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CompletedNCT02785016Updated Mar 20, 2026

Surgical Management for Suburethral Slings

An observational study in Stress Urinary Incontinence, sponsored by Cantonal Hospital, Frauenfeld. Completed at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Cantonal Hospital, Frauenfeld · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
Female
01

Study 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 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.

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Conditions studied

  • Stress Urinary Incontinence

Keywords

  • Stress Urinary Incontinence
  • Suburethral Sling
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In context

Urinary Incontinence, Stress

658 studies on the registry are indexed under Urinary Incontinence, Stress; 123 are open to participants now.

This study's enrollment of 100 is below the median of 139 across 130 observational studies indexed under Urinary Incontinence, Stress.

Browse Urinary Incontinence, Stress studies →

Lead sponsor

Cantonal Hospital, Frauenfeld is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects that have surgically-correctable Stress Urinary Incontinence and undergo a suburethral sling operative procedure.

Inclusion criteria

  1. 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.
  2. Patient is age 18 or older.
  3. 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.
  4. Patient is able to fill in all questionnaires (on judgement of investigator)

Exclusion criteria

Exclusion Criteria:

  1. Patient has an associated or suspected neurological disease.
  2. Patient has an active lesion or present injury to perineum or urethra.
  3. Patient has a urethral obstruction.
  4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
  5. The subject has current urinary tract infection.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Stress Urinary Incontinence

    Females with stress urinary incontinence, who undergo a tension free surgical sling procedure.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 3 months

Secondary outcomes

  1. Subjective symptom assessment by visual analogue scale

    Scale: 0-10 (0-no suffering, 10-severe suffering)

    Time frame: 3 and 6 months

  2. Post-Operative Pain Assessment

    Scale: 0-10 (0-no pain, 10-severe pain)

    Time frame: 1 day

  3. 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.

    Time frame: baseline, 3 and 6 months

  4. King Health Questionnaire

    Time frame: pre-operation, 3 and 6 months

  5. International Consultation on Incontinence Questionnaire

    Time frame: pre-operation, 3 and 6 months

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Study locations

1 site
  • Blasenzentrum, Cantonal Hospital
    Frauenfeld, Thurgau 8501, Switzerland
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02785016
Lead sponsor
Cantonal Hospital, Frauenfeld
Responsible party
Prof. Dr. Volker Viereck (Prof. Dr., Cantonal Hospital, Frauenfeld) — Principal investigator
First posted
May 27, 2016
Start date
May 2013
Primary completion
Dec 2025
Completion
Dec 2025
Last update
Mar 20, 2026

Study contacts

Volker Viereck, Physican
principal investigator · Cantonal Hospital, Frauenfeld

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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