Stress Urinary IncontinencePhase 3NCT01057550
Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)
A Phase 3 study testing Autologous fascial sling, TVT and Pelvicol in people with Stress Urinary Incontinence, run by Abertawe Bro Morgannwg University NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, TVT or Pelvicol slings. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Autologous fascial sling, TVT and Pelvicol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2001to Nov 2006
- Phase
- Phase 3
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women requiring surgery for SUI following failed conservative treatment
Who cannot join
- Under 18 years of age
- Previous surgery for SUI
- Evidence of neurological disease
- Pelvic Organ Prolapse (POP) greater than Grade 2
- Women with any evidence of Detrusor Overactivity or bladder hypocompliance on urodynamic assessment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
ABM University Hospital NHS trust
Swansea, Wales, SA2 8QA
About this study
Official title: A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women
The purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Autologous fascial sling, TVT, Pelvicol
- Keywords
- Stress urinary Incontinence, autologous slings, slings, tvt, grafts, surgery
- 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.
Autologous fascial slingProcedure or surgery
Retropubic bottom up mid urethral sling made using autologous rectus sheath fascia
TVTProcedure or surgery
Standard TVT as described by Ulmsten 1996
PelvicolProcedure or surgery
retropubic mid urethral sling made from Pelvicol
| Study group | Role | What they receive |
|---|---|---|
| Autologous Fascial Sling | Active comparator | Retropubic, bottom up autologous sling Receives: Procedure: Autologous fascial sling |
| TVT | Active comparator | Standard retropubic TVT Receives: Procedure: TVT |
| Pelvicol | Active comparator | Retropubic mid urethral sling made from Pelvicol Receives: Procedure: Pelvicol |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate at improving symptom of stress urinary incontinence
Measured: 1 year
Secondary outcomes (6)
completely dry rates
Measured: 1 year
quality of life scores
Measured: 1 year
intra & post-operative complications
Measured: 1 year
re-operation rates
Measured: 1 year
hospital stay
Measured: 5 days
operative time
Measured: hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startOct 2001
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abertawe Bro Morgannwg University NHS Trust
- Sponsor type
- Other government
- Collaborators
- C. R. Bard
- Investigators
- Malcolm G Lucas, Study chair, ABM University Hospital NHS trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057550
- Sponsor's protocol ID
- 2000.117
- Status last verified
- Mar 2004
- First submitted
- 26 Jan 2010
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guerrero KL, Emery SJ, Wareham K, Ismail S, Watkins A, Lucas MG. A randomised controlled trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women. BJOG. 2010 Nov;117(12):1493-502. doi: 10.1111/j.1471-0528.2010.02696.x. Epub 2010 Sep 24.
PubMed 20939862
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women
- ClinicalTrials.gov ID
- NCT01057550
- Acronym / sponsor ID
- 2000.117
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary Incontinence, autologous slings, slings, tvt, grafts, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Abertawe Bro Morgannwg University NHS TrustOther government
- Collaborators
- C. R. Bard
- Study start
- Oct 2001
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 27 Jan 2010 (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.
The purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autologous Fascial Sling | Active comparator | Procedure: Autologous fascial slingRetropubic, bottom up autologous sling |
| TVT | Active comparator | Procedure: TVTStandard retropubic TVT |
| Pelvicol | Active comparator | Procedure: PelvicolRetropubic mid urethral sling made from Pelvicol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women requiring surgery for SUI following failed conservative treatment
Key exclusion criteria (5 listed)
- Under 18 years of age
- Previous surgery for SUI
- Evidence of neurological disease
- Pelvic Organ Prolapse (POP) greater than Grade 2
- Women with any evidence of Detrusor Overactivity or bladder hypocompliance on urodynamic assessment
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 |
|---|---|---|
| Autologous fascial slingRetropubic bottom up mid urethral sling made using autologous rectus sheath fascia | Procedure or surgery | Autologous Fascial Sling |
| TVTStandard TVT as described by Ulmsten 1996 | Procedure or surgery | TVT |
| Pelvicolretropubic mid urethral sling made from Pelvicol | Procedure or surgery | Pelvicol |
Primary outcome
success rate at improving symptom of stress urinary incontinence
Time frame: 1 year
6 secondary outcomes
completely dry rates
Time frame: 1 year
quality of life scores
Time frame: 1 year
intra & post-operative complications
Time frame: 1 year
re-operation rates
Time frame: 1 year
hospital stay
Time frame: 5 days
operative time
Time frame: hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2010.
- Results publication: PubMed 20939862Guerrero KL, Emery SJ, Wareham K, Ismail S, Watkins A, Lucas MG. A randomised controlled trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women. BJOG. 2010 Nov;117(12):1493-502. doi: 10.1111/j.1471-0528.2010.02696.x. Epub 2010 Sep 24.
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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.
Malcolm G Lucas study chair
ABM University Hospital NHS trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous fascial sling, TVT and Pelvicol in people with Stress Urinary Incontinence, run by Abertawe Bro Morgannwg University 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 5 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: finished, as of the sponsor's last update on 27 Jan 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate at improving symptom of stress urinary incontinence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01057550, which also lists 1 linked publication.
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 27 Jan 2010.