Stress Urinary IncontinenceNCT02785016
Surgical Management for Suburethral Slings
An observational study of Stress Urinary Incontinence, run by Cantonal Hospital, Frauenfeld at 1 site in Switzerland.
Trial summary
This is a prospective, non-randomized, observational, single center study in which subjects that have surgically-correctable Stress Urinary Incontinence 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
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Dec 2025
- 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: Subjects that 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 IRB/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.
- The subject has current urinary tract infection.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Blasenzentrum, Cantonal Hospital
Frauenfeld, Thurgau, 8501
About this study
Official title: Prospective, Non-Randomized, Observational Trial of the Surgical Management for Suburethral Slings in Women With Stress Urinary Incontinence
This is a prospective, non-randomized, observational, single center study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a suburethral sling operative procedure.
Read the detailed description
The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires. Intraoperative procedural data will be collected.
Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals. The anatomic position of the device will be characterize by introital ultrasound testing.
- 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 | Females with stress urinary incontinence, who undergo a tension free surgical sling procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure/improvement rate
Patients are classified as cured if the postoperative cough test (see Outcome 4 below) is negative and the degree of subjective suffering (see Outcome 2 below) improves to over 90% (VAS score of 0 or 1). Criteria for improvement are involuntary loss of only a few drops of urine during straining and an improvement of the degree of suffering to over 75% (VAS score of 2 or 3). All other patients are classified as therapeutic failures (even if they show marked improvement of one of the parameters compared with their preoperative status).
Measured: 3 months
Secondary outcomes (5)
Subjective symptom assessment by visual analogue scale
Scale: 0-10 (0-no suffering, 10-severe suffering)
Measured: 3 and 6 months
Post-Operative Pain Assessment
Scale: 0-10 (0-no pain, 10-severe pain)
Measured: 1 day
Standing Cough Stress Test
3 categories: negative/severe, if flow of urine is observed. negative/mild, if the loss of only a few drops is observed. positive, if no urine loss occurs.
Measured: baseline, 3 and 6 months
King Health Questionnaire
Measured: pre-operation, 3 and 6 months
International Consultation on Incontinence Questionnaire
Measured: pre-operation, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMay 2013
- Primary completionDec 2025
- Study completionDec 2025
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
- 100 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, Physican, Principal investigator, Cantonal Hospital, Frauenfeld
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785016
- Sponsor's protocol ID
- TVT 3D
- Status last verified
- Mar 2026
- First submitted
- 19 May 2016
- Last updated
- 20 Mar 2026
- 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 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Randomized, Observational Trial of the Surgical Management for Suburethral Slings in Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02785016
- Acronym / sponsor ID
- TVT 3D
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress Urinary Incontinence, Suburethral Sling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cantonal Hospital, FrauenfeldUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Dec 2025 (actual)
- Study completion
- Dec 2025 (actual)
- First posted
- 27 May 2016 (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, single center study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a suburethral sling operative procedure.
Detailed description
The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires. Intraoperative procedural data will be collected.
Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals. The anatomic position of the device will be characterize by introital ultrasound testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress Urinary Incontinence | – | –Females with stress urinary incontinence, who undergo a tension free surgical sling procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that 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 IRB/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.
- The subject 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/improvement rate
Time frame: 3 months
Patients are classified as cured if the postoperative cough test (see Outcome 4 below) is negative and the degree of subjective suffering (see Outcome 2 below) improves to over 90% (VAS score of 0 or 1). Criteria for improvement are involuntary loss of only a few drops of urine during straining and an improvement of the degree of suffering to over 75% (VAS score of 2 or 3). All other patients are classified as therapeutic failures (even if they show marked improvement of one of the parameters compared with their preoperative status).
5 secondary outcomes
Subjective symptom assessment by visual analogue scale
Time frame: 3 and 6 months
Post-Operative Pain Assessment
Time frame: 1 day
Standing Cough Stress Test
Time frame: baseline, 3 and 6 months
King Health Questionnaire
Time frame: pre-operation, 3 and 6 months
International Consultation on Incontinence Questionnaire
Time frame: pre-operation, 3 and 6 months
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 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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, Physican principal investigator
Cantonal Hospital, Frauenfeld
1 site in 1 country: 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 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 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 Mar 2026. 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 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/improvement 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 Mar 2026.