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Transvaginal Tension Free Vaginal Tape-Obturator (TVT-O) Versus Transobturator Tape-Mentor (TOT) in the Management of Urodynamic Stress Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00136071
Recruitment Status : Unknown
Verified May 2005 by South Glasgow University Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : August 26, 2005
Last Update Posted : December 20, 2005
Henry Smith Grant
Information provided by:
South Glasgow University Hospitals NHS Trust

Brief Summary:

Urinary incontinence (involuntary leakage of urine) is an extremely common, distressing and socially disabling condition. It is known to affect up to 14 % of the adult female population in the United Kingdom. Sufferers tend to become social recluses, not wanting to socialise for fear of embarrassment and ridicule. It typically takes up to 5 years from the onset of symptoms for a patient to admit their problem, seek help and reach a specialist. Unfortunately, it is commonest in the elderly when the incidence is as high as 50% in some studies. Furthermore, this group of patients are the least likely to seek help, the least likely to receive help and up until recently the least likely to be cured of their problems.

Things are improving however, as everyone is more prepared to talk about this awful condition rather than accept it as a part of growing old. Furthermore, better treatments are becoming available which can help the old as well as the young.

Two years ago a new operation for urinary leakage was launched in the United Kingdom (UK). This is a smaller operation than those previously available and more suitable for the frail and elderly. We, the researchers at South Glasgow University Hospital, have been using this operation for 18 months with good success. Several versions however are now on the market, some much more expensive than the original, and perhaps not as good. We need to know which one is best and hence we intend to do a study to find out.

We aim to select patients with leakage to have one or the other operation and to follow the patients over several years to find out which operation is best, safest, lasts longest and is most acceptable to patients. Only then will we know which of the versions of this procedure we should be offering our patients.

Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Device: Transobturator tape-ARIS Device: TVT-O Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Randomised Prospective Blinded Trial Comparing Transvaginal Tension Free Vaginal Tape-Obturator (Outside-In) With Transobturator Tape-Mentor (Inside-Out) in Surgical Management of Urodynamic Stress Urinary Incontinence
Study Start Date : May 2005
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Objective cure rates of stress incontinence according to urodynamics

Secondary Outcome Measures :
  1. Improvement in total King's Health Questionnaire (KHQ) scores { > or = 10%}
  2. Complication rates
  3. Patient satisfaction rates

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All women undergoing transobturator tension free vaginal tape procedure in our department for USI, whether a primary or secondary anti-incontinence procedure and as the sole procedure at time of surgery, will be invited to participate in the study and will receive information leaflet and will sign consent form.

Exclusion Criteria:

  • Concomitant surgical procedure
  • Non-english speakers
  • Lack of consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00136071

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Contact: Mohamed Abdel-fattah, MRCOG 01412012818
Contact: Ian Ramsay, MRCOG 01412012237

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United Kingdom
Southern General Hospital Recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Mohamed Abdel-fattah, MRCOG    01412012818   
Contact: Ian Ramsay, MRCOG    01412012237   
Sponsors and Collaborators
South Glasgow University Hospitals NHS Trust
Henry Smith Grant
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Study Chair: Ian Ramsay, MRCOG Southern General Hospital
Study Director: Mohamed Abdel-fattah, MRCOG Southern General Hospital
Layout table for additonal information Identifier: NCT00136071    
Other Study ID Numbers: msakr99
Henry Smith Grant
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: December 20, 2005
Last Verified: May 2005
Keywords provided by South Glasgow University Hospitals NHS Trust:
Stress Urinary Incontinence,
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders