Stress Urinary IncontinenceNCT01753011
Urethral Length and TOT (Transobturator Tape) Positioning
An observational study of Stress Urinary Incontinence, run by Cantonal Hospital, Frauenfeld at 2 sites in 2 countries.
Trial summary
This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- How many people
- 123 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2007to May 2009
- Phase
- Observational
- 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes women with surgically-corrected stress urinary incontinence who undergo a TOT operative procedure.
Who may be able to join
- Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
- Patient is age 18 or older.
- Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Institutional Review Board (IRB)/Ethic commission (EC)-approved informed consent.
- Patient is able to fill in all questionnaires (on judgement of investigator)
Who cannot join
- Patient has an associated or suspected neurological disease.
- Patient has an active lesion or present injury to perineum or urethra.
- Patient has a urethral obstruction.
- Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
- Patient currently has an urinary tract infection.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe
Hagen
About this study
Official title: Prospective, Observational Study: Can Pelvic Floor Ultrasound Help to Optimize TOT (Transobturator Tape) Positioning?
This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure.
Read the detailed description
This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. Outcome data will be collected 1-3 days and 6 months after procedure.
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary Incontinence, Transobturator sling, TOT
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Stress Urinary Incontinence | Stress Urinary Incontinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
The primary outcome of the TOT procedure will be assessed using a combination of objective and subjective criteria. Patients with a negative stress test, a negative 1-h pad test (less than 2 g) and the degree of subjective suffering improving to over 90% (VAS score of 0-1) at 6 months follow-up evaluation are classified as cured. All other patients are classified as treatment failure even if one aspect shows marked improvement from the preoperative condition.
Measured: 6 months postoperative
Secondary outcomes (5)
Urethral length
Urethral length will be measured by pelvic floor sonography.
Measured: Preoperative
Linear urethral dorsocaudal movement (LUDM)
Linear urethral dorsocaudal movement (LUDM) will be assessed by pelvic floor sonography.
Measured: Preoperative
Urethral tape position
The position of the TOT along the urethra will be determined by pelvic floor sonography and expressed as percentage of urethral length.
Measured: 1-3 days and 6 months postoperative
Distance between tape and longitudinal smooth muscle (LSM) complex
To characterize the location of the TOT, the shortest distance between the tape and the longitudinal smooth muscle (LSM) complex of the urethra will be measured by pelvic floor sonography.
Measured: 1-3 days and 6 months postoperative
Urodynamic testing
Urodynamic testing will be performed only for patients undergoing recurrent incontinence surgery.
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startMay 2007
- Primary completionMay 2009
- Study completionMay 2009
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital, Frauenfeld
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld
- Investigators
- Volker Viereck, Prof. Dr., Principal investigator, Cantonal Hospital, Frauenfeld
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753011
- Sponsor's protocol ID
- TOT 1/2-Rule
- Status last verified
- Mar 2024
- First submitted
- 17 Dec 2012
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study: Can Pelvic Floor Ultrasound Help to Optimize TOT (Transobturator Tape) Positioning?
- ClinicalTrials.gov ID
- NCT01753011
- Acronym / sponsor ID
- TOT 1/2-Rule
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary Incontinence, Transobturator sling, TOT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Cantonal Hospital, FrauenfeldUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 19 Dec 2012 (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.
This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure.
Detailed description
This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. Outcome data will be collected 1-3 days and 6 months after procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress Urinary Incontinence | – | –Stress Urinary Incontinence |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes women with surgically-corrected stress urinary incontinence who undergo a TOT operative procedure.
Key inclusion criteria (4 listed)
- Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
- Patient is age 18 or older.
- Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Institutional Review Board (IRB)/Ethic commission (EC)-approved informed consent.
- Patient is able to fill in all questionnaires (on judgement of investigator)
Key exclusion criteria (5 listed)
- Patient has an associated or suspected neurological disease.
- Patient has an active lesion or present injury to perineum or urethra.
- Patient has a urethral obstruction.
- Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
- Patient currently has an 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.
Primary outcome
Cure rate
Time frame: 6 months postoperative
The primary outcome of the TOT procedure will be assessed using a combination of objective and subjective criteria. Patients with a negative stress test, a negative 1-h pad test (less than 2 g) and the degree of subjective suffering improving to over 90% (VAS score of 0-1) at 6 months follow-up evaluation are classified as cured. All other patients are classified as treatment failure even if one aspect shows marked improvement from the preoperative condition.
5 secondary outcomes
Urethral length
Time frame: Preoperative
Linear urethral dorsocaudal movement (LUDM)
Time frame: Preoperative
Urethral tape position
Time frame: 1-3 days and 6 months postoperative
Distance between tape and longitudinal smooth muscle (LSM) complex
Time frame: 1-3 days and 6 months postoperative
Urodynamic testing
Time frame: Preoperative
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 7 Mar 2024.
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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.
Volker Viereck, Prof. Dr. principal investigator
Cantonal Hospital, Frauenfeld
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Cantonal Hospital, Frauenfeld at 2 sites in 2 countries.
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 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 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, 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 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?
Cure rate (time frame: 6 months postoperative). 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 7 Mar 2024.