Stress Urinary IncontinenceNCT00642109
A Comparison of the Retropubic (TVT) With the Transobturator Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary Incontinence
A study testing midurethral sling procedure in people with Stress Urinary Incontinence, run by David Scheiner at 1 site in Switzerland.
Trial summary
The midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a well established technique for treating female stress urinary incontinence in patients with (hyper)mobile urethra. Postoperative continence rates are achieved in up to 95%. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- midurethral sling procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2006to Oct 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Urodynamic stress urinary incontinence or stress dominated mixed urinary incontinence with mobile urethra
- With or without concomitant surgery for pelvic organ prolapse
- With or without hysterectomy
Who cannot join
- No informed consent
- No preoperative urodynamic investigation
- Mixed urinary incontinence with predominant overactive bladder
- Recurrent stress urinary incontinence after sling procedure
- Begin of treatment of overactive bladder less then a month ago or non stable condition
- Pregnancy
Show all 10Show fewer
- Desires future childbearing
- Concomitant incontinence procedure like intravesikal injection of Botulinumtoxin
- Preoperative postvoid residual urinary volume exceeding 100cc
- Coagulopathies
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich, clinic for gynaecology
Zurich, 8091
About this study
Official title: A Prospective Randomized Clinical Trial: Comparison of the Retropubic (TVT) With the Transobturator (outside-in T.O.T. Monarc or Inside-out TVT-O) Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary Incontinence
The midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a well established technique for treating female stress urinary incontinence in patients with (hyper)mobile urethra. Postoperative continence rates are achieved in up to 95%. Currently, several anatomical approaches are developed and investigated to simplify this minimal invasive technique and make it safer. While the retropubic approach consists of the passage of the needles from under the midurethra up behind the pubic bone through the cavum retzii, the transobturator technique traverses the foramina obturatoria. Intraoperative complications like bladder perforation (in 4%) can be treated conservatively, while postoperative complications like voiding dysfunction (urinary outlet obstruction in up to 16% or urinary retention) are troublesome, impair the quality of life and require occasionally surgical sling release (transection of the sling). The aim of this study is to compare quality of life, postoperative voiding dysfunction, success rates and tape position after retropubic and transobturator sling procedure.
- Trial with surgical intervention
- Conditions
- Stress Urinary Incontinence
- Being tested
- midurethral sling procedure
- 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.
midurethral sling procedureProcedure or surgery
quality of life, voiding dysfunction
| Study group | Role | What they receive |
|---|---|---|
| TVT | Other | Tension-free Vaginal Tape (TVT) Receives: Procedure: midurethral sling procedure |
| TOT | Other | Transobturator Tape outside-in (TOT Monarc) Receives: Procedure: midurethral sling procedure |
| TVT-O | Other | Transobturator Tape inside-out (TVT-O) Receives: Procedure: midurethral sling procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urodynamic stress urinary incontinence measurement
Measured: December 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startJan 2006
- Primary completionSep 2010
- Study completionOct 2010
Why it stopped: higher incidence of pain related sexual dysfunction in the TO arm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Scheiner
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, David Scheiner, University of Zurich
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642109
- Sponsor's protocol ID
- slingrnd06
- Status last verified
- Jul 2015
- First submitted
- 17 Mar 2008
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial: Comparison of the Retropubic (TVT) With the Transobturator (outside-in T.O.T. Monarc or Inside-out TVT-O) Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00642109
- Acronym / sponsor ID
- slingrnd06
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: higher incidence of pain related sexual dysfunction in the TO arm
- Enrolment
- 160 participants (actual)
- Lead sponsor
- David ScheinerUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- Jan 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Mar 2008 (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 midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a well established technique for treating female stress urinary incontinence in patients with (hyper)mobile urethra. Postoperative continence rates are achieved in up to 95%. Currently, several anatomical approaches are developed and investigated to simplify this minimal invasive technique and make it safer. While the retropubic approach consists of the passage of the needles from under the midurethra up behind the pubic bone through the cavum retzii, the transobturator technique traverses the foramina obturatoria. Intraoperative complications like bladder perforation (in 4%) can be treated conservatively, while postoperative complications like voiding dysfunction (urinary outlet obstruction in up to 16% or urinary retention) are troublesome, impair the quality of life and require occasionally surgical sling release (transection of the sling). The aim of this study is to compare quality of life, postoperative voiding dysfunction, success rates and tape position after retropubic and transobturator sling procedure.
- Trial with surgical intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TVT | Other | Procedure: midurethral sling procedureTension-free Vaginal Tape (TVT) |
| TOT | Other | Procedure: midurethral sling procedureTransobturator Tape outside-in (TOT Monarc) |
| TVT-O | Other | Procedure: midurethral sling procedureTransobturator Tape inside-out (TVT-O) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Urodynamic stress urinary incontinence or stress dominated mixed urinary incontinence with mobile urethra
- With or without concomitant surgery for pelvic organ prolapse
- With or without hysterectomy
Key exclusion criteria (10 listed)
- No informed consent
- No preoperative urodynamic investigation
- Mixed urinary incontinence with predominant overactive bladder
- Recurrent stress urinary incontinence after sling procedure
- Begin of treatment of overactive bladder less then a month ago or non stable condition
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 |
|---|---|---|
| midurethral sling procedurequality of life, voiding dysfunction | Procedure or surgery | TOT, TVT, TVT-O |
Primary outcome
Urodynamic stress urinary incontinence measurement
Time frame: December 2009
Results and safety
The study was stopped early (reason given: higher incidence of pain related sexual dysfunction in the TO arm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing midurethral sling procedure in people with Stress Urinary Incontinence, run by David Scheiner at 1 site in Switzerland.
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 10 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: stopped early, as of the sponsor's last update on 28 Jul 2015. 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 Switzerland. 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 was stopped early (reason given: higher incidence of pain related sexual dysfunction in the TO arm). 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?
Urodynamic stress urinary incontinence measurement (time frame: December 2009). 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 28 Jul 2015.