Stress Urinary IncontinenceNCT01660438
Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure
An observational study of Stress Urinary Incontinence, run by Cantonal Hospital, Frauenfeld at 3 sites in 3 countries.
Trial summary
This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- How many people
- 188 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Aug 2010to Feb 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who have surgically-correctable stress urinary incontinence and undergo a suburethral sling 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/Ethics Committee-approved informed consent form.
- Patient is able to fill in all questionnaires (based on judgment 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 has current urinary tract infection.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe
Hagen
About this study
Official title: Prospective, Non-randomized, Observational Study of the Surgical Management of Suburethral Slings in Women With Stress Urinary Incontinence
This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure.
Read the detailed description
This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. The urethral length will be measured intraoperatively using scaled catheters. Outcome data, including the development of postoperative complications, will be collected at several time intervals.
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence, Suburethral sling
- 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
Patients are classified as 'cured' if the postoperative cough test is negative, the 1-hour pad test is negative (less than 2 g) and the degree of subjective suffering improves to over 90% (VAS score of 0 or 1). All other patients are classified as therapeutic 'failures', even though they may experience marked improvement in one of the parameters compared with their preoperative status.
Measured: 3 months
Secondary outcomes (4)
Pelvic floor sonography
Measured: Pre-operation, day 1 and 3 months
Residual urine
Measured: Pre-operation, day 1 and 3 months
Pad test
Measured: Pre-operation and 3 months
Urethral length measurement
Urethral length will be measured using scaled catheters.
Measured: Intra-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startAug 2010
- Primary completionFeb 2013
- Study completionFeb 2013
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
- 188 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
- NCT01660438
- Sponsor's protocol ID
- TVT 112010
- Status last verified
- May 2016
- First submitted
- 6 Aug 2012
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomized, Observational Study of the Surgical Management of Suburethral Slings in Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01660438
- Acronym / sponsor ID
- TVT 112010
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence, Suburethral sling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Cantonal Hospital, FrauenfeldUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 8 Aug 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, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure.
Detailed description
This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. The urethral length will be measured intraoperatively using scaled catheters. Outcome data, including the development of postoperative complications, will be collected at several time intervals.
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 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have surgically-correctable stress urinary incontinence and undergo a suburethral sling 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/Ethics Committee-approved informed consent form.
- Patient is able to fill in all questionnaires (based on judgment 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 has current 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: 3 months
Patients are classified as 'cured' if the postoperative cough test is negative, the 1-hour pad test is negative (less than 2 g) and the degree of subjective suffering improves to over 90% (VAS score of 0 or 1). All other patients are classified as therapeutic 'failures', even though they may experience marked improvement in one of the parameters compared with their preoperative status.
4 secondary outcomes
Pelvic floor sonography
Time frame: Pre-operation, day 1 and 3 months
Residual urine
Time frame: Pre-operation, day 1 and 3 months
Pad test
Time frame: Pre-operation and 3 months
Urethral length measurement
Time frame: Intra-operation
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 20 May 2016.
- Individual participant dataSharing planned: Undecided
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Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
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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
3 sites in 3 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 3 sites in 3 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 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Poland, 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: 3 months). 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 20 May 2016.