Urinary Stress Incontinence Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 230 |
Est. completion date | May 2010 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Southern General Hospital | Glasgow |
Lead Sponsor | Collaborator |
---|---|
South Glasgow University Hospitals NHS Trust | Henry Smith Grant |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective cure rates of stress incontinence according to urodynamics | |||
Secondary | Improvement in total King's Health Questionnaire (KHQ) scores { > or = 10%} | |||
Secondary | Complication rates | |||
Secondary | Patient satisfaction rates |
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