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OpenTrials
Completed

NCT Number: NCT02785016

Surgical Management for Suburethral Slings

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. Subjective symptom assessment by visual analogue scale

    Time frame: 3 and 6 months

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

  2. Post-Operative Pain Assessment

    Time frame: 1 day

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

  3. Standing Cough Stress Test

    Time frame: baseline, 3 and 6 months

    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.

  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

Sponsors and collaborators

Lead sponsor

Cantonal Hospital, Frauenfeld

Other

Registry information

Official study title

Prospective, Non-Randomized, Observational Trial of the Surgical Management for Suburethral Slings in Women With Stress Urinary Incontinence

Important dates

Study start
2013
Primary completion
2025
Study completion
2025
First posted
May 27, 2016
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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