Urinary Incontinence, StressPhase 4NCT00135616
Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach
A Phase 4 study testing surgical placement of a suburethral sling tvt or tvt-o in people with Urinary Incontinence, Stress, run by Hopital Antoine Beclere at 14 sites in France.
Trial summary
The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- surgical placement of a suburethral sling tvt or tvt-o
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 14 sitesFrance
- Study dates
- Mar 2005to Mar 2008
- Phase
- Phase 4
- 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 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman over 18 years old
- Clinical diagnosis of stress urinary incontinence requiring surgical management
- Must be able to read and sign the consent
Who cannot join
- Pregnancy
- Anti-coagulant treatment
- Isolated overactive bladder syndrome
- Genital prolapse requiring surgical treatment
- Concomitant hysterectomy
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
CHU Amiens
Amiens, 80000
Centre Hospitalier Universitaire
Angers, 49000
CHU Pellegrin
Bordeaux, 33000
Hopital Saint Andre
Bordeaux, 33000
CH Chambery
Chambéry, 73000
Hopital Antoine Beclere
Clamart, 92140
Hôtel Dieu
Clermont-Ferrand, 63058
CH Dunkerque
Dunkirk, 59000
Centre Hospitalier Paul Ardier
Issoire, 63500
Chu Nancy
Nancy
CH Caremeau
Nîmes, 30000
Hopital Diaconesses Croix Saint Simon
Paris, 75012
CH Rennes
Rennes, 35000
CH Rouen
Rouen, 76000
About this study
Official title: Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.
The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.
Read the detailed description
Urinary stress incontinence (USI) is a frequent pathology in women. Surgical treatment is required in 30 to 50% of women presenting with USI. Several surgical techniques are currently available.
At the present time, the placement of suburethral slings is one of the most efficient techniques. Furthermore, the placement of a suburethral sling is known to be associated with a low rate of complications.
Currently, two approaches are available for the placement of a suburethral sling: retropubic approach (TVT) and trans-obturator approach (TVT-O). The efficacy of these two approaches seem equivalents. However, the morbidity related to these two techniques is probably different. In retrospective studies, the retropubic approach is associated with a higher rate of bladder perforation. On the other hand, the trans-obturator approach is supposed to be associated with a higher rate of post-operative pain.
Thus, the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- surgical placement of a suburethral sling tvt or tvt-o
- Keywords
- urinary incontinence, stress incontinence, urethra, gynaecologic surgical procedures, suburethral sling
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical placement of a suburethral sling tvt or tvt-oDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
pre operative complication: rate of bladder perforation
post operative complication: rate of post-operative pain
Secondary outcomes (2)
efficacy: disparation of urinary incontinence
safety: sexual behaviour
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 startMar 2005
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Antoine Beclere
- Sponsor type
- University, hospital or other
- Investigators
- Xavier Deffieux, MD, Principal investigator, Hopital Antoine Beclere, Clamart, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135616
- Sponsor's protocol ID
- xd01
- Status last verified
- Apr 2007
- First submitted
- 25 Aug 2005
- Last updated
- 30 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.
- ClinicalTrials.gov ID
- NCT00135616
- Acronym / sponsor ID
- xd01
- Conditions
- Urinary Incontinence, Stress
- Keywords
- urinary incontinence, stress incontinence, urethra, gynaecologic surgical procedures, suburethral sling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hopital Antoine BeclereUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Mar 2008 (estimated)
- 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.
The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.
Detailed description
Urinary stress incontinence (USI) is a frequent pathology in women. Surgical treatment is required in 30 to 50% of women presenting with USI. Several surgical techniques are currently available.
At the present time, the placement of suburethral slings is one of the most efficient techniques. Furthermore, the placement of a suburethral sling is known to be associated with a low rate of complications.
Currently, two approaches are available for the placement of a suburethral sling: retropubic approach (TVT) and trans-obturator approach (TVT-O). The efficacy of these two approaches seem equivalents. However, the morbidity related to these two techniques is probably different. In retrospective studies, the retropubic approach is associated with a higher rate of bladder perforation. On the other hand, the trans-obturator approach is supposed to be associated with a higher rate of post-operative pain.
Thus, the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Woman over 18 years old
- Clinical diagnosis of stress urinary incontinence requiring surgical management
- Must be able to read and sign the consent
Key exclusion criteria (5 listed)
- Pregnancy
- Anti-coagulant treatment
- Isolated overactive bladder syndrome
- Genital prolapse requiring surgical treatment
- Concomitant hysterectomy
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 |
|---|---|---|
| surgical placement of a suburethral sling tvt or tvt-o | Device | – |
Primary outcome
pre operative complication: rate of bladder perforation
post operative complication: rate of post-operative pain
2 secondary outcomes
efficacy: disparation of urinary incontinence
safety: sexual behaviour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2007.
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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.
Xavier Deffieux, MD principal investigator
Hopital Antoine Beclere, Clamart, France
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing surgical placement of a suburethral sling tvt or tvt-o in people with Urinary Incontinence, Stress, run by Hopital Antoine Beclere at 14 sites in France.
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 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: status not confirmed, as of the sponsor's last update on 30 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
pre operative complication: rate of bladder perforation. 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?
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 30 Apr 2007.