Urinary Stress IncontinencePhase 3NCT00379314
Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence
A Phase 3 study testing TVT and TVT-O minimally invasive surgical procedures and Surgery for female stress urinary incontinence in people with Urinary Stress Incontinence, run by University of Helsinki at 1 site in Finland.
Trial summary
The Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for treatment of female urinary stress incontinence. The TVT procedure has a documented efficacy and safety but is still associated with the risk of intra- and post-operative complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- TVT and TVT-O minimally invasive surgical procedures and Surgery for female stress urinary incontinence
- Type of treatment
- Surgery or procedure
- How many people
- 260 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2004to Dec 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of stress incontinence
- indications for surgical treatment
- positive cough stress test
- urgency score < 7
Who cannot join
- prior incontinence surgery
- need of concomitant surgery
- post void residual urine volume < 100 ml
- urinary tract anomalies
- urinary tract infection
- more than 3 urinary tract infection within last year
Show all 17Show fewer
- more than grade 2 urogenital prolapse
- Body mass index > 35
- Radiotherapy of the pelvic region
- active malignancy
- hemophilia
- anticoagulant treatment
- neurological disorder or other disease which affects bladder function
- anticholinergic treatment
- use of duloxetine
- do not understand the purpose of the trial
- immobility
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
Helsinki, 00029 HUS
About this study
Official title: A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence
The Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for treatment of female urinary stress incontinence. The TVT procedure has a documented efficacy and safety but is still associated with the risk of intra- and post-operative complications. A modification of the TVT procedure called TVT-O (Tensionfree Vaginal Tape Obturator), which utilises the obturator foramen for passage of the tape, is thought to lower the risk of complications. The trial compares the TVT procedure with the TVT-O procedure in a randomized fashion in order to detect differences in the rate of complications and in cure rate.
- Conditions
- Urinary Stress Incontinence
- Being tested
- TVT and TVT-O minimally invasive surgical procedures, Surgery for female stress urinary incontinence
- Keywords
- Incontinence, Urinary, Female, Surgery, Complications
- 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.
TVT and TVT-O minimally invasive surgical proceduresProcedure or surgery
Surgery for female stress urinary incontinenceProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Objective cure rate by stress test and pad weighing test
Secondary outcomes (1)
Quality of life questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startApr 2004
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Investigators
- Carl G Nilsson, MD,PhD, Principal investigator, Helsinki University, Dept Obstet Gynecol, Helsinki University Central HospitalCarl G Nilsson, MD,PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379314
- Sponsor's protocol ID
- 42/E8/04
- Status last verified
- Sep 2006
- First submitted
- 19 Sep 2006
- Last updated
- 1 Nov 2006
- Results posted
- No
Publications
Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002 Jan;81(1):72-7. doi: 10.1034/j.1600-0412.2002.810113.x.
PubMed 11942891Laurikainen E, Valpas A, Aukee P, Kivela A, Rinne K, Takala T, Nilsson CG. Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence. Eur Urol. 2014 Jun;65(6):1109-14. doi: 10.1016/j.eururo.2014.01.031. Epub 2014 Jan 31.
PubMed 24508070Laurikainen E, Valpas A, Kivela A, Kalliola T, Rinne K, Takala T, Nilsson CG. Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):4-11. doi: 10.1097/01.AOG.0000249607.82768.a1.
PubMed 17197581
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence
- ClinicalTrials.gov ID
- NCT00379314
- Acronym / sponsor ID
- 42/E8/04
- Conditions
- Urinary Stress Incontinence
- Keywords
- Incontinence, Urinary, Female, Surgery, Complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Dec 2010
- First posted
- 21 Sep 2006 (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 Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for treatment of female urinary stress incontinence. The TVT procedure has a documented efficacy and safety but is still associated with the risk of intra- and post-operative complications. A modification of the TVT procedure called TVT-O (Tensionfree Vaginal Tape Obturator), which utilises the obturator foramen for passage of the tape, is thought to lower the risk of complications. The trial compares the TVT procedure with the TVT-O procedure in a randomized fashion in order to detect differences in the rate of complications and in cure rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- history of stress incontinence
- indications for surgical treatment
- positive cough stress test
- urgency score < 7
Key exclusion criteria (17 listed)
- prior incontinence surgery
- need of concomitant surgery
- post void residual urine volume < 100 ml
- urinary tract anomalies
- urinary tract infection
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 |
|---|---|---|
| TVT and TVT-O minimally invasive surgical procedures | Procedure or surgery | – |
| Surgery for female stress urinary incontinence | Procedure or surgery | – |
Primary outcome
Complications
Objective cure rate by stress test and pad weighing test
1 secondary outcome
Quality of life questionnaires
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2006.
- Background: PubMed 11942891Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002 Jan;81(1):72-7. doi: 10.1034/j.1600-0412.2002.810113.x.
- Derived from this study: PubMed 24508070Laurikainen E, Valpas A, Aukee P, Kivela A, Rinne K, Takala T, Nilsson CG. Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence. Eur Urol. 2014 Jun;65(6):1109-14. doi: 10.1016/j.eururo.2014.01.031. Epub 2014 Jan 31.
- Derived from this study: PubMed 17197581Laurikainen E, Valpas A, Kivela A, Kalliola T, Rinne K, Takala T, Nilsson CG. Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):4-11. doi: 10.1097/01.AOG.0000249607.82768.a1.
- International urogynecological associationLink provided by the sponsor.
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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.
Carl G Nilsson, MD,PhD principal investigator
Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
Carl G Nilsson, MD,PhD principal investigator
University of Helsinki
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 TVT and TVT-O minimally invasive surgical procedures and Surgery for female stress urinary incontinence in people with Urinary Stress Incontinence, run by University of Helsinki at 1 site in Finland.
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 4 inclusion and 17 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 1 Nov 2006. 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 Finland. 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?
Results are not available in the source record.
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?
Complications. The study lists 2 primary outcomes in all. 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 NCT00379314, which also lists 3 linked publications.
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 1 Nov 2006.