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

Not Applicable

Completed

• Conditions: Urinary Incontinence, Urge; Urinary Incontinence,Stress
• Interventions: Device: TVT-O

• Registration Number: NCT04240613
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2011-12
• Study Completion: 2017-12
• Status Verified: 2020-01
• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-23
• Last Update Submitted: 2020-01-23
• Study First Posted: 2020-01-27
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
objective and subjective treatment success	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.