Urinary Stress IncontinenceNCT00136071
Transvaginal Tension Free Vaginal Tape-Obturator (TVT-O) Versus Transobturator Tape-Mentor (TOT) in the Management of Urodynamic Stress Urinary Incontinence
A study testing Transobturator tape-ARIS and TVT-O in people with Urinary Stress Incontinence, run by South Glasgow University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- Transobturator tape-ARIS and TVT-O
- Type of treatment
- Medical device
- How many people
- 230 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2005to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Concomitant surgical procedure
- Non-english speakers
- Lack of consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Southern General Hospital
Glasgow, G51 4TF
Mohamed Abdel-fattah, MRCOG, 01412012818, msakr99@aol.com
Ian Ramsay, MRCOG, 01412012237, IRamsay@sgh.scot.nhs.uk
About this study
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.
Read more
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.
Read the 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 King's Health Questionnaire- version 7 (KHQ).
- Incontinence Bothersome Scale.
- Bristol Lower Urinary Tract Symptoms Questionnaire (BULTS).
- Pelvic Organ Prolapse/Urinary 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:
- Bladder/Urethral 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 release/excision 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 King's 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 King's Health Questionnaire- version 7 (KHQ).
- Completion of the Incontinence Bothersome Scale.
- Bristol Lower Urinary Tract Symptoms Questionnaire (BULTS).
- Pelvic Organ Prolapse/Urinary 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.
- Conditions
- Urinary Stress Incontinence
- Being tested
- Transobturator tape-ARIS, TVT-O
- Keywords
- Stress Urinary Incontinence,, TOT,, TVT-O
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transobturator tape-ARISDevice
TVT-ODevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startMay 2005
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Stress IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 230 participants
Sponsor and investigators
- Lead sponsor
- South Glasgow University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Smith Grant
- Investigators
- Ian Ramsay, MRCOG, Study chair, Southern General HospitalMohamed Abdel-fattah, MRCOG, Study director, Southern General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136071
- Sponsor's protocol ID
- msakr99
- Other IDs
- Henry Smith Grant
- Status last verified
- May 2005
- First submitted
- 25 Aug 2005
- Last updated
- 20 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00136071
- Acronym / sponsor ID
- msakr99
- Conditions
- Urinary Stress Incontinence
- Keywords
- Stress Urinary Incontinence,, TOT,, TVT-O
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants
- Lead sponsor
- South Glasgow University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Henry Smith Grant
- Study start
- May 2005
- Study completion
- May 2010
- First posted
- 26 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 King's Health Questionnaire- version 7 (KHQ).
- Incontinence Bothersome Scale.
- Bristol Lower Urinary Tract Symptoms Questionnaire (BULTS).
- Pelvic Organ Prolapse/Urinary 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:
- Bladder/Urethral 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 release/excision 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 King's 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 King's Health Questionnaire- version 7 (KHQ).
- Completion of the Incontinence Bothersome Scale.
- Bristol Lower Urinary Tract Symptoms Questionnaire (BULTS).
- Pelvic Organ Prolapse/Urinary 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Concomitant surgical procedure
- Non-english speakers
- Lack of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transobturator tape-ARIS | Device | – |
| TVT-O | Device | – |
Primary outcome
Objective cure rates of stress incontinence according to urodynamics
3 secondary outcomes
Improvement in total King's Health Questionnaire (KHQ) scores { > or = 10%}
Complication rates
Patient satisfaction rates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Ramsay, MRCOG study chair
Southern General Hospital
Mohamed Abdel-fattah, MRCOG study director
Southern General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transobturator tape-ARIS and TVT-O in people with Urinary Stress Incontinence, run by South Glasgow University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdel-fattah, MRCOG (01412012818, msakr99@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective cure rates of stress incontinence according to urodynamics. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2005.