search
Back to results

Ultrasound and Cure Rate Three Months and 15 Years After TOT-procedure

Primary Purpose

Urinary Incontinence,Stress

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transobturator tape
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Urinary Incontinence,Stress focused on measuring TOT, Perineal ultrasound

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Has been stress or mixed incontinence, for which surgical treatment has been indicated. The cough test must have been positive with a 300 ml bladder filling The separation points <7 in the incontinence charts Exclusion Criteria: previous incontinence surgery simultaneous other gynecological surgery residual urine volume >100 ml lower urinary tract anomaly urinary tract infection more than three urinary tract infections per year more than second-degree gynecological organ deposition BMI >35 previous pelvic radiation therapy or active malignancy. Patients with anticoagulant therapy hemophilia or neurological disease that could cause bladder dysfunction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Patients operated with TOT

    Arm Description

    The study is a retrospective cohort study. Between 2005 and 2008, a total of 54 patients were examined with ultrasound before and after TOT surgery. The collected data has not been previously published. Now these same patients are to be examined again with a more advanced ultrasound device.

    Outcomes

    Primary Outcome Measures

    Subjective cure
    Subjective cure is defined if patient answer to be very satisfied or satisfied with the TOT-procedure
    Objective cure
    The cough stress test is negative performed in a semilithotomy position with a comfortably filled bladder (200-300 ml)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 20, 2023
    Last Updated
    March 15, 2023
    Sponsor
    Turku University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05787730
    Brief Title
    Ultrasound and Cure Rate Three Months and 15 Years After TOT-procedure
    Official Title
    Ultrasound and Cure Rate Three Months and 15 Years After TOT-procedure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    January 1, 2005 (Actual)
    Primary Completion Date
    December 31, 2008 (Actual)
    Study Completion Date
    April 1, 2023 (Anticipated)

    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

    5. Study Description

    Brief Summary
    The study is a cohort study. Between 2005 and 2008, a total of 54 patients were examined with ultrasound before and after TOT surgery. The collected data has not been previously published. Now these same patients are to be examined again with a more advanced ultrasound device. The subjects underwent a urogynecological ultrasound examination before surgery and during the follow-up examination 2-3 months after the procedure. In connection with the follow-up examination, the success of the procedure and the satisfaction of the patients have been evaluated. The data was collected between 2005 and 2008, and the purpose is to invite the patients in question to a research visit, so that the long-term effect of the procedure can be evaluated and the position of the band can be determined with a newer technology ultrasound device. The patients' subjective satisfaction with the procedure is assessed using questionnaires.
    Detailed Description
    The study is a retrospective cohort study. Between 2005 and 2008, a total of 54 patients were examined with ultrasound before and after TOT surgery. The collected data has not been previously published. Now these same patients are to be examined again with a more advanced ultrasound device. The study's inclusion criterion has been stress or mixed incontinence, for which surgical treatment has been indicated. The cough test must have been positive with a 300 ml bladder filling and the separation points <7 in the incontinence charts.. Exclusion criteria included previous incontinence surgery, simultaneous other gynecological surgery, residual urine volume >100 ml, lower urinary tract anomaly, urinary tract infection, more than three urinary tract infections per year, more than second-degree gynecological organ deposition, BMI >35, previous pelvic radiation therapy or active malignancy. Patients with anticoagulant therapy, anticholinergic or duloxetine medication, hemophilia or neurological disease that could cause bladder dysfunction were also not included in the study. Patients who did not understand the importance of research and treatment or who were unable to exercise were also not suitable for the study. The subjects underwent a urogynecological ultrasound examination before surgery and during the follow-up examination 2-3 months after the procedure. In connection with the follow-up examination, the success of the procedure and the satisfaction of the patients have been evaluated. The data was collected between 2005 and 2008, and the purpose is to invite the patients in question to a research visit, so that the long-term effect of the procedure can be evaluated and the position of the band can be determined with a newer technology ultrasound device. The patients' subjective satisfaction with the procedure is assessed using questionnaires. The research visit is carried out at Tyks' Gynecology Outpatient Clinic. During the research visit, the subject is subjected to a gynecological clinical examination, which includes a cough test, and a urogynecological ultrasound examination. Prior to the study visit, the subject is provided with written information about the study and questionnaire forms, which the patient brings with her to the study visit. Written consent to the study has been requested from all women participating in the study. Now the subjects will be asked for their consent again. Permission for the research has been requested from the Ethics Committee.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence,Stress
    Keywords
    TOT, Perineal ultrasound

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Patients operated with TOT
    Arm Type
    Other
    Arm Description
    The study is a retrospective cohort study. Between 2005 and 2008, a total of 54 patients were examined with ultrasound before and after TOT surgery. The collected data has not been previously published. Now these same patients are to be examined again with a more advanced ultrasound device.
    Intervention Type
    Device
    Intervention Name(s)
    Transobturator tape
    Primary Outcome Measure Information:
    Title
    Subjective cure
    Description
    Subjective cure is defined if patient answer to be very satisfied or satisfied with the TOT-procedure
    Time Frame
    15 years after operation
    Title
    Objective cure
    Description
    The cough stress test is negative performed in a semilithotomy position with a comfortably filled bladder (200-300 ml)
    Time Frame
    15 years after operation

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Has been stress or mixed incontinence, for which surgical treatment has been indicated. The cough test must have been positive with a 300 ml bladder filling The separation points <7 in the incontinence charts Exclusion Criteria: previous incontinence surgery simultaneous other gynecological surgery residual urine volume >100 ml lower urinary tract anomaly urinary tract infection more than three urinary tract infections per year more than second-degree gynecological organ deposition BMI >35 previous pelvic radiation therapy or active malignancy. Patients with anticoagulant therapy hemophilia or neurological disease that could cause bladder dysfunction

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Ultrasound and Cure Rate Three Months and 15 Years After TOT-procedure

    We'll reach out to this number within 24 hrs