Surgical Management for Suburethral Slings

Sponsor
Cantonal Hospital, Frauenfeld (Other)
Overall Status
Recruiting
CT.gov ID
NCT02785016
Collaborator
(none)
100
1
134
0.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective, Non-Randomized, Observational Trial of the Surgical Management for Suburethral Slings in Women With Stress Urinary Incontinence
    Study Start Date :
    May 1, 2013
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Jul 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Stress Urinary Incontinence

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

    Outcome Measures

    Primary Outcome Measures

    1. Cure/improvement rate [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 Outcome Measures

    1. Subjective symptom assessment by visual analogue scale [3 and 6 months]

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

    2. Post-Operative Pain Assessment [1 day]

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

    3. Standing Cough Stress Test [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 [pre-operation, 3 and 6 months]

    5. International Consultation on Incontinence Questionnaire [pre-operation, 3 and 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Blasenzentrum, Cantonal Hospital Frauenfeld Thurgau Switzerland 8501

    Sponsors and Collaborators

    • Cantonal Hospital, Frauenfeld

    Investigators

    • Principal Investigator: Volker Viereck, Physican, Cantonal Hospital, Frauenfeld

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Volker Viereck, Prof. Dr., Cantonal Hospital, Frauenfeld
    ClinicalTrials.gov Identifier:
    NCT02785016
    Other Study ID Numbers:
    • TVT 3D
    First Posted:
    May 27, 2016
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Prof. Dr. Volker Viereck, Prof. Dr., Cantonal Hospital, Frauenfeld
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022