Stress Urinary IncontinenceNCT00441454
Retropubic vs. Transobturator Tension-free Vaginal Tape
A study testing Transobturator Tension-free vaginal tape (TVT-O) and Retropubic Tension-free vaginal tape (TVT) in people with Stress Urinary Incontinence, run by Austrian Urogynecology Working Group (AUWG) at 4 sites in Austria.
Trial summary
The so-called tension-free vaginal tape (TVT), first described in Sweden in 1996, has become a standard operation worldwide for the treatment of women with stress urinary incontinence. This tape is placed from the vagina behind the pubic bone and exits through the skin of the lower abdomen, just above the pubic bone. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Transobturator Tension-free vaginal tape (TVT-O) and Retropubic Tension-free vaginal tape (TVT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 4 sitesAustria
- Study dates
- Sep 2004to Oct 2012
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned surgery for primary stress incontinence (positive stress test at bladder filling of 300 ml) without concomitant prolapse surgery or hysterectomy
- Patient able and willing to participate in follow-up
- Informed consent
Who cannot join
- Detrusor overactivity, predominant complaint overactive bladder (OAB)
- Major concomitant surgery
- Prolapse beyond introitus or any prolapse necessitating surgery
- Previous incontinence surgery other than colporrhaphy
- Residual urine >100 ml
- Neurologic disease
- Allergy to local anesthetic agents
- Coagulation disorders
Trial locations and contacts
4 sites in 1 country.
Austria4 sites
Dept. of Gynecology, Krankenhaus der Barmherzigen Brüder
Graz, 8020
Department of OB/GYN, Medical University of Graz
Graz, 8036
Dept. OB/GYN, Medical University of Vienna
Vienna, 1090
Dept. OB/GYN, Wilhelminenspital
Vienna, 1160
About this study
Official title: Retropubic vs. Transobturator Tension-free Vaginal Tape (TVT vs. TVT-O): A Randomized Trial
The so-called tension-free vaginal tape (TVT), first described in Sweden in 1996, has become a standard operation worldwide for the treatment of women with stress urinary incontinence. This tape is placed from the vagina behind the pubic bone and exits through the skin of the lower abdomen, just above the pubic bone. In 2001 a urologist in France proposed passing a similar tape laterally (as opposed to behind the pubic bone). This tape is passed through a window of the pelvic bones (the so-called obturator foramen), by what is called a transobturator approach. It is passed through the skin of the thigh (as opposed to the lower abdomen). The reason for this modification was to avoid injuring the bladder and, possibly, provide a more physiologic restoration of the continence mechanism. However, it is unclear whether the lateral (so-called transobturator approach) is as good as or better than the initial approach behind the pubic bone.
The purpose of the present study is to compare the standard (retropubic) and the newer (transobturator) approach for the placement of a tape for treating women with stress urinary incontinence.
Read the detailed description
After informed consent women scheduled for surgery for stress urinary incontinence are randomized to receive a tension-free vaginal tape either by the retropubic or the transobturator approach.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Transobturator Tension-free vaginal tape (TVT-O), Retropubic Tension-free vaginal tape (TVT)
- Keywords
- stress urinary incontinence, surgery, tension-free vaginal tape, retropubic, transobturator, quality-of-life
- 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 Tension-free vaginal tape (TVT-O)Device
tension-free vaginal tape (TVT)
Retropubic Tension-free vaginal tape (TVT)Device
Retropubic Tension-free vaginal tape (TVT)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Retropubic Tension-free Vaginal Tape (TVT) Receives: Device: Retropubic Tension-free vaginal tape (TVT) |
| B | Active comparator | Transobturator Tension-free Vaginal Tape (TVT-O) Receives: Device: Transobturator Tension-free vaginal tape (TVT-O) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continence
Measured: 5 years
Secondary outcomes (1)
Quality of life
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startSep 2004
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austrian Urogynecology Working Group (AUWG)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl Tamussino, MD, Austrian Urogynecology Working Group (AUWG)
- Investigators
- Karl F Tamussino, MD, Principal investigator, Medical University of Graz, Dept. OB/GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441454
- Sponsor's protocol ID
- TVT vs. TVT-O
- Status last verified
- Dec 2012
- First submitted
- 28 Feb 2007
- Last updated
- 11 Dec 2012
- Results posted
- No
Publications
de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003 Dec;44(6):724-30. doi: 10.1016/j.eururo.2003.09.003.
PubMed 14644127Delorme E. [Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women]. Prog Urol. 2001 Dec;11(6):1306-13. French.
PubMed 11859672Tamussino KF, Hanzal E, Kolle D, Ralph G, Riss PA; Austrian Urogynecology Working Group. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol. 2001 Nov;98(5 Pt 1):732-6. doi: 10.1016/s0029-7844(01)01565-4.
PubMed 11704161Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):81-5; discussion 85-6. doi: 10.1007/BF01902378.
PubMed 8798092Ward K, Hilton P; United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ. 2002 Jul 13;325(7355):67. doi: 10.1136/bmj.325.7355.67.
PubMed 12114234Ward KL, Hilton P; UK and Ireland TVT Trial Group. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol. 2004 Feb;190(2):324-31. doi: 10.1016/j.ajog.2003.07.029.
PubMed 14981369Tammaa A, Aigmuller T, Hanzal E, Umek W, Kropshofer S, Lang PFJ, Ralph G, Riss P, Koelle D, Jundt K, Tamussino K, Bjelic-Radisic V; Austrian Urogynecology Working Group. Retropubic versus transobturator tension-free vaginal tape (TVT vs TVT-O): Five-year results of the Austrian randomized trial. Neurourol Urodyn. 2018 Jan;37(1):331-338. doi: 10.1002/nau.23298. Epub 2017 May 2.
PubMed 28464312Aigmuller T, Tammaa A, Tamussino K, Hanzal E, Umek W, Kolle D, Kropshofer S, Bjelic-Radisic V, Haas J, Giuliani A, Lang PF, Preyer O, Peschers U, Jundt K, Ralph G, Dungl A, Riss PA; Austrian TVT vs. TVT-O Study Group. Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial. Int Urogynecol J. 2014 Aug;25(8):1023-30. doi: 10.1007/s00192-014-2384-z. Epub 2014 May 13.
PubMed 24819327
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retropubic vs. Transobturator Tension-free Vaginal Tape (TVT vs. TVT-O): A Randomized Trial
- ClinicalTrials.gov ID
- NCT00441454
- Acronym / sponsor ID
- TVT vs. TVT-O
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, surgery, tension-free vaginal tape, retropubic, transobturator, quality-of-life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Austrian Urogynecology Working Group (AUWG)University, hospital or other
- Study start
- Sep 2004
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Mar 2007 (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 so-called tension-free vaginal tape (TVT), first described in Sweden in 1996, has become a standard operation worldwide for the treatment of women with stress urinary incontinence. This tape is placed from the vagina behind the pubic bone and exits through the skin of the lower abdomen, just above the pubic bone. In 2001 a urologist in France proposed passing a similar tape laterally (as opposed to behind the pubic bone). This tape is passed through a window of the pelvic bones (the so-called obturator foramen), by what is called a transobturator approach. It is passed through the skin of the thigh (as opposed to the lower abdomen). The reason for this modification was to avoid injuring the bladder and, possibly, provide a more physiologic restoration of the continence mechanism. However, it is unclear whether the lateral (so-called transobturator approach) is as good as or better than the initial approach behind the pubic bone.
The purpose of the present study is to compare the standard (retropubic) and the newer (transobturator) approach for the placement of a tape for treating women with stress urinary incontinence.
Detailed description
After informed consent women scheduled for surgery for stress urinary incontinence are randomized to receive a tension-free vaginal tape either by the retropubic or the transobturator approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Retropubic Tension-free vaginal tape (TVT)Retropubic Tension-free Vaginal Tape (TVT) |
| B | Active comparator | Device: Transobturator Tension-free vaginal tape (TVT-O)Transobturator Tension-free Vaginal Tape (TVT-O) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned surgery for primary stress incontinence (positive stress test at bladder filling of 300 ml) without concomitant prolapse surgery or hysterectomy
- Patient able and willing to participate in follow-up
- Informed consent
Key exclusion criteria (8 listed)
- Detrusor overactivity, predominant complaint overactive bladder (OAB)
- Major concomitant surgery
- Prolapse beyond introitus or any prolapse necessitating surgery
- Previous incontinence surgery other than colporrhaphy
- Residual urine >100 ml
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 Tension-free vaginal tape (TVT-O)tension-free vaginal tape (TVT) | Device | B |
| Retropubic Tension-free vaginal tape (TVT)Retropubic Tension-free vaginal tape (TVT) | Device | A |
Primary outcome
Continence
Time frame: 5 years
1 secondary outcome
Quality of life
Time frame: 5 years
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 11 Dec 2012.
- Background: PubMed 14644127de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003 Dec;44(6):724-30. doi: 10.1016/j.eururo.2003.09.003.
- Background: PubMed 11859672Delorme E. [Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women]. Prog Urol. 2001 Dec;11(6):1306-13. French.
- Background: PubMed 11704161Tamussino KF, Hanzal E, Kolle D, Ralph G, Riss PA; Austrian Urogynecology Working Group. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol. 2001 Nov;98(5 Pt 1):732-6. doi: 10.1016/s0029-7844(01)01565-4.
- Background: PubMed 8798092Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):81-5; discussion 85-6. doi: 10.1007/BF01902378.
- Background: PubMed 12114234Ward K, Hilton P; United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ. 2002 Jul 13;325(7355):67. doi: 10.1136/bmj.325.7355.67.
- Background: PubMed 14981369Ward KL, Hilton P; UK and Ireland TVT Trial Group. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol. 2004 Feb;190(2):324-31. doi: 10.1016/j.ajog.2003.07.029.
- Derived from this study: PubMed 28464312Tammaa A, Aigmuller T, Hanzal E, Umek W, Kropshofer S, Lang PFJ, Ralph G, Riss P, Koelle D, Jundt K, Tamussino K, Bjelic-Radisic V; Austrian Urogynecology Working Group. Retropubic versus transobturator tension-free vaginal tape (TVT vs TVT-O): Five-year results of the Austrian randomized trial. Neurourol Urodyn. 2018 Jan;37(1):331-338. doi: 10.1002/nau.23298. Epub 2017 May 2.
- Derived from this study: PubMed 24819327Aigmuller T, Tammaa A, Tamussino K, Hanzal E, Umek W, Kolle D, Kropshofer S, Bjelic-Radisic V, Haas J, Giuliani A, Lang PF, Preyer O, Peschers U, Jundt K, Ralph G, Dungl A, Riss PA; Austrian TVT vs. TVT-O Study Group. Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial. Int Urogynecol J. 2014 Aug;25(8):1023-30. doi: 10.1007/s00192-014-2384-z. Epub 2014 May 13.
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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.
Karl F Tamussino, MD principal investigator
Medical University of Graz, Dept. OB/GYN
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transobturator Tension-free vaginal tape (TVT-O) and Retropubic Tension-free vaginal tape (TVT) in people with Stress Urinary Incontinence, run by Austrian Urogynecology Working Group (AUWG) at 4 sites in Austria.
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 3 inclusion and 8 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 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria. 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?
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?
Continence (time frame: 5 years). 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 NCT00441454, which also lists 8 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 11 Dec 2012.