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TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

NCT ID: NCT00676273

Last Updated: 2008-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Patient satisfaction will be measured by symptom quality of life questionnaires (pre-operatively, 3 months and one year) and patient pain will be measured by verbal analogue rating scale (post-operative day 1 and day 7). Clinical efficacy will be measured by a cough stress test pre-operatively and post-operatively at 3 months and 1 year. A Q-tip test will also be performed pre-operatively and at 3 months and 1 year post-operatively. Subjects will be followed for a minimum of one year to evaluate recurrence of symptoms and complications, including the rate of mesh erosion, time to normal void in the post-operative period, the rate of sling revision, post-operative pain, voiding dysfunction and de novo urgency.

Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

TVTO

Group Type ACTIVE_COMPARATOR

TVT-Obturator (TVT-O)

Intervention Type DEVICE

sub urethral sling

2

TVTS

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

suburethral sling

Interventions

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TVT-Obturator (TVT-O)

sub urethral sling

Intervention Type DEVICE

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

suburethral sling

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Urogynecology Associates

OTHER

Sponsor Role lead

Responsible Party

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Boston Urogynecology Associates

Principal Investigators

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Peter Rosenblatt, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Urogynecology Associates

Lekha Hota, MD

Role: STUDY_DIRECTOR

Boston Urogynecology Associates

Locations

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Boston Urogynecology Associates

Cambridge, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Lekha Hota, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37888839 (View on PubMed)

Other Identifiers

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28142

Identifier Type: -

Identifier Source: org_study_id