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

T

Turku University Hospital (TYKS)

Status

Completed

Conditions

Urinary Incontinence, Urge
Urinary Incontinence,Stress

Treatments

Device: TVT-O

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

106 patients

Sex

Female

Volunteers

No 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.

Exclusion criteria

No exclusion criteria were applied.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

106 participants in 1 patient group

women treated by TVT-O
Other group
Description:
All women treated by TVT-O during the years this study was made were included.
Treatment:
Device: TVT-O

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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