Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136071
Status:
UNKNOWN
Last Update Posted:
2005-12-20
First Post:
2005-08-25
Brief Title:
Transvaginal Tension Free Vaginal Tape-Obturator TVT-O Versus Transobturator Tape-Mentor TOT in the Management of Urodynamic Stress Urinary Incontinence
Sponsor:
South Glasgow University Hospitals NHS Trust
Organization:
South Glasgow University Hospitals NHS Trust
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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
Detailed history pelvic examination
Urodynamic assessment
Preoperative quality of life assessment will include
Completion of the Kings Health Questionnaire- version 7 KHQ
Incontinence Bothersome Scale
Bristol Lower Urinary Tract Symptoms Questionnaire BULTS
Pelvic Organ ProlapseUrinary Incontinence Sexual Function Questionnaire PISQ-12
Operative assessment would include
Operative time
Blood loss
Surgeon assessment of procedure difficulty using visual analogue score VAS
Intra-operative complications
BladderUrethral injury
Haemorrhage 200 mls
Further procedures needed
Immediate postoperative assessment
Postoperative pain assessment will include
Patient self assessment using visual analogue score VAS
Unscheduled ward admission for postoperative pain
Postoperative voiding dysfunction will be defined as any deviation from satisfactory postoperative voiding described above This will include assessment of
Days of catheterization
Intermittent self catheterization or permanent supra-pubic catheter
Urethral dilatation
Surgical releaseexcision of the tape
Postoperative pyrexia
Urinary tract infection UTI
Hospital stay for medical reasons
Outpatient postoperative assessment
Patients will be reviewed at three months for
Urodynamic assessment
Completion of the Kings Health Questionnaire- version 7 KHQ
Completion of the Incontinence Bothersome Scale
Completion of the Patient Satisfaction questionnaire
Bristol Lower Urinary Tract Symptoms Questionnaire BULTS
Complications Tape erosions De-novo urgency Worsening of pre-existing urgency long-term voiding dysfunction
Patients will be reviewed at Six month 12 month 3 years 5 years for
24 hour Pad test
Completion of the Kings Health Questionnaire- version 7 KHQ
Completion of the Incontinence Bothersome Scale
Bristol Lower Urinary Tract Symptoms Questionnaire BULTS
Pelvic Organ ProlapseUrinary Incontinence Sexual Function Questionnaire PISQ-12
Completion of the Patient Satisfaction questionnaire
Complications Tape erosions De-novo Urgency Worsening of pre-existing urgency long-term voiding dysfunction
Further treatment needed
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
Detailed history pelvic examination
Urodynamic assessment
Preoperative quality of life assessment will include
Completion of the Kings Health Questionnaire- version 7 KHQ
Incontinence Bothersome Scale
Bristol Lower Urinary Tract Symptoms Questionnaire BULTS
Pelvic Organ ProlapseUrinary Incontinence Sexual Function Questionnaire PISQ-12
Operative assessment would include
Operative time
Blood loss
Surgeon assessment of procedure difficulty using visual analogue score VAS
Intra-operative complications
BladderUrethral injury
Haemorrhage 200 mls
Further procedures needed
Immediate postoperative assessment
Postoperative pain assessment will include
Patient self assessment using visual analogue score VAS
Unscheduled ward admission for postoperative pain
Postoperative voiding dysfunction will be defined as any deviation from satisfactory postoperative voiding described above This will include assessment of
Days of catheterization
Intermittent self catheterization or permanent supra-pubic catheter
Urethral dilatation
Surgical releaseexcision of the tape
Postoperative pyrexia
Urinary tract infection UTI
Hospital stay for medical reasons
Outpatient postoperative assessment
Patients will be reviewed at three months for
Urodynamic assessment
Completion of the Kings Health Questionnaire- version 7 KHQ
Completion of the Incontinence Bothersome Scale
Completion of the Patient Satisfaction questionnaire
Bristol Lower Urinary Tract Symptoms Questionnaire BULTS
Complications Tape erosions De-novo urgency Worsening of pre-existing urgency long-term voiding dysfunction
Patients will be reviewed at Six month 12 month 3 years 5 years for
24 hour Pad test
Completion of the Kings Health Questionnaire- version 7 KHQ
Completion of the Incontinence Bothersome Scale
Bristol Lower Urinary Tract Symptoms Questionnaire BULTS
Pelvic Organ ProlapseUrinary Incontinence Sexual Function Questionnaire PISQ-12
Completion of the Patient Satisfaction questionnaire
Complications Tape erosions De-novo Urgency Worsening of pre-existing urgency long-term voiding dysfunction
Further treatment needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Henry Smith Grant | None | None | None |