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
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
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
NCT ID
NCT04240613
First Posted
January 2, 2020
Last Updated
January 23, 2020
Sponsor
Turku University Hospital
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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