NCT00534365

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
281

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2007

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

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

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

June 9, 2017

Completed
Last Updated

June 9, 2017

Status Verified

May 1, 2017

Enrollment Period

3.7 years

First QC Date

September 20, 2007

Results QC Date

January 9, 2017

Last Update Submit

May 8, 2017

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinencesling procedurestension-free vaginal tape

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (4)

  • Post Operative Complications at 6 Week or Less

    6 week

  • Long Term Complications > 6 Weeks

    6 weeks-12 months

  • Patient Global Impression Improvement

    12 months

  • Incontinence Severity Index Score

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Tension-free vaginal tape procedure (TVT)

Device: tension-free vaginal tape

2

ACTIVE COMPARATOR

TVT-SECUR device

Device: TVT-SECUR device

Interventions

tension-free vaginal tapeDEVICE

Retropubic mid-urethral sling

Also known as: TVT
1
TVT-SECUR deviceDEVICE

Mid-urethral mini-sling

2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27706, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45520, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44145, United States

Location

Main Line Health

Paoli, Pennsylvania, 19301, United States

Location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

  • 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.

    PMID: 22270285RESULT

  • Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

    PMID: 37888839DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination 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
Lynn Borzi (Research Administrator)
Organization
Cleveland Clinic
BORZIL@ccf.org
216-445-3158

Study Officials

  • Matthew D Barber, MD, MHS

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 24, 2007

Study Start

August 1, 2007

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 9, 2017

Results First Posted

June 9, 2017

Record last verified: 2017-05

Locations

US(7)