Surgical Management for Suburethral Slings

Last updated: March 6, 2024
Sponsor: Cantonal Hospital, Frauenfeld
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Urinary Incontinence

Treatment

N/A

Clinical Study ID

NCT02785016
TVT 3D
  • Ages > 18
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient has objective demonstrable signs of stress urinary incontinence (SUI),including patients with intrinsic sphincter deficiency (ISD). Objective testingincludes: 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-relatedprocedures and evaluations, and documents this agreement by signing theIRB/EC-approved informed consent.
  4. Patient is able to fill in all questionnaires (on judgement of investigator)

Exclusion

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 surgicaltreatment.
  5. The subject has current urinary tract infection.

Study Design

Total Participants: 100
Study Start date:
May 01, 2013
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Blasenzentrum, Cantonal Hospital

    Frauenfeld, Thurgau 8501
    Switzerland

    Active - Recruiting

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