Long Term Complications > 6 Weeks
Patient Global Impression Improvement
Incontinence Severity Index Score
The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe).

Full Information

First Posted
September 20, 2007
Last Updated
May 8, 2017
Sponsor
The Cleveland Clinic
Collaborators
Good Samaritan Hospital, Ohio, Greater Baltimore Medical Center, Medstar Health Research Institute, Duke University, Foundation for Female Health Awareness, Women and Infants Hospital of Rhode Island, Main Line Health
search

1. Study Identification

Unique Protocol Identification Number
NCT00534365
Brief Title
Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence
Acronym
SECURiTy
Official Title
A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR for the Surgical Treatment of Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
Good Samaritan Hospital, Ohio, Greater Baltimore Medical Center, Medstar Health Research Institute, Duke University, Foundation for Female Health Awareness, Women and Infants Hospital of Rhode Island, Main Line Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
stress urinary incontinence, sling procedures, tension-free vaginal tape

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Tension-free vaginal tape procedure (TVT)
Arm Title
2
Arm Type
Active Comparator
Arm Description
TVT-SECUR device
Intervention Type
Device
Intervention Name(s)
tension-free vaginal tape
Other Intervention Name(s)
TVT
Intervention Description
Retropubic mid-urethral sling
Intervention Type
Device
Intervention Name(s)
TVT-SECUR device
Intervention Description
Mid-urethral mini-sling
Primary Outcome Measure Information:
Title
Subjective Cure of Urinary Incontinence at 12 Months After Surgery
Description
Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Post Operative Complications at 6 Week or Less
Time Frame
6 week
Title
Long Term Complications > 6 Weeks
Time Frame
6 weeks-12 months
Title
Patient Global Impression Improvement
Time Frame
12 months
Title
Incontinence Severity Index Score
Description
The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe).
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Urinary incontinence symptoms Urodynamic stress incontinence confirmed with multichannel urodynamic testing Age of at least 21 years Desires surgical correction of stress urinary incontinence Exclusion Criteria: Post-void residual volume >100cc Detrusor overactivity on preoperative multichannel urodynamic testing History of previous synthetic, biologic or fascial sub-urethral sling Desires future childbearing History of bleeding diathesis or current anti-coagulation therapy Current genitourinary fistula or urethral diverticulum Reversible cause of incontinence (i.e. drug effect) Contraindication to surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew D Barber, MD, MHS
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27706
Country
United States
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45520
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Main Line Health
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22270285
Citation
Barber MD, Weidner AC, Sokol AI, Amundsen CL, Jelovsek JE, Karram MM, Ellerkmann M, Rardin CR, Iglesia CB, Toglia M; Foundation for Female Health Awareness Research Network. Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):328-37. doi: 10.1097/AOG.0b013e318242a849.
Results Reference
result

Learn more about this trial

Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence

We'll reach out to this number within 24 hrs