NCT00676273

Brief Summary

The purpose of this study is to determine whether TVT-Secur (TVT-S) (Hammock method) and TVT-Obturator (TVT-O) suburethral sling procedures have equivalent patient satisfaction and clinical efficacy in the treatment of stress urinary incontinence alone or the stress component in mixed urinary incontinence.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 13, 2008

Status Verified

May 1, 2008

Enrollment Period

2 years

First QC Date

November 16, 2007

Last Update Submit

May 12, 2008

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of TVT-S versus TVT-O suburethral slings in the treatment of stress urinary incontinence or the stress incontinence component of mixed urinary incontinence by the presence or absence or urinary incontinence on cough stress test.

    1 year

Secondary Outcomes (1)

  • To describe or assess known side effects or complications,post-operative pain, time of return to daily activities of living, improvement in patient quality of life, change in Q-tip test

    1 year

Study Arms (2)

1

ACTIVE COMPARATOR

TVTO

Device: TVT-Obturator (TVT-O)

2

ACTIVE COMPARATOR

TVTS

Device: TVT-Secur (TVT-S) (Hammock method)

Interventions

TVT-Obturator (TVT-O)DEVICE

sub urethral sling

1
TVT-Secur (TVT-S) (Hammock method)DEVICE

suburethral sling

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are at least 18 years of age
  • Demonstrate a positive cough stress test during complex multi-channel urodynamic testing
  • Demonstrate impact of stress urinary incontinence on quality of life questionnaire
  • Are able to comprehend and sign a written informed consent
  • Understand and are willing to comply with the study requirements, including agreeing to be available for the follow-up evaluations
  • Are psychologically stable and suitable for interventions determined by the investigator
  • Are ambulatory and able to use a toilet independently

You may not qualify if:

  • Patients:
  • Who are pregnant or planning to become pregnant during the study or in the future
  • With a elevated post-void residual (defined as PVR \> 100cc)
  • With a bleeding condition or on anti-coagulant therapy
  • With immunosuppression (i.e. HIV, lymphoma)
  • With multiple sclerosis or other progressive neurological disease
  • With evidence of a local or systemic infection, including urinary tract infection
  • With evidence of intrinsic sphincter deficiency as defined by a maximal urethral closure pressure of \<20 cm H2O
  • Previous sub-urethral sling
  • Predominant overactive bladder symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Urogynecology Associates

Cambridge, Massachusetts, 02138, United States

RECRUITING

Related Publications (1)

  • 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

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

Study Officials

  • Peter Rosenblatt, MD

    Boston Urogynecology Associates

    PRINCIPAL INVESTIGATOR

  • Lekha Hota, MD

    Boston Urogynecology Associates

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2007

First Posted

May 13, 2008

Study Start

March 1, 2007

Primary Completion

March 1, 2009

Study Completion

December 1, 2009

Last Updated

May 13, 2008

Record last verified: 2008-05

Locations

US(1)