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

Sponsor

Turku University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04240613

Collaborator

(none)

106

Enrollment

Arm

167

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence,Stress Urinary Incontinence, Urge	Device: TVT-O	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2004

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.