Transvaginal Tension Free Vaginal Tape-Obturator (TVT-O) Versus Transobturator Tape-Mentor (TOT) in the Management of Urodynamic Stress Urinary Incontinence
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Urinary Stress Incontinence |
Device: Transobturator tape-ARIS Device: TVT-O |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind 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 |
- Objective cure rates of stress incontinence according to urodynamics
- Improvement in total King's Health Questionnaire (KHQ) scores { > or = 10%}
- Complication rates
- Patient satisfaction rates
| Estimated Enrollment: | 230 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | May 2010 |
Show Detailed Description
Eligibility| Genders 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
Contacts and Locations| Contact: Mohamed Abdel-fattah, MRCOG | 01412012818 | msakr99@aol.com |
| Contact: Ian Ramsay, MRCOG | 01412012237 | IRamsay@sgh.scot.nhs.uk |
| United Kingdom | |
| Southern General Hospital | Recruiting |
| Glasgow, United Kingdom, G51 4TF | |
| Contact: Mohamed Abdel-fattah, MRCOG 01412012818 msakr99@aol.com | |
| Contact: Ian Ramsay, MRCOG 01412012237 IRamsay@sgh.scot.nhs.uk | |
| Study Chair: | Ian Ramsay, MRCOG | Southern General Hospital |
| Study Director: | Mohamed Abdel-fattah, MRCOG | Southern General Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00136071 History of Changes |
| Other Study ID Numbers: | msakr99, Henry Smith Grant |
| Study First Received: | August 25, 2005 |
| Last Updated: | December 19, 2005 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by South Glasgow University Hospitals NHS Trust:
|
Stress Urinary Incontinence, TOT, TVT-O |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013