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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04240613
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Information provided by (Responsible Party):
Turku University Hospital

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence,Stress Urinary Incontinence, Urge Device: TVT-O Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tension-free Vaginal Tape Obturator for the Treatment of Urinary Incontinence - Efficacy and Patient Satisfaction in Long-term Follow-up
Actual Study Start Date : January 2004
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
women treated by TVT-O
All women treated by TVT-O during the years this study was made were included.
Device: TVT-O
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 Measures :
  1. objective and subjective treatment success [ Time Frame: 9.25 years ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   TVT-O is only for females, to treat female urinary incontinence.
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04240613

Sponsors and Collaborators
Turku University Hospital
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Study Director: Eija Laurikainen Turku University Hospital
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Responsible Party: Turku University Hospital Identifier: NCT04240613    
Other Study ID Numbers: 13533
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Turku University Hospital:
long-term follow-up
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders