Transvaginal Tension Free Vaginal Tape-Obturator (TVT-O) Versus Transobturator Tape-Mentor (TOT) in the Management of Urodynamic Stress Urinary Incontinence
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|ClinicalTrials.gov 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
|First Submitted Date ICMJE||August 25, 2005|
|First Posted Date ICMJE||August 26, 2005|
|Last Update Posted Date||December 20, 2005|
|Study Start Date ICMJE||May 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Objective cure rates of stress incontinence according to urodynamics|
|Original Primary Outcome Measures ICMJE
||the Objective cure rates of STRESS INCONTINENCEaccording to URODYNAMICS|
|Change History||Complete list of historical versions of study NCT00136071 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Transvaginal Tension Free Vaginal Tape-Obturator (TVT-O) Versus Transobturator Tape-Mentor (TOT) in the Management of Urodynamic Stress Urinary Incontinence|
|Official Title ICMJE||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.
Randomised trial comparing TVT-O & TOT in surgical management of USI (Urodynamic Stress Incontinence):
Aim: To compare two transobturator tension free vaginal tape procedures; TVT-O Gynecare vs. TOT mentor for management of USI. This study will compare the surgical approach & tape material in both procedures [In-Out (TVT-O) Vs. the Out-In (TOT)] as regards to; Complication rates, Objective & subjective cure rates, Patient satisfaction & quality of life (QoL) changes.
Design: Randomised trial in a regional referral centre, approved by ethical committee.
Background: Transobturator tension free vaginal tape is currently the first choice mid-urethral tape procedure for surgical treatment of USI in our unit. The choice of the surgical approach and tape material; In-Out (TVT-O) vs. the Out-In (TOT) is currently taken predominately according to the surgeon preference without any solid clinical evidence to support that one approach or one tape is superior to the other.
Methods: All women undergoing transobturator tension free vaginal tape procedure in our department for pure USI, done as a primary anti-incontinence procedure and as the sole procedure at time of surgery, will be invited to participate in the study and will receive an information leaflet and will sign a consent form. All would have had failed or declined physiotherapy treatment. Procedures mainly take place in the surgery unit under general anaesthesia; those that are done in the main surgical list are due to patients' associated medical conditions or needing spinal anaesthesia or living in remote areas. Randomisation will be performed using sealed opaque envelopes. TVT-O & TOT will be done as originally described, we do not perform cough stress test routinely. All patients will receive intra-operative; prophylactic antibiotics & anti- inflammatory drugs if not contraindicated. Lidocaine 1% will be infiltrated into the needle pathway at the end of the procedure; 10mls. on each side. Satisfactory postoperative voiding - for the purpose of this study - is defined as passing at least 200mls with post-voiding residual urinary volume <100mls assessed at least twice.
Preoperative assessment would include:
Operative assessment would include:
Outpatient postoperative assessment:
Patients will be reviewed at three months for:
Patients will be reviewed at Six month, 12 month, 3 years & 5 years for:
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Urinary Stress Incontinence|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||May 2010|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT00136071|
|Other Study ID Numbers ICMJE||msakr99
Henry Smith Grant
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||South Glasgow University Hospitals NHS Trust|
|Collaborators ICMJE||Henry Smith Grant|
|PRS Account||South Glasgow University Hospitals NHS Trust|
|Verification Date||May 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP