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Tension-free Vaginal Tape Obturator for the Treatment of Urinary Incontinence -Long-term Follow-up

Primary Purpose

Urinary Incontinence,Stress, Urinary Incontinence, Urge

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TVT-O
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence,Stress focused on measuring TVT-O, long-term follow-up, retrospective

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

We included all the patients who underwent the TVT-O operation between August 2004 and October 2011 in our hospital, Turku university hospital Finland.

Exclusion Criteria:

No exclusion criteria were applied.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    women treated by TVT-O

    Arm Description

    All women treated by TVT-O during the years this study was made were included.

    Outcomes

    Primary Outcome Measures

    objective and subjective treatment success
    Objective treatment success was a negative cough stress test (CST), The CST was performed with a bladder volume of 300 ml aiming on adjusting the tape to allow a drop of saline to escape from the outer meatus of the urethra on strong coughing. The patient was subjectively cured if she answered to being very satisfied or satisfied with the operation.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 2, 2020
    Last Updated
    January 23, 2020
    Sponsor
    Turku University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04240613
    Brief Title
    Tension-free Vaginal Tape Obturator for the Treatment of Urinary Incontinence -Long-term Follow-up
    Official Title
    Tension-free Vaginal Tape Obturator for the Treatment of Urinary Incontinence - Efficacy and Patient Satisfaction in Long-term Follow-up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (Actual)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Turku University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The efficacy of TVT-O (tension-free vaginal tape obturator) is well established in patients with stress urinary incontinence (SUI). The objective of this study was to evaluate the efficacy, safety and patient satisfaction of TVT-O in patients suffering from primary, mixed (MUI) or recurrent urinary incontinence (UI) in long-term follow-up.
    Detailed Description
    The long-term results after TVT-O have been scarce. At five years no significant differences were seen between TVT (tension-free vaginal tape) and TVT-O for female SUI in a randomized trial. In two studies the patients were followed-up for ten years after the TVT-O procedure. The first randomized study reporting long term outcomes of TVT-O and outside-in TOT (transobturator tape) in women with urodynamic mixed urinary incontinence (MUI) showed that transobturator tension-free vaginal tapes are associated with a good and sustained patient-reported success rate. The success of the incontinence procedures should be assessed not only with objective measures but also with methods evaluating subjective satisfaction. The aim of this study was to evaluate the efficacy, safety and overall patient satisfaction of the TVT-O technique in a long-term follow-up of patients suffering from primary or recurrent SUI or MUI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence,Stress, Urinary Incontinence, Urge
    Keywords
    TVT-O, long-term follow-up, retrospective

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    106 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    women treated by TVT-O
    Arm Type
    Other
    Arm Description
    All women treated by TVT-O during the years this study was made were included.
    Intervention Type
    Device
    Intervention Name(s)
    TVT-O
    Intervention Description
    TVT-O is one of the most popular treatments for urinary incontinence (UI). Its efficacy is well established in patients with pure stress urinary incontinence (SUI). Data reporting long-term outcomes of TVT-O for the treatment of mixed urinary incontinence (MUI) or recurrent SUI is scarce. The objective of this study was to evaluate the efficacy and safety and overall patient satisfaction of TVT-O in different subgroups of UI in a long-term follow-up.
    Primary Outcome Measure Information:
    Title
    objective and subjective treatment success
    Description
    Objective treatment success was a negative cough stress test (CST), The CST was performed with a bladder volume of 300 ml aiming on adjusting the tape to allow a drop of saline to escape from the outer meatus of the urethra on strong coughing. The patient was subjectively cured if she answered to being very satisfied or satisfied with the operation.
    Time Frame
    9.25 years

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    TVT-O is only for females, to treat female urinary incontinence.
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: We included all the patients who underwent the TVT-O operation between August 2004 and October 2011 in our hospital, Turku university hospital Finland. Exclusion Criteria: No exclusion criteria were applied.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eija Laurikainen
    Organizational Affiliation
    Turku University Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Tension-free Vaginal Tape Obturator for the Treatment of Urinary Incontinence -Long-term Follow-up

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