Tension-free Vaginal Tape Obturator for the Treatment of Urinary Incontinence -Long-term Follow-up
|ClinicalTrials.gov Identifier: NCT04240613|
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence,Stress Urinary Incontinence, Urge||Device: TVT-O||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
women treated by TVT-O
All women treated by TVT-O during the years this study was made were included.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240613
|Study Director:||Eija Laurikainen||Turku University Hospital|