Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-04-30

Brief Summary

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This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT Secur or a standard TVT surgical procedure. The main outcome is effectiveness of the procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after surgery. The study will be carried out in 4 to 6 centers and will involve urogynaecologists, urologists and general obstetrician-gynaecologists: all clinicians will have received adequate training.

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Detailed Description

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Conditions

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Urinary Incontinence, Stress

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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TVT Secur surgical device

Single incision tape device

Group Type EXPERIMENTAL

TVT Secur (Gynecare)

Intervention Type PROCEDURE

Sling device for stress urinary incontinence

TVT surgical device

Usual care retropubic tape device

Group Type ACTIVE_COMPARATOR

TVT (Gynecare)

Intervention Type PROCEDURE

Sling procedure for stress urinary incontinence

Interventions

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TVT Secur (Gynecare)

Sling device for stress urinary incontinence

Intervention Type PROCEDURE

TVT (Gynecare)

Sling procedure for stress urinary incontinence

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women with stress incontinence, defined as leaking with increased abdominal pressure
* Eligible for both types of surgery

Exclusion Criteria

Women who:

* Have vaginal prolapse requiring surgical repair
* Have had previous incontinence surgery
* Have overactive bladder or incontinence is caused only by bladder overflow
* Intend to have further children
* Have Alzheimer's or Parkinson's disease, progressive neurological disease such as multiple sclerosis, or are immunocompromised
* Are unable to understand English
* Will be unavailable for follow-up

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No