Transvaginal Tension Free Vaginal Tape-Obturator (TVT-O) Versus Transobturator Tape-Mentor (TOT) in the Management of Urodynamic Stress Urinary Incontinence
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
2 other identifiers
interventional
230
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 26, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedDecember 20, 2005
May 1, 2005
August 25, 2005
December 19, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective cure rates of stress incontinence according to urodynamics
Secondary Outcomes (3)
Improvement in total King's Health Questionnaire (KHQ) scores { > or = 10%}
Complication rates
Patient satisfaction rates
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Concomitant surgical procedure
- Non-english speakers
- Lack of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- South Glasgow University Hospitals NHS Trustlead
- Henry Smith Grantcollaborator
Study Sites (1)
Southern General Hospital
Glasgow, G51 4TF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ian Ramsay, MRCOG
Southern General Hospital
- STUDY DIRECTOR
Mohamed Abdel-fattah, MRCOG
Southern General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 26, 2005
Study Start
May 1, 2005
Study Completion
May 1, 2010
Last Updated
December 20, 2005
Record last verified: 2005-05